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 adults, adolescents and children 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 you/your child do not feel better or feel worse after 3 days of treatment.

Do not use Tachipirina

• if you/the person who is going to take this medicinal product is allergic to paracetamol or any other of its ingredients (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Tachipirina.

In the following cases, Tachipirina should be used with caution if the person intending to take it:

• is a chronic or excessive consumer of alcohol (3 or more alcoholic beverages a day)
• suffers from anorexia (behavioral nutritional disorder characterized by a lack or reduction of appetite)
• suffers from bulimia (behavioral nutrition disorder in which a person ingests an excessive quantity of food and subsequently uses various methods to eliminate it)
• suffers from cachexia (a condition characterized by extreme thinness, reduced muscle mass and thinning of the skin caused by chronic diseases)
• has followed an improper diet for a long period of time (chronic malnutrition) 
• suffers from dehydration (severe loss of water/fluids in the body)
• suffers from hypovolaemia (reduced volume of blood in circulation)
• suffers from liver diseases causing its impairment (liver impairment, hepatitis, Gilbert’s syndrome)
• is undergoing concomitant treatment with medicines that alter liver function (see "Other medicines and Tachipirina").
• suffers from a shortage of glucose-6-phosphate dehydrogenase (a substance normally present in the human body, a deficiency of which can cause a blood disease)
• suffers from hemolytic anemia (destruction of red blood cells).

Use at high doses and/or for extended periods

High doses and/or extended use of this medicinal product can cause kidney and blood alterations, some of which severe. In such cases, the doctor will perform specific tests to monitor liver and kidney function and blood composition over time. Before taking this medicinal product, tell your doctor if the person intending to take it suffers from any liver or kidney disorders. 

Children and adolescents

Tachipirina may 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, have 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 or giving any other medicinal product to the child, check that it does not contain paracetamol, as when taken at high doses severe side effects may occur
• medicinal products which slow the emptying of the stomach (for example anticholinergics, opioids), since these medicinal products delay the effect of Tachipirina
• medicinal products which accelerate the emptying of the stomach (for example prokinetics), since these medicinal products accelerate the effect of Tachipirina
• cholestyramine (a medicinal product used to reduce cholesterol levels in the blood), since this reduces the effect of paracetamol
• chloramphenicol (an antibiotic), as this can increase the risk of side effects
• anticoagulants (medicinal products used to improve blood flow). During treatment with high doses of paracetamol (4 g daily for at least 4 days), Tachipirina should only be taken or given to children under strict medical supervision
• rifampicin (an antibiotic)
• cimetidine (a medicinal product used to treat stomach ulcers)

• antiepileptics (medicinal products used to treat epilepsy) such as glutethimide, phenobarbital or carbamazepine
• zidovudine (medicinal product used to treat HIV).

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

Interferences with blood tests:

If the person taking this medicinal product needs to undergo blood tests, be aware that the administration of paracetamol can interfere with the determination of uricemia and glycemia.

Tachipirina with alcohol

Tachipirina should be used with caution if the person taking it is a chronic or excessive consumer of alcohol (3 or more alcoholic beverages per day) since there is a risk of intoxication (see sections “Warnings and precautions” and “If you take more Tachipirina than you should”).

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Tachipirina can be used during pregnancy if needed. The lowest dose able to reduce pain and/or fever should be used for the shortest time possible. Contact your doctor if the pain and/or fever does not improve or if you need to take the medicine more frequently.

This medicinal product should only be administered during breastfeeding if effectively necessary and under medical supervision.

Driving and using machines

Tachipirina has no influence on the ability to drive and use machines.

Tachipirina 500 mg effervescent granules contain maltitol, sodium and aspartame

Maltitol: contact your doctor before taking this medicinal product if you have been diagnosed with an intolerance to some sugars.

Sodium: this medicinal product contains 12.3 mmol (or 283 mg) of sodium (the main ingredient of cooking salt) per sachet. This is equivalent to 14.1 % of the maximum recommended daily intake in an adult dietTo be taken into account in persons with reduced renal function or on a low sodium diet.

Talk to your pharmacist or doctor if you need more than 2 sachets a day for an extended period, especially if you have been told to follow a low sodium diet.

Aspartame: this medicinal product contains a source of phenylalanine. It can be harmful if you suffer from phenylketonuria.

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Use in children and adolescents

For children, it is essential to follow the dose determined according to the child’s body weight. The doctor will indicate the most suitable form based on the child’s body weight. Ages as an approximation of body weight are provided for your information.

Dissolve the effervescent granules in a glass of water.

For children weighing less than 26 kg there are other specific forms of Tachipirina on the market. Ask your doctor or pharmacist for advice.

If you/your child suffers from severe liver impairment (severe reduction in liver function)

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

Treatment duration

Do not use 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 take 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 you/your child may experience 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 support treatment based on the nature and severity of the symptoms. 

If you forget to take Tachipirina 

Do not take a double dose to make up for a forgotten dose.

If you stop taking 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 everybody gets them.

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

• allergic reactions with:

• reddening of skin accompanied by itchiness (urticaria)
• swelling of the throat (laryngeal edema)
• 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, in addition, 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 hemoglobin, a substance that transports oxygen in the blood (anemia)
• vertigo
• stomach and intestinal disorders
• impaired liver function
• liver inflammation (hepatitis)
• red spots, bullous lesions 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 (hematuria)
• cessation or reduced production of urine (anuria)).

Very rare cases have been reported of severe skin reactions.

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-avverseBy 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 use this medicine after the expiry date which is stated on the box after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions. 

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 contains

• the active substance is: paracetamol (each sachet contains 500 mg of paracetamol)
• the other ingredients are: mannitol, maltitol, sodium bicarbonate, docusate sodium, aspartame (see section “Tachipirina 500 mg effervescent granules contain maltitol, sodium and aspartame”), anhydrous citric acid, citrus flavor.

What Tachipirina looks like and contents of the pack

Comes in the form of white to light yellow granules contained in aluminum paper sachets packaged in boxes of twenty 500 mg sachets.

Marketing Authorization 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

Fine Foods & Pharmaceuticals NTM S.p.A. – Via Grignano, 43 - 24041 Brembate, BERGAMO, ITALY 

This package leaflet was last revised in December 2019

Use the QR Code on the box or go to https://leaflet.angelinipharma.com/L29 to read the updated leaflet and the package leaflet in other languages.