Paracetamol Pensavital 500 mg tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Paracetamol pensavital 500 mg tablets EFG

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

Always follow exactly the instructions for taking this medicine as described in this leaflet or as provided by your doctor, pharmacist, or nurse.

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

• Keep this leaflet, as you may need to read 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 if pain persists for more than 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 side 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.

Paracetamol is used for the treatment of mild to moderate pain and feverish conditions in adults and children aged 12 years and older (or body weight above 40 kg).

2. What you need to know before taking Paracetamol pensavital

Do not take Paracetamol pensavital:

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

Warnings and precautions:

• Do not take more medicine than the recommended dose stated in section 3. How to take Paracetamol pensavital.

• Avoid using this medicine simultaneously with other medicines containing paracetamol, such as cold and flu remedies, as high doses may 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 liver, kidney, 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 undergoing treatment with medications for epilepsy, consult your doctor before taking this medicine, since concomitant use may reduce efficacy and increase the hepatotoxicity of paracetamol, especially with high-dose paracetamol regimens.

• In chronic alcoholics, take care not to exceed 4 tablets of 500 mg or 2 g of paracetamol per day.

• 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 reevaluate the clinical situation.

• For children under 10 years of age, consult your doctor or pharmacist, as other formulations with doses adapted to this patient group are available.

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

You have severe illnesses 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 in these conditions when paracetamol is used at regular doses over a prolonged period or when paracetamol is taken concomitantly with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing 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.

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 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 to treat gout: probenecid and sulfinpyrazone.
• Medicines used to prevent nausea and vomiting: metoclopramide and domperidone.
• Medicines used to treat 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 (medicines that reduce pain) 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 another 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 to undergo any diagnostic 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 per day: beer, wine, liquor, etc.) 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.

If necessary, this medicine may be used during pregnancy. You should use the lowest possible dose that relieves pain or fever and take 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 operating machinery:

The influence of paracetamol on the ability to drive and operate machinery is none or negligible.

Paracetamol pensavital contains sodium (Sodium starch glycolate from potato (Type A)):

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

3. How to take Paracetamol pensavital

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

The usual dose is:

Adults and children aged 12 years and over, or with a body weight above 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. Doses should be spaced at least 4 hours apart.

Avoid using high daily doses of paracetamol for prolonged periods, 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, you should stop treatment and consult your doctor.

Children: It is necessary to follow dosage guidelines based on body weight. The child's age corresponding to body weight is provided for informational purposes only.

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

• Children weighing between 33 and 40 kg: 1 tablet per dose every 6 hours, up to a maximum of 4 tablets per day.
• Children weighing between 41 and 50 kg: 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, 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 grams (4 tablets of 500 mg) of paracetamol in 24 hours.

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

Elderly patients: You should consult your doctor.

Use in children and adolescents:

Do not use in children under 12 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 500 mg of paracetamol per administration 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 center 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, contact 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 missed doses. Simply take the missed dose as soon as you remember, and take the following doses at the recommended intervals (at least 4 hours apart).

4. Possible adverse effects

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

Rare adverse effects (occurring in up to 1 in 1,000 people) include: malaise, drop in blood pressure (hypotension), and increased blood transaminase levels.

Very rare adverse effects (occurring in up to 1 in 10,000 people) include: kidney disorders, 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 serious 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 may damage the liver 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 may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: 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 the sight and reach of children.

This medicine does not require any 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 containers and medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Paracetamol pensavital:

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

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

Appearance of the product and contents of the pack:

Paracetamol pensavital is presented as tablets for oral administration.

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

Packs contain 20 tablets, packed in PVC/PVDC/Aluminium 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 most recent review of this leaflet: February 2025

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