Paracetamol Benel 500 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Paracetamol Benel 500 mg tablets

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

Always follow exactly the instructions for taking this medicine as described in this leaflet or as advised by your doctor, pharmacist, or nurse.

Package leaflet contents:

1. What Paracetamol Benel 500 mg is and what it is used for
2. What you need to know before taking Paracetamol Benel 500 mg
3. How to take Paracetamol Benel 500 mg
4. Possible side effects
5. How to store Paracetamol Benel 500 mg
6. Contents of the pack and other information

1. What Paracetamol Benel 500 mg 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 feverish conditions in adults and children from 12 years of age (or body weight over 40 kg).

2. What you need to know before taking Paracetamol Benel 500 mg

Do not take Paracetamol Benel 500 mg

• 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 Paracetamol Benel 500 mg.

• Do not take more than the recommended dose stated in section 3.

• The simultaneous use of this medicine with other medicines containing paracetamol (e.g. cold and flu remedies) should be avoided, as high doses may cause liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.

• Chronic alcoholics should take care not to exceed 2 g/day of paracetamol.

• Patients with kidney, heart or lung disease, and those with anaemia, should consult their doctor before taking this medicine.

• If you are being treated with medicines for epilepsy, consult your doctor before taking this medicine, as concomitant use may reduce effectiveness and increase the hepatotoxicity of paracetamol, especially with high-dose paracetamol treatment.

• Asthmatic patients who are sensitive to acetylsalicylic acid should consult their doctor before taking this medicine.

During treatment with Paracetamol Benel, 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 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 circumstances when paracetamol