Инструкция по применению TAKIPIRINA
Содержание инструкции
- TACHIPIRINA 1000 mg tablets, 1000 mg effervescent tablets, 1000 mg granules for oral solution in sachet
- TACHIPIRINA 125 mg effervescent granules
- TACHIPIRINA 500 mg tablets
- TACHIPIRINA 500 mg effervescent granules
- TACHIPIRINA Neonati 62,5 mg suppositories, Prima Infanzia 125 mg suppositories
- TACHIPIRINA Bambini 250 mg supposte, Bambini 500 mg supposte
- TACHIPIRINA Adulti 1000 mg suppositories
- Tachipirina 10 mg/ml solution for infusion
- TACHIPIRINA 120 mg/5 ml sugar-free syrup
- TACHIPIRINA SCIROPPO
- TACHIPIRINA 120 mg/5 ml oral suspension vanilla caramel flavour, 120 mg/5 ml oral suspension strawberry flavour
TACHIPIRINA 1000 mg tablets, 1000 mg effervescent tablets, 1000 mg granules for oral solution in sachet
Paracetamol
Read this leaflet carefully before taking this medicine as it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist or nurse. See section 4.
Contents of this leaflet:
- 1. What Tachipirina is and what it is used for
- 2. What you need to know before you take Tachipirina
- 3. How to take Tachipirina
- 4. Possible side effects
- 5. How to store Tachipirina
- 6. Contents of the pack and other information
1. What is Tachipirina and what is it for
Tachipirina contains paracetamol which works by relieving pain and reducing fever.
Tachipirina is used in adultsand in adolescents over 15 years of agefor the symptomatic treatment
of all types of pain (for example, headache, joint pain, stiff neck, back pain,
toothache, menstrual pain, minor surgical procedures).
Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.
2. What you need to know before taking Tachipirina
Do not take Tachipirina
- if you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6)
- if you are under 15 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking Tachipirina.
In particular, tell your doctor:
- if you suffer from glucose-6-phosphate dehydrogenase deficiency (a substance normally present in the human body, the deficiency of which can cause a blood disease);
- if you suffer from hemolytic anemia (destruction of red blood cells);
- if you suffer from liver diseases that reduce its functionality (mild/moderate hepatic insufficiency, Gilbert's syndrome, severe hepatocellular insufficiency, acute hepatitis) or if you are undergoing concomitant treatment with medicines that alter liver function;
- if you suffer from reduced kidney function (mild/moderate renal insufficiency);
- if you are undergoing concomitant treatment with any other medicine (see “Other medicines and Tachipirina”).
During treatment with Tachipirina, immediately inform your doctor if:
- If you suffer from serious illnesses, including severe kidney impairment or sepsis (when bacteria and their toxins circulate in the blood causing organ damage) or malnutrition, chronic alcoholism or if you are also taking flucloxacillin (an antibiotic). In patients in these situations, a serious condition called metabolic acidosis (an abnormality of the blood and fluids) has been reported when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken in combination with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with rapid deep breathing, drowsiness, nausea and vomiting.
Use with caution in case of chronic alcoholism, excessive alcohol consumption (3 or more alcoholic beverages per day), anorexia, bulimia or cachexia, chronic malnutrition (low hepatic glutathione reserves), dehydration, hypovolemia.
Use of high doses and/or for prolonged periods
The use of high doses and/or prolonged use of this medicine can cause liver disorders (hepatopathy) and severe alterations to the kidneys and blood.
Before taking this medicine, tellyour doctor if the person who is going to take the medicine suffers from a kidney or liver disease.
Children and adolescents
Donot give Tachipirina to children and adolescents under 15 years of age (see section “Do not take Tachipirina”).
Other medicines and Tachipirina
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
In particular, tell your doctor if you are taking:
- medicines that contain paracetamol.During treatment with paracetamol, before taking any other medicine, check that it does not contain paracetamol, as if paracetamol is taken in high doses, serious side effects can occur;
- medicines that slow down stomach emptying(e.g. anticholinergics, opioids), as these medicines delay the effect of Tachipirina;
- medicines that speed up stomach emptying(e.g. prokinetics), as these medicines accelerate the effect of Tachipirina;
- cholestyramine(a medicine used to reduce cholesterol levels in the blood), as it reduces the effect of paracetamol;
- chloramphenicol(an antibiotic), as it can increase the risk of side effects;
- rifampicin(an antibiotic);
- cimetidine(a medicine used to treat stomach ulcers);
- antiepileptics(medicines used to treat epilepsy), such as glutethimide, phenobarbital, carbamazepine;
- zidovudine(a medicine for the treatment of HIV);
- oral anticoagulants(medicines used to make the blood more fluid). In the case of high-dose treatments with paracetamol (4 g per day for at least 4 days), take Tachipirina only under strict medical supervision;
- flucloxacillin(antibiotic), due to a serious risk of alterations in the blood and fluids (called metabolic acidosis with a high anion gap) which must be treated urgently. Interference with blood testsIf the person taking the medicine needs to have blood tests, keep in mind that the administration ofparacetamol can interfere with the determination of uricemia and glycemia.
Tachipirina with alcohol
Take Tachipirina with caution and only under strict medical supervision if you abuse alcohol (see section “Warnings and precautions”).
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
If necessary, Tachipirina can be used in pregnancy. It is advisable to use the lowest possible dose that relieves pain and/or fever and take it for the shortest possible time. Contact your doctor if the pain and/or fever does not decrease or if you need to take the medicine more often.
This medicine can be taken during breastfeeding only if absolutely necessary and under the control of your doctor.
Driving and operating machinery
Tachipirina does not impair the ability to drive vehicles or operate machinery.
Tachipirina 1000 mg effervescent tablets contains sodium and sorbitol
Sodium: this medicine contains 499 mg of sodium (the main component of table salt) per tablet. This is equivalent to 25% of the recommended maximum daily intake with the diet of an adult. This medicine is considered to have a high sodium content.
Talk to your doctor or pharmacist if you need Tachipirina 1000 mg effervescent tablets daily, for a prolonged period of time, especially if you have been advised to follow a low-sodium diet.
Sorbitol: Sorbitol is a source of fructose. If your doctor has told you that you are intolerant to certain sugars, or if you have a diagnosis of hereditary fructose intolerance, a rare genetic disease in which patients cannot transform fructose, talk to your doctor before taking this medicine.
Tachipirina 1000 mg granules for oral solution in sachets contains sodium and sorbitol
Sodium: this medicine contains 580 mg of sodium (the main component of table salt) per sachet.
This is equivalent to 29% of the recommended maximum daily intake with the diet of an adult.
This medicine is considered to have a high sodium content. Talk to your doctor or pharmacist if you need Tachipirina 1000 mg granules daily, for a prolonged period of time, especially if you have been advised to follow a low-sodium diet.
Sorbitol: Sorbitol is a source of fructose. If your doctor has told you that you are intolerant to certain sugars, or if you have a diagnosis of hereditary fructose intolerance, a rare genetic disease in which patients cannot transform fructose, talk to your doctor before taking this medicine.
Tachipirina 1000 mg tabletscontains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.
3. How to take Tachipirina
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Adults and adolescents over 15 years
The recommended dose is 1 tablet or 1 effervescent tablet or 1 sachet, up to 3 times a day.
The interval between different administrations must not be less than four hours.
Swallow the tablets with some water.
Dissolve the effervescent tablets or the contents of a sachet in a glass of water.
Renal insufficiency
In case of renal insufficiency, the dose must be reduced:
- creatinine clearance less than 10-50 ml/min dose of 500 mg every 6 hours
- creatinine clearance less than 10 ml/min dose 500 mg every 8 hours
If you take more Tachipirina than you should
In case of accidental intake of an excessive dose of Tachipirina, immediately inform your doctor or
go to the nearest hospital.
Symptoms
In case of accidental intake of very high doses of paracetamol, the symptoms that you may generally
experience within the first 12-48 hours include:
- loss or reduction of appetite (anorexia), nausea and vomiting followed by a profound deterioration of general conditions
- alterations in blood laboratory values (increased bilirubin in the blood, lactic dehydrogenase, levels of hepatic transaminases, reduced levels of prothrombin in the blood)
- liver damage that can lead to coma and death.
Treatment
The doctor, based on the nature and severity of the symptoms, will carry out the appropriate supportive therapy.
There is a risk of poisoning, especially in patients with liver disease, in case of chronic alcoholism,
in patients with chronic malnutrition and in patients receiving enzyme inducers. In these
cases, overdose may be fatal.
If you forget to use Tachipirina
Do not take a double dose to make up for a missed dose.
If you stop taking Tachipirina
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you experience the following side effects STOPtreatment with this medicine and contact
immediatelyyour doctor:
- allergic reactions with:
- skin rashes with skin irritation (erythema) and skin redness accompanied by itching (urticaria)
- swelling of the throat (laryngeal edema)
- swelling of hands, feet, ankles, face, lips, tongue and/or throat (angioedema)
- severe allergic reaction (anaphylactic shock). Furthermore, people taking the medicine may experience the following side effects, for which there are not sufficient data to establish the frequency:
- reduction in the number of platelets in the blood (thrombocytopenia)
- reduction in the number of white blood cells in the blood (leukopenia/agranulocytosis)
- reduction of hemoglobin in the blood, a substance that carries oxygen in the blood (anemia)
- dizziness
- stomach and intestinal disorders
- abnormal liver function
- liver inflammation (hepatitis)
- red spots, blistering lesions with areas of skin detachment, blisters, skin rashes (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis)
- reduction of kidney function (acute renal failure)
- kidney inflammation (interstitial nephritis)
- blood in the urine (hematuria)
- cessation or reduction of urine production (anuria)
- severe condition that can make the blood more acidic (called metabolic acidosis), in patients with a serious illness who use paracetamol (see paragraph 2)
Very rare cases of severe skin reactions have been reported.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.
5. How to store Tachipirina
Keep this medicine out of the sight and reach of children.
Tachipirina 1000 mg tablets and Tachipirina 1000 mg effervescent tablets: this medicine does not
require any particular storage conditions
Tachipirina 1000 mg granules for oral solution in sachets: store at a temperature below 30°C.
Do not use this medicine after the expiry date which is stated on the pack after Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package Contents and Other Information
What Tachipirina Contains
Tachipirina 1000 mg tablets
- the active ingredient is: paracetamol (each tablet contains 1000 mg of paracetamol)
- the other ingredients are: microcrystalline cellulose, pregelatinized starch, stearic acid, sodium croscarmellose, povidone.
Tachipirina 1000 mg effervescent tablets
- the active ingredient is: paracetamol (each effervescent tablet contains 1000 mg of paracetamol)
- the other ingredients are: sodiumcarbonate, sodiumbicarbonate, sodiumbenzoate, sodiumdocusate, sorbitol(see paragraph “Tachipirina 1000 mg effervescent tablets contains sodium and sorbitol”), citric acid, orange flavour, acesulfame K, simethicone emulsion.
Tachipirina 1000 mg granules for oral solution in sachet
- the active ingredient is: paracetamol (each sachet contains 1000 mg of paracetamol)
- the other ingredients are: sodiumdibasic citrate, sodiumcitrate, sorbitol(see paragraph “Tachipirina 1000 mg granules for oral solution contains sodium and sorbitol”), acesulfame K, orange flavour, simethicone emulsion, polysorbate 20.
Description of the Appearance of Tachipirina and Package Contents
Tachipirina 1000 mg tablets
It is presented as white, elongated tablets with a score line imprinted on both sides. The tablets are divisible and are packaged in blisters in a carton containing 8 tablets (1 blister), 16 tablets (2 blisters of 8 tablets each) or 24 tablets (3 blisters of 8 tablets each).
Tachipirina 1000 mg effervescent tablets
It is presented as white-whitish effervescent tablets, round in shape. The effervescent tablets are packaged in blisters in a carton containing 12 tablets (4 blisters of 3 tablets each).
Tachipirina 1000 mg granules for oral solution in sachet
It is presented as white-whitish granules for oral solution. The granules are contained in sachets packaged in a carton containing 16 sachets in paper/polyethylene/aluminium/surlyn co-laminate or in paper/aluminium/PE co-laminate.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.
Viale Amelia, 70 - 00181 Rome.
Manufacturer
Tachipirina 1000 mg tablets
A.C.R.A.F. S.p.A. – Via Vecchia del Pinocchio, 22 - 60131 Ancona.
Fine Foods & Pharmaceuticals N.T.M. S.p.A. - Via Grignano, 43 – 24041 Brembate (BG).
Tachipirina 1000 mg effervescent tablets and Tachipirina 1000 mg granules for oral solution in sachet
A.C.R.A.F. S.p.A. - Via Vecchia del Pinocchio, 22 - 60131 Ancona.
E-Pharma Trento S.p.A. - Frazione Ravina - Via Provina, 2 - 38123 Trento (TN).
TACHIPIRINA 125 mg effervescent granules
Paracetamol
Read this leaflet carefully before you start using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- If you want more information or advice, ask your pharmacist.
- If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
- Talk to your doctor if you do not feel better or if your symptoms get worse after 3 days of treatment.
Contents of this leaflet:
- 1. What Tachipirina is and what it is used for
- 2. What you need to know before you use Tachipirina
- 3. How to use Tachipirina
- 4. Possible side effects
- 5. How to store Tachipirina
- 6. Contents of the pack and other information
1. What is Tachipirina and what is it used for
Tachipirina contains the active ingredient paracetamol which works by reducing fever (antipyretic) and
relieving pain (analgesic).
Tachipirina is used in children with a body weightbetween7 and 25 kgfor:
- the symptomatic treatment of febrile conditions such as influenza, exanthematous diseases (typical infectious diseases of children and adolescents), acute respiratory tract diseases, etc.
- pains of various origins and nature (headache, neuralgia, muscle pain and other manifestations of moderate pain).
Consult a doctor if the child does not feel better or if they feel worse after 3 days of treatment.
2. What you need to know before using Tachipirina
Do not give Tachipirina to the child
- if they are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6)
- if they suffer from severe hemolytic anemia (destruction of red blood cells)
- if they suffer from a severe liver disease (severe hepatocellular insufficiency).
Warnings and precautions
Consult your doctor or pharmacist before using Tachipirina.
In the following cases, give Tachipirina to the child with caution:
- if they suffer from anorexia (eating disorder characterized by lack or reduction of appetite)
- if they suffer from bulimia (eating disorder in which a person ingests an excessive amount of food and then resorts to various methods to eliminate it)
- if they suffer from cachexia (condition characterized by extreme thinness, reduction of muscle mass and thinning of the skin due to chronic diseases)
- if they have been following an incorrect diet for a long time (chronic malnutrition)
- if they suffer from dehydration (severe loss of water/fluids from the body)
- if they suffer from hypovolemia (reduced blood volume in circulation)
- if they suffer from liver diseases that reduce its functionality (hepatic insufficiency, hepatitis, Gilbert's syndrome)
- if they are undergoing concomitant treatment with medicines that alter liver function (see “Other medicines and Tachipirina”)
- if they suffer from glucose-6-phosphate dehydrogenase deficiency (a substance normally present in the human body, the deficiency of which can cause a blood disease)
- if they suffer from hemolytic anemia (destruction of red blood cells).
During treatment with TACHIPIRINA, immediately inform your doctor if:
- If they suffer from serious illnesses, including severe kidney impairment or sepsis (when bacteria and their toxins circulate in the blood causing organ damage) or malnutrition, chronic alcoholism or if they are also taking flucloxacillin (an antibiotic). In patients in these situations, a serious condition called metabolic acidosis (an abnormality of the blood and fluids) has been reported when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken in association with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with rapid deep breathing, drowsiness, nausea and vomiting.
Use of high doses and/or for prolonged periods
The use of high doses and/or prolonged periods of this medicine can cause alterations, even serious, to the
kidney and blood. In these cases, the doctor will monitor over time, through appropriate tests, the functionality
of the liver, kidneys and blood composition. Before giving this medicine to the child, informthe
doctor if they suffer from a kidney or liver disease.
Children and adolescents
Tachipirina 125 mg effervescent granules can be given to children with a body weight between 7 kg
and 25 kg (see section 3 “How to take/give Tachipirina to the child”).
Other medicines and Tachipirina
Inform your doctor or pharmacist if the child is taking or has recently taken or might
take any other medicine.
In particular, inform your doctor if the person taking the medicine is taking:
- medicines that contain paracetamol.During treatment with paracetamol, before giving the child any other medicine, check that it does not contain paracetamol, as if paracetamol is taken in high doses, serious side effects may occur
- medicines that slow down stomach emptying(e.g. anticholinergics, opioids), as these medicines delay the effect of Tachipirina
- medicines that speed up stomach emptying(e.g. prokinetics), as these medicines accelerate the effect of Tachipirina
- cholestyramine(medicine used to reduce cholesterol levels in the blood), as it reduces the effect of paracetamol
- chloramphenicol(an antibiotic), as it may increase the risk of side effects
- anticoagulants(medicines used to make the blood more fluid). In case of high-dose treatments with paracetamol (4 g per day for at least 4 days), give Tachipirina to the child only under strict medical supervision
- rifampicin(an antibiotic)
- cimetidine(a medicine used in the treatment of stomach ulcers)
- antiepileptics(medicines used to treat epilepsy), for example glutethimide, phenobarbital, carbamazepine
- zidovudine(medicine for the treatment of HIV)
- flucloxacillin(antibiotic), due to a serious risk of alterations of the blood and fluids (called metabolic acidosis with high anion gap) which must be treated urgently. The use of these medicines with Tachipirina requires strict medical supervision.
Interference with blood tests
If the person taking the medicine has to undergo blood tests, keep in mind that the administration of
paracetamol may interfere with the determination of uricemia and glycemia.
Tachipirina with alcohol
The use of alcohol increases the risk of intoxication.
Driving and operating machinery
Tachipirina does not impair the ability to drive vehicles (including bicycles) or operate machinery.
Tachipirina 125 mg effervescent granules contains maltitol, sodium and aspartame
Maltitol: if your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking
this medicine.
Sodium:
This medicine contains 70.6 mg of sodium (component of table salt) per sachet. This is equivalent to
3.53 % of the recommended daily intake with the diet of an adult.
Aspartame: this medicine contains a source of phenylalanine. It may be harmful if you suffer from
phenylketonuria.
3. How to use Tachipirina
