Name
TACHIPIRINA FLASHTAB 500 mg orodispersible tablets
Paracetamol


What it is and what it is used for
This medicine is an analgesic and antipyretic. It contains paracetamol.
It is indicated for the symptomatic treatment of fever and/or mild to moderate pain, such as headache, flu syndromes, toothache, muscle contractures or other painful manifestations.

It is a medicinal product for adults and children weighing more than 27 kg (approximately 8 years).
For children weighing less than 27 kg, other formulations of paracetamol are available: ask your doctor or pharmacist for advice.


What you need to know before taking the medicine
Do not take TACHIPIRINA FLASHTAB 500 mg:
- if you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6);
- if you suffer from severe liver disease;
- if you suffer from phenylketonuria (a hereditary disease detected at birth), as this medicine contains aspartame.


Warnings and precautions
During treatment with TACHIPIRINA FLASHTAB 500 mg, inform your doctor immediately if:
• if it weighs less than 50 kg;
• if you suffer from liver disease;
• if you suffer from chronic alcoholism;
• if you suffer from chronic malnutrition;
• if you suffer from dehydration;
• if you suffer from kidney disease;
• if you use other medicines that affect liver function;
• if you have any serious illnesses, including severe kidney failure 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). A serious condition called metabolic acidosis (an abnormality of the blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses over a long period or when paracetamol is taken in combination with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with rapid deep breathing, drowsiness, nausea and vomiting.

You may need to reduce the amount of paracetamol you take or avoid taking the product altogether.
In case of acute viral hepatitis, stop treatment and consult your doctor.

This medicine contains paracetamol. To avoid the risk of overdose during treatment with this medicine, do not take any other medicine containing paracetamol.

Children
This medicine should not be given to children weighing less than 27 kg.
In children treated with paracetamol, the association with other medicines that reduce fever (antipyretics) is justified only in case of ineffectiveness. The association must be initiated and monitored only by a doctor.

This medicine contains blackcurrant flavouring which may make the medicine palatable to children. Keep out of the sight and reach of children.


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

Possible side effects:
Rare (may affect up to 1 in 1,000 people): increased level of liver enzymes (transaminases).

Very rare (may affect up to 1 in 10,000 people): allergic reactions: rash or skin eruption with itchy blisters, swelling of the face or tongue, shortness of breath or difficulty breathing which may be a serious allergic reaction.
If a severe allergic reaction occurs, stop taking TACHIPIRINA FLASHTAB 500 mg and consult your doctor immediately.

Skin reactions: Very rare cases of serious skin reactions have been reported.

Not known (frequency cannot be estimated from the available data):
- Decrease or increase in liver enzymes (damage caused to the liver);
- Blood disorders: decreased number of platelets in the blood resulting in nose or gum bleeding and decreased number of white blood cells in the blood resulting in increased susceptibility to infections;
- Serious condition which can make the blood more acidic (called metabolic acidosis), in patients with a serious illness who use paracetamol (see section 2).

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 at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.