PARACETAMOL PENSAVITAL 500 mg TABLETS

2. What you need to know before taking Paracetamol pensavital

Do not take Paracetamol pensavital:

If you are allergic to paracetamol or any of the other components of this medicine (listed in section 6).

Warnings and precautions:

• Do not take more medicine than recommended in section 3. How to take Paracetamol pensavital.
• The simultaneous use of this medicine with other medicines containing paracetamol, such as flu and cold medicines, should be avoided, as high doses can cause liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.

• In patients with asthma who are sensitive to acetylsalicylic acid, consult your doctor before taking this medicine.

• If you have any liver, kidney, heart, or lung disease, or if you have anemia (reduced hemoglobin levels in the blood, due to or not due to a reduction in red blood cells), you should consult your doctor before taking this medicine.

• When being treated with any medicine for epilepsy, consult your doctor before taking this medicine, as the efficacy of paracetamol may be reduced and hepatotoxicity may be increased, especially with high doses of paracetamol.

• In chronic alcoholics, caution should be exercised not to take more than 4 tablets of 500 mg or 2 grams per day of paracetamol.

• If the pain persists for more than 5 days, the fever for more than 3 days, or the pain or fever worsen or other symptoms appear, consult your doctor and reevaluate the clinical situation.

• In children under 10 years old, consult your doctor or pharmacist, as there are other presentations with doses that are suitable for this group of patients.

During treatment with Paracetamol pensavital, inform your doctor immediately if:

If you have severe diseases, such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (an anomaly in the blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling of discomfort (nausea) and vomiting.

Other medicines and Paracetamol pensavital:

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

Paracetamol may interact with the following medicines:

• Medicines to prevent blood clots: oral anticoagulants (acenocoumarol, warfarin).
• Medicines to treat epilepsy: antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medicines to treat tuberculosis: isoniazid, rifampicin.
• Medicines to treat depression and convulsions: barbiturics (used as hypnotics, sedatives, and anticonvulsants).
• Medicines to lower cholesterol levels in the blood: colestyramine.
• Medicines used to increase urine elimination (loop diuretics such as furosemide).
• Medicines used to treat gout: probenecid and sulfinpyrazone.
• Medicines used to prevent nausea and vomiting: metoclopramide and domperidone.
• Medicines used to treat high blood pressure and heart rhythm disorders (arrhythmias): propranolol.

Flucloxacillin (antibiotic), due to a serious risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).

Do not use with other analgesics (pain-relieving medicines) without consulting your doctor.

As a general rule for any medicine, it is recommended to systematically inform your doctor or pharmacist if you are being treated with another medicine. In the case of treatment with oral anticoagulants, paracetamol can be administered occasionally as the analgesic of choice.

Interference with analytical tests:

If you are going to have any analytical tests (including blood tests, urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter the results of these tests.

Taking Paracetamol pensavital with food, drinks, and alcohol:

The use of paracetamol in patients who habitually consume alcohol (3 or more alcoholic beverages per day: beer, wine, liquor...) may cause liver damage.

Taking this medicine with food does not affect its efficacy.

Pregnancy and breastfeeding:

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

In case of need, this medicine can be used during pregnancy. You should use the lowest possible dose that reduces pain or fever and use it for the shortest possible time. Contact your doctor if the pain or fever does not decrease or if you need to take the medicine more frequently.

Small amounts of paracetamol may appear in breast milk; therefore, it is recommended that you consult your doctor or pharmacist before taking this medicine.

Driving and using machines:

The influence of paracetamol on the ability to drive and use machines is nil or insignificant.

Paracetamol pensavital contains sodium (Potato starch glycolate sodium (Type A)):

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially "sodium-free".

3. How to take Paracetamol pensavital

Follow these instructions unless your doctor has given you different instructions. Remember to take your medicine. Paracetamol should be taken orally.