Give the child this medicine following exactly as stated in this leaflet or as instructed by the doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Dissolve the effervescent granules in a glass of water.
For children, it is essential to respect the dose defined according to their body weight. The approximate ages based on body weight are provided for informational purposes:
| WEIGHT | AGE | D O S E | HOW MANY TIMES A DAY? | MAXIMUM DAILY DOSE (IN 24 HOURS) |
| 7-10 kg | 6-19 months approximately | o n e s a c h e t a t a t i m e | Repeat if necessary, after 6 hours. Do not exceed 4 administrations in 24 hours. | 4 sachets |
| 11-12 kg | a 20-29 months approximately | o n e s a c h e t a t a t i m e | Repeat if necessary, after 4 hours. Do not exceed 6 administrations in 24 hours. | 6 sachets |
| 13-20 kg | n 30 months - less than - e 6.5 years approximately | 2 sachets at a time (corresponding to 250 mg of paracetamol) | Repeat if necessary, after 6 hours. Do not exceed 4 administrations in 24 hours. | 8 sachets |
| 21-25 kg | A 6.5 - less than 8 years approximately | 2 sachets at a time (corresponding to 250 mg of paracetamol) | Repeat if necessary, after 4 hours. Do not exceed 6 administrations in 24 | 12 sachets |
For children weighing less than 7 kg, other specific formulations of Tachipirina are available on the market.
Ask your doctor or pharmacist for advice.
If the child suffers from severe renal failure (severe reduction in kidney function)
If the doctor has diagnosed the child with severe renal failure, the interval between administrations must be at least 8 hours.
Duration of treatment
Do not give the child Tachipirina for more than 3 consecutive days without consulting a doctor. The doctor must evaluate the need for treatments for more than 3 consecutive days.
If you use more Tachipirina than you should
In case of accidental ingestion/intake of an excessive dose of Tachipirina, immediately warn the doctor or go to the nearest hospital.
Symptoms
In case of accidental intake of very high doses of paracetamol, the symptoms that the child may manifest within the first 12-48 hours generally include:
- anorexia (lack or reduction of appetite), nausea and vomiting followed by a profound deterioration of general conditions
- alterations in blood laboratory values (increased bilirubin in the blood, lactic dehydrogenase, liver transaminase levels, reduced prothrombin levels in the blood)
- liver damage that can lead to coma and death.
Taking an excessive dose of paracetamol increases the risk of poisoning and can lead to death, especially in the following cases:
- if the person taking the medicine suffers from liver diseases
- chronic alcoholism
- if the person taking the medicine has been following an incorrect diet for a long time (chronic malnutrition)
- if the person taking the medicine is taking other medicines or substances that increase liver function.
Treatment
The doctor, based on the nature and severity of the symptoms, will carry out the appropriate supportive therapy.
If you forget to use Tachipirina
Do not give the child a double dose to make up for the missed dose.
If you stop the treatment with Tachipirina
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If the child experiences the following side effects STOPtreatment with this medicine
and contact your doctor immediately:
- allergic reactions with:
- skin redness accompanied by itching (urticaria)
- swelling of the throat (laryngeal edema)
- swelling of hands, feet, ankles, face, lips, tongue and/or throat (angioedema)
- severe allergic reaction (anaphylactic shock).
| hours. |
In addition, people taking the medicine may experience the following side effects, for which sufficient data are not
available to establish the frequency.
- reduction in the number of platelets in the blood (thrombocytopenia)
- reduction in the number of white blood cells in the blood (leukopenia/agranulocytosis)
- reduction of hemoglobin in the blood, a substance that carries oxygen in the blood (anemia)
- dizziness
- stomach and intestinal disorders
- abnormal liver function
- liver inflammation (hepatitis)
- red spots, blistering lesions with areas of skin detachment, blisters, skin rashes (erythema multiforme, Stevens Johnson syndrome, toxic epidermal necrolysis)
- reduction in kidney function (acute renal failure)
- kidney inflammation (interstitial nephritis)
- blood in the urine (hematuria)
- cessation or reduction of urine production (anuria) .
- severe condition that can make the blood more acidic (called metabolic acidosis), in patients with a serious illness who use paracetamol (see section 2) Very rare cases of severe skin reactions have been reported.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.
5. How to store Tachipirina
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after Scad. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Tachipirina contains
- the active ingredient is: paracetamol (each sachet contains 125 mg of paracetamol
- the other ingredients are: maltitol, sodiumbicarbonate, sodiumdocusate, aspartame(see section “Tachipirina 125 mg effervescent granules contains maltitol, sodium and aspartame”), mannitol, anhydrous citric acid, orange flavour.
Description of the appearance of Tachipirina and contents of the pack
It is presented as granules from white to slightly yellow contained in aluminum foil sachets
packaged in cartons of 20 sachets of 125 mg.
Marketing Authorisation Holder
Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.- Viale Amelia, 70 – 00181
Rome.
Manufacturer
A.C.R.A.F. S.p.A. - Via Vecchia del Pinocchio, 22 - 60131 Ancona.
TACHIPIRINA 500 mg tablets
Paracetamol
Read this leaflet carefully before you start using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- If you would like more information or advice, ask your pharmacist.
- If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
- Talk to your doctor if you do not feel better or if your symptoms get worse after 3 days of treatment.
Contents of this leaflet:
- 1. What Tachipirina is and what it is used for
- 2. What you need to know before you use Tachipirina
- 3. How to use Tachipirina
- 4. Possible side effects
- 5. How to store Tachipirina
- 6. Contents of the pack and other information
1. What is Tachipirina and what is it used for
Tachipirina contains the active ingredient paracetamol which works by reducing fever (antipyretic) and
relieving pain (analgesic).
Tachipirina is used in adults, adolescentsand childrenfor:
- the symptomatic treatment of febrile states such as influenza, exanthematous diseases (typical infectious diseases of children and adolescents), acute respiratory tract diseases, etc.
- pains of various origins and nature (headache, neuralgia, muscle pain and other manifestations of moderate pain).
Consult a doctor if you/the child does not feel better or if you feel worse after 3 days of treatment.
2. What you need to know before using Tachipirina
Do not use Tachipirina
- if the person who is going to take the medicine is allergic to paracetamol or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before using Tachipirina.
In the following cases, use Tachipirina with caution if the person who is going to take the medicine:
- consumes alcohol chronically or excessively (3 or more alcoholic drinks per day)
- suffers from anorexia (eating disorder characterized by lack or reduction of appetite)
- suffers from bulimia (eating disorder in which a person ingests an excessive amount of food and then resorts to various methods to eliminate it)
- suffers from cachexia (condition characterized by extreme thinness, reduction of muscle mass and thinning of the skin due to chronic diseases)
- has been following an incorrect diet for a long time (chronic malnutrition)
- suffers from dehydration (severe loss of water/fluids from the body)
- suffers from hypovolemia (reduced blood volume in circulation)
- suffers from liver diseases that reduce its functionality (hepatic insufficiency, hepatitis, Gilbert's syndrome)
- is undergoing concomitant treatment with medicines that alter liver function (see “Other medicines and Tachipirina”)
- suffers from glucose-6-phosphate dehydrogenase deficiency (a substance normally present in the human body, the deficiency of which can cause a blood disease)
- suffers from hemolytic anemia (destruction of red blood cells).
During treatment with TACHIPIRINA, immediately inform your doctor if:
- If you suffer from serious illnesses, including severe kidney impairment or sepsis (when bacteria and their toxins circulate in the blood causing organ damage) or malnutrition, chronic alcoholism or if you are also taking flucloxacillin (an antibiotic). In patients in these situations, a serious condition called metabolic acidosis (an abnormality of the blood and fluids) has been reported when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken in combination with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with rapid deep breathing, drowsiness, nausea and vomiting.
Use of high doses and/or for prolonged periods
The use of high doses and/or prolonged periods of this medicine can cause alterations, even serious, to the
kidney and blood. In these cases, the doctor will monitor over time, through appropriate tests, the functionality
of the liver, kidneys and blood composition. Before taking this medicine, informyour doctor if
the person who is going to take the medicine suffers from a kidney or liver disease.
Children and adolescents
Tachipirina can be given to children and adolescents (see section 3 “How to use Tachipirina”).
Other medicines and Tachipirina
Tell your doctor or pharmacist if you are taking or have recently taken or might take any
other medicine.
In particular, inform your doctor if the person who is going to take the medicine is taking:
- medicines that contain paracetamol.During treatment with paracetamol, before taking or giving a child any other medicine, check that it does not contain paracetamol, as if paracetamol is taken in high doses, serious side effects can occur;
- medicines that slow down stomach emptying(e.g. anticholinergics, opioids), as these medicines delay the effect of Tachipirina;
- medicines that speed up stomach emptying(e.g. prokinetics), as these medicines accelerate the effect of Tachipirina;
- cholestyramine(medicine used to reduce cholesterol levels in the blood), as it reduces the effect of paracetamol;
- chloramphenicol(an antibiotic), as it may increase the risk of side effects;
- anticoagulants(medicines used to make the blood more fluid). In the case of high-dose treatments with paracetamol (4 g per day for at least 4 days), take or give the child Tachipirina only under strict medical supervision;
- rifampicin(an antibiotic);
- cimetidine(a medicine used in the treatment of stomach ulcers);
- antiepileptics(medicines used to treat epilepsy), for example glutethimide, phenobarbital, carbamazepine;
- zidovudine(medicine for the treatment of HIV);
- flucloxacillin (antibiotic),due to a serious risk of alterations in blood and fluids (calledelevated anion gap metabolic acidosis)that require urgent treatment. The use of these medicines with Tachipirina requires strict medical supervision.
Interference with blood tests
If the person taking the medicine needs to undergo blood tests, keep in mind that the administration of
paracetamol may interfere with the determination of uricemia and glycemia.
Tachipirina with alcohol
Use Tachipirina with caution if you consume alcohol chronically or excessively (3 or more drinks
alcohol per day), as there is a risk of intoxication (see sections “Warnings and precautions”
and “If you use more Tachipirina than you should”).
Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
If necessary, Tachipirina can be used during pregnancy. It is advisable to use the lowest possible dose that
reduces pain and/or fever and take it for the shortest possible time. Contact your doctor if the pain and/or
fever does not decrease or if you need to take the medicine more often.
This medicine can be taken during breastfeeding only if absolutely necessary and under
doctor's control.
Driving and operating machinery
Tachipirina does not impair the ability to drive vehicles or operate machinery.
3. How to use Tachipirina
Use this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults
The recommended dose is 1 tablet at a time, to be repeated if necessary after 4 hours, without exceeding 6 administrations per day.
In case of severe pain or high fever, 2 tablets of 500 mg to be repeated if necessary after no less than 4 hours.
In adults, the maximum oral dose is 3000 mg of paracetamol per day (see “If you use more Tachipirina than you should”).
Use in children and adolescents
For children, it is essential to respect the dose defined according to their body weight; the doctor will indicate the most suitable formulation based on the child's body weight. The approximate ages based on body weight are provided for informational purposes.
The tablet can be divided into two equal doses.
| WEIGHT | A I AGE | DOSE | HOW MANY TIMES A DAY? | MAXIMUM DAILY DOSE (IN 24 HOURS) |
| 21-25 kg | Z 6.5 – under 8 years N approximately E | ½ tablet at a time | To be repeated, if necessary, after 4 hours. Do not exceed 6 administrations in 24 hours. | 3 tablets |
| 26-40 kg A | G 8-11 years approximately | 1 tablet at a time | To be repeated, if necessary, after 6 hours. Do not exceed 4 administrations in 24 hours. | 4 tablets |
| 41-50 kg | 12-15 years approximately | 1 tablet at a time | To be repeated, if necessary, after 4 hours. | 6 tablets |
For children weighing less than 21 kg, other specific formulations of Tachipirina are available on the market.
Ask your doctor or pharmacist for advice.
If you/the child suffers from severe kidney failure (severe reduction in kidney function)
If the doctor has diagnosed severe kidney failure, the interval between administrations must be at least 8 hours.
Duration of treatment
Do not use Tachipirina for more than 3 consecutive days without consulting your doctor. The doctor must assess the need for treatments for more than 3 consecutive days.
If you use more Tachipirina than you should
In case of accidental ingestion/intake of an excessive dose of Tachipirina, immediately notify your doctor or go to the nearest hospital.
Symptoms
In case of accidental intake of very high doses of paracetamol, the symptoms that you/the child may generally experience within the first 12-48 hours include:
- anorexia (loss or reduction of appetite), nausea and vomiting followed by a profound deterioration of general conditions
- alterations in blood laboratory values (increased bilirubin in the blood, lactic dehydrogenase, liver transaminase levels, decreased prothrombin levels in the blood)
- liver damage that can lead to coma and death. Taking an excessive dose of paracetamol increases the risk of poisoning and can lead to death, especially in the following cases:
- if the person taking the medicine suffers from liver diseases
- chronic alcoholism
- if the person taking the medicine has been following an incorrect diet for a long time (chronic malnutrition)
- if the person taking the medicine is taking other medicines or substances that increase liver function.
Treatment
The doctor, based on the nature and severity of the symptoms, will carry out the appropriate supportive therapy.
If you forget to use Tachipirina
Do not use a double dose to make up for a missed dose.
If you stop using Tachipirina
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you/the child experiences the following side effects STOPtreatment with this
medicine and contact your doctor immediately:
| Do not exceed 6 administrations in 24 hours. | ||||
| Weight over 50 kg | Over 15 years approximately | 1 tablet at a time | Repeat, if necessary, after 4 hours. Do not exceed 6 administrations in 24 hours. | or 6 tablets c |
- allergic reactions with:
- redness of the skin accompanied by itching (urticaria)
- swelling of the throat (laryngeal edema)
- swelling of hands, feet, ankles, face, lips, tongue and/or throat (angioedema)
- severe allergic reaction (anaphylactic shock).
In addition, people taking the medicine may experience the following side effects, for which sufficient
data are not available to establish the frequency.
- reduction in the number of platelets in the blood (thrombocytopenia)
- reduction in the number of white blood cells in the blood (leukopenia/agranulocytosis)
- reduction of hemoglobin in the blood, a substance that carries oxygen in the blood (anemia)
- dizziness
- stomach and intestinal disorders
- abnormal liver function
- liver inflammation (hepatitis)
- red spots, blistering lesions with areas of skin detachment, blisters, skin rashes (erythema multiforme, Stevens Johnson syndrome, toxic epidermal necrolysis)
- reduction of kidney function (acute renal failure)
- kidney inflammation (interstitial nephritis)
- blood in the urine (hematuria)
- cessation or reduction of urine production (anuria) .
- severe condition that can make the blood more acidic (called metabolic acidosis), in patients with a serious illness who use paracetamol (see paragraph 2) Very rare cases of severe skin reactions have been reported.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.
5. How to store Tachipirina
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after Scad. The expiry date refers to the last day of that month.
The half tablet can be stored for 24 hours in the original packaging.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Tachipirina contains
- the active ingredient is: paracetamol (each tablet contains 500 mg of paracetamol)
- the other ingredients are: microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, sodium croscarmellose.
Description of the appearance of Tachipirina and contents of the pack
It is presented in white, round, biconvex tablets, with a central fracture line on one side. The tablets
are packaged in white blisters in packs of 10, 20 or 30 divisible 500 mg tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.- Viale Amelia, 70 – 00181
Rome.
Manufacturer
A.C.R.A.F. S.p.A. - Via Vecchia del Pinocchio, 22 - 60131 Ancona.
ISTITUTO DE ANGELI S.r.l. - Località Prulli 103/C, 50066 Reggello (FI).
Through the QR Code on the package or at the address https://leaflet.angelinipharma.com/L28 it is possible
TACHIPIRINA 500 mg effervescent granules
Paracetamol
Read this leaflet carefully before using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- If you want more information or advice, ask your pharmacist.
- If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
- See a doctor if you do not feel better or if your symptoms worsen after 3 days of treatment.
Contents of this leaflet:
- 1. What Tachipirina is and what it is used for
- 2. What you need to know before using Tachipirina
- 3. How to use Tachipirina
- 4. Possible side effects
- 5. How to store Tachipirina
- 6. Contents of the pack and other information
1. What is Tachipirina and what is it used for
Tachipirina contains the active ingredient paracetamol which works by reducing fever (antipyretic) and
relieving pain (analgesic).
Tachipirina is used in adults, adolescents and childrenfor:
- the symptomatic treatment of febrile states such as influenza, exanthematous diseases (typical infectious diseases of children and adolescents), acute respiratory tract diseases, etc.
- pains of various origins and nature (headache, neuralgia, muscle pain and other painful manifestations of moderate intensity.
Consult your doctor if you/the child do not feel better or if you feel worse after 3 days of treatment.
2. What you need to know before using Tachipirina
Do not use Tachipirina
- if the person who is going to take the medicine is allergic to paracetamol or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before taking Tachipirina.
In the following cases, use Tachipirina with caution if the person who is going to take the medicine:
- consumes alcohol chronically or excessively (3 or more alcoholic beverages per day)
- suffers from anorexia (an eating disorder characterized by a lack or reduction of appetite)
- suffers from bulimia (an eating disorder in which a person ingests an excessive amount of food and then resorts to various methods to eliminate it)
- suffers from cachexia (a condition characterized by extreme thinness, reduction of muscle mass and thinning of the skin due to chronic diseases)
- has been following an incorrect diet for a long time (chronic malnutrition)
- suffers from dehydration (severe loss of water/fluids from the body)
- suffers from hypovolemia (reduced blood volume in circulation)
- suffers from liver diseases that reduce its functionality (hepatic insufficiency, hepatitis, Gilbert's syndrome)
- is undergoing concomitant treatment with medicines that alter liver function (see “Other medicines and Tachipirina”).
