TACHIPIRINAKID 120 mg /5 Ml Oral Suspension

Зміст інструкції

1. TACHIPIRINAKID 120 mg/5 ml oral suspension
   1. What is TACHIPIRINAKID and what is it used for
   2. What you need to know before using TACHIPIRINAKID
   3. How to use TACHIPIRINAKID
2. TACHIPIRINAKID SUSPENSION
   1. Possible side effects
   2. How to store TACHIPIRINAKID
   3. Contents of the pack and other information

TACHIPIRINAKID 120 mg/5 ml oral suspension

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 TACHIPIRINAKID is and what it is used for
• 2. What you need to know before using TACHIPIRINAKID
• 3. How to use TACHIPIRINAKID
• 4. Possible side effects
• 5. How to store TACHIPIRINAKID
• 6. Contents of the pack and other information

1. What is TACHIPIRINAKID and what is it used for

TACHIPIRINAKID is an oral suspension containing the active ingredient paracetamol.
Paracetamol works by reducing fever (antipyretic) and relieving pain (analgesic).
TACHIPIRINAKID suspension is used in adolescents and children from 7.2 kg of weight (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 does not feel better or if you feel worse after 3 days of treatment.

2. What you need to know before using TACHIPIRINAKID

Do not use TACHIPIRINAKID

• 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 TACHIPIRINAKID.
In the following cases, use TACHIPIRINAKID 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 (an eating disorder characterized by a lack or reduction of appetite)
• if the person who is going to take the medicine 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)
• if the person who is going to take the medicine suffers from cachexia (a 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 TACHIPIRINAKID”).
• 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 TACHIPIRINAKID, 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). 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. Use of high doses and/or for prolonged periodsThe use of high doses and/or prolonged use of this medicine can cause alterations, even serious, to the kidney and blood. In these cases, the doctor will monitor the functionality of the liver, kidneys and blood composition 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 TACHIPIRINAKID
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 TACHIPIRINAKID;
• medicines that speed up stomach emptying(e.g. prokinetics). As these medicines accelerate the effect of TACHIPIRINAKID;
• 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 TACHIPIRINAKID 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 (a 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 TACHIPIRINAKID 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.

TACHIPIRINAKID with alcohol
Take TACHIPIRINAKID with caution if you chronically 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 take/give the child more TACHIPIRINAKID than you should”).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
If necessary, TACHIPIRINAKID can be used during pregnancy. It is advisable to use the lowest possible
dose that relieves pain and/or fever and to 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.

Driving and using machines
TACHIPIRINAKID does not impair the ability to drive vehicles or operate machinery.

TACHIPIRINAKID contains sucrose
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this
medicine.
TACHIPIRINAKID contains 10 g of sucrose per 20 ml of suspension. To be taken into consideration in
people affected by diabetes mellitus.

TACHIPIRINAKID contains methyl parahydroxybenzoate
It may cause allergic reactions (even delayed).

TACHIPIRINAKID contains sodium
This medicine contains less than 1 mmol per 20 ml, i.e. it is essentially “sodium-free”

TACHIPIRINAKID 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 the child) 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 you (or the child) take this medicine.
It may cause gastrointestinal discomfort and have a mild laxative effect.

3. How to use TACHIPIRINAKID

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.

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 TACHIPIRINAKID suspension is as follows.

TACHIPIRINAKID 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 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, for 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 (over 10 years of age 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 (12 years of age or older): 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 the doctor has diagnosed severe renal failure, the interval between administrations must be
at least 8 hours.

Duration of treatment
Do not take/give the child TACHIPIRINAKID for more than 3 consecutive days without consulting the 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 TACHIPIRINAKID 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 turning it to the left at the same time,
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 allow the suspension 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, encouraging him/her to drink.
For dosages in children over 10 years of age, 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.

Ifyou give the child more TACHIPIRINAKID than you should
In case of accidental ingestion/intake of an excessive dose of TACHIPIRINAKID, 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 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 TACHIPIRINAKID
Do not use a double dose to make up for the missed dose.

If you stop using TACHIPIRINAKID
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:
• 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)
• inflammation of the kidneys (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 TACHIPIRINAKID

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 the
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What TACHIPIRINAKID contains

• The active ingredient is paracetamol (each ml of suspension contains 24 mg of paracetamol).
• The other ingredients are: sorbitol, sucrose, xanthan gum, disodium edetate (dihydrate), methyl parahydroxybenzoate, microcrystalline cellulose and sodiumcarmellose (Avicel RC591), sodiumcitrate, sodiumchloride, potassiumsorbate, anhydrous colloidal silica, citric acid monohydrate, vanilla-caramel flavour, purified water.

Description of the appearance of TACHIPIRINAKID and contents of the pack
TACHIPIRINAKID is presented as a homogeneous suspension from milky white to slightly
brownish in colour contained in an amber bottle of 120 ml closed with a safety cap.
The pack also contains a dosing syringe and a measuring cup to facilitate the calculation of the dose
of the product 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.