Paracetamol
100 mg/ml oral drops, solution

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Read all of this leaflet carefully before you start using this medicine because it contains important information for you.


Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.



  • Keep this leaflet. You may need to read it again.

  • Ask your pharmacist if you need more information or advice.

  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

  • You must talk to a doctor if you do not feel better or if you feel worse after 3 days of treatment.

  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 is a solution in drops for oral use and contains the main active ingredient paracetamol.

Paracetamol acts by reducing fever (antipyretic) and alleviating pain (analgesic).

Tachipirina oral drops are used in children weighing less than 12 kg for:

-       the 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 take Tachipirina

-    if the person who is going to use this medicinal product is allergic to paracetamol or any of the other ingredients in this medicine (listed in section 6)

-    if the person who is going to take this medicine suffers from severe haemolytic anaemia (illness caused by the destruction of red blood cells)

-    if the person who is going to take this medicine suffers from severe liver disease (severe hepatocellular disease).

Warnings and precautions

Talk to your doctor or pharmacist before using Tachipirina.

Use with caution in the following cases:

-       if the person who is going to take this medicine suffers from bulimia (eating behaviour disorder in which a person ingests an excessive quantity of food and subsequently uses various methods to eliminate it)

-       if the person who is going to take this medicine suffers from cachexia (a condition characterised by extreme thinness, reduced muscle mass and thinning of the skin caused by chronic illness)

-       if the person who is going to take this medicine has followed an improper diet over a long period of time (chronic malnutrition)

-       if the person who is going to take this medicine suffers from dehydration (severe loss of water/fluids in the body)

-       if the person who is going to take this medicine suffers from hypovolaemia (low blood volume in the body)

-       if the person who is going to take this medicine suffers from liver diseases which reduce functionality (liver impairment, hepatitis, Gilbert’s syndrome)

-       if the person who is going to take this medicine is under concomitant treatment with medicinal products which alter liver function (see “Other medicines and Tachipirina”).

-       if the person who is going to take this medicine suffers 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)

-       if the person who is going to take this medicine suffers from haemolytic anaemia (illness caused by the 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 liver disorders (liver disease) and 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 the child, tell your doctor if the child who is going to take it suffers from any liver or kidney disorders.

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 who is going to take the medicine is taking:

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

-        medicinal products which slow the emptying of the stomach (e.g. anticholinergics, opioids), as these delay the effect of Tachipirina;

-        medicinal products which accelerate the emptying of the stomach (e.g. prokinetics), as these accelerate the effect of Tachipirina;

-        cholestyramine (a medicinal product used to reduce cholesterol levels in the blood) as this reduces the effect of paracetamol;

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

-        anticoagulants, medicinal products used to slow down the coagulation of the blood. In this case, especially for prolonged treatment and high doses of paracetamol (4 g daily for at least 4 days), Tachipirina should only be given to the child under strict medical supervision;

-         medicinal products or substances that alter liver function during chronic treatment, for example:

-    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 child 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 contains sorbitol

Sorbitol is a source of fructose. If your doctor has told you that the child has an intolerance to certain sugars or if the child has been diagnosed with hereditary fructose intolerance, a rare genetic disease in which patients are unable to digest fructose, talk to your doctor before the child takes this medicine.

Tachipirina contains propylene glycol,

which may cause alcohol-like symptoms.

 

Tachipirina and latex

The drop-counter pump is made from natural rubber (latex), which may cause severe allergic reactions.

