Paracetamol Pensavital 1 g tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Paracetamol pensavital 1 g tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the instructions for administration of the medicine contained in this leaflet or as directed by your doctor, pharmacist, or nurse.

This medicine is available without a prescription. However, to achieve the best results, it must be used carefully.

• Keep this leaflet, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.
• You should consult your doctor if your condition worsens or if fever persists beyond 3 days of treatment or pain beyond 5 days.

Leaflet contents:

1. What Paracetamol pensavital is and what it is used for.
2. What you need to know before taking Paracetamol pensavital.
3. How to take Paracetamol pensavital.
4. Possible adverse effects.
5. How to store Paracetamol pensavital.
6. Contents of the pack and other information.

1. What Paracetamol pensavital is and what it is used for

Paracetamol belongs to a group of medicines called analgesics and antipyretics.

It is indicated for the treatment of pain and fever symptoms.

Paracetamol is used for the treatment of moderate-intensity pain and febrile conditions in adults and adolescents aged 16 years and older (or with body weight above 50 kg).

2. What you need to know before starting to take Paracetamol pensavital

Do not take Paracetamol pensavital:

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

Take special care with Paracetamol pensavital:

• Do not take more than the recommended dose stated in section 3, "How to take Paracetamol pensavital."
• Concomitant use of this medicine with other medicines containing paracetamol (e.g. cold and flu remedies) should be avoided, as high doses may cause liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.
• If you are an asthmatic patient sensitive to acetylsalicylic acid, consult your doctor before taking this medicine.
• If you suffer from kidney, liver, heart, or lung disease, or have anemia (reduced hemoglobin levels in the blood, with or without a reduction in red blood cells), consult your doctor before taking this medicine.
• If you are being treated with medication for epilepsy, consult your doctor before taking this medicine, as simultaneous use may reduce efficacy and increase the hepatotoxicity of paracetamol, especially with high-dose paracetamol regimens.
• Chronic alcoholics should take care not to exceed 2 grams of paracetamol in 24 hours.
• If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or new symptoms appear, consult your doctor and reassess the clinical situation.
• For adolescents under 16 years of age, consult your doctor or pharmacist, as other formulations with appropriate doses are available for this patient group.

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

You have serious conditions 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 serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients under these conditions when paracetamol is used at regular doses over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulty with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.

Other medicines and Paracetamol pensavital:

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

Paracetamol may interact with the following medicines:

• Medicines to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin).
• Medicines for epilepsy: Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medicines for tuberculosis: (isoniazid, rifampicin).
• Medicines for depression and seizures: Barbiturates (used as hypnotics, sedatives, and anticonvulsants).
• Medicines to lower blood cholesterol levels: (cholestyramine).
• Medicines used to increase urine elimination (loop diuretics such as furosemide).
• Medicines used in the treatment of gout (probenecid and sulfinpyrazone).
• Medicines used to prevent nausea and vomiting: Metoclopramide and domperidone.
• Medicines used in the treatment of high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias): Propranolol.
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) requiring 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 advisable to systematically inform your doctor or pharmacist if you are taking any other medicine. In patients treated with oral anticoagulants, paracetamol may occasionally be administered as the analgesic of choice.

Interference with diagnostic tests:

If you are scheduled for any laboratory tests (including blood and urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter the results of such tests.

Taking Paracetamol pensavital with food, drinks, and alcohol:

The use of paracetamol in patients who habitually consume alcohol (3 or more alcoholic drinks: beer, wine, spirits, etc., 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 might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

If necessary, this medicine may be used during pregnancy. Use the lowest possible dose that relieves pain or fever, and use it for the shortest possible time. Contact your doctor if pain or fever do not improve or if you need to take the medicine more frequently.

Small amounts of paracetamol may pass into 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 negligible or none.

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

3. How to take Paracetamol pensavital

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

The usual dose is:

Adults and adolescents over 16 years of age: The usual dose is 1 tablet (1,000 mg paracetamol) 3 times a day. Doses should be spaced at least 4 hours apart. Do not take more than 3 grams (3 tablets) in 24 hours.

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

If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or new symptoms appear, treatment should be stopped and a doctor consulted.

Patients with liver disease: Before taking this medicine, you must consult your doctor. You should take the amount prescribed by your doctor, with a minimum interval of 8 hours between doses.

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

Patients with kidney disease: Before taking this medicine, you must consult your doctor. Take a maximum of 500 mg per dose.

Due to the dosage (1 gram of paracetamol), this medicine 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 of age.

If you think the effect of paracetamol is too strong or too weak, inform your doctor or pharmacist. When doses lower than 1,000 mg of paracetamol per dose are required, other paracetamol formulations suitable for the required dosage should be used.

If you take more Paracetamol pensavital than you should:

You should contact your doctor or pharmacist immediately.

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

If you have taken an overdose, you must go immediately to a medical centre even if you do not have symptoms, as symptoms often do not appear until 3 days after the overdose, even in cases of severe poisoning.

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

Patients undergoing treatment with barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

In case of overdose or accidental ingestion, go immediately to a medical centre 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 missed dose when you remember, then take the following doses at the recommended intervals (at least 4 hours apart).

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Rare adverse effects (occurring in between 1 and 10 out of 10,000 people) are: malaise, low blood pressure (hypotension), and increased levels of transaminases in the blood.

Very rare adverse effects (occurring in less than 1 out of 10,000 people) are: kidney disorders, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, haemolytic anaemia), and hypoglycaemia (low blood sugar). Very rare cases of severe skin reactions have been reported.

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

Paracetamol can cause liver damage when taken at high doses or during prolonged treatment.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of paracetamol pensavital:

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

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

Appearance of the product and contents of the container:

Paracetamol pensavital is presented as tablets for oral administration.

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

Packaged in packs of 10 tablets, contained in PVC/PVDC/Aluminium 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 most recent review of this leaflet: February 2025

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included on the packaging. You can also access this information at the following URL: https://towapharmaceutical.es/prospecto2/pensavital-paracetamol-1g-comprimidos/ and at the following internet address: https://cima.aemps.es/cima/dochtml/p/85210/P_85210.html