PARACETAMOL PENSAV 500 MG TABLETS 20 TABLETS IN PVC/PVDC/AL BLISTER

Name
Paracetamol Pensavital 500 mg tablets
Paracetamol
Equivalent medicine


What is it and what is it used for?
Paracetamol is a medicine that works by relieving pain and reducing fever (analgesic and antipyretic).

Paracetamol Pensavital is used to reduce mild to moderate pain and/or fever in adults and children aged 10 years and over ( or weighing more than 33 kg ).


What you need to know before taking the medicine
Do not take Paracetamol Pensavital
- if you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6).


Warnings and precautions
Talk to your doctor or pharmacist before taking Paracetamol Pensavital:
- if you suffer from kidney problems;
- if you suffer from heart or lung disease;
- if you suffer from liver disease or if you are taking medicines that alter liver function;
- if you suffer from anemia (a reduction in red blood cells which can make your skin pale yellow and cause weakness or shortness of breath);
- if you regularly consume large amounts of alcohol. Chronic alcoholics should be careful not to take more than 2 g of paracetamol every 24 hours;
- if you are taking other medicines containing paracetamol, as they can seriously damage your liver;
- if you are asthmatic and sensitive to acetylsalicylic acid (aspirin).

While taking Paracetamol Pensavital, tell 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), 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 with these conditions when paracetamol is used at regular doses over 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 not take paracetamol frequently for prolonged periods of time, as prolonged or frequent use can cause liver problems. Talk to your doctor or pharmacist if you plan to take paracetamol for a longer period of time.

Do not use Paracetamol Pensavital without consulting a doctor if you have alcohol problems or liver damage. Do not use Paracetamol Pensavital with alcohol. The effect of alcohol is not enhanced by taking Paracetamol Pensavital.

Never take more paracetamol than indicated in section 3 of this leaflet. A higher dose does not increase the effectiveness of the medicine for pain, but can cause serious liver damage. Symptoms of liver damage usually appear after a couple of days. Therefore, it is very important to contact your doctor as soon as possible if you have taken a higher than recommended dose.

If you develop a high fever or signs of infection after more than 3 days of treatment, or if pain persists after more than 5 days of treatment, you should contact your doctor.

Children
Do not use in children under 10 years of age. For children under 10 years of age, consult your doctor or pharmacist as there are other presentations with doses more suitable for this patient group.


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

This medicine may cause the following side effects:
Rare (may affect up to 1 in 1,000 people): discomfort, drop in blood pressure (hypotension) and increased levels of transaminases in the blood.

Very rare (may affect up to 1 in 10,000 people): kidney disease, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leukopenia, neutropenia, haemolytic anaemia), and hypoglycaemia (low blood sugar). There have been very rare cases of serious skin reactions.

Frequency not known (cannot be estimated from the available data): serious condition that can make the blood more acidic (called metabolic acidosis), in patients with a serious illness who use paracetamol (see section 2).

Paracetamol can cause liver damage if taken in high doses or for prolonged treatment.

Reporting of side effects
If you experience 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.