What is in this leaflet
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 fever in adults and children over 12 years of age (or body weight over 40 kg).
2. What you need to know before you take Paracetamol pensavital
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
Other medicines and Paracetamol pensavital
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Paracetamol may interact with the following medicines:
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.
Paracetamol pensavital contains sodium (sodium starch glycolate type A potato)
This medicine contains less than 23 mg of sodium (1 mmol) per tablet, i.e. 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 by mouth.
The recommended dose is:
Adults and children over 12 years of age, or body weight over 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.
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.
Children: It is important to respect the dosages defined according to weight. The age of the child according to weight is given for information purposes.
The recommended daily dose of paracetamol is approximately 60 mg/kg/day, divided into 4 or 6 daily doses, 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.
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: 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 grams (four 500 mg tablets) of paracetamol in 24 hours.
Patients with kidney disease: you should consult your doctor before taking this medicine. Do not take more than 500 mg per dose.
Elderly patients: please consult your doctor.
Use in children and adolescents:
Do not use in children under 12 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 500 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, 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).
4. Possible side effects
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.
5. How to store 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 which is stated on the carton after CAD. 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.
6. Contents of the pack and other information
What Paracetamol pensavital contains
The active substance is paracetamol. Each tablet contains 500 mg of paracetamol.
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, biconvex and round in shape.
The packs contain 20 tablets, packed in PVC/PVDC/Aluminium blister packs.
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 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-500mg-comprimidos and on the following website: https://cima.aemps.es/cima/dochtml/p/85112/P_85112.html