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

Use in children (weighing between 3.2 kg and 12 kg)

In children, it is critical to respect the dose defined based on body weight and not based on age, which is approximate and indicated only for informational purposes. If the child’s age does not correspond to the weight given in the table, always make sure to refer to body weight when selecting the dosage. The dosage regimen for Tachipirina drops is as follows:

TACHIPIRINA DROPS

Weight

Age

(approximate)

Single dose

Daily dose

from 3.2 kg

0-30 days

8 drops

Up to 4 times (every 6 hours)

from 4.3 kg

1 month

10 drops

Up to 4 times (every 6 hours)

from 5.3 kg

2 months

13 drops

Up to 4 times (every 6 hours)

from 6.1 kg

3 months

22 drops

Up to 4 times (every 6 hours)

from 6.7 kg

4 months

25 drops

Up to 4 times (every 6 hours)

from 7.2 kg

5-6 months

27 drops

Up to 4 times (every 6 hours)

from 8 kg

7-10 months

30 drops

Up to 4 times (every 6 hours)

from 9 kg

11-14 months

33 drops

Up to 4 times (every 6 hours)

from 10 kg

15-19 months

36 drops

Up to 4 times (every 6 hours)

from 11 kg

20-23 months

39 drops

Up to 4 times (every 6 hours)

 

One drop corresponds to 4 mg of paracetamol.

For children weighing more than or equal to 12 kg, there are other forms of Tachipirina on the market, in particular: Tachipirina suppositories, Tachipirina syrup, Tachipirina effervescent granules and Tachipirina tablets.

 

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 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.

Instructions for use

Tamper-evident cap

The Tachipirina oral drops container is fitted with a tamper-evident cap.

Instructions for opening and closing are given below:

 

To open:

To close:

press down
and turn
at the same time

fully screw on the cap,
pressing downwards

 

 

Turn the bottle upside down and pour the number of drops corresponding to the dose into 25‑50 ml of water for the child to drink.

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 you/your child may experience within the first 12-48 hours include:

-         anorexia (lack or reduction of appetite)

-         nausea

-         vomiting

-         significant deterioration in general condition

-         severe liver damage (hepatic cytolysis) which can lead to the liver not being able to fulfil its function (hepatocellular insufficiency), excessive production of metabolic acids (metabolic acidosis) and brain damage (encephalopathy)

-         alterations in blood laboratory levels (increased levels of transaminases, lactate dehydrogenase and bilirubin in the blood, reduced blood prothrombin levels).

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

-         if you suffer from liver disease,

-         chronic alcoholism,

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

-         if you are taking medicinal products or substances which increase liver function.

If you forget to use Tachipirina

Do not use 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 any of the following side effects arise, STOP treatment with this medicine and contact your doctor immediately:

  • allergic reactions with:

-    reddening of skin accompanied by itchiness (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.

 

Effects involving the blood

  • reduction in blood platelet count (thrombocytopenia)
  • reduced white blood cell count (leukopenia/agranulocytosis)
  • reduced haemoglobin, a substance that transports oxygen in the blood (anaemia).

Effects involving the nervous system

  • vertigo.

Effects involving the stomach and intestine

  • stomach and intestinal disorders.

Effects involving the liver

  • impaired liver function
  • liver inflammation (hepatitis).

Effects involving the skin and subcutaneous tissue

red spots, blisters with areas of skin detachment, blisters, skin eruptions (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis)

Very rare cases of severe skin reactions have been reported.

Effects involving the kidneys and the urinary tract

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

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.

This medicinal product does not require any special storage conditions.

Shelf life after first opening: 1 year

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 contains

-         the main active ingredient is: paracetamol (1 ml of solution contains 100 mg of paracetamol)

-         the other ingredients are: propylene glycol (see section “Tachipirina contains propylene glycol”), sorbitol (see section “Tachipirina contains sorbitol”), sodium edetate, sodium saccharin(see section “Tachipirina contains sodium”), Macrogol 6000, citrus-vanilla flavouring, propyl gallate, caramel (E150a), purified water.

What Tachipirina looks like and contents of the pack

Tachipirina comes in the form of oral drops (solution) contained in a 30-ml glass bottle closed with a tamper-evident cap with a dropper.

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.

 

This package leaflet was last revised in July 2020.

 

Use the QR Code on the box or go to https://leaflet.angelinipharma.com/L24 to read the updated leaflet and to read the package leaflet in other languages