- suffers from glucose-6-phosphate dehydrogenase deficiency (a substance normally present in the human body, the deficiency of which can cause a blood disease)
- suffers from hemolytic anemia (destruction of red blood cells).
During treatment with Tachipirina, immediately inform your doctor if:
- If you suffer from serious illnesses, including severe kidney impairment or sepsis (when bacteria and their toxins circulate in the blood causing organ damage) or malnutrition, chronic alcoholism or if you are also taking flucloxacillin (an antibiotic). In patients in these situations, a serious condition called metabolic acidosis (an abnormality of the blood and fluids) has been reported when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken in association with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with rapid, deep breathing, drowsiness, nausea and vomiting.
Use of high doses and/or for prolonged periods
The use of high doses and/or prolonged periods of this medicine can cause even serious alterations to the
kidney and blood. In these cases, the doctor will monitor over time, through appropriate tests, the functionality
of the liver, kidneys and blood composition. Before taking this medicine, informthe doctor if
the person who is going to take the medicine suffers from a kidney or liver disease.
Children and adolescents
Tachipirina can be given to children and adolescents (see section 3 “How to use Tachipirina”).
Other medicines and Tachipirina
Inform your doctor or pharmacist if you are taking or have recently taken or might take any
other medicine.
In particular, inform your doctor if the person who is going to take the medicine is taking:
- medicines that contain paracetamol.During treatment with paracetamol, before taking or giving the child any other medicine, check that it does not contain paracetamol, as if paracetamol is taken in high doses, serious side effects can occur
- medicines that slow down stomach emptying(e.g. anticholinergics, opioids), as these medicines delay the effect of Tachipirina
- medicines that speed up stomach emptying(e.g. prokinetics), as these medicines accelerate the effect of Tachipirina
- cholestyramine(a medicine used to reduce cholesterol levels in the blood), as it reduces the effect of paracetamol
- chloramphenicol(an antibiotic), as it may increase the risk of side effects
- anticoagulants(medicines used to make the blood more fluid). In the case of high-dose treatments with paracetamol (4 g per day for at least 4 days), take or give the child Tachipirina only under strict medical supervision
- rifampicin(an antibiotic)
- cimetidine(a medicine used in the treatment of stomach ulcers)
- antiepileptics(medicines used to treat epilepsy), for example glutethimide, phenobarbital, carbamazepine
- zidovudine(medicine for the treatment of HIV);
- flucloxacillin(antibiotic), due to a serious risk of alterations in blood and fluids (called metabolic acidosis with high anion gap) which must be treated urgently .
The use of these medicines with Tachipirina requires strict medical supervision.
Interference with blood tests
If the person taking the medicine needs to undergo blood tests, keep in mind that the administration of
paracetamol may interfere with the determination of uricemia and glycemia.
Tachipirina with alcohol
Take Tachipirina with caution if you consume alcohol chronically or excessively (3 or more beverages
alcoholic per day), as there is a risk of intoxication (see sections “Warnings and precautions”
and “If you use more Tachipirina than you should”).
Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with breast milk
ask your doctor or pharmacist for advice before taking this medicine.
If necessary, Tachipirina can be used during pregnancy. It is advisable to use the lowest possible dose that
reduces pain and/or fever and take it for the shortest possible time. Contact your doctor if the pain and/or
fever does not decrease or if you need to take the medicine more often .
This medicine can be taken during breastfeeding only if absolutely necessary and
under the control of the doctor.
Driving and operating machinery
Tachipirina does not impair the ability to drive vehicles or operate machinery.
Tachipirina 500 mg effervescent granules contains maltitol, sodium and aspartame
Maltitol: if your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking
this medicine.
Sodium:. this medicine contains 12.3 mmol (or 283 mg) of sodium (the main component of table salt) per sachet. This is equivalent to 14.1% of the recommended maximum daily intake with the
diet of an adult. To be taken into consideration in people with reduced kidney function or who are following a
low-sodium diet.
Talk to your doctor or pharmacist if you need 2 or more sachets a day for a prolonged period,
especially if you have been advised to follow a low-sodium diet.
Aspartame: this medicine contains a source of phenylalanine. It may be harmful if you suffer from
phenylketonuria.
3. How to use Tachipirina
Use this medicine following exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults
The recommended dose is 1 sachet at a time, to be repeated if necessary after 4 hours, without exceeding 6 administrations per day.
In case of severe pain or high fever, 2 sachets of 500 mg to be repeated if necessary after no less than 4 hours.
In adults, the maximum oral dose is 3000 mg of paracetamol per day (see “If you use more Tachipirina than you should”).
Use in children and adolescents
For children, it is essential to respect the dose defined based on their body weight; the doctor will indicate the most suitable formulation based on the child's body weight. Approximate ages based on body weight are provided for informational purposes.
Dissolve the effervescent granules in a glass of water.
For children weighing less than 26 kg, other specific formulations of Tachipirina are available on the market.
Ask your doctor or pharmacist for advice.
If you/the child suffers from severe renal insufficiency (severe reduction of kidney function)
If the doctor has diagnosed severe renal insufficiency, the interval between administrations must be at least 8 hours.
Duration of treatment
Do not use Tachipirina for more than 3 consecutive days without consulting your doctor. The doctor must evaluate the need for treatments for more than 3 consecutive days.
If you use more Tachipirina than you should
In case of accidental ingestion/administration of an excessive dose of Tachipirina, immediately notify your doctor or go to the nearest hospital.
Symptoms
In case of accidental administration of very high doses of paracetamol, the symptoms that you/the child may generally experience within the first 12-48 hours include:
- anorexia (loss or reduction of appetite), nausea and vomiting followed by a profound deterioration of general conditions
- alterations in blood laboratory values (increased bilirubin in the blood, lactic dehydrogenase, liver transaminase levels, reduction of prothrombin levels in the blood)
- liver damage that can lead to coma and death. Taking an excessive dose of paracetamol increases the risk of poisoning and can lead to death, especially in the following cases:
- if the person taking the medicine suffers from liver diseases
- chronic alcoholism
- if the person taking the medicine has been following an incorrect diet for a long time (chronic malnutrition)
- if the person taking the medicine is taking other medicines or substances that increase liver function.
Treatment
The doctor, based on the nature and severity of the symptoms, will carry out the appropriate supportive therapy.
If you forget to use Tachipirina
Do not use a double dose to compensate for a missed dose.
| WEIGHT | AGE | DOSE | HOW MANY TIMES A DAY? | MAXIMUM DOSE OR DAILY (IN 24 HOURS) |
| 26-40 kg | 8-11 years approximately | 1 sachet at a time | To be repeated, if necessary, after 6 hours. Do not exceed 4 administrations in 24 hours. | c 4 sachets a |
| 41-50 kg | 12-15 years approximately | 1 sachet at a time | m To be repeated, if necessary, after 4 hours. r Do not exceed 6 administrations in 24 hours. | 6 sachets |
| Weight over 50 kg | Over 15 years approximately | 1 sachet at a time | a To be repeated, if necessary, F after 4 hours. Do not exceed 6 administrations in 24 hours. | 6 sachets |
If you stop the treatment with Tachipirina
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you/the child experience the following side effects STOPtreatment with this
medicine and contact your doctor immediately:
- allergic reactions with:
- skin redness accompanied by itching (urticaria)
- swelling of the throat (laryngeal edema)
- swelling of hands, feet, ankles, face, lips, tongue and/or throat (angioedema)
- severe allergic reaction (anaphylactic shock).
In addition, people taking the medicine may experience the following side effects, for which sufficient data are not
available to establish the frequency:
- reduction in the number of platelets in the blood (thrombocytopenia)
- reduction in the number of white blood cells in the blood (leukopenia/agranulocytosis)
- reduction of hemoglobin in the blood, a substance that carries oxygen in the blood (anemia)
- dizziness
- stomach and intestinal disorders
- abnormal liver function
- liver inflammation (hepatitis)
- red spots, blistering lesions with areas of skin detachment, blisters, skin rashes (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis)
- reduced kidney function (acute renal failure)
- kidney inflammation (interstitial nephritis)
- blood in the urine (hematuria)
- cessation or reduction of urine production (anuria) .
- severe condition that can make the blood more acidic (called metabolic acidosis), in patients with a serious illness who use paracetamol (see section 2)
Very rare cases of severe skin reactions have been reported.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.By reporting side effects you can
help provide more information on the safety of this medicine.
5. How to store Tachipirina
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Tachipirina contains
- the active ingredient is: paracetamol (each sachet contains 500 mg of paracetamol
- the other ingredients are: mannitol, maltitol, sodiumbicarbonate, sodiumdocusate, aspartame(see section “Tachipirina 500 mg effervescent granules contains maltitol, sodium and aspartame”), anhydrous citric acid, orange flavour.
Description of the appearance of Tachipirina and contents of the pack
It is presented in the form of granules from white to slightly yellow contained in aluminum paper sachets
packaged in cartons of 20 sachets of 500 mg.
Marketing Authorisation Holder
Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.- Viale Amelia, 70 – 00181
Rome.
Manufacturer
A.C.R.A.F. S.p.A. - Via Vecchia del Pinocchio, 22 - 60131 Ancona.
Fine Foods & Pharmaceuticals NTM S.p.A. – Via Grignano, 43 - 24041 Brembate (BG)
Through the QR Code on the package or at the address https://leaflet.angelinipharma.com/L29 it is possible
TACHIPIRINA Neonati 62,5 mg suppositories, Prima Infanzia 125 mg suppositories
Paracetamol
Read this leaflet carefully before using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- If you would like more information or advice, ask your pharmacist.
- If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
- Talk to your doctor if you do not feel better or if your symptoms worsen after 3 days of treatment.
Contents of this leaflet:
- 1. What Tachipirina is and what it is used for
- 2. What you need to know before using Tachipirina
- 3. How to use Tachipirina
- 4. Possible side effects
- 5. How to store Tachipirina
- 6. Contents of the pack and other information
1. What is Tachipirina and what is it used for
Tachipirina contains the active ingredient paracetamol which works by reducing fever (antipyretic) and
relieving pain (analgesic).
Tachipirina neonati and Tachipirina prima infanzia must be used in children with a body weight
between3.2 and 12 kgfor:
- the symptomatic treatment of febrile conditions such as influenza, exanthematous diseases (infectious diseases typical of children and adolescents), acute respiratory tract diseases, etc.;
- pains of various origins and nature (headache, neuralgia, muscle pain and other manifestations of moderate intensity).
Consult your doctor if the child does not feel better or if they feel worse after 3 days of treatment.
2. What you need to know before using Tachipirina
Do not give Tachipirina to the child
- if they are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6);
- if they suffer from severe hemolytic anemia (destruction of red blood cells);
- if they suffer from a severe liver disease (severe hepatocellular insufficiency).
Warnings and precautions
Consult your doctor or pharmacist before using Tachipirina.
In the following cases, give Tachipirina to the child with caution:
- if they suffer from anorexia (eating disorder characterized by lack or reduction of appetite);
- if they suffer from bulimia (eating disorder in which a person ingests an excessive amount of food and then resorts to various methods to eliminate it);
- if they suffer from cachexia (condition characterized by extreme thinness, reduction of muscle mass and thinning of the skin due to chronic diseases);
- if they have been following an incorrect diet for a long time (chronic malnutrition);
- if they suffer from dehydration (severe loss of water/fluids from the body);
- if they suffer from hypovolemia (reduced blood volume in circulation);
- if they suffer from liver diseases that reduce its functionality (hepatic insufficiency, hepatitis, Gilbert's syndrome);
- if they are undergoing concomitant treatment with medicines that alter liver function (see “Other medicines and Tachipirina”);
- if they suffer from glucose-6-phosphate dehydrogenase deficiency (a substance normally present in the human body, the deficiency of which can cause a blood disease);
- if they suffer from hemolytic anemia (destruction of red blood cells).
During treatment with TACHIPIRINA, immediately inform your doctor if:
- If they suffer from serious illnesses, including severe kidney impairment or sepsis (when bacteria and their toxins circulate in the blood causing organ damage) or malnutrition, chronic alcoholism or if they are also taking flucloxacillin (an antibiotic). In patients in these situations, a serious condition called metabolic acidosis (an abnormality of the blood and fluids) has been reported when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken in association with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with rapid deep breathing, drowsiness, nausea and vomiting.
Use of high doses and/or for prolonged periods
The use of high doses and/or prolonged periods of this medicine can cause even serious alterations to the
kidney and blood. In these cases, the doctor will monitor the functionality over time
of the liver, kidneys and blood composition through appropriate tests.
Before giving this medicine to the child, informthe doctor if they suffer from a kidney or liver disease.
Children and adolescents
Tachipirina suppositories can be given to children with a body weight between 3.2 kg and 12 kg (see
section 3 “How to use Tachipirina”).
Other medicines and Tachipirina
Inform your doctor or pharmacist if the child is taking or has recently taken or may
take any other medicine.
In particular, inform your doctor if the person taking the medicine is taking:
- medicines that contain paracetamol.During treatment with paracetamol, before taking any other medicine, check that it does not contain paracetamol, as if paracetamol is taken in high doses, serious side effects may occur;
- chloramphenicol(an antibiotic), as it may increase the risk of side effects;
- anticoagulants(medicines used to make the blood more fluid). In the case of high-dose treatments with paracetamol (4 g per day for at least 4 days), take Tachipirina only under strict medical supervision;
- rifampicin(an antibiotic);
- cimetidine(a medicine used in the treatment of stomach ulcers);
- antiepileptics(medicines used to treat epilepsy), for example glutethimide, phenobarbital, carbamazepine;
- zidovudine(medicine for the treatment of HIV);
- flucloxacillin(antibiotic), due to a serious risk of alterations in the blood and fluids (called metabolic acidosis with high anion gap) which must be treated urgently .
The use of these medicines with Tachipirina requires strict medical supervision.
Interference with blood tests
If the person taking the medicine needs to undergo blood tests, keep in mind that the administration of
paracetamol may interfere with the determination of uricemia and glycemia.
3. How to use Tachipirina
Give this medicine to the child always following exactly what is reported in this leaflet or the instructions of the doctor or pharmacist. If you have doubts, consult the doctor or pharmacist.
For children it is essential to respect the dose defined according to their body weight. The approximate ages based on body weight are indicated for informational purposes:
Tachipirina Neonati 62.5 mg suppositories
Tachipirina Prima Infanzia 125 mg suppositories
| WEIGHT | AGE | DOSE | a HOW MANY TIMES A DAY? |
| 3.2-5 kg | From birth to 2 months approximately | 1 suppository at a time | F To be repeated, if necessary, after 6 hours. Do not exceed 4 suppositories in 24 hours. |
| WEIGHT | AGE | DOSE | HOW MANY TIMES A DAY? |
| 6-7 kg | 3-5 months approximately | 1 suppository at a time | d To be repeated, if necessary, after 6 hours. Do not exceed 4 suppositories in 24 hours. |
| 7-10 kg | 6-19 months approximately | a 1 suppository at a time n | To be repeated, if necessary, after 4-6 hours. Do not exceed 5 suppositories in 24 hours. |
| 11-12 kg | 20-29 months approximately | a 1 suppository at a time | To be repeated, if necessary, after 4 hours. Do not exceed 6 suppositories in 24 hours. |
For children weighing more than 12 kg, other suppositories of Tachipirina or other
specific formulations of Tachipirina can be used. Ask your doctor or pharmacist for advice.
If the child suffers from severe renal failure (severe reduction of kidney function)
If the doctor has diagnosed the child with severe renal failure, the interval between administrations
must be at least 8 hours.
Duration of treatment
Do not give the child Tachipirina for more than 3 consecutive days without consulting the doctor. The doctor must
evaluate the need for treatments for more than 3 consecutive days.
If you use more Tachipirina than you should
In case of accidental ingestion/intake of an excessive dose of Tachipirina, immediately warn the
doctor or go to the nearest hospital.
Symptoms
In case of accidental intake of very high doses of paracetamol, the symptoms that generally could
manifest within the first 12-48 hours include:
- anorexia (loss or reduction of appetite), nausea and vomiting followed by a profound deterioration of general conditions, alterations in blood laboratory values (increased bilirubin in the blood, lactic dehydrogenase, levels of hepatic transaminases, reduction of prothrombin levels in the blood);
- liver damage that can lead to coma and death.
Taking an excessive dose of paracetamol increases the risk of poisoning and can lead to
death, especially in the following cases:
- if the person taking the medicine suffers from liver diseases;
- chronic alcoholism;
- if the person taking the medicine has been following an incorrect diet for a long time (chronic malnutrition);
- if the person taking the medicine is taking other medicines or substances that increase liver function.
Treatment
The doctor, based on the nature and severity of the symptoms, will carry out the appropriate supportive therapy.
If you forget to use Tachipirina
Do not give the child a double dose to compensate for the forgotten suppository.
If you stop the treatment with Tachipirina
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If the child experiences the following side effects STOPtreatment with this medicine
and contact your doctor immediately:
- allergic reactions with:
- skin redness accompanied by itching (urticaria),
- swelling of the throat (laryngeal edema),
- swelling of hands, feet, ankles, face, lips, tongue and/or throat (angioedema),
- severe allergic reaction (anaphylactic shock).
In addition, people taking this medicine may experience the following side effects, for which
sufficient data are not available to establish the frequency.
- reduction in the number of platelets in the blood (thrombocytopenia);
- reduction in the number of white blood cells in the blood (leukopenia/agranulocytosis);
- reduction of hemoglobin in the blood, a substance that carries oxygen in the blood (anemia);
- dizziness;
- stomach and intestinal reactions;
- abnormal liver function;
- liver inflammation (hepatitis);
- red spots, blistering lesions with areas of skin detachment, blisters, skin rashes (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis);
