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

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

Paracetamol is used for the treatment of moderate pain and fever in adults and children over 16 years
of age (or body weight over 50 kg).

Do not take Paracetamol pensavital

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

Be especially careful with 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.
• Asthmatic patients sensitive to acetylsalicylic acid should consult a doctor before taking this medicine.
• If you have kidney, liver, heart or lung disease, or if you have anaemia (a decrease in the haemoglobin level in your blood, whether or not it is caused by a decrease in red blood cells), you should talk to your 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.
• Chronic alcoholics should be careful not to take more than 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 other symptoms appear, a doctor should be consulted and the clinical situation re-evaluated.
• In adolescents under 16 years of age, please talk to your doctor or pharmacist as there are other dosage forms suitable for this group of patients.

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.

Paracetamol may interact with the following medicines:

• Medicine 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 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.

Do not use with other analgesics (pain relievers) without consulting a doctor.

As a general rule for any medicine, it is advisable to routinely inform your doctor or pharmacist if you are being treated with another medicine. In case of treatment with oral anticoagulants, it can be administered occasionally as the analgesic of choice.

Interference with analytical tests

If you are going to undergo any diagnostic test (including blood tests, urine tests, skin tests using allergens, etc.) tell your doctor that you are taking this medicine, as it may alter the results of these tests.

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.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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.

Small amounts of paracetamol may appear in breast milk, so it is recommended that you speak to your 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 1 mmol of sodium (23 mg) per film-coated tablet, i.e. it is essentially “sodium-free”.

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

The recommended 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.

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.

Patients with liver disease: you should consult 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 2 tablets of paracetamol in 24 hours, divided into 2 doses.

Patients with kidney disease: you should consult your doctor before taking this medicine.

Do not take more than 500 mg per dose.

Due to the dosage, 1 gram of paracetamol is not indicated for this group of patients.

Elderly patients: please consult your doctor.

Use in children and adolescents: Do not use in children and adolescents under 16 years of age.

If you think that the action of paracetamol is too strong or too weak, tell your doctor or pharmacist. When doses of less than 1,000 mg of paracetamol per dose are required, other paracetamol formulations should be used that are appropriate to the required dosage.

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, seek medical attention 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.

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 Spanish Pharmacovigilance System for Human Use: 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

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

The other ingredients (excipients) 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

Paracetamol pensavital is available as tablets for oral administration.

The tablets are white, oblong, biconvex, scored on one side and marked with PC on the other side. The tablet can be divided into equal doses.

The packs contain 10 tablets, packaged in PVC/PVDC/Aluminium blister packs.

Marketing authorisation 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

This leaflet was last revised in April 2022

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (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-1g-comprimidos and on the following website: https://cima.aemps.es/cima/dochtml/p/85210/P_85210.html