Paracetamol Pensapharma 1 g tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Paracetamol pensa pharma 1 g tablets EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Package leaflet

1. What Paracetamol pensa pharma is and what it is used for
2. What you need to know before taking Paracetamol pensa pharma
3. How to take Paracetamol pensa pharma
4. Possible side effects
5. How to store Paracetamol pensa pharma
6. Contents of the pack and other information

1. What Paracetamol pensa pharma is and what it is used for

Paracetamol is a medicine effective in reducing pain and fever (analgesic and antipyretic).

Paracetamol is used for the relief of mild to moderate pain and/or fever in adults.

2. What you need to know before taking Paracetamol pensa pharma

Do not take Paracetamol pensa pharma

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

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine:

• If you have any kidney disease.
• If you have any heart or lung disease.
• If you have any liver problems or are taking medication that affects liver function.
• If you have anaemia (reduced red blood cells, which may cause pale or yellowish skin, weakness, and difficulty breathing).
• If you regularly consume excessive amounts of alcohol. In chronic alcoholics, care must be taken not to exceed 2 grams of paracetamol in 24 hours.
• If you are being treated with medication for epilepsy, consult your doctor before taking this medicine, as concomitant use may reduce the efficacy of paracetamol and increase its hepatotoxicity, especially with high-dose paracetamol regimens.
• If you are taking this medicine simultaneously with other medicines containing paracetamol, as this may lead to liver damage.
• If you are asthmatic and sensitive to acetylsalicylic acid (aspirin).

During treatment with Paracetamol pensa pharma, 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 have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition known as metabolic acidosis (an abnormality 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 difficulty breathing with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.

You should not use paracetamol habitually for long periods, as prolonged exposure may cause liver damage. Consult your doctor or pharmacist if you intend to take paracetamol for a long duration.

Do not use paracetamol without consulting your doctor if you have alcohol-related problems or any liver problems. Do not take Paracetamol pensa pharma with alcohol. The effect of alcohol is not increased by taking Paracetamol pensa pharma.

Do not take more paracetamol than recommended in section 3 of this leaflet. Higher doses do not increase pain relief but may cause serious liver damage. Symptoms of liver damage usually appear after a few days. Therefore, it is very important to contact your doctor as soon as possible if you have taken more than the recommended dose.

Children and adolescents

Do not use in children or adolescents under 18 years of age.

Other medicines and Paracetamol pensa pharma

Inform your doctor or pharmacist if you are currently taking, have recently taken, or might need to take any other medicines.

Do not take any other medicine containing paracetamol.

Paracetamol may affect or be affected by other medicines. Inform your doctor or pharmacist if you are taking any of the following medicines:

• Metoclopramide or domperidone (medicines used to prevent nausea and vomiting).
• Colestyramine (medicines used to lower blood cholesterol levels). Paracetamol should be taken at least 1 hour before or after this medicine.
• Warfarin or other anticoagulant medicines, if you need to take a painkiller daily for a prolonged period.
• Medicines used to increase urine output (loop diuretics such as furosemide).
• Probenecid (medicines used to treat gout).
• Substances that reduce liver enzymes, e.g. rifampicin (used to treat infections) and medicines for epilepsy such as barbiturates, phenytoin, carbamazepine, primidone.
• Lamotrigine (a medicine used to treat epilepsy); paracetamol may reduce its efficacy.
• Propranolol (medicines used to treat high blood pressure and heart rhythm disorders).
• Flucloxacillin (an antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) requiring urgent treatment (see section 2).

Paracetamol may alter the results of certain laboratory tests, such as blood glucose or uric acid tests.

Taking Paracetamol pensa pharma with food and alcohol

The use of paracetamol in patients who habitually consume alcohol (3 or more alcoholic drinks – beer, wine, spirits – per day) 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

If necessary, Paracetamol pensa pharma 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.

Although small amounts of paracetamol are excreted in breast milk, no adverse effects have been reported in breastfed infants. Paracetamol may be used during breastfeeding.

Driving and using machines

The influence of paracetamol on the ability to drive and use machines is none or negligible.

Paracetamol pensa pharma contains sodium

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

3. How to take Paracetamol pensa pharma

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

Recommended dose:

Adults:

The recommended dose is 1 tablet every 6–8 hours as needed. Do not take more than 3 tablets (3,000 mg) per day.

Patients with renal or hepatic impairment:

In patients with renal or hepatic impairment, the dose should be reduced or the dosing interval prolonged.

In patients with severe renal impairment, the dosing interval for paracetamol must be at least 8 hours between doses.

Consult your doctor if in doubt.

The tablet may be divided into equal doses. Always use the lowest effective dose.

Do not use in combination with other medicines containing paracetamol.

Do not exceed the stated dose.

Prolonged use of paracetamol should be avoided, as it increases the risk of adverse effects such as liver damage. Consult your doctor or pharmacist if you intend to take paracetamol for a prolonged period.

This medicine should only be administered when pain or fever occurs. As these symptoms subside, treatment should be discontinued.

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.

If you consider the effect of paracetamol to be too strong or too weak, inform your doctor or pharmacist.

If you take more Paracetamol pensa pharma than you should

If you have taken more paracetamol than you should, consult your doctor or pharmacist immediately.

Liver damage may occur even if you feel well. To prevent liver damage, it is important that your doctor initiates treatment as soon as possible (preferably within 10–12 hours after ingestion of the medicine).

Symptoms of overdose may include: nausea, vomiting, anorexia (loss of appetite), sweating and malaise, yellowing of the skin and eyes (jaundice), and abdominal pain. In such cases, seek immediate medical attention.

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, go immediately to a medical center or call the Toxicology Information Service (telephone 91 562 04 20), stating the medicine and the amount ingested.

If you forget to take Paracetamol pensa pharma

Do not take a double dose to make up for missed doses.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

This medicine may cause the following adverse effects:

Rare (may affect 1 in 1,000 people): malaise, drop in blood pressure (hypotension), and increased blood transaminase levels.

Very rare (may affect 1 in 10,000 people): 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 rarely, 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 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 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 pensa pharma

Keep this medicine out of the sight and reach of children.

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.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Paracetamol pensa pharma

• The active substance is paracetamol.
• The other components (excipients) are: sodium carboxymethylstarch type A (from potato), purified water, pregelatinized starch (from corn), povidone (E-1201), stearic acid (E-570) and crospovidone (E-1202).

Appearance of the product and contents of the pack:

Paracetamol pensa pharma are oval, biconvex, white tablets with a functional score on one side and marked "PC" on the other, measuring 21.0 ± 0.5 mm in length.

The tablet can be divided into equal doses.

Paracetamol pensa pharma is available in packs of 16, 18, 20 and 40 tablets.

Prescription only.

Only certain pack sizes may be marketed.

Marketing Authorization 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.U.
Crta. N-I, Km 36
San Agustin de Guadalix
28750 Madrid
Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Spain: Paracetamol pensa pharma 1 g tablets EFG
Portugal: Paracetamol toLife 1000 mg tablets
Italy: Paracetamolo pensa pharma 1000 mg, compresse

Date of the most recent review of this leaflet: 01/2025

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