PARACETAMOL PENSAVITAL 650 mg TABLETS

2. What you need to know before taking Paracetamol Pensavital

Do not take Paracetamol Pensavital

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take this medicine.

• Do not take more than the recommended dose of the medicine as stated in section 3, "How to take Paracetamol Pensavital".
• Avoid taking this medicine simultaneously with other medicines that contain paracetamol, such as cold and flu medicines, as high doses can cause liver damage. Do not use more than one medicine that contains paracetamol without consulting your doctor.
• Chronic alcoholics should be cautious not to take more than 3 grams of paracetamol in 24 hours.
• Patient with kidney, liver, heart, or lung diseases, and patients with anemia, should consult their doctor before taking this medicine.
• If you are being treated with a medicine for epilepsy, consult your doctor before taking this medicine, as the efficacy of paracetamol may be reduced and hepatotoxicity increased, especially with high doses of paracetamol.
• Asthmatic patients sensitive to acetylsalicylic acid should consult their doctor before taking this medicine.

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 organ damage), or if you suffer from 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 unwell (nausea), and vomiting.

Other medicines and Paracetamol Pensavital

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medicine, including those purchased without a prescription.

In particular, if you are using any of the following medicines, it may be necessary to modify the dose of some of them or interrupt treatment:

• 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 for lowering cholesterol levels in the blood: colestyramine.
• Medicines used to increase urine elimination (loop diuretics such as furosemide).
• Medicines used for treating gout: (probenecid and sulfinpyrazone).
• Medicines used to prevent nausea and vomiting: metoclopramide and domperidone.
• Medicines used for treating 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).

Interference with analytical tests

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

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.

Use in children

Do not use in adolescents under 14 years old.

Pregnancy and Breastfeeding

Pregnancy:

Consult your doctor or pharmacist before using any medicine.

Important for women

If you are pregnant or think you may be pregnant, consult your doctor before taking this medicine. The use of medicines during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

In case of necessity, 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.

Breastfeeding

Consult your doctor or pharmacist before using any medicine. Paracetamol passes into breast milk, so breastfeeding women should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

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

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

3. How to take Paracetamol Pensavital

Follow the administration instructions of this medicine as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medicine. Paracetamol should be taken orally.

The recommended dose is:

Adults and adolescents over 14 years old (weight 64-65 kg):

Take 1 tablet every 4 or 6 hours as needed. Do not take more than 4 tablets of paracetamol in 24 hours.

Patient with liver diseases:

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

They should not take more than 3 tablets of 650 mg of paracetamol in 24 hours, divided into 3 doses.

Patient with kidney diseases:

Before taking this medicine, they must consult their doctor. Take a maximum of 500 mg per dose.

Due to the dose, 650 mg of paracetamol, it is not indicated for this group of patients.

High daily doses of paracetamol should be avoided during prolonged periods, as the risk of adverse 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 other symptoms appear, treatment should be discontinued and a doctor consulted.

Always use the lowest effective dose. The use of this medicine is subject to the appearance of pain or fever. As they disappear, treatment should be suspended.

Use in children and adolescents:

This medicine is for exclusive use in adults and adolescents from 14 years old. Children and adolescents under 14 years old cannot take this medicine.

This medicine is taken orally.

The tablets should be swallowed whole or broken in half, with the help of a glass of liquid, preferably water.

The tablets are scored, which allows them to be broken in half. The score serves only to break the tablet if it is difficult to swallow whole.

Always use the lowest effective dose.

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

The administration of this medicine is subject to the appearance of pain or fever. As they disappear, treatment should be suspended.

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 ingested 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 ingestion of the medicine.

Patient treated with barbiturates 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 ingested.

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 following doses with the indicated interval between doses (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 (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 (up to 1 in 10,000 people) are: kidney disease, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leukopenia, 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 the available data): headache induced by analgesic abuse and a severe disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

Paracetamol may damage the liver when taken in high doses or in prolonged treatments.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect 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 sight and reach of children.

This medicine does not require special storage conditions.

Do not use this medicine after the expiration date stated 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 650 mg of paracetamol.

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

Appearance of the product and package contents:

This medicine is presented in oral tablets.

The tablets are oblong, biconvex, white, with a score on one face and marked with PB on the other face.

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

Only some package sizes may be marketed.

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/