- reduced kidney function (acute renal failure);
- kidney inflammation (interstitial nephritis);
- blood in the urine (hematuria);
- cessation or reduction of urine production by the kidney (anuria) .
- severe condition that can make the blood more acidic (called metabolic acidosis), in patients with a serious illness who use paracetamol (see paragraph 2) Very rare cases of severe skin reactions have been reported.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.
5. How to store Tachipirina
Keep this medicine out of the sight and reach of children.
Store at a temperature not exceeding 25°C.
Do not use this medicine after the expiry date which is stated on the pack after Exp. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Tachipirina Neonati 62,5 mg contains
- the active ingredient is: paracetamol (each suppository contains 62.5 mg of paracetamol).
- the other ingredients are: solid semi-synthetic glycerides.
What Tachipirina Prima Infanzia 125 mg contains
- the active ingredient is: paracetamol (each suppository contains 125 mg of paracetamol).
- the other ingredients are: solid semi-synthetic glycerides.
Description of the appearance of Tachipirina and package contents
Tachipirina is available as white to cream-colored suppositories of 62.5 mg or 125 mg packaged in a carton
containing 10 suppositories with 2 white blisters of 5 suppositories each or 20 suppositories with 4
white blisters of 5 suppositories each.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.
Viale Amelia, 70
00181 Rome.
Manufacturer
TACHIPIRINA Neonati 62,5 mg suppositories
A.C.R.A.F. S.p.A.
Via Vecchia del Pinocchio, 22
60131 Ancona.
TACHIPIRINA Prima Infanzia 125 mg suppositories
A.C.R.A.F. S.p.A.
Via Vecchia del Pinocchio, 22
60131 Ancona.
Istituto de Angeli Italia s.r.l.
Località Prulli 103/C
50066 Reggello (FI)
You can read it through the QR Code on the package or at the address https://leaflet.angelinipharma.com/L27
TACHIPIRINA Bambini 250 mg supposte, Bambini 500 mg supposte
Paracetamol
Read this leaflet carefully before using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has
told you to.
- Keep this leaflet. You may need to read it again.
- If you want more information or advice, ask your pharmacist.
- If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
- See a doctor if you do not feel better or if your symptoms worsen after 3 days of treatment.
Contents of this leaflet:
- 1. What Tachipirina is and what it is used for
- 2. What you need to know before using Tachipirina
- 3. How to use Tachipirina
- 4. Possible side effects
- 5. How to store Tachipirina
- 6. Contents of the pack and other information
1. What is Tachipirina and what is it used for
Tachipirina contains the active ingredient paracetamol which works by reducing fever (antipyretic) and
relieving pain (analgesic).
Tachipirina is used in children with a body weightbetween11 and 40 kgfor:
- the symptomatic treatment of febrile states such as influenza, exanthematous diseases (typical infectious diseases of children and adolescents), acute respiratory tract diseases, etc.;
- pain of various origins and nature (headache, neuralgia, muscle pain and other manifestations of moderate pain).
Consult a doctor if the child does not feel better or if they feel worse after 3 days of treatment.
2. What you need to know before using Tachipirina
Do not give Tachipirina to the child
- if they are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6);
- if they suffer from severe hemolytic anemia (destruction of red blood cells);
- if they suffer from a severe liver disease (severe hepatocellular insufficiency).
Warnings and precautions
Consult your doctor or pharmacist before using Tachipirina.
In the following cases, give Tachipirina to the child with caution:
- if they suffer from anorexia (eating disorder characterized by lack or reduction of appetite);
- if they suffer from bulimia (eating disorder in which a person ingests an excessive amount of food and then resorts to various methods to eliminate it);
- if they suffer from cachexia (condition characterized by extreme thinness, reduction of muscle mass and thinning of the skin due to chronic diseases);
- if they have been following an incorrect diet for a long time (chronic malnutrition);
- if they suffer from dehydration (severe loss of water/fluids from the body);
- if they suffer from hypovolemia (reduced blood volume in circulation);
- if they suffer from liver diseases that reduce its functionality (hepatic insufficiency, hepatitis, Gilbert's syndrome);
- if they are undergoing concomitant treatment with medicines that alter liver function (see “Other medicines and Tachipirina”);
- if they suffer from glucose-6-phosphate dehydrogenase deficiency (a substance normally present in the human body, the deficiency of which can cause a blood disease);
- if they suffer from hemolytic anemia (destruction of red blood cells).
During treatment with Tachipirina, immediately inform your doctor if:
- If they suffer from serious illnesses, including severe kidney impairment or sepsis (when bacteria and their toxins circulate in the blood causing organ damage) or malnutrition, chronic alcoholism or if they are also taking flucloxacillin (an antibiotic). In patients in these situations, a serious condition called metabolic acidosis (an abnormality of the blood and fluids) has been reported when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken in association with flucloxacillin. The symptoms of metabolic acidosis may include: severe difficulty breathing with rapid deep breathing, drowsiness, nausea and vomiting.
Use of high doses and/or for prolonged periods
The use of high doses and/or prolonged periods of this medicine can cause even serious alterations to the
kidney and blood. In these cases, the doctor will monitor the functionality over time
of the liver, kidneys and blood composition through appropriate tests.
Before giving this medicine to the child, informthe doctor if they suffer from a kidney or liver disease.
Children and adolescents
Tachipirina suppositories can be given to children weighing between 11 kg and 40 kg (see
section 3 “How to use Tachipirina”).
Other medicines and Tachipirina
Inform your doctor or pharmacist if the child is taking or has recently taken or may
take any other medicine.
In particular, inform your doctor if the person taking the medicine is taking:
- medicines that contain paracetamol.During treatment with paracetamol, before taking any other medicine, check that it does not contain paracetamol, as if paracetamol is taken in high doses, serious side effects may occur;
- chloramphenicol(an antibiotic), as it may increase the risk of side effects;
- anticoagulants(medicines used to make the blood more fluid). In case of high-dose treatments with paracetamol (4 g per day for at least 4 days), take Tachipirina only under strict medical supervision;
- rifampicin(an antibiotic);
- cimetidine(a medicine used in the treatment of stomach ulcers);
- antiepileptics(medicines used to treat epilepsy), such as glutethimide, phenobarbital, carbamazepine;
- zidovudine(medicine for the treatment of HIV);
- flucloxacillin(antibiotic), due to a serious risk of alterations in the blood and fluids (called metabolic acidosis with high anion gap) which must be treated urgently .
The use of these medicines with Tachipirina requires strict medical supervision.
Interference with blood tests
If the person taking the medicine needs to undergo blood tests, keep in mind that the administration of
paracetamol may interfere with the determination of uricemia and glycemia.
Tachipirina with alcohol
The use of alcohol involves an increased risk of intoxication (see sections “Warnings and
precautions” and “If you take more Tachipirina than you should”).
Driving and using machines
Tachipirina does not impair the ability to drive vehicles (including bicycles) or use machinery.
3. How to use Tachipirina
Give this medicine to the child always exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
For children, it is essential to respect the dose defined according to their body weight.
The approximate ages based on body weight are provided for informational purposes:
Tachipirina Bambini 250 mg suppositories
| WEIGHT | AGE | DOSE | and HOW MANY TIMES A DAY? |
| 11-12 kg | 20-29 months approximately | 1 suppository at a time | d To be repeated, if necessary, after 8 hours. Do not exceed 3 suppositories in 24 hours. |
| 13-20 kg | 30 months-less than 6.5 years approximately | a 1 suppository at a time n | To be repeated, if necessary, after 6 hours. Do not exceed 4 suppositories in 24 hours. |
Tachipirina Bambini 500 mg suppositories
| WEIGHT | AGE | DOSE | HOW MANY TIMES A DAY? |
| 21-25 kg | 6.5-less than 8 years approximately | l a 1 suppository at a time | To be repeated, if necessary, after 8 hours. Do not exceed 3 suppositories in 24 hours. |
| 26-40 kg | I 8-11 years approximately | t 1 suppository at a time | To be repeated, if necessary, after 6 hours. Do not exceed 4 suppositories in 24 hours. |
For children weighing less than 11 kg, other Tachipirina suppositories or other
specific formulations of Tachipirina may be used. Ask your doctor or pharmacist for advice.
If the child suffers from severe renal failure (severe reduction in kidney function)
If the doctor has diagnosed the child with severe renal failure, the interval between administrations
must be at least 8 hours.
Duration of treatment
Do not give the child Tachipirina for more than 3 consecutive days without consulting a doctor. The doctor must
assess the need for treatments for more than 3 consecutive days.
If you use more Tachipirina than you should
In case of accidental ingestion/administration of an excessive dose of Tachipirina, immediately warn
your doctor or go to the nearest hospital.
Symptoms
In case of accidental intake of very high doses of paracetamol, the symptoms that generally may
manifest within the first 12-48 hours include:
- anorexia (loss or reduction of appetite), nausea and vomiting followed by a profound deterioration of general conditions, alterations in blood laboratory values (increased bilirubin in the blood, lactic dehydrogenase, liver transaminase levels, reduced prothrombin levels in the blood);
- liver damage that can lead to coma and death. Taking an excessive dose of paracetamol increases the risk of poisoning and can lead to death, especially in the following cases:
- if the person taking the medicine suffers from liver diseases;
- chronic alcoholism,
- if the person taking the medicine has been following an incorrect diet for a long time (chronic malnutrition);
- if the person taking the medicine is taking other medicines or substances that increase liver function.
Treatment
The doctor, based on the nature and severity of the symptoms, will carry out the appropriate supportive therapy.
If you forget to use Tachipirina
Do not give the child a double dose to make up for the missed suppository.
If you stop using Tachipirina
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If the child experiences the following side effects STOPtreatment with this medicine
and contact your doctor immediately:
- allergic reactions with:
- skin redness accompanied by itching (urticaria);
- swelling of the throat (laryngeal edema);
- swelling of hands, feet, ankles, face, lips, tongue and/or throat (angioedema);
- severe allergic reaction (anaphylactic shock).
In addition, people taking this medicine may experience the following side effects, for which
sufficient data are not available to establish the frequency.
- reduction in the number of platelets in the blood (thrombocytopenia);
- reduction in the number of white blood cells in the blood (leukopenia/agranulocytosis);
- reduction of hemoglobin in the blood, a substance that carries oxygen in the blood (anemia);
- dizziness;
- stomach and intestinal reactions;
- abnormal liver function;
- liver inflammation (hepatitis);
- red spots, blistering lesions with areas of skin detachment, blisters, skin rashes (erythema multiforme, Stevens Johnson syndrome, toxic epidermal necrolysis);
- reduction of kidney function (acute renal failure);
- kidney inflammation (interstitial nephritis);
- blood in the urine (hematuria);
- cessation or reduction of urine production by the kidney (anuria) .
- severe condition that can make the blood more acidic (called metabolic acidosis), in patients with a serious illness who use paracetamol (see section 2). Very rare cases of severe skin reactions have been reported.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.
5. How to store Tachipirina
Keep this medicine out of the sight and reach of children.
Store at a temperature not exceeding 25°C.
Do not use this medicine after the expiry date that is reported on the pack after Exp. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Tachipirina Bambini 250 mg contains
- the active ingredient is: paracetamol (each suppository contains 250 mg of paracetamol).
- the other ingredients are: solid semi-synthetic glycerides.
What Tachipirina Bambini 500 mg contains
- the active ingredient is: paracetamol (each suppository contains 500 mg of paracetamol).
- the other ingredients are: solid semi-synthetic glycerides.
Description of the appearance of Tachipirina and contents of the pack
Tachipirina is available as white to cream-colored suppositories of 250 mg or 500 mg packaged in a carton
containing 10 suppositories with 2 white blisters of 5 suppositories each, or 20 suppositories with 4 white
blisters of 5 suppositories each.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.
Viale Amelia, 70
00181 Rome.
Manufacturer
A.C.R.A.F. S.p.A.
Via Vecchia del Pinocchio, 22
60131 Ancona.
Istituto de Angeli Italia s.r.l.
Località Prulli 103/C
50066 Reggello (FI)
Through the QR Code on the packaging or at the address https://leaflet.angelinipharma.com/L26 it is possible to read
TACHIPIRINA Adulti 1000 mg suppositories
Paracetamol
Read this leaflet carefully before using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- If you want more information or advice, ask your pharmacist.
- If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
- See a doctor if you do not feel better or if your symptoms worsen after 3 days of treatment.
Contents of this leaflet:
- 1. What Tachipirina is and what it is used for
- 2. What you need to know before using Tachipirina
- 3. How to use Tachipirina
- 4. Possible side effects
- 5. How to store Tachipirina
- 6. Contents of the pack and other information
1. What is Tachipirina and what is it used for
Tachipirina contains the active ingredient paracetamol which works by reducing fever (antipyretic) and
relieving pain (analgesic).
Tachipirina is used in adultsand adolescents (weighing 41 kg or more)for:
- the symptomatic treatment of feverish conditions such as influenza, exanthematous diseases (infectious diseases typical of children and adolescents), acute respiratory tract diseases, etc.
- pains of various origins and nature (headache, neuralgia, muscle pain and other manifestations of moderate pain).
See a doctor if you do not feel better or if you feel worse after 3 days of treatment.
2. What you need to know before using Tachipirina
Do not use Tachipirina
- if you are allergic to paracetamol or to any of the other ingredients of this medicine (listed in section 6)
- if you suffer from severe hemolytic anemia (destruction of red blood cells)
- if you suffer from a severe liver disease (severe hepatocellular insufficiency).
Warnings and precautions
Consult your doctor or pharmacist before using Tachipirina.
In the following cases, use Tachipirina with caution:
- if you consume alcohol chronically or excessively (3 or more alcoholic drinks per day)
- if you suffer from anorexia (eating disorder characterized by lack or reduction of appetite)
- if you suffer from bulimia (eating disorder in which a person ingests an excessive amount of food and then resorts to various methods to eliminate it)
- if you suffer from cachexia (condition characterized by extreme thinness, reduction of muscle mass and thinning of the skin due to chronic diseases)
- if you have been following an incorrect diet for a long time (chronic malnutrition)
- if you suffer from dehydration (severe loss of water/fluids from the body)
- if you suffer from hypovolemia (reduced blood volume in circulation)
- if you suffer from liver diseases that reduce its functionality (hepatic insufficiency, hepatitis, Gilbert's syndrome)
- if you are undergoing concomitant treatment with medicines that alter liver function (see “Other medicines and Tachipirina”).
- if you suffer from glucose-6-phosphate dehydrogenase deficiency (a substance normally present in the human body, the deficiency of which can cause a blood disease)
- if you suffer from hemolytic anemia (destruction of red blood cells).
During treatment with TACHIPIRINA immediately inform your doctor if:
- If you suffer from serious illnesses, including severe kidney impairment or sepsis (when bacteria and their toxins circulate in the blood causing organ damage) or malnutrition, chronic alcoholism or if you are also taking flucloxacillin (an antibiotic). In patients in these situations, a serious condition called metabolic acidosis (an abnormality of the blood and fluids) has been reported when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken in association with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with rapid deep breathing, drowsiness, nausea and vomiting.
Use of high doses and/or for prolonged periods
The use of high doses and/or prolonged use of this medicine can cause even serious alterations to the
kidney and blood. In these cases, the doctor will monitor over time, through appropriate tests, the functionality
of the liver, kidneys and blood composition.
Before using this medicine, informyour doctor if you suffer from a kidney or liver disease.
Children and adolescents
Tachipirina can be given to adolescents weighing 41 kg or more (see section 3 “How to use
Tachipirina”).
Other medicines and Tachipirina
Inform your doctor or pharmacist if you are taking or have recently taken or may take any
other medicine.
In particular, inform your doctor if you are taking:
- medicines containing paracetamol.During treatment with paracetamol, before taking any other medicine, check that it does not contain paracetamol, as if paracetamol is taken in high doses, serious side effects may occur;
- chloramphenicol(an antibiotic), as it may increase the risk of side effects;
- anticoagulants(medicines used to make the blood more fluid). In the case of high-dose treatments with paracetamol (4 g per day for at least 4 days), take Tachipirina only under strict medical supervision;
- rifampicin(an antibiotic);
- cimetidine(a medicine used in the treatment of stomach ulcers);
- antiepileptics(medicines used to treat epilepsy), such as glutethimide, phenobarbital, carbamazepine;
- chronic alcohol use;
- zidovudine(medicine for the treatment of HIV);
- flucloxacillin(antibiotic), due to a serious risk of alterations in the blood and fluids (called metabolic acidosis with high anion gap) which must be treated urgently .The use of these medicines with Tachipirina requires strict medical supervision.
Interference with blood tests
If you need to have blood tests, keep in mind that the administration of paracetamol may interfere with
the determination of uricemia and glycemia.
Tachipirina with alcohol
Use Tachipirina with caution if you consume alcohol chronically or excessively (3 or more alcoholic drinks
per day), as there is a risk of intoxication (see sections “Warnings and precautions”
and “If you take more Tachipirina than you should”).
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before using this medicine.
If necessary, Tachipirina can be used during pregnancy. It is advisable to use the lowest possible dose that
reduces pain and/or fever and take it for the shortest possible time. Contact your doctor if the pain and/or
fever does not decrease or if you need to take the medicine more often.
This medicine can be taken during breastfeeding only if absolutely necessary and
under the supervision of a doctor.
Driving and operating machinery
Tachipirina does not impair the ability to drive vehicles or operate machinery.
3. How to use Tachipirina
Use this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adolescents weighing 41 kg or more
For adolescents, it is essential to respect the dose defined according to their body weight. Approximate ages based on body weight are provided for informational purposes:
Adults
The recommended dose is 1 suppository at a time rectally, to be repeated if necessary after 6 hours.
Do not exceed the maximum rectal dose of 4 suppositories (4000 mg) per day.
| WEIGHT | AGE | DOSE | HOW MANY TIMES A DAY? |
| 41-50 kg | 12-15 years approximately | 1 suppository at a time | To be repeated, if necessary, after 8 hours. Do not exceed 3 suppositories in 24 hours. |
