TACHIPIRINA FLASHTAB*12TAB 125

TACHIPIRINA FLASHTAB 125 mg orodispersible tablets
Paracetamol

What it is and what it is used for
It is indicated for the symptomatic treatment of fever and/or mild to moderate pain, such as headache, flu-like syndromes, toothache, muscle contractures or other painful manifestations.

This medicine is reserved for CHILDREN weighing between 7 and 25 kg (approximately 6 months to 10 years old). See section 3.

What you need to know before taking the medicine
Do not take TACHIPIRINA FLASHTAB 125 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 125 mg, immediately inform your doctor if:
• if you weigh less than 50 kg (if you are an adult);
• 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 are taking other medicines that affect liver function;
• if you suffer from serious illnesses, including severe renal 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 combination with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with rapid deep breathing, drowsiness, nausea and vomiting.

You should reduce the amount of paracetamol taken 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
The total dose of paracetamol should not exceed 80 mg/kg per day for children weighing less than 37 kg and 3 g per day for children weighing more than 38 kg. See section: If you take more TACHIPIRINA FLASHTAB 125 mg than you should.
This medicine contains banana flavouring which may make the medicine appealing 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 are:

Rare (may affect up to 1 in 1,000 people): Increased levels 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 prove to be a severe allergic reaction.
If a severe allergic reaction occurs, stop taking TACHIPIRINA FLASHTAB 125 mg and consult your doctor immediately.

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

Not known (frequency cannot be estimated from the available data):
- decrease or increase in liver enzymes (liver damage);
- blood disorders: decrease in the number of platelets in the blood resulting in nosebleeds or bleeding gums and decrease in the number of white blood cells in the blood resulting in increased susceptibility to infections;
- serious condition that 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, including any not listed in this leaflet, talk to your doctor or pharmacist. 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.