TACHICAF 1000 mg/130 mg Granulat

Treść ulotki

1. TACHICAF 1000 mg/130 mg effervescent granules for oral solution
   1. What is Tachicaf and what is it for
   2. What you need to know before taking Tachicaf
   3. How to take Tachicaf
   4. Possible side effects
   5. How to store Tachicaf
   6. Contents of the pack and other information

TACHICAF 1000 mg/130 mg effervescent granules for oral solution

Paracetamol/Caffeine

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 may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is Tachicaf and what is it for

Tachicaf contains two active ingredients: paracetamol and caffeine.
Paracetamol works by relieving pain, and caffeine increases the effect of paracetamol.
Tachicaf is used in adultsand adolescents over 15 years of agefor pain of all
kinds (for example, headache, joint, bone and muscle pain, toothache, menstrual pain,
surgical procedures).
See your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Tachicaf

Do not take Tachicaf

• if you are allergic to paracetamol, caffeine or any of the other ingredients of this medicine (listed in section 6)
• if the person who is going to take the medicine is under 15 years of age
• if you suffer from severe hemolytic anemia (a disease due to the destruction of some blood cells, red blood cells)
• if you suffer from a severe liver disease (severe hepatocellular insufficiency)
• if you suffer from phenylketonuria as Tachicaf contains a sweetener (aspartame) which is a source of phenylalanine, a substance that is not processed by those who have this disease (see section “Tachicaf contains maltitol, sodium and aspartame”).

Warnings and precautions
Consult your doctor or pharmacist before taking Tachicaf.
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 liver diseases that reduce its functionality (mild/moderate hepatic insufficiency, Gilbert's syndrome)
• 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 Tachicaf”).

During treatment with Tachicaf, 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. The symptoms of metabolic acidosis may include: severe breathing difficulties 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 liver disorders
(hepatopathy) and alterations also serious to the kidney and blood. In this case, the doctor
will monitor over time, through appropriate tests, the functionality of the liver, kidneys and the
composition of the blood. Furthermore, the doctor will check for the presence of any symptoms related to the
excessive presence of caffeine in the blood (see the entries “If you take more Tachicaf than you should” and
“Possible side effects”).
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
Donot give Tachicaf to children and adolescents under 15 years of age (see section “Do not take
Tachicaf”).

Other medicines and Tachicaf
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 Tachicaf;
• medicines that speed up stomach emptying(e.g. prokinetics). As these medicines accelerate the effect of Tachicaf;
• 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;
• 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);
• oral anticoagulantswhich are medicines used to make the blood more fluid. In this case, especially for prolonged and high-dose treatments with paracetamol (4 g per day for at least 4 days), take Tachicaf only under strict medical control;
• clozapine(a medicine used to treat mental disorders), as it may increase the risk of side effects;
• lithium(a medicine used to treat mental disorders), as it may decrease the effect of lithium;
• flucloxacillin(antibiotic), due to a serious risk of blood and fluid alterations (called metabolic acidosis with high anion gap) which must be treated urgently.

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.

Tachicaf with food, drinks and alcohol
During treatment with Tachicaf, avoid consuming excessive amounts of coffee and tea, or other
substances containing caffeine.
Also, take Tachicaf with caution and only under strict medical control if you abuse alcohol.

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, Tachicaf 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.

Driving and operating machinery
Tachicaf normally does not alter the ability to drive vehicles or operate machinery. However, keep in
mind that you may experience dizziness.

Tachicaf 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 15 mmol (or 345 mg) of sodium per sachet. To be taken into
consideration in people with reduced kidney function or who are following a low-sodium diet.

Aspartame: this medicine contains a source of phenylalanine. It may be harmful if you suffer from
phenylketonuria.

3. How to take Tachicaf

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 of age
The recommended dose is 1 sachet, to be dissolved in water, 1-2 times a day; in more severe cases, the
dose may be increased up to 3 sachets per day.
The interval between different administrations must not be less than four hours.

If you take more Tachicaf than you should
In case of accidental intake of an excessive dose of Tachicaf, immediately inform your
doctor or go to the nearest hospital.
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
• vomiting
• severe deterioration of general conditions
• yellowish skin and eyes (increased bilirubin in the blood)
• alterations in blood laboratory values (reduction of prothrombin levels in the blood, increase of liver transaminases, lactate dehydrogenase enzyme and bilirubinemia)
• severe liver disease (which can cause serious conditions: hepatocellular insufficiency, metabolic acidosis and encephalopathy) and finally coma and death.

Furthermore, you may experience the following adverse effects due to the excessive presence of caffeine
in the blood:

• anxiety, agitation, insomnia, which generally disappear shortly after stopping therapy
• disorders of heart rate and rhythm (tachycardia, arrhythmia)
• increased urine production
• stomach and intestinal disorders.

Treatment
The doctor, based on the nature and severity of the symptoms, will carry out the appropriate supportive therapy.

Note for healthcare professionals: the specific antidote in case of paracetamol poisoning is N-
acetylcysteine administered intravenously: the dosage is 150 mg/kg i.v. in glucose solution in 15
minutes, then 50 mg/kg in the following 4 hours and 100 mg/kg in the following 16 hours, for a total of 300
mg/kg in 20 hours. In case of caffeine poisoning, it is suggested to perform early gastric emptying and to practice supportive therapy.

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 your doctor immediately:

• 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 life-threatening allergic reaction (anaphylactic shock).

In addition, very rare cases of severe skin reactions have been reported.
The person taking the medicine may experience the following side effects, for which there are
insufficient data to establish the frequency.

Effects affecting the blood

• 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).

Effects affecting the nervous system

• dizziness.

Effects affecting the stomach and intestines

• stomach and intestinal disorders, such as vomiting, diarrhea and abdominal pain.

Effects affecting the liver

• abnormal liver function
• inflammation of the liver (hepatitis).

Effects affecting the skin and subcutaneous tissue

• red spots, blistering lesions with areas of skin detachment, blisters, skin rashes (erythema multiforme, Stevens Johnson syndrome, toxic epidermal necrolysis)

Very rare cases of severe skin reactions have been reported.

Effects affecting the kidneys and urinary tract

• reduction in kidney function (acute renal failure)
• inflammation of the kidneys (interstitial nephritis)
• blood in the urine (hematuria)
• cessation or reduction in urine production (anuria) .

Frequency not known (cannot be estimated on the basis of available data): severe condition that can
make the blood more acidic (called metabolic acidosis), in patients with a serious illness who
use paracetamol (see section 2).
In addition, you may experience the following side effects, the onset of which can be avoided if
during treatment with Tachicaf you reduce your daily intake of coffee and tea, or other substances
containing caffeine.

Effects affecting the mind

• insomnia
• restlessness
• excitement.

Effects affecting the heart

• increased heart rate (tachycardia)
• irregular heartbeat, i.e. the number of heartbeats per minute (arrhythmia).

Reporting of side effects
If anyone taking the medicine experiences 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
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 Tachicaf

Keep this medicine out of sight and reach of children.
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 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 Tachicaf contains

• the active ingredients are: paracetamol and caffeine (each sachet contains 1000 mg of paracetamol and 130 mg of caffeine)
• the other ingredients are :maltitol, sodiumbicarbonate, sodiumdocusate, aspartame(see section “Tachicaf contains maltitol, sodium and aspartame”), mannitol, anhydrous citric acid, orange flavour, simethicone emulsion.

Description of the appearance of Tachicaf and contents of the pack
Tachicaf is presented as an effervescent granules for oral use, ranging in colour from white to slightly yellow.
The granules are contained in sachets packaged in cartons of 10, 12, 16 and 20 sachets
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.