| Weight over 50 kg | Over 15 years approximately | 1 suppository at a time | To be repeated, if necessary, after 6 hours. Do not exceed 4 suppositories in 24 hours. |
For children weighing less than 41 kg, in addition to suppositories with lower dosages, other specific formulations of Tachipirina are available on the market. Ask your doctor or pharmacist for advice.
If you suffer from severe renal insufficiency (severe reduction in kidney function)
If your doctor has diagnosed you with severe renal insufficiency, the interval between administrations must be at least 8 hours.
Duration of treatment
Do not use Tachipirina for more than 3 consecutive days without consulting your doctor. The doctor must evaluate the need for treatments for more than 3 consecutive days.
If you use more Tachipirina than you should
In case of accidental ingestion/intake of an excessive dose of Tachipirina, immediately inform your doctor or go to the nearest hospital.
Symptoms
In case of accidental intake of very high doses of paracetamol, the symptoms that you may generally experience within the first 12-48 hours include:
- anorexia (lack or reduction of appetite), nausea and vomiting followed by a profound deterioration of general conditions
- alterations in blood laboratory values (increased bilirubin in the blood, lactic dehydrogenase, liver transaminase levels, decreased prothrombin levels in the blood).
- liver damage that can lead to coma and death. Taking an excessive dose of paracetamol increases the risk of poisoning and can lead to death, especially in the following cases:
- if you suffer from liver diseases,
- chronic alcoholism,
- if you have been following an incorrect diet for a long time (chronic malnutrition),
- if you are taking medicines or substances that increase liver function.
Treatment
The doctor, based on the nature and severity of the symptoms, will carry out the appropriate supportive therapy.
If you forget to use Tachipirina
Do not use a double dose to make up for the forgotten suppository.
If you stop the treatment with Tachipirina
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience the following side effects STOPtreatment with this medicine and contact
immediatelyyour doctor:
- allergic reactions with:
- redness of the skin accompanied by itching (urticaria)
- swelling of the throat (laryngeal edema)
- swelling of hands, feet, ankles, face, lips, tongue and/or throat (angioedema)
- severe allergic reaction (anaphylactic shock).
In addition, you may experience the following side effects, for which sufficient data are not available to
establish the frequency:
- reduction in the number of platelets in the blood (thrombocytopenia)
- reduction in the number of white blood cells in the blood (leukopenia/agranulocytosis)
- reduction of hemoglobin in the blood, a substance that carries oxygen in the blood (anemia)
- dizziness
- stomach and intestinal reactions
- abnormal liver function
- liver inflammation (hepatitis)
- red spots, blistering lesions with areas of skin detachment, blisters, skin rashes (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis)
- reduction of kidney function (acute renal failure)
- kidney inflammation (interstitial nephritis)
- blood in the urine (hematuria)
- cessation or reduction of urine production by the kidney (anuria) .
- severe condition that can make the blood more acidic (called metabolic acidosis), in patients with a serious illness who use paracetamol (see paragraph 2) Very rare cases of severe skin reactions have been reported.
Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.
5. How to store Tachipirina
Keep this medicine out of the sight and reach of children.
Store at a temperature not exceeding 25°C.
Do not use this medicine after the expiry date which is stated on the pack after Exp. The expiry date
refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.
6. Package Contents and Other Information
What Tachipirina contains
- the active ingredient is: paracetamol (each suppository contains 1000 mg of paracetamol);
- the other ingredients are: solid semi-synthetic glycerides.
Description of the appearance of Tachipirina and package contents
Tachipirina is presented in white to cream-colored 1000 mg suppositories packaged in a carton box containing 10
suppositories: 2 white blisters of 5 suppositories each.
Marketing Authorisation Holder
Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.
Viale Amelia, 70
00181 Roma.
Manufacturer
A.C.R.A.F. S.p.A.
Via Vecchia del Pinocchio, 22
60131 Ancona.
Through the QR Code on the package or at the address https://leaflet.angelinipharma.com/L3 0 it is possible
Tachipirina 10 mg/ml solution for infusion
Paracetamol
Read this leaflet carefully before using this medicine as it contains important information for you.
- Keep this leaflet. You may need to read it again.
- This medicine has been prescribed only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
- If you have any doubts, ask your doctor, pharmacist or nurse.
- If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet:
- 1. What Tachipirina is and what it is used for
- 2. What you need to know before using Tachipirina
- 3. How to use Tachipirina
- 4. Possible side effects
- 5. How to store Tachipirina
- 6. Contents of the pack and other information
1. What is Tachipirina and what is it used for
Tachipirina contains paracetamol, a medicinal analgesic (relieves pain) and antipyretic (reduces
fever).
Tachipirina solution for intravenous infusion is indicated for the short-term treatment of moderate pain, especially following surgical intervention and for the short-term treatment of
fever, when other routes of administration are impossible to practice.
Tachipirina - 100 ml bag
The 100 ml bag is indicated for adults, adolescentsand children with a body weight greater than 33 kg.
Tachipirina - 50 ml bag
The 50 ml bag is indicated for children with a body weight less than 33 Kg(including term newborns, early infancy, children who are beginning to walk).
2. What you need to know before using Tachipirina
Tachipirina will not be used
- if you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6)
- if you are allergic to proparacetamol (another analgesic for infusion and a precursor of paracetamol)
- if you suffer from severe liver disease.
Warnings and precautions
This medicine will only be administered to you by qualified personnel under strict medical supervision.
Before Tachipirina is used, tell your doctor:
- if you suffer from liver or kidney disease or alcohol abuse
- if you are taking other medicines containing paracetamol (see section “Other medicines and Tachipirina”)
- if you suffer from nutritional problems (malnutrition) or dehydration (severe loss of water from the body). As soon as possible, the doctor will switch to oral therapy with Tachipirina.
During treatment with TACHIPIRINA, immediately inform your doctor if:
- If you suffer from serious illnesses, including severe kidney impairment or sepsis (when bacteria and their toxins circulate in the blood causing organ damage) or malnutrition, chronic alcoholism or if you are also taking flucloxacillin (an antibiotic). In patients in these situations, a serious condition called metabolic acidosis (an abnormality of the blood and fluids) has been reported when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken in association with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with rapid deep breathing, drowsiness, nausea and vomiting.
The use of high doses of this medicine can cause even serious alterations to the liver. Before
taking this medicine, tellyour doctor if you suffer from a liver disease.
Children and adolescents
The use of Tachipirina solution for infusion is not recommended in premature infants, as efficacy and
safety have not been established.
Other medicines and Tachipirina
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might
take any other medicines.
In particular, tell your doctor if the person taking the medicine is taking:
- other medicines containing paracetamol or proparacetamol(a medicine similar to paracetamol). In this case, the doctor will adjust the dose to be administered to avoid exceeding the recommended daily dose of paracetamol
- probenecid(a medicine used to treat gout); in this case, the doctor will consider a reduction in the dose of paracetamol
- oral anticoagulants(medicines used to thin the blood). In this case, the doctor will perform the necessary checks to assess the effect of the anticoagulant.
- salicylamide (a medicine that relieves pain and lowers fever)
- enzyme inducers(drugs that increase liver function)
- flucloxacillin(antibiotic), due to a serious risk of alterations in the blood and fluids (called metabolic acidosis with high anion gap) which must be treated urgently. Pregnancy and breastfeedingIf you are pregnant, suspect you are pregnant or are planning to become pregnant, or are breastfeeding, ask your doctor for advice before this medicine is administered to you. If necessary, Tachipirina can be used during pregnancy. It is advisable to use the lowest possible dose that reduces pain and/or fever and take it for the shortest possible time. Contact your doctor or midwife if the pain and/or fever does not decrease or if you have to take the medicine more often. In this case, the dosage and duration of treatment must be strictly observed.
Tachipirina contains sodium
This medicine contains 79.4 mg of sodium (the main component of table salt) per 100 ml
This is equivalent to 4% of the maximum recommended daily intake with the diet of an adult.
Driving and operating machinery
Tachipirina does not impair the ability to drive vehicles or operate machinery.
3. How to use Tachipirina
This medicine will only be administered by qualified personnel under strict medical supervision.
The most appropriate dose will be established by the doctor based on weight, and any other medicines that you are
taking at the same time.
100 ml bag
The 100 ml bag is indicated for adults, adolescents and children with a body weight greater than 33 kg.
50 ml bag
The 50 ml bag is indicated for full-term newborns, early infancy, children who are beginning to walk and for
children with a body weight less than 33 kg.
Tachipirina will be administered via intravenous infusion. The duration of administration is 15
minutes.
If you feel that the effect of Tachipirina is too strong or too weak, consult your doctor.
If more Tachipirina than necessary is used
If an excessive dose of paracetamol is administered, you may experience undesirable effects
including: nausea, vomiting, anorexia (loss or reduction of appetite), pallor and abdominal pain, alterations in
blood laboratory values (increased bilirubin in the blood, lactic
dehydrogenase, liver transaminase levels, reduced prothrombin levels in the blood) and risk of
liver damage that can lead to coma and death. These undesirable effects occur within the
first 12-48 hours.
Taking an excessive dose of paracetamol increases the risk of poisoning and can lead to
death, especially in the following cases:
- if you are elderly
- if you suffer from liver disease
- chronic alcoholism
- in the presence of chronic malnutrition
- if you are taking other medicines or substances that increase liver function.
If an excessive dose of paracetamol is administered, the doctor will adopt the appropriate supportive therapy.
If you forget to use Tachipirina
It is unlikely that the doctor treating you will forget to administer Tachipirina. Inform the doctor
if you think that they or the nurse have not administered a dose.
If you stop using Tachipirina
Before stopping treatment with Tachipirina consult your doctor. Do not stop treatment with
Tachipirina until the doctor tells you that you can.
If you have any questions about the use of this medicine, ask your doctor.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you/the child experience the following side effects STOPtreatment with this
medicine and contact your doctor immediately:
- hypersensitivity reactions, from simple skin rash or urticaria to anaphylactic shock.
- serious skin reactions
In addition, the following side effects may occur:
Rare (may affect up to 1 in 1000 people)
- malaise
- hypotension (low blood pressure)
- changes in laboratory values (increased levels of liver transaminases). Your doctor will perform regular blood tests if necessary.
Very rare (may affect up to 1 in 10,000 people)
- abnormal decrease in the levels of certain types of blood cells (platelets, white blood cells).
Not known (frequency cannot be estimated from available data)
- skin redness
- flushing
- itching.
- abnormally accelerated heartbeat.
- pain and burning sensation at the site of administration.
- serious condition that can make the blood more acidic (called metabolic acidosis), in patients with a serious illness who use paracetamol (see section 2) Reporting of side effectsIf you get any side effects, even those not listed in this leaflet, tell your doctor. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store tachipirina
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after Scad.
The expiry date refers to the last day of that month.
Do not store at a temperature above 25 °C. Do not refrigerate or freeze. Keep the bag in the outer packaging
to protect the medicine from light.
This medicine must be used immediately. If not used immediately, the storage times and conditions
are the responsibility of the user.
Do not administer this medicine if you notice particles or a change in the color of the solution.
Do not reuse. Any unused solution must be disposed of.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Tachipirina contains
- the active ingredient is: paracetamol (1 ml of solution contains 10 mg of paracetamol)
- the other ingredients are: glucose monohydrate, acetic acid, sodiumacetate trihydrate, sodiumcitrate dihydrate (see section 2. Tachipirina contains sodium), water for injections.
Description of the appearance of Tachipirina and contents of the pack
Tachipirina is presented as a clear solution from colourless to slightly yellowish to be administered by
infusion into a vein.
The solution is contained in bags of 50 ml or 100 ml equipped with a connection point for the administration set
and enclosed in a silver plastic container.
Each pack can contain 1 or 12 bags.
Marketing Authorisation Holder
Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.
Viale Amelia, 70 - 00181 ROME.
Manufacturer
50 ml bags
A.C.R.A.F. S.p.A., Via Vecchia del Pinocchio 22 - 60131 ANCONA
ALTAN PHARMACEUTICALS, S.A, Poligono industrial de Bernedo s/n - 01118 Bernedo, Alava (Spain)
100 ml bags
A.C.R.A.F. S.p.A., Via Vecchia del Pinocchio 22 - 60131 ANCONA
ALTAN PHARMACEUTICALS, S.A, Poligono industrial de Bernedo s/n - 01118 Bernedo, Alava (Spain)
SC INFOMED FLUIDS SRL, Theodor Pallady Street 50 - Bucharest 3 – 032266 Romania
---------------------------------------------------------------------------------------------------------------------------
The following information is intended exclusively for doctors or healthcare professionals
For intravenous use.
The 100 ml bag is reserved for adults, adolescents and children with a body weight greater than 33 kg.
The 50 ml bag is reserved for full-term newborns, early infancy, children starting to
walk and children weighing less than 33 kg.
Dosage
The dosage must be based on the patient's weight (refer to the table below).
| Patient weight | Dose per administration | Volume per administration a n | d Maximum volume of Tachipirina 10 mg/ml solution for infusion per administration based on the upper weight limits of the group (ml)*** | Maximum daily dose** |
| ≤10 kg* (patients weighing exactly 10 kg are included in this group) | 7.5 mg/kg | i 0.75 ml/kg l a t I | 7.5 ml | 30 mg/kg |
| >10 kg to ≤33 kg (patients weighing exactly 33kg are included in this group) | a 15 mg/kg i z n e | 1.5 ml/kg | 49.5 ml | 60 mg/kg not exceeding 2 g |
| > 33 kg to ≤50 kg A (patients weighing exactly 50 kg are included in this group) | g 15 mg/kg | 1.5 ml/kg | 75 ml | 60 mg/kg not exceeding 3 g |
* Premature infants:No safety and efficacy data are available for premature infants.
** Maximum daily dose:The maximum daily dose, as indicated in the table above,
relates to patients who are not taking other products containing paracetamol and must be adjusted
accordingly taking into account the intake of these products.
*** Patients with lower weight require lower volumes.
The minimum interval between each administration must be at least 4 hours.
The minimum interval between each administration in patients with severe renal impairment must be at least
6 hours.
More than 4 doses in 24 hours must not be administered.
Method of administration
To avoid dosage errors due to confusion between milligrams (mg) and millilitres (ml), which could
lead to accidental overdose and death, attention must be paid when prescribing and
administering Tachipirina 10 mg/ml solution for infusion.
Ensure that the correct dose is communicated and dispensed. Include both the total dose in
mg and volume in prescriptions. Ensure that the dose is measured and administered accurately.
Paracetamol in solution is administered as an intravenous infusion in 15 minutes.
Patients weighing ≤ 10 kg:
- The bag must not be hung as in the case of an infusion, given the small volume of product to be administered to these patients.
- The volume to be administered must be drawn from the bag and diluted in 0.9% sodium chloride solution or 5% glucose solution to one-tenth (one volume of Tachipirina 10 mg/ml solution for infusion in nine volumes of diluent) and administered in 15 minutes.
- Use a 5 or 10 ml syringe to measure the appropriate dose for the child's weight and the desired volume. However, this volume should never exceed 7.5 ml per dose.
- Follow the dosage instructions on the leaflets strictly.
As with all infusion solutions contained in PVC bags, it should be remembered that close
monitoring is required, especially at the end of the infusion, regardless of the route of
administration. This monitoring at the end of the perfusion must be adopted especially in the case of
infusions through central veins, in order to avoid gaseous embolism.
Overdose
Emergency measures
Before starting treatment and as soon as possible after an overdose, take a blood sample to
determine plasma levels of paracetamol.
| >50 kg with additional risk factors for hepatic toxicity | 1 g | 100 ml | 100 ml | 3 g o c a |
| >50 kg without additional risk factors for hepatic toxicity | 1 g | 100 ml | 100 ml | m 4 g r |
Treatment includes the administration of the antidote, N-acetylcysteine (NAC), by intravenous or
oral route, preferably before the 10th hour. NAC can, however, provide a certain degree of protection even
after 10 hours, but in these cases the treatment must be prolonged.
Symptomatic treatment
Liver tests should be performed at the beginning of treatment, which will be repeated every 24 hours. In
most cases, liver transaminases return to normal in one or two weeks with a full
recovery of liver function. In very serious cases, however, a liver transplant may be necessary.
Incompatibilities
Tachipirina solution for infusion should not be mixed with other medicines.
Special precautions for storage
Do not store at temperatures above 25°C. Do not refrigerate or freeze.
Keep the bags in the outer packaging to protect the medicine from light.
From a microbiological point of view, unless the opening method guarantees against the risk of
microbial contamination, the medicine must be used immediately. If not used immediately, the
storage times and conditions are the responsibility of the user.
Special precautions for disposal and handling
The solution must be visually inspected and must not be used if there is opalescence,
visible particles or precipitates.
Do not reuse. Unused solution must be discarded.
Unused medicine and waste derived from this medicine must be disposed of in accordance with
local regulations.
For further information, consult the Summary of Product Characteristics.
During treatment with TACHIPIRINA, immediately inform your doctor if:
- If you suffer from serious illnesses, including severe renal impairment or sepsis (when bacteria and their toxins circulate in the blood causing organ damage) or malnutrition, chronic alcoholism or if you are also taking flucloxacillin (an antibiotic). Patients in these situations have reported a serious condition called metabolic acidosis (an abnormality of the blood and fluids) when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken in combination with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with rapid deep breathing, drowsiness, nausea and vomiting.
| A TACHIPIRINA GOCCE | |||
| Weight | Age (approximate) | Single dose | Daily dose |
| from 3.2 kg | 0-30 days | 8 drops | Up to 4 times (every 6 hours) |


