Paracetamol Pensa Pharma 650 mg tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Paracetamol pensa pharma 650 mg tablets EFG

Read all of this 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, ask 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.

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Contents of the 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. Storage of Paracetamol pensa pharma
6. Contents of the package and other information

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

This medicinal product belongs to a group of medicines called analgesics and antipyretics.

This medicine is indicated for the treatment of mild to moderate pain and fever.

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

Do not take Paracetamol pensa pharma

• • if you are allergic (hypersensitive) to paracetamol, propacetamol hydrochloride, or any of the other components of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take paracetamol.

• Do not exceed the recommended dose indicated in section 3, “How to take Paracetamol pensa pharma”.
• In asthmatic patients who are sensitive to acetylsalicylic acid, you should consult your doctor before taking this medicine.
• If you have liver, kidney, heart, or lung disease, or suffer from anemia (reduced hemoglobin levels in the blood, with or without a decrease in red blood cells), you should consult your doctor before taking this medicine.
• If you are being treated with medications for epilepsy, consult your doctor before taking this medicine, as concomitant use may reduce efficacy and increase the hepatotoxic potential of paracetamol, especially when high doses of paracetamol are used.
• In chronic alcoholics, caution should be taken not to exceed 3 tablets of 650 mg 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 new symptoms appear, you should consult your doctor and reevaluate the clinical situation.

During treatment with Paracetamol pensa pharma, inform your doctor immediately if:

You have serious medical 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 abnormality in blood and body fluids) has been reported in patients under these conditions 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 difficulty with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.

Children and adolescents

For children and adolescents under 15 years of age, consult your doctor or pharmacist, as other formulations with doses adapted to this patient group are available.

Other medicines and Paracetamol pensa pharma

Inform 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.

Paracetamol may interact with the following medicines:

• Medicines used to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin)
• Medicines used to treat epilepsy: Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Medicines used to treat tuberculosis (isoniazid, rifampicin)
• Medicines used to treat depression and seizures: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medicines used to lower blood cholesterol levels: cholestyramine
• Medicines used to increase urine elimination (loop diuretics such as furosemide)
• Medicines used in the treatment of 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 abnormalities (called metabolic acidosis) that require urgent treatment (see section 2)

Do not use with other analgesics (medicines that reduce pain) without consulting your doctor.

As a general rule for any medicine, it is advisable to systematically inform your doctor or pharmacist if you are receiving treatment with another medicine. In patients taking oral anticoagulants, paracetamol may occasionally be used as the analgesic of choice.

Interference with diagnostic tests:

If you are scheduled for any diagnostic tests (including blood and urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter the results of such tests.

Taking Paracetamol pensa pharma with food, drinks, and alcohol

The use of 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 efficacy.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medicine.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using 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 controls pain or fever, and use it for the shortest possible duration. Contact your doctor if pain or fever do not improve or if you need to take the medicine more frequently.

Small amounts of paracetamol may pass into breast milk; therefore, it is recommended that you consult your doctor or pharmacist before taking this medicine.

Driving and using machines

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

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

3. How to take Paracetamol pensa pharma

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

Remember to take your medicine. Paracetamol should be taken orally.

The tablet may be divided into equal halves.

The recommended dose is:

Adults and adolescents over 15 years of age:

The usual dose is 1 tablet (650 mg paracetamol) every 4 or 6 hours. Doses should be spaced at least 4 hours apart. Do not take more than 6 tablets 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.

Patients with kidney disease:

Before taking this medicine, they must consult their doctor. Take a maximum of 500 milligrams per dose. Due to the dosage (650 mg paracetamol), this medicine is not indicated for this group of patients.

Elderly patients: should consult their doctor.

Use in children and adolescents: do not use in children under 15 years of age.

The score line is intended to divide the tablet into equal doses and may assist if you find it difficult to swallow the tablet whole.

If you feel that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist. When doses lower than 650 mg paracetamol per dose are required, other formulations of paracetamol suited to the required dosage should be used.

If you take more Paracetamol pensa pharma 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 ingested an overdose, you must go immediately to a medical center even if you do not have symptoms, as these often do not appear until 3 days after the overdose has occurred, even in cases of severe poisoning.

Treatment of overdose is most effective if started within 4 hours of ingestion of 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 at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Paracetamol pensa pharma

Do not take a double dose to make up for forgotten doses. Simply take the missed dose as soon as you remember, and take the following doses with the recommended interval between doses (at least 4 hours).

4. Possible adverse effects

Like all medicines, this medicine may 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 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 can also report them directly via 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 out of the sight and reach of children.

No special storage conditions required.

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 should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Paracetamol pensa pharma

• 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 medicine and contents of the pack

This medicine is presented as oblong, biconvex, white tablets, with a score line on one side and marked "PB" on the other.

Packs contain 20 or 40 tablets, packed in PVC/PVdC/Aluminum blisters.

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

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 revision of this leaflet: January 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