Paracetamol Pensavital 650 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Paracetamol pensavital 650 mg 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 taking this medicine as described 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 read it again.
• If you need advice or more information, consult your doctor, pharmacist, or nurse.
• 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 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

This medicine is indicated for adults and adolescents over 14 years of age.

It is indicated for the symptomatic relief of mild to moderate occasional pain, such as headache, dental pain, muscle pain (muscle spasms), or back pain (lumbago), and for febrile conditions.

You should consult a doctor if your condition worsens or does not improve, pain after 5 days, or fever after 3 days.

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 indicated 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.
• Chronic alcoholics should take care not to exceed 3 grams of paracetamol in 24 hours.
• Patients with kidney, liver, heart, or lung disease, or those with anemia, should consult their doctor before taking this medicine.
• If you are being treated with medication for epilepsy, consult your doctor before taking this medicine, as concomitant use may reduce efficacy and increase the hepatotoxicity of paracetamol, especially with high-dose paracetamol regimens.
• Asthmatic patients who are sensitive to acetylsalicylic acid should consult their doctor before taking this medicine.

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 imbalance in blood and body fluids) has been reported in patients under these circumstances 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 difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Other medicines and Paracetamol pensavital

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

In particular, if you are taking any of the following medicines, dosage adjustments or discontinuation of treatment may be necessary:

• 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: 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 (hypertension) and heart rhythm disorders (cardiac arrhythmias): propranolol.
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (called metabolic acidosis) requiring urgent treatment (see section 2).

Interference with diagnostic tests

If you are scheduled to undergo any laboratory tests (including blood and urine tests, etc.), inform your doctor that you are taking/using this medicine, as it may alter test results.

Taking Paracetamol pensavital with food, drinks, and alcohol

Using paracetamol in patients who habitually consume alcohol (3 or more alcoholic drinks per day: beer, wine, spirits, etc.) may cause liver damage.

Taking this medicine with food does not affect its effectiveness.

Use in children

Do not use in adolescents under 14 years of age.

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. Taking medicines during pregnancy may be harmful to the embryo or fetus and should be monitored by your doctor.

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 does not subside 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; therefore, women who are breastfeeding should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

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

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

3. How to take Paracetamol pensavital

Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine. Paracetamol is taken orally.

Recommended dose:

Adults and adolescents over 14 years of age (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.

Patients with liver disease:

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 doses.

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

Patients with kidney disease:

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

Due to the dosage (650 mg of paracetamol), this medicine is not indicated for this patient group.

High daily doses of paracetamol should be avoided over 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, treatment should be stopped and a doctor consulted.

Always use the lowest effective dose. This medicine should only be taken when pain or fever occurs. As these symptoms subside, treatment should be discontinued.

Use in children and adolescents:

This medicine is intended for use only in adults and adolescents aged 14 years and older. Children and adolescents under 14 years of age must not take this medicine.

This medicine is taken orally.

Tablets should be swallowed whole or split in half, with a glass of liquid, preferably water.

The tablets are scored, allowing them to be split in half. The score line is provided solely to assist splitting the tablet if it is difficult to swallow whole.

Always use the lowest effective dose.

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

Administration of this medicine should be based on the occurrence of pain or fever. As these symptoms subside, treatment should be discontinued.

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 ingested 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 of 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), stating 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 can cause adverse effects, although not everyone will experience them.

Rare adverse effects (occurring in up to 1 in 1,000 people) include: malaise, low 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, leucopenia, neutropenia, haemolytic anaemia), and hypoglycaemia (low blood sugar). Very rare cases of serious skin reactions have been reported.

Frequency not known (cannot be estimated from the available data): headache caused by analgesic abuse and a serious condition that may cause the blood to become more acidic (called metabolic acidosis) in critically ill patients using paracetamol (see section 2).

Paracetamol may damage the liver when taken in 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 through 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 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 the wastewater system or in household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you 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 650 mg of paracetamol.

The other components 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:

This medicine is presented as tablets for oral administration.

The tablets are oblong, biconvex, white in colour, with a score line on one side and marked "PB" on the other.

Pack sizes contain 20 tablets in PVC/PVDC/Aluminum blisters.

Only certain pack 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 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/