PARACETAMOL PENSAVITAL 1 g TABLETS

2. What you need to know before taking Paracetamol Pensavital

Do not take Paracetamol Pensavital:

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

Be cautious when taking Paracetamol Pensavital:

• Do not take more than the recommended dose in section 3. How to take Paracetamol Pensavital.
• Avoid taking this medicine simultaneously with other medicines that contain paracetamol, such as medicines for flu and colds, as high doses can cause liver damage. Do not use more than one medicine that contains 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 kidney, liver, 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 decreased and hepatotoxicity may be increased, especially with high doses of paracetamol.
• In chronic alcoholics, do not take more than 2 grams of paracetamol in 24 hours.
• If the pain persists for more than 5 days, the fever for more than 3 days, or the pain or fever worsens, or if other symptoms appear, consult your doctor and reevaluate the clinical situation.
• In adolescents under 16 years old, consult your doctor or pharmacist, as there are other presentations with doses 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 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 unwell (nausea) and vomiting.

Other medicines and Paracetamol Pensavital:

Inform your doctor or pharmacist if you are using or have recently used other medicines, or if you may need to use any other medicine, including those obtained without a prescription.

Paracetamol may interact with the following medicines:

• Medicines to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin).
• Medicines for treating epilepsy: Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medicines for treating tuberculosis: (isoniazid, rifampicin).
• Medicines for treating depression and convulsions: Barbiturates (used as hypnotics, sedatives, and anticonvulsants).
• Medicines to lower cholesterol levels in the blood: (cholestyramine).
• 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, it 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 that use 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: beer, wine, liquor, ... per day) 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 necessity, this medicine can be used during pregnancy. You should use the lowest possible dose that reduces the 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 to 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 negligible or nonexistent.

This medicine contains less than 1 mmol of sodium (23 mg) per coated tablet; it 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 adolescents over 16 years old: the usual dose is 1 tablet (1,000 mg of paracetamol) 3 times a day. The doses should be spaced at least 4 hours apart. Do not take more than 3 grams (3 tablets) in 24 hours.

High daily doses of paracetamol should be avoided during prolonged periods, as the risk of side effects such as liver damage increases.

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

Patient with liver disease: before taking this medicine, they must consult their doctor. They should take the prescribed amount of medicine by their doctor with a minimum interval of 8 hours between each dose.

Do not take more than 2 tablets of paracetamol in 24 hours, divided into 2 doses.

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

Due to the dose, 1 gram of paracetamol, it is not indicated for this group of patients.

Elderly patients: should consult their doctor.

Use in children and adolescents: Do not use in children and adolescents under 16 years old.

If the effect of paracetamol is too strong or too weak, inform your doctor or pharmacist. When lower doses of 1,000 mg of paracetamol per dose are required, other presentations of paracetamol that adapt to the required dosage should be used.

If you take more Paracetamol Pensavital than 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, go to a medical center immediately, even if you do not notice symptoms, as they often do not appear until 3 days after ingestion of the overdose, even in cases of severe poisoning.

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

Patient taking barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

In case of overdose or accidental ingestion, go to a medical center 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 between doses (at least 4 hours).

4. Possible side effects

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

Rare side effects that may occur (between 1 and 10 in every 10,000 people) are: discomfort, low blood pressure (hypotension), and increased transaminase levels in the blood.

Very rare side effects that may occur (in less than 1 in every 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 in prolonged treatments.

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 package 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 EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in 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:

Each tablet contains 1 g of paracetamol as the active ingredient.

The other components (excipients) are potato starch glycolate (Type A), purified water, pregelatinized corn starch, povidone K30 (E-1201), stearic acid (E-570), and crospovidone (E-1202).

Appearance of the product and package contents:

Paracetamol Pensavital is presented in tablets for oral administration.

The tablets are oblong, biconvex, white, with a score line on one face and marked with PC on the other face. The tablet can be divided into equal doses.

In packages of 10 tablets, packaged in PVC/PVDC/Aluminum blisters.

Marketing authorization holder:

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer:

Galenicum Health, S.L.U.

Sant Gabriel, 50

Esplugues de Llobregat, 08950,

Barcelona – Spain

or

SAG Manufacturing S.L.

Crta. N-I, Km 36

28750 San Agustin de Guadalix,

Madrid – Spain

Date of the last revision of this package 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/