The normal dose is:

Adults and children over 12 years old, or with a body weight over 40 kg:

Take 1 tablet every 4-6 hours, as needed, up to a maximum of 6 tablets per day. Do not take more than 3 grams of paracetamol in 24 hours. The doses should be spaced at least 4 hours apart.

The use of high daily doses of paracetamol for prolonged periods of time should be avoided, as it increases the risk of adverse effects such as liver damage.

If the pain persists for more than 5 days, the fever for more than 3 days, or the pain or fever worsen or other symptoms appear, you should stop treatment and consult your doctor.

Children: It is necessary to respect the dosages defined according to weight. The age of the child according to weight is given for informational purposes.

The recommended daily dose of paracetamol is approximately 60 mg/kg/day, divided into 4 or 6 daily doses, i.e., 15 mg/kg every 6 hours or 10 mg/kg every 4 hours.

Children between 33 and 40 kg in weight: 1 tablet per dose, every 6 hours, up to a maximum of 4 tablets per day.

Between 41 and 50 kg in weight: 1 tablet per dose, every 4-6 hours, up to a maximum of 6 tablets per day.

Patients with liver disease: before taking this medicine, they must consult their doctor.

They should take the prescribed amount of medicine with a minimum interval of 8 hours between each dose.

They should not take more than 2 grams (4 tablets of 500 mg) of paracetamol in 24 hours.

Patients with kidney disease: before taking this medicine, they must consult their doctor. Take a maximum of 500 mg per dose.

Elderly patients: should consult their doctor.

Use in children and adolescents:

Do not use in children under 12 years old.

If the effect of Paracetamol is too strong or too weak, inform your doctor or pharmacist.

When lower doses of paracetamol are required (less than 500 mg per dose), other presentations of paracetamol that adapt to the required dosage should be used.

If you take more Paracetamol pensavital than you should:

You should consult your doctor or pharmacist immediately.

The symptoms of overdose may be: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

If you have taken an overdose, you should go to a medical center immediately, even if you do not notice symptoms, as they often do not appear until 3 days after ingestion, even in cases of severe poisoning.

Treatment of overdose is more effective if started within 4 hours of taking the medicine.

Patients being treated with barbiturics or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount taken.

If you forget to take Paracetamol pensavital:

Do not take a double dose to make up for forgotten doses; simply take the forgotten dose when you remember, taking the next doses with the indicated interval (at least 4 hours).

4. Possible side effects

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

Rare side effects that may occur (in up to 1 in 1,000 people) are: discomfort, low blood pressure (hypotension), and increased transaminase levels in the blood.

Very rare side effects that may occur (in up to 1 in 10,000 people) are: kidney disease, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, hemolytic anemia), and hypoglycemia (low blood sugar). Very rare cases of severe skin reactions have been reported.

Frequency not known (cannot be estimated from available data): a severe disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

Paracetamol can damage the liver when taken in high doses or for prolonged periods.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Paracetamol pensavital

Keep this medicine out of the sight and reach of children.

This medicine does not require special storage conditions.

Do not use this medicine after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Paracetamol pensavital:

The active ingredient is paracetamol. Each tablet contains 500 mg of paracetamol.

The other components (excipients) are: potato starch glycolate sodium (Type A), purified water, pregelatinized corn starch, povidone K30 (E1201), stearic acid (E570), and crospovidone (E1202).

Appearance of the product and package contents:

Paracetamol pensavital is presented in tablets for oral administration.

The tablets are biconvex, white, and round in shape.

The packaging is 20 tablets, packaged in PVC/PVDC/Aluminum blisters.

Marketing authorization holder and manufacturer:

Marketing authorization holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer:

SAG Manufacturing S.L.U

Crta. N-I, Km 36,

San Agustín de Guadalix,

28750 Madrid

Spain

or

Galenicum Health, S.L.U.

Sant Gabriel, 50

Esplugues de Llobregat

08950 Barcelona

Spain

Date of the last revision of this leaflet:February 2025

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/