TACHIPIRINA 120 mg/5 ml sugar-free syrup
Paracetamol
Read this leaflet carefully before using this medicine as it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- If you want more information or advice, ask your pharmacist.
- If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
- See a doctor if you do not feel better or if your symptoms worsen after 3 days of treatment.
Contents of this leaflet:
- 1. What Tachipirina is and what it is used for
- 2. What you need to know before using Tachipirina
- 3. How to use Tachipirina
- 4. Possible side effects
- 5. How to store Tachipirina
- 6. Contents of the pack and other information
1. What is Tachipirina and what is it used for
Tachipirina is an oral syrup containing the active ingredient paracetamol, which works by reducing
fever (antipyretic) and relieving pain (analgesic).
Tachipirina syrup is used in adults, adolescents and children weighing 7.2 kg or more (approximately 5-6 months)
for:
- the symptomatic treatment of febrile conditions such as influenza, exanthematous diseases (typical childhood and adolescent infectious diseases), acute respiratory tract diseases, etc.
- pains of various origins and nature (headache, neuralgia, muscle pain and other manifestations of moderate pain).
Consult a doctor if you/the child do not feel better or if you feel worse after 3 days of treatment.
2. What you need to know before using Tachipirina
Do not use Tachipirina
- if the person who is going to take the medicine is allergic to paracetamol or to any of the other ingredients of this medicine (listed in section 6)
- if the person who is going to take the medicine suffers from severe hemolytic anemia (destruction of red blood cells)
- if the person who is going to take the medicine suffers from a severe liver disease (severe hepatocellular insufficiency).
Warnings and precautions
Consult your doctor or pharmacist before using Tachipirina.
In the following cases, use Tachipirina with caution:
- if the person who is going to take the medicine chronically uses alcohol or abuses it (3 or more alcoholic drinks per day)
- if the person who is going to take the medicine suffers from anorexia (eating disorder characterized by lack or reduction of appetite)
- if the person who is going to take the medicine suffers from bulimia (eating disorder in which a person ingests an excessive amount of food and then resorts to various methods to eliminate it)
- if the person who is going to take the medicine suffers from cachexia (condition characterized by extreme thinness, reduction of muscle mass and thinning of the skin due to chronic diseases)
- if the person who is going to take the medicine has been following an incorrect diet for a long time (chronic malnutrition)
- if the person who is going to take the medicine suffers from dehydration (severe loss of water/fluids from the body)
- if the person who is going to take the medicine suffers from hypovolemia (reduced blood volume in circulation)
- if the person who is going to take the medicine suffers from liver diseases that reduce its functionality (liver insufficiency, hepatitis, Gilbert's syndrome)
- if the person who is going to take the medicine is undergoing concomitant treatment with medicines that alter liver function (see “Other medicines and Tachipirina”).
- if the person who is going to take the medicine suffers from glucose-6-phosphate dehydrogenase deficiency (a substance normally present in the human body, the deficiency of which can cause a blood disease)
- if the person who is going to take the medicine suffers from hemolytic anemia (destruction of red blood cells)
During treatment with TACHIPIRINA, immediately inform your doctor if:
- If you suffer from serious illnesses, including severe kidney impairment or sepsis (when bacteria and their toxins circulate in the blood causing organ damage) or malnutrition, chronic alcoholism or if you are also taking flucloxacillin (an antibiotic). In patients in these situations, a serious condition called metabolic acidosis (an abnormality of the blood and fluids) has been reported when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken in association with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with rapid deep breathing, drowsiness, nausea and vomiting.
Use of high doses and/or for prolonged periods
The use of high doses and/or prolonged periods of this medicine can cause alterations, even serious, to the
kidney and blood. In these cases, the doctor will monitor over time, through appropriate tests, the functionality
of the liver, kidneys and blood composition. Before taking this medicine, informyour doctor if
the person who is going to take the medicine suffers from a kidney or liver disease.
Other medicines and Tachipirina
Inform your doctor or pharmacist if you are taking or have recently taken or may take any
other medicine.
In particular, inform your doctor if the person who is going to take the medicine is taking:
- medicines that contain paracetamol.During treatment with paracetamol, before taking or giving the child any other medicine, check that it does not contain paracetamol, as if paracetamol is taken in high doses, serious side effects may occur;
- medicines that slow down stomach emptying(e.g. anticholinergics, opioids), as these medicines delay the effect of Tachipirina;
- medicines that speed up stomach emptying(e.g. prokinetics). As these medicines speed up the effect of Tachipirina;
- cholestyramine(a medicine used to reduce cholesterol levels in the blood), as it reduces the effect of paracetamol;
- chloramphenicol(an antibiotic), as it may increase the risk of side effects:
- anticoagulants(medicines used to make the blood more fluid). In case of high-dose treatments with paracetamol (4 g per day for at least 4 days), take or give the child Tachipirina only under strict medical supervision; rifampicin(an antibiotic); cimetidine(a medicine used in the treatment of stomach ulcers);
- antiepileptics(medicines used to treat epilepsy), such as glutethimide, phenobarbital, carbamazepine;
- chronic alcohol usezidovudine(medicine for the treatment of HIV);
- flucloxacillin(antibiotic), due to a serious risk of alterations in blood and fluids (called metabolic acidosis with high anion gap) which must be treated urgently. The use of these medicines with Tachipirina requires strict medical supervision.
Interference with blood tests
If the person taking the medicine needs to undergo blood tests, keep in mind that the administration of
paracetamol may interfere with the determination of uricemia and glycemia.
Tachipirina with alcohol
Take Tachipirina with caution if you chronically use alcohol or abuse it (3 or more drinks
alcohol per day), as there is a risk of intoxication (see sections “Warnings and precautions”
and “If you use more Tachipirina than you should”).
Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
If necessary, Tachipirina can be used during pregnancy. It is advisable to use the lowest possible dose that
reduces pain and/or fever and take it for the shortest possible time. Contact your doctor if the pain and/or
fever does not decrease or if you need to take the medicine more often.
This medicine can be taken during breastfeeding only if absolutely necessary and
under the control of the doctor.
Driving and operating machinery
Tachipirina does not impair the ability to drive vehicles or operate machinery.
Tachipirina contains sorbitol
If your doctor has diagnosed an intolerance to certain sugars (sorbitol), contact him before using this
medicine. Sorbitol is a source of fructose. If your doctor has told you that the child is intolerant to certain
sugars, or if you have a diagnosis of hereditary fructose intolerance, a rare genetic disease in which
patients are unable to transform fructose, talk to your doctor before the child takes this
medicine
Tachipirina contains methyl parahydroxybenzoate
It may cause allergic reactions (even delayed).
Tachipirina contains sodium
This medicine contains 24 mg of sodium per 20 ml of syrup. This is equivalent to 1.2% of the maximum
recommended daily intake with the diet of an adult.
To be taken into consideration in people with reduced kidney function or who are following a low
sodium diet.
3. How to use Tachipirina
Use this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults
20 ml at a time (corresponding to 480 mg), to be repeated if necessary after 4 hours, without exceeding 6 administrations per day.
Children (from 7.2 kg)
In children it is essential to respect the dosage defined based on body weight and not on age, which is approximate and is indicated for informational purposes only. If the child's age does not correspond to the weight shown in the table, always refer to the body weight when choosing the dosage.
The dosage scheme for Tachipirina syrup is as follows.
TACHIPIRINA SCIROPPO
Weight
Age
(approximate)
Single doseDaily dose
from 7.2 kg 5-6 months 4.5 mlUp to 4 times (every 6 hours)
from 8 kg 7-10 months 5 mlUp to 4 times (every 6 hours)
from 9 kg 11-14 months 5.5 mlUp to 4 times (every 6 hours)
from 10 kg 15-19 months 6 mlUp to 4 times (every 6 hours)
from 11 kg 20-23 months 6.5 mlUp to 4 times (every 6 hours)
from 12 kg 2 years 7.5 mlUp to 4 times (every 6 hours)
from 14 kg 3 years 8.5 mlUp to 4 times (every 6 hours)
from 16 kg 4 years 10 mlUp to 4 times (every 6 hours)
from 18 kg 5 years 11 mlUp to 4 times (every 6 hours)
from 20 kg 6 years 12.5 mlUp to 4 times (every 6 hours)
from 22 kg 7 years 13.5 mlUp to 4 times (every 6 hours)
from 25 kg 8 years 15.5 mlUp to 4 times (every 6 hours)
from 28 kg 9 years 17.5 mlUp to 4 times (every 6 hours)
from 31 kg up to
32 kg
10 years 19 mlUp to 4 times (every 6 hours)
For children weighing less than 7.2 kg, specific formulations of Tachipirina are available on the market, in
particular, Tachipirina 100 mg/ml drops, solution and Tachipirina neonati 62.5 mg, suppositories which can
be taken/used from 3.2 kg.
In children over 10 years of age, the relationship between weight and age becomes no longer homogeneous due to
pubertal development which, with the same age, has a different impact on body weight depending on gender and
individual characteristics of the child. Therefore, over 10 years of age, the dosage of the syrup is
indicated in terms of weight and age ranges, as reported below.
Children weighing between 33 and 40 kg (over 10 years of age and under 12 years): 20 ml of syrup at a
time (corresponding to 480 mg), to be repeated if necessary after 6 hours, without exceeding 4 administrations per
day.
Adolescents weighing over 40 kg (12 years of age or older) and adults: 20 ml of syrup at a
time (corresponding to 480 mg), to be repeated if necessary after 4 hours, without exceeding 6 administrations per
day.
If the doctor has diagnosed severe renal insufficiency, the interval between administrations must be
at least 8 hours.
Duration of treatment
Do not take/give Tachipirina for more than 3 consecutive days without consulting your doctor. The doctor
must assess the need for treatments for more than 3 consecutive days.
Instructions for use
To measure the dose to be given to the child, the package contains a dosing syringe with indicated level markings corresponding to 1 ml, 2 ml, 3 ml, 4 ml, 4.5 ml and 5 ml and a measuring cup with indicated level markings corresponding to 5.5 ml, 6 ml, 6.5 ml, 7.5 ml, 8.5 ml, 10 ml, 11 ml, 12.5 ml, 13.5 ml, 15.5 ml, 17.5 ml,
19 ml.
Safety cap
The Tachipirina syrup package is equipped with a safety cap.
The instructions for opening and closing are reported below:
To open:To close:
press screw on tightly
simultaneously pressing


