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

Tachipirina contains the active ingredient paracetamol which reduces fever (antipyretic) and alleviates pain (analgesic).

Tachipirina is used in children with a body weight of between 11 and 40 kg for:

-       the symptomatic treatment of feverish conditions such as influenza, exanthematous diseases (infectious diseases typical in children and adolescents), acute diseases of the respiratory tract, etc.;

-       pain of various types and origins (headache, neuralgia, muscular pain and other moderate manifestations of pain).

You must talk to a doctor if your child does not feel better or feels worse after 3 days of treatment.

Do not give Tachipirina to children

-      if they are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6);

-      if they suffer from severe haemolytic anaemia (destruction of red blood cells);

-      if they suffer from severe liver disease (severe hepatocellular disease).

Warnings and precautions

Talk to your doctor or pharmacist before using Tachipirina.

Use caution when giving Tachipirina to children if they:

-       suffer from anorexia (eating behaviour disorder characterised by a lack or reduction of appetite);

-       suffer from bulimia (eating behaviour disorder in which a person ingests an excessive quantity of food and subsequently uses various methods to eliminate it);

-       suffer from cachexia (a condition characterised by extreme thinness, reduced muscle mass and thinning of the skin caused by chronic diseases);

-       have followed an improper diet over a long period of time (chronic malnutrition);

-       suffer from dehydration (severe loss of water/fluids in the body);

-       suffer from hypovolaemia (low blood volume in the body);

-       suffer from liver disease which reduces functionality (liver impairment, hepatitis, Gilbert’s syndrome);

-       are under concomitant treatment with medicinal products which alter liver function (see “Other medicines and Tachipirina”);

-       suffer from a shortage of glucose-6-phosphate dehydrogenase (a substance normally present in the human body, a shortage of which can cause a blood disorder);

-       suffer from haemolytic anaemia (destruction of red blood cells).

Use at high doses and/or for prolonged periods

The use of high and/or prolonged doses of this medicinal product can cause kidney and blood alterations, some severe. In such cases, the doctor will perform specific tests to monitor liver and kidney function and blood composition over time.

Before giving this medicinal product to a child, tell your doctor if the child suffers from any liver or kidney disorder.

Children and adolescents

Tachipirina suppositories may be given to children with a body weight of between 11 kg and 40 kg (see section 3 “How to take Tachipirina”).

Other medicines and Tachipirina

Tell your doctor or pharmacist if the child is taking, has recently taken or might take any other medicines.

In particular, tell your doctor if the person intending to take the medicinal product is taking:

-     medicinal products which contain paracetamol. During treatment with paracetamol, before taking any other medicine, check that it does not contain paracetamol, as when taken at high doses paracetamol can result in severe adverse effects;

-     chloramphenicol (an antibiotic) as this can increase the risk of side effects;

-     anticoagulants (medicinal products used to improve blood flow). If under treatment with high doses of paracetamol (4 g daily for at least 4 days), Tachipirina should only be taken under strict medical supervision;

-     rifampicin (an antibiotic);

-     cimetidine (a medicinal product used in the treatment of stomach ulcers);

-     antiepileptics (medicinal products used to treat epilepsy) such as glutethimide, phenobarbital or carbamazepine;

-     zidovudine (medicinal product used in the treatment of HIV).

The use of these medicinal products with Tachipirina requires close medical supervision.

Interference with blood tests

Should the person taking this medicinal product have to undergo blood tests, be aware that the administration of paracetamol can interfere with the determination of uricaemia and glycaemia.

Tachipirina with alcohol

The use of alcohol increases the risk of intoxication (see sections “Warnings and precautions” and “If you take more Tachipirina than you should”).

Driving and using machines

Tachipirina has no influence on the ability to drive (including bicycles) and use machines.

Always give this medicine to children exactly as described in this leaflet or as advised by a doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

For children, it is essential to follow the dose prescribed based on their body weight.

