TACHIPIRINA OROSOL "500 MG GRANULES STRAWBERRY AND VANILLA FLAVOUR" 12 SACHETS IN AL"

Name
TACHIPIRINA OROSOLUBILE 500 mg strawberry-vanilla flavoured granules
Paracetamol


What it is and what it is used for
Paracetamol belongs to the pharmacotherapeutic class of analgesics (pain-relieving drugs) that also act simultaneously as antipyretics (drugs that lower fever) with weak anti-inflammatory effects.

TACHIPIRINA OROSOLUBILE is used to lower fever and provide relief from mild to moderate pain.


What you need to know before taking the medicine
Do not take TACHIPIRINA OROSOLUBILE
- if you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6);
- if you suffer from severe kidney failure;
- if you abuse alcohol.


Warnings and precautions
Talk to your doctor or pharmacist before taking TACHIPIRINA OROSOLUBILE.

Take special care with TACHIPIRINA OROSOLUBILE: - If you suffer from severe renal insufficiency;
- The risks of overdose are greater in patients with non-cirrhotic alcoholic liver disease;
- Never exceed the recommended dose:
- if you suffer from chronic alcoholism;
- if you have glucose-6-phosphate dehydrogenase deficiency;
- if you suffer from haemolytic anaemia;
- if you suffer from liver failure or Gilbert's syndrome (familial non-haemolytic jaundice) or acute hepatitis, in concomitant treatment with drugs that alter liver function.

During treatment with TACHIPIRINA OROSOLUBILE, inform your doctor immediately if:
If you have 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.

Prolonged or frequent use is not recommended. Patients should be advised not to take other products containing paracetamol at the same time. Taking multiple daily doses in a single administration can seriously damage the liver. In this case, the patient does not lose consciousness, however, a doctor should be consulted immediately. Prolonged use without medical supervision can be harmful. In children treated with 60 mg/kg per day of paracetamol, the combination with another antipyretic is not justified unless ineffective.

Caution should be exercised when administering paracetamol to patients with renal insufficiency (creatinine clearance ≥30 ml/min. (see paragraph 3 "HOW TO TAKE TACHIPIRINA OROSOLUBILE")), mild to moderate hepatocellular insufficiency (including Gilbert's syndrome), severe hepatic insufficiency (Child-Pugh >9), acute hepatitis, concomitant treatment with drugs that alter liver function, glucose-6-phosphate dehydrogenase deficiency, haemolytic anaemia.

The risks of overdose are greater in patients with non-cirrhotic alcoholic liver disease.
Caution should be exercised in case of chronic alcoholism. In this case, the daily dose should not exceed 2 grams.

In case of high fever or signs of secondary infection or persistence of symptoms beyond 3 days, a re-evaluation of treatment should be performed.

Paracetamol should be used with caution in cases of dehydration and chronic malnutrition. The total dose of paracetamol should not exceed 3 g per day for adults and children weighing 50 kg or more.
If your symptoms worsen or do not improve after 3 days or if you develop a high fever, you should contact your doctor.

Do not use paracetamol unless prescribed by your doctor if you are addicted to alcohol or have liver damage. Do not use paracetamol with alcohol. Paracetamol does not enhance the effect of alcohol.

If you are taking other painkillers containing paracetamol at the same time, do not use TACHIPIRINA OROSOLUBILE without first consulting your doctor or pharmacist.

Never take more TACHIPIRINA OROSOLUBILE than recommended. A higher dose does not increase the analgesic action, but can instead cause serious damage to the liver. Symptoms of liver damage appear after a few days. For this reason, it is very important that you contact your doctor as soon as possible if you have taken more TACHIPIRINA OROSOLUBILE than recommended in this leaflet.

In case of prolonged incorrect use of high-dose painkillers, headache episodes may occur which should not be treated with higher doses of the medicine.

In general, the habitual intake of painkillers, especially the combination of several analgesic drugs, can cause permanent kidney damage with the risk of kidney failure (analgesic nephropathy).

Abruptly stopping taking painkillers after a prolonged period of high-dose misuse may cause headache, fatigue, muscle pain, nervousness, and autonomic symptoms. These withdrawal symptoms resolve within a few days. Until then, avoid taking other painkillers and do not restart them without consulting your doctor.

You should not take TACHIPIRINA OROSOLUBILE for prolonged periods or at high doses without consulting your doctor or pharmacist.


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

The frequency of "rare" means that it affects 1 to 10 users in 10,000.
The frequency of 'very rare' means that less than 1 user in 10,000 is affected.
Frequency not known means an effect that cannot be estimated from the available data.

The following rare side effects may occur:
• non-hemolytic anemia and bone marrow depression;
• anemia;
• thrombocytopenia;
• edema;
• diseases of the exocrine pancreas: acute and chronic pancreatitis;
• gastrointestinal bleeding, abdominal pain, diarrhea, nausea, vomiting;
• liver failure, liver necrosis, jaundice;
• allergic conditions, anaphylactic reactions, drug or food allergies;
• urticaria, pruritus, rash, sweating, purpura, angioedema;
• nephropathies and tubular disorders.

Frequency not known: serious condition which can make the blood more acidic (called metabolic acidosis), in patients with a serious illness who use paracetamol (see section 2).

Very rare cases of serious 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 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.