turn
➢ After unscrewing the cap, push it down and turn it to the left at the same time,
insert the tip of the syringe fully into the hole in the undercap:

➢ Turn the bottle upside down:
➢ Holding the syringe firmly, gently pull the plunger down, filling the syringe up to

the mark corresponding to the desired dose:

Return the bottle to the upright position:

➢ Remove the syringe by gently twisting it:

➢ Insert the tip of the syringe into the child's mouth and apply slight pressure to the plunger
to allow the solution to flow. The product must be used immediately after withdrawal from
the bottle. Any residual product in the syringe must be discarded.

For dosages greater than 5 ml, draw the necessary amount with the syringe and pour the contents into
the measuring cup. Repeat the operation until reaching the mark corresponding to the indicated dosage, and
administer it to the child, inviting him/her to drink.
For dosages in children over 10 years of age and in adults, equal to 20 ml, use the measuring cup
filling it 2 times up to the 10 ml mark.
➢ The product must be used immediately after withdrawal from the bottle. Any residual product in
the syringe or measuring cup must be discarded.

After use, close the bottle by screwing the cap on tightly and wash the syringe and measuring cup with warm water.
Let them dry, keeping them out of the reach and sight of children.
If you use more Tachipirina than you should
In case of accidental ingestion/intake of an excessive dose of Tachipirina, immediately warn
your doctor or go to the nearest hospital.
Symptoms
In case of accidental intake of very high doses of paracetamol, the symptoms that you/the child may generally manifest within the first 12-48 hours include:
- anorexia (loss or reduction of appetite), nausea and vomiting followed by a profound deterioration of general conditions alterations in blood laboratory values (increased bilirubin in the blood, lactic dehydrogenase, liver transaminase levels, decreased prothrombin levels in the blood).
- liver damage that can lead to coma and death. Taking an excessive dose of paracetamol increases the risk of poisoning and can lead to death, especially in the following cases:
- if the person taking the medicine suffers from liver disease,
- chronic alcoholism,
- if the person taking the medicine has been following a poor diet for a long time (chronic malnutrition)
- if the person taking the medicine is taking other medicines or substances that increase liver function.
Treatment
The doctor, based on the nature and severity of the symptoms, will carry out the appropriate supportive therapy.
If you forget to use Tachipirina
Do not use a double dose to make up for a missed dose.
If you stop using Tachipirina
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you/the child experience the following side effects STOPtreatment with this
medicine and contact your doctor immediately:
- allergic reactions with:
- skin redness accompanied by itching (urticaria)
- swelling of the throat (laryngeal edema)
- swelling of hands, feet, ankles, face, lips, tongue and/or throat (angioedema)
- severe allergic reaction (anaphylactic shock).
In addition, people taking the medicine may experience the following side effects, for which sufficient data are not
available to establish the frequency.
- reduction in the number of platelets in the blood (thrombocytopenia)
- reduction in the number of white blood cells in the blood (leukopenia/agranulocytosis)
- reduction of hemoglobin in the blood, a substance that carries oxygen in the blood (anemia).
- dizziness.
- stomach and intestinal disorders
- abnormal liver function
- liver inflammation (hepatitis).
- red spots, blistering lesions with areas of skin detachment, blisters, skin rashes (erythema multiforme, Stevens Johnson syndrome, toxic epidermal necrolysis)
- reduced kidney function (acute renal failure)
- kidney inflammation (interstitial nephritis)
- blood in the urine (hematuria)
- cessation or reduction of urine production (anuria) .
Very rare cases of severe skin reactions have been reported
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.By reporting side effects you can
contribute to providing more information on the safety of this medicine.
5. How to store Tachipirina
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Period of validity after first opening: 1 year
Do not use this medicine after the expiry date which is reported on the pack after Exp. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
the medicines that you no longer use. This will help to protect the environment.
6. Package contents and other information
What Tachipirina contains
- the active ingredient is: paracetamol (5 ml of syrup contains 120 mg of paracetamol)
- the other ingredients are: macrogol, glycerol, sorbitol(see paragraph “Tachipirina contains sorbitol”), xylitol, methyl parahydroxybenzoate(see paragraph “Tachipirina contains methyl parahydroxybenzoate”), sodium citrate(see paragraph “Tachipirina contains sodium”), xanthan gum, citric acid, strawberry aroma, mandarin aroma, potassium sorbate, sucralose, purified water.
Description of the appearance of Tachipirina and package contents
Tachipirina is presented as a clear syrup from colorless to slightly yellow contained in a glass bottle
of 120 ml closed with a safety cap.
The package also contains a measuring cup and a dosing syringe to facilitate the calculation of the
dose of the medicine based on the child's body weight.
Marketing Authorisation Holder
Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.
Viale Amelia, 70 - 00181 Rome.
Manufacturer
A.C.R.A.F. S.p.A. - Via Vecchia del Pinocchio, 22 - 60131 Ancona.
During treatment with Tachipirina, immediately inform your doctor if:
- If you suffer from serious illnesses, including severe kidney impairment or sepsis (when bacteria and their toxins circulate in the blood causing organ damage) or malnutrition, chronic alcoholism or if you are also taking flucloxacillin (an antibiotic). In patients in these situations, a serious condition called metabolic acidosis (an abnormality of the blood and fluids) has been reported when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken in association with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with rapid deep breathing, drowsiness, nausea and vomiting.
f
| TACHIPIRINA SYRUP | |||
| Weight | Age (approximate) | Single dose | o Daily dose |
| from 22 kg | 7 years | 13.5 ml | c Up to 4 times (every 6 hours) |
| from 25 kg | 8 years | 15.5 ml | Up to 4 times (every 6 hours) |
| from 28 kg | 9 years | 17.5 ml | a Up to 4 times (every 6 hours) |
| from 31 kg to 32 kg | 10 years | 19 ml | m Up to 4 times (every 6 hours) |









TACHIPIRINA 120 mg/5 ml oral suspension vanilla caramel flavour, 120 mg/5 ml oral suspension strawberry flavour
Paracetamol
Read this leaflet carefully before using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- If you want more information or advice, ask your pharmacist.
- If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
- See a doctor if you do not feel better or if your symptoms worsen after 3 days of treatment.
Contents of this leaflet:
- 1. What Tachipirina is and what it is used for
- 2. What you need to know before using Tachipirina
- 3. How to use Tachipirina
- 4. Possible side effects
- 5. How to store Tachipirina
- 6. Contents of the pack and other information
1. What is Tachipirina and what is it used for
Tachipirina is an oral suspension containing the active ingredient paracetamol.
Paracetamol works by reducing fever (antipyretic) and relieving pain (analgesic).
Tachipirina suspension is used in adults, adolescents and children weighing 7.2 kg or more (approximately 5-6 months)
for:
- the symptomatic treatment of febrile states such as influenza, exanthematous diseases (typical infectious diseases of children and adolescents), acute respiratory tract diseases, etc.
- pains of various origins and nature (headache, neuralgia, muscle pain and other manifestations of moderate pain). Consult a doctor if you/the child do not feel better or if you feel worse after 3 days of treatment.
2. What you need to know before using Tachipirina
Do not use Tachipirina
- if the person who is going to take the medicine is allergic to paracetamol or to any of the other ingredients of this medicine (listed in section 6)
- if the person who is going to take the medicine suffers from severe hemolytic anemia (a disease due to the destruction of some blood cells, red blood cells)
- if the person who is going to take the medicine suffers from a severe liver disease (severe hepatocellular insufficiency).
Warnings and precautions
Consult your doctor or pharmacist before using Tachipirina.
In the following cases, use Tachipirina with caution:
- if the person who is going to take the medicine regularly uses alcohol or abuses it (3 or more alcoholic drinks per day)
- if the person who is going to take the medicine suffers from anorexia (eating disorder characterized by a lack or reduction of appetite)
- if the person who is going to take the medicine suffers from bulimia (eating disorder in which a person ingests an excessive amount of food and then resorts to various methods to eliminate it)
- if the person who is going to take the medicine suffers from cachexia (condition characterized by extreme thinness, reduction of muscle mass and thinning of the skin due to chronic diseases)
- if the person who is going to take the medicine has been following an incorrect diet for a long time (chronic malnutrition)
- if the person who is going to take the medicine suffers from dehydration (severe loss of water/fluids from the body)
- if the person who is going to take the medicine suffers from hypovolemia (reduced blood volume in circulation)
- if the person who is going to take the medicine has liver diseases that reduce its functionality (hepatic insufficiency, hepatitis, Gilbert's syndrome)
- if the person who is going to take the medicine is undergoing concomitant treatment with drugs that alter liver function (see “Other medicines and Tachipirina”)
- if the person who is going to take the medicine suffers from glucose-6-phosphate dehydrogenase deficiency (a substance normally present in the human body, the deficiency of which can cause a blood disease)
- if the person who is going to take the medicine suffers from hemolytic anemia (a disease due to the destruction of some blood cells, red blood cells).
During treatment with Tachipirina, immediately inform your doctor if:
- If you suffer from serious illnesses, including severe kidney impairment or sepsis (when bacteria and their toxins circulate in the blood causing organ damage) or malnutrition, chronic alcoholism or if you are also taking flucloxacillin (an antibiotic). In patients in these situations, a serious condition called metabolic acidosis (an abnormality of the blood and fluids) has been reported when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken in association with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with rapid deep breathing, drowsiness, nausea and vomiting. Use of high doses and/or for prolonged periodsThe use of high doses and/or prolonged use of this medicine can cause even serious alterations to the kidney and blood. In these cases, the doctor will monitor the functionality of the liver, kidneys and the composition of the blood over time, through appropriate tests. Before taking this medicine, informthe doctor if the person who is going to take the medicine suffers from a kidney or liver disease.
Other medicines and Tachipirina
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
In particular, tell your doctor if the person who is going to take the medicine is taking:
- medicines that contain paracetamol.During treatment with paracetamol, before taking or giving the child any other medicine, check that it does not contain paracetamol, as if paracetamol is taken in high doses, serious side effects can occur;
- medicines that slow down stomach emptying(e.g. anticholinergics, opioids), as these medicines delay the effect of Tachipirina;
- medicines that speed up stomach emptying(e.g. prokinetics). As these medicines accelerate the effect of Tachipirina;
- cholestyramine(a medicine used to reduce cholesterol levels in the blood), as it reduces the effect of paracetamol;
- chloramphenicol(an antibiotic), as it may increase the risk of side effects;
- anticoagulants(medicines used to make the blood more fluid). In case of high-dose treatments with paracetamol (4 g per day for at least 4 days), take or give the child Tachipirina only under strict medical supervision;
- rifampicin(an antibiotic);
- cimetidine(a medicine used in the treatment of stomach ulcers);
- antiepileptics(medicines used to treat epilepsy), for example glutethimide, phenobarbital, carbamazepine;
- chronic alcohol use;
- zidovudine(a medicine for the treatment of HIV);
- flucloxacillin(antibiotic), due to a serious risk of alterations in blood and fluids (called metabolic acidosis with high anion gap) which must be treated urgently ().
The use of these medicines with Tachipirina requires strict medical supervision.
Interference with blood tests
If the person taking the medicine has to undergo blood tests, keep in mind that the administration of
paracetamol may interfere with the determination of uricemia and glycemia.
Tachipirina with alcohol
Take Tachipirina with caution if you regularly use alcohol or abuse it (3 or more alcoholic drinks
per day), as there is a risk of intoxication (see sections “Warnings and precautions”
and “If you use more Tachipirina than you should”).
Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
If necessary, Tachipirina can be used during pregnancy. It is advisable to use the lowest possible dose that
reduces pain and/or fever and take it for the shortest possible time. Contact your doctor if the pain and/or
fever does not decrease or if you have to take the medicine more often.
This medicine can be taken during breastfeeding only if absolutely necessary and under the
control of the doctor.
Driving and operating machinery
Tachipirina does not impair the ability to drive vehicles or operate machinery.
Tachipirina contains sucrose
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this
medicine.
Tachipirina contains 10 g of sucrose per 20 ml of suspension. To be taken into consideration in people
affected by diabetes mellitus.
Tachipirina contains methyl parahydroxybenzoate
It may cause allergic reactions (even delayed).
Tachipirina contains sodium
This medicine contains less than 1 mmol per 20 ml, i.e. it is essentially “sodium-free”.
Tachipirina contains sorbitol
This medicine contains 1806 mg of sorbitol per 20 ml dose. Sorbitol is a source of fructose. If
your doctor has told you that you (or your child) are intolerant to certain sugars, or if you have a diagnosis of
hereditary fructose intolerance, a rare genetic disease (HFI) where patients are unable to
transform fructose, talk to your doctor before you (or your child) take this medicine.
It may cause gastrointestinal discomfort and have a mild laxative effect.
3. How to use Tachipirina
Use this medicine following exactly as indicated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults
20 ml at a time (corresponding to 480 mg), to be repeated if necessary after 4 hours, without exceeding 6 administrations per day.
Children (weighing 7.2 kg and over)
In children, it is essential to respect the dosage defined based on body weight and not on age, which is approximate and is provided for informational purposes only. If the child's age does not correspond to the weight shown in the table, always refer to the body weight when choosing the dosage.
The dosage schedule for Tachipirina suspension is as follows.
TACHIPIRINA SUSPENSION
Weight
Age
(approximate)
Single doseDaily dose
from 7.2 kg 5-6 months 4.5 mlUp to 4 times (every 6 hours)
from 8 kg 7-10 months 5 mlUp to 4 times (every 6 hours)
from 9 kg 11-14 months 5.5 mlUp to 4 times (every 6 hours)
from 10 kg 15-19 months 6 mlUp to 4 times (every 6 hours)
from 11 kg 20-23 months 6.5 mlUp to 4 times (every 6 hours)
from 12 kg 2 years 7.5 mlUp to 4 times (every 6 hours)
from 14 kg 3 years 8.5 mlUp to 4 times (every 6 hours)
from 16 kg 4 years 10 mlUp to 4 times (every 6 hours)
from 18 kg 5 years 11 mlUp to 4 times (every 6 hours)
from 20 kg 6 years 12.5 mlUp to 4 times (every 6 hours)
from 22 kg 7 years 13.5 mlUp to 4 times (every 6 hours)
from 25 kg 8 years 15.5 mlUp to 4 times (every 6 hours)
from 28 kg 9 years 17.5 mlUp to 4 times (every 6 hours)
from 31 kg up to
32 kg
10 years 19 mlUp to 4 times (every 6 hours)
For children weighing less than 7.2 kg, specific formulations of Tachipirina are available on the market, in particular, Tachipirina 100 mg/ml drops, solution and Tachipirina neonates 62.5 mg, suppositories which can be taken/used from 3.2 kg.
In children over 10 years of age, the relationship between weight and age becomes no longer homogeneous due to pubertal development which, with the same age, has a different impact on body weight depending on sex and individual characteristics of the child. Therefore, over 10 years of age, the dosage of the suspension is indicated in terms of weight and age ranges, as reported below.
Children weighing between 33 and 40 kg (aged over 10 years and under 12 years): 20 ml of suspension at a time (corresponding to 480 mg), to be repeated if necessary after 6 hours, without exceeding 4 administrations per day.
Adolescents weighing over 40 kg (aged 12 years or over) and adults: 20 ml of suspension at a time (corresponding to 480 mg), to be repeated if necessary after 4 hours, without exceeding 6 administrations per day.
If your doctor has diagnosed severe renal insufficiency, the interval between administrations must be at least 8 hours.
Duration of treatment
Do not take/give Tachipirina to the child for more than 3 consecutive days without consulting your doctor. The doctor must assess the need for treatments for more than 3 consecutive days.
Instructions for use
Shake the bottle before use, then follow the instructions below.
To measure the dose to be given to the child, the package contains a dosing syringe with indicated level markings corresponding to 1 ml, 2 ml, 3 ml, 4 ml, 4.5 ml and 5 ml and a measuring cup with indicated level markings corresponding to 5.5 ml, 6 ml, 6.5 ml, 7.5 ml, 8.5 ml, 10 ml, 11 ml, 12.5 ml, 13.5 ml, 15.5 ml, 17.5 ml, 19 ml.
Safety cap
The Tachipirina suspension package is equipped with a safety cap.
The instructions for opening and closing are reported below:
To open:To close:
press screw on tightly
simultaneously pressing
turn


➢ After unscrewing the cap, pushing it down and simultaneously turning to the left,
fully insert the tip of the syringe into the hole in the stopper:

➢ Turn the bottle upside down:
➢ Holding the syringe firmly, gently pull the plunger down, filling the syringe up to

the mark corresponding to the desired dose:

Return the bottle to the vertical position:

➢ Remove the syringe by gently rotating it:

➢ Insert the tip of the syringe into the child's mouth and apply slight pressure to the plunger to dispense the suspension. The product must be used immediately after removal from the bottle. Any residual product in the syringe must be discarded.

For dosages greater than 5 ml, draw the necessary amount with the syringe and pour the contents into the measuring cup. Repeat the operation until reaching the mark corresponding to the indicated dosage, and administer it to the child, encouraging him/her to drink.
For dosages in children over 10 years of age and in adults, equal to 20 ml, use the measuring cup filling it 2 times up to the 10 ml mark.
➢ The product must be used immediately after removal from the bottle. Any residual product in the syringe or measuring cup must be discarded.

After use, close the bottle by screwing the cap on tightly and wash the syringe and measuring cup with warm water.
Let them dry, keeping them out of the reach and sight of children.
If you use more Tachipirina than you should
In case of accidental ingestion/intake of an excessive dose of Tachipirina, immediately inform your doctor or go to the nearest hospital.
Symptoms
In case of accidental intake of very high doses of paracetamol, the symptoms that you/the child may generally manifest within the first 12-48 hours include:
- anorexia (loss or reduction of appetite), nausea and vomiting followed by a profound deterioration of general conditions and alterations in blood laboratory values (increased transaminases, lactic dehydrogenase and bilirubin, reduction of prothrombin levels);
- liver damage that can lead to coma and death. Taking an excessive dose of paracetamol increases the risk of poisoning and can lead to death, especially in the following cases:
- if the person taking the medicine suffers from liver disease,
- chronic alcoholism,
- if the person taking the medicine has been following a poor diet for a long time (chronic malnutrition),
- if the person taking the medicine is taking medicines or substances that increase liver function. Treatment The doctor, based on the nature and severity of the symptoms, will carry out the appropriate supportive therapy.
If you forget to use Tachipirina
Do not use a double dose to make up for a missed dose.
If you stop using Tachipirina
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you/the child experience the following side effects STOPtreatment with this
medicine and contact your doctor immediately:
- allergic reactions with:
- redness of the skin accompanied by itching (urticaria)
- swelling of the throat (laryngeal edema)
- swelling of hands, feet, ankles, face, lips, tongue and/or throat (angioedema)
- severe allergic reaction (anaphylactic shock).
In addition, people taking the medicine may experience the following side effects, for which sufficient data are not
available to establish the frequency.
- reduction in the number of platelets in the blood (thrombocytopenia)
- reduction in the number of white blood cells in the blood (leukopenia/agranulocytosis)
- reduction in hemoglobin in the blood, a substance that carries oxygen in the blood (anemia)
- dizziness
- stomach and intestinal disorders
- abnormal liver function
- liver inflammation (hepatitis)
- red spots, blistering lesions with areas of skin detachment, blisters, skin rashes (erythema multiforme, Stevens Johnson syndrome, toxic epidermal necrolysis)
- reduced kidney function (acute renal failure)
- kidney inflammation (interstitial nephritis)
- blood in the urine (hematuria)
- cessation or reduction in urine production (anuria)
- severe condition that can make the blood more acidic (called metabolic acidosis), in patients with a serious illness who use paracetamol (see paragraph 2)
Very rare cases of severe skin reactions have been reported.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.
5. How to store Tachipirina
Keep this medicine out of the sight and reach of children.
Do not store at a temperature above 25°C.
Period of validity after first opening: 1 year.
Do not use this medicine after the expiry date which is reported on the package after Scad. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Tachipirina contains
Vanilla caramel flavour suspension
- The active ingredient is paracetamol (each ml of suspension contains 24 mg of paracetamol).
- The other ingredients are: sorbitol, saccharose, xanthan gum, disodium edetate (dihydrate), methyl parahydroxybenzoate, microcrystalline cellulose and sodium carboxymethylcellulose, sodiumcitrate, sodiumchloride, potassiumsorbate, anhydrous colloidal silica, citric acid monohydrate, vanilla-caramel flavour, purified water. Strawberry flavour suspension
- The active ingredient is paracetamol (each ml of suspension contains 24 mg of paracetamol).
- The other ingredients are: sorbitol, saccharose, xanthan gum, disodium edetate (dihydrate), methyl parahydroxybenzoate, microcrystalline cellulose and sodium carboxymethylcellulose, sodiumcitrate, sodiumchloride, potassiumsorbate, anhydrous colloidal silica, citric acid monohydrate, strawberry flavour, purified water.
Description of the appearance of Tachipirina and contents of the pack
Tachipirina is presented as a homogeneous suspension ranging in colour from milky white to slightly
brownish, contained in an amber bottle of 120 ml closed with a safety cap.
The pack also contains an oral administration syringe and a measuring cup to facilitate
calculation of the product dose based on the child's body weight.
Marketing Authorisation Holder
Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.
Viale Amelia, 70 - 00181 Rome.
Manufacturer
A.C.R.A.F. S.p.A. - Via Vecchia del Pinocchio, 22 - 60131 Ancona.
By scanning the QR Code on the package or visiting https://leaflet.angelinipharma.com/L31 you can read

- Страна регистрации
- Форма выпускаSyrup, 120 MG/5 ML
- Код АТХN02BE01
- Действующее вещество
- Отпускается по рецептуНет
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги TAKIPIRINAФорма выпуска: Effervescent granules, 300 MGДействующее вещество: ПарацетамолПроизводитель: ABIOGEN PHARMA S.P.A.Отпускается без рецептаФорма выпуска: Effervescent tablet, 500 MGДействующее вещество: ПарацетамолПроизводитель: UPSA SASОтпускается без рецептаФорма выпуска: Effervescent tablet, 1000 MGДействующее вещество: ПарацетамолОтпускается по рецепту
Аналоги TAKIPIRINA в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог TAKIPIRINA в Испания
Аналог TAKIPIRINA в Польша
Аналог TAKIPIRINA в Украина
Врачи онлайн по TAKIPIRINA
Обсудите применение TAKIPIRINA и возможные следующие шаги — по оценке врача.
Получите рецепт на TAKIPIRINA онлайн
Заполните форму за 2 минуты
Расскажите о симптомах, истории болезни и нужном препарате.
Выберите врача или мы назначим
Выберите специалиста или мы подберём ближайшего доступного врача.
Врач рассматривает ваш случай
Обычно в течение 30 минут. Может задать уточняющие вопросы в чате.
Получите в любой аптеке
Электронный рецепт отправляется на вашу почту — действителен по всей Польше.
Часто задаваемые вопросы
TAKIPIRINA не требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество TAKIPIRINA — Парацетамол. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
TAKIPIRINA производится компанией AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO A.C.R.A.F. S.P.A.. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
Врачи, включая Семейные врачи, Психиатры, Дерматологи, Кардиологи, Эндокринологи, Гастроэнтерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Инфекционисты, Аллергологи, Гериатры, Педиатры, Онкологи, могут оценить целесообразность применения TAKIPIRINA с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
Польша имеет хорошо развитую систему здравоохранения в крупных городах, таких как Варшава, Краков, Вроцлав и Гданьск. Аптеки широко доступны и работают в соответствии с действующим законодательством, обеспечивая доступ к рецептурным препаратам.
Вы можете купить TAKIPIRINA в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
Чтобы получить рецепт, вы можете воспользоваться Oladoctor:
Другие лекарства с тем же действующим веществом (Парацетамол) включают AKETAMOL, EFFERALGAN, EFFERAMOL. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
















