Patient Information Leaflet

Paracetamol pensa pharma 1 g tablets EFG

Read 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 must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Table of Contents

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 pack and additional information

Paracetamol is an effective medication to reduce pain and fever (analgesic and antipyretic).

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

Do not take Paracetamol pensa pharma

-If you are allergic to paracetamol or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication:

• 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 anemia (decrease in red blood cells that may cause pale and yellowish face, leading to weakness and difficulty breathing).
• If you regularly consume excessive amounts of alcohol. Chronic alcoholics should be careful not to take more than 2 grams in 24 hours of paracetamol.
• If you are being treated with any medication for epilepsy, consult your doctor before taking this medication, as when used together, the efficacy is reduced and the hepatotoxicity of paracetamol is increased, especially in high-dose treatments with paracetamol.
• If you are taking this medication simultaneously with other medications that contain paracetamol, as they may cause liver damage.
• If you are asthmatic and sensitive to acetylsalicylic acid (aspirin).

Do not use paracetamol habitually for a long time, as long exposure may cause liver damage. Consult your doctor or pharmacist if you intend to take paracetamol for a long period of time.

Do not use paracetamol without consulting your doctor if you have alcohol problems or liver problems. Do not use 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 prospectus. Higher doses do not increase the effect of pain relief, but may cause serious liver damage. The symptoms of liver damage usually appear after a couple of days. Therefore, it is very important to contact your doctor as soon as possible if you have taken more doses than recommended.

Children and adolescents

Do not use in children or adolescents under 18 years old.

Other medications and Paracetamol pensa pharma

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Do not takeany other medication that contains paracetamol.

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

• Metoclopramide or domperidone (medications used to prevent nausea and vomiting).
• Colestiramine (medications to reduce blood cholesterol levels). Paracetamol should be taken at least 1 hour before or after this medication.
• Warfarin or other medications to prevent blood clots, in case you need to take a pain reliever daily for a prolonged period.
• Diuretics of the asa group, such as furosemide.
• Probenecid (medications used to treat gout).
• Substances that reduce liver enzymes, e.g. rifampicin (used to treat infections) and medications to treat epilepsy, such as barbiturates, phenytoin, carbamazepine, primidone.
• Lamotrigine (medication to treat epilepsy), paracetamol may reduce its efficacy.
• Propranolol (medications used to treat high blood pressure and heart rhythm disorders).
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (metabolic acidosis with high anion gap) that must be treated urgently and may occur particularly in severe kidney failure, sepsis (when bacteria and their toxins circulate in the blood causing organ damage), malnutrition, chronic alcoholism, and if the maximum daily doses of paracetamol are used.

Paracetamol may alter some analytical test results, such as blood sugar analysis or uric acid test.

Taking Paracetamol pensa pharma with food and alcohol

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

The taking of this medication with food does not affect the efficacy of this medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

In case of need, Paracetamol pensa pharma can be used during pregnancy. You should use the lowest possible dose that reduces pain or fever and use it for the shortest possible time. Contact your doctor if the pain or fever does not decrease or if you need to take the medication more frequently.

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

Driving and operating machinery

The influence of paracetamol on the ability to drive and operate machinery is negligible or insignificant.

Paracetamol pensa pharma contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per coated tablet; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

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 insufficiency:

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

In patients with severe renal insufficiency, the paracetamol dosing interval must be at least 8 hours between each dose.

Consult your doctor in case of doubt.

The tablet can be divided into equal doses. Always use the smallest effective dose.

Do not use in combination with other medications containing paracetamol.

Do not exceed the indicated dose.

Paracetamol use should be avoided for prolonged periods of time, 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 of time.

The administration of this medication is subject to the appearance of pain or fever. As these symptoms disappear, 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 other symptoms appear, treatment should be interrupted and your doctor consulted.

If it is estimated that the paracetamol action is 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.

You may be at risk of liver damage, even if you feel well. To prevent liver damage, it is essential that your doctor initiates treatment as soon as possible (preferably within 10-12 hours after medication ingestion).

The symptoms of overdose may include: nausea (feeling sick), vomiting (being sick), anorexia (loss of appetite), sweating, and feeling unwell, yellowing of the skin and eyes (jaundice), and abdominal pain. In this case, seek immediate medical attention.

Patients undergoing barbiturate treatment or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

In case of overdose or accidental ingestion, seek immediate medical attention or call the Toxicological Information Service (phone 91 562 04 20), indicating the medication and the amount ingested.

If you forgot to take Paracetamol pensa pharma

Do not take a double dose to compensate for the missed doses.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

This medication may cause the following adverse effects:

Rare (may affect 1 in 1,000 people): discomfort, low blood pressure (hypotension), and increased levels of transaminases in the blood.

Very rare (may affect 1 in 10,000 people): kidney diseases, cloudy urine, allergic dermatitis (skin rash), jaundice (yellow discoloration of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, hemolytic anemia) and hypoglycemia (low blood sugar). Very rarely, severe skin reactions have been reported.

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

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Paracetamol pensa pharma

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

Appearance of the product and contents of the packaging:

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

The tablet can be divided into equal doses.

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

Available only by prescription.

Only some package sizes may be commercially available.

Holder of the marketing authorization:

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing:

Galenicum Health, S.L.U.

Sant Gabriel, 50

Esplugues de Llobregat

08950 Barcelona

Spain

O

SAG Manufacturing S.L.U.

Crta. N-I, Km 36

San Agustin de Guadalix,

28750 Madrid

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Spain: Paracetamol pensa pharma 1 g tablets EFG

Portugal: Paracetamol Lumec 1000 mg tablets

Italy: Paracetamolo pensa pharma 1000 mg, compresse

Date of the last review of this leaflet: 06/2022

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/