Ages as an approximation of body weight are given for your information:

For children weighing less than 11 kg, other Tachipirina suppositories or other specific forms of Tachipirina can be used. Ask your doctor or pharmacist for advice.

If the child suffers from severe liver impairment (severe reduction in liver function)

If your doctor has diagnosed your child with a severe liver impairment, you must wait at least 8 hours between doses.

Duration of use

Do not give your child Tachipirina for more than 3 consecutive days without consulting a doctor. A doctor must assess the need for treatment for more than 3 consecutive days.

If you use more Tachipirina than you should

In the event of accidental ingestion/intake of an excessive dose of Tachipirina, contact a doctor immediately or go to the nearest hospital.

Symptoms

In the event of accidental ingestion of very high doses of paracetamol, the symptoms that generally appear within the first 12-48 hours include:

-         anorexia (lack or reduction of appetite), nausea and vomiting followed by a significant deterioration in general condition, alterations of blood laboratory levels (increased levels of bilirubin in the blood, lactate dehydrogenase, liver transaminase, reduced blood prothrombin levels);

-         liver damage that can lead to coma or death.

Taking an excessive dose of paracetamol increases the risk of intoxication and can lead to death, particularly in the following cases:

-         if the person taking the medicinal product suffers from liver disease;

-         chronic alcoholism,

-         if the person taking the medicinal product has followed an improper diet over a long period of time (chronic malnutrition);

-         if the person taking the medicinal product is taking other medicinal products or substances which increase liver function.

Treatment

The doctor will prescribe the most suitable supportive treatment according to the nature and severity of the symptoms.

If you forget to use Tachipirina

Do not give your child a double dose to make up for a forgotten dose.

If you stop using Tachipirina

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone gets them.

If your child shows any of the following side effects, STOP treatment with this medicine and contact your doctor immediately:

• allergic reactions with:

-    reddening of skin accompanied by itching (urticaria);

-    swelling of the throat (laryngeal oedema);

-    swelling of the hands, feet, ankles, face, lips, tongue and/or throat (angioedema);

-    serious allergic reactions (anaphylactic shock).

The person taking this medicinal product could experience the following side effects, on which there is insufficient data available to establish their frequency.

• reduction in blood platelet count (thrombocytopenia);
• reduced white blood cell count (leukopenia/agranulocytosis);
• reduced haemoglobin, a substance that transports oxygen in the blood (anaemia);
• vertigo;
• stomach or intestinal reactions;
• impaired liver function;
• liver inflammation (hepatitis);
• red spots, blisters with areas of skin detachment, blisters, skin eruptions (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis);
• impaired kidney function (acute renal failure);
• inflammation of the kidneys (interstitial nephritis);
• blood in the urine (haematuria);
• cessation or reduced production of urine from the kidney (anuria).

Very rare cases of severe skin reactions have been reported.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system on the website 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.

Keep this medicine out of the sight and reach of children.

Do not store above 25ºC.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Tachipirina for children 250 mg suppositories contain

-         the active ingredient is: paracetamol (each suppository contains 250 mg of paracetamol).

-         the other ingredients are: semi-synthetic solid glycerides.

What Tachipirina for children 500 mg suppositories contain

-         the active ingredient is: paracetamol (each suppository contains 500 mg of paracetamol).

-         the other ingredients are: semi-synthetic solid glycerides.

What Tachipirina looks like and contents of the pack

Tachipirina comes in the form of 250 mg or 500 mg suppositories ranging from white to cream coloured, packaged in boxes containing 10 suppositories: 2 white blister packs each containing 5 suppositories.

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, Italy.

Manufacturer

A.C.R.A.F. S.p.A.

Via Vecchia del Pinocchio, 22

60131 Ancona, Italy.

Istituto de Angeli Italia s.r.l.

Località Prulli 103/C

50066 Reggello (FI), Italy

This package leaflet was last revised in July 2020.

Use the QR Code on the box or go to https://leaflet.angelinipharma.com/L26 to read the updated leaflet and to read the package leaflet in other languages