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

It is indicated for the symptomatic relief of occasional mild to moderate pain, such as headache, toothache, muscle (contractures) or back pain (lumbago) and in febrile states.

You should talk to your doctor if fever worsens or does not improve after 3 days or if pain persists or does not improve after 5 days.

Do not take Paracetamol pensavital

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

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Paracetamol pensavital.

• Do not take more medicine than recommended in section 3. “How to take Paracetamol pensavital”.
• The concurrent use of this medicinal product with other medicines containing paracetamol, e.g. cold and flu medicines, should be avoided as high doses may result in liver damage. Do not use more than one medicine containing paracetamol without talking to your doctor.
• Chronic alcoholics should be careful not to take more than 3 grams of paracetamol in 24 hours.
• Patients with kidney, liver, heart or lung disease and patients with anaemia should consult a doctor before taking this medicine.
• When you are being treated with a medicine to treat epilepsy you should consult your doctor before taking this medicine, because when they are used at the same time the efficacy is reduced and the liver toxicity of paracetamol is increased, especially in treatments with high doses of paracetamol.
• Asthmatic patients sensitive to acetylsalicylic acid should consult a doctor before taking this medicine.

Other medicines and Paracetamol pensavital

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

This is particularly important if you are using any of the following medicines, as it may be necessary to change the dosage of some of them or to discontinue treatment:

• Medicines to prevent blood clots: oral anticoagulants (acenocoumarol, warfarin).
• Medicines to treat epilepsy: anti-epileptic drugs (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 the elimination of urine (loop diuretics such as those in the furosemide group).
• Medicines used for 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 disturbances (cardiac arrhythmias): propranolol.
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid disturbance (high anion gap metabolic acidosis), which must be treated urgently and which can occur particularly in cases of severe kidney failure, sepsis (when bacteria and their toxins circulate in the blood resulting in organ damage), malnutrition, chronic alcoholism and if maximum daily doses of paracetamol are used.

Interference with analytical tests

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

Paracetamol pensavital with food, drink and alcohol

The use of paracetamol in patients who regularly consume alcohol (3 or more alcoholic drinks per day: beer, wine, liquor, etc.) may cause liver damage.

Taking this medicine with food does not alter its efficacy.

Use in children

Do not use in adolescents under 14 years of age.

Pregnancy and breast-feeding

Pregnancy

Talk to your doctor or pharmacist before using any medicine.

Important for women

If you are pregnant or think you may be pregnant, ask your doctor for advice before taking this medicine. Taking medicines during pregnancy can be dangerous for the embryo or foetus, and you should be monitored by your doctor.

If necessary, this medicine can be used during pregnancy. You should use the lowest possible dose that reduces your pain and/or your fever and use it for the shortest time possible. Contact your doctor if the pain and/or fever are not reduced or if you need to take the medicine more often.

Breast-feeding

Talk to your doctor or pharmacist before using any medicine. Paracetamol is excreted in breast milk, so breast-feeding women should talk to their doctor or pharmacist before taking this medicine.

Driving and using machines

Paracetamol has no or negligible influence on the ability to drive and use machines.

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

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.

Remember to take your medicine. Paracetamol should be taken by mouth.

The recommended dose is:

Adults and adolescents over 14 years of age (weighing 64–65 kg):

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

Patients with liver disease:

You should talk to your doctor before taking this medicine. You should take the amount of medicine prescribed by your doctor with a minimum interval of 8 hours between each dose.

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

Patients with kidney disease:

You should talk to your doctor before taking this medicine. Do not take more than 500 mg per dose.

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

High daily doses of paracetamol should be avoided for prolonged periods of time 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 other symptoms appear, you should stop treatment and contact your doctor.

Always use the lowest effective dose. The use of this medicine is subject to the onset of pain or fever. As soon as the pain or fever disappears, treatment should be discontinued.

Use in children and adolescents:

This medicine is for use only in adults and adolescents over 14 years of age. Children and adolescents under 14 years of age should not take this medicine.

This medicine is taken orally.

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

The tablets have a score line so that they can be broken in half. The score line is only there to help you break the tablet if you have difficulty swallowing it whole.

Always use the lowest effective dose.

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

The administration of this medicine is subject to the onset of pain or fever. As soon as the pain or fever disappears, treatment should be discontinued.

If you take more Paracetamol pensavital than you should

You should consult 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 should go to a medical centre immediately, even if you do not notice symptoms, as these often do not become apparent until 3 days after ingestion of the overdose, even in cases of severe intoxication.

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

Patients treated with barbiturates or patients with chronic alcoholism may be more susceptible to paracetamol overdose toxicity.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, telephone +34 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 a forgotten dose, just take the missed dose when you remember, taking the next doses at the intervals indicated in each case (at least 4 hours apart).

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Rare side effects that may affect up to 1 in 1,000 people include: malaise, low blood pressure (hypotension) and increased levels of transaminases in the blood.

Very rare side effects that may affect up to 1 in 10,000 people include: kidney disease, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leukopenia, neutropenia, haemolytic anaemia) and hypoglycaemia (low blood sugar). Very rarely, cases of severe skin reactions have been reported.

Not known (frequency cannot be estimated from the available data): headache induced by abuse of analgesics.

Paracetamol can damage the liver when taken in high doses or with prolonged treatment.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Sistema Español de Farmacovigilancia de Medicamentos de Uso Humano: https://www.notificaram.es. By reporting side effects you can help provide more information on the safety of this medicine.

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 which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Dispose of containers and medicines that you do not need at the SIGRE Point in the pharmacy. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Paracetamol pensavital contains

The active substance is paracetamol. Each tablet contains 650 mg of paracetamol.

The other ingredients are sodium starch glycolate type A potato, purified water, pregelatinised maize starch, povidone K30 (E-1201), stearic acid (E-570) and crospovidone (E-1202).

What Paracetamol pensavital looks like and contents of the pack

This medicine is available as tablets for oral administration.

The tablets are white, oblong, biconvex, scored on one side and marked with PB on the other side.

The packs contain 20 tablets, packed in PVC/PVDC/Aluminium blister packs.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Marketing authorisation 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

This leaflet was last revised in May 2022

Detailed information on this medicinal product is available on the website of the Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) http://www.aemps.gob.es/

Detailed and updated information on this product is available by scanning the QR code included in the outer carton with a smartphone. The same information is also available at the following URL: https://www.pensapharma.es/info/pensavital-paracetamol-650mg-comprimidos and on the following website: https://cima.aemps.es/cima/dochtml/p/85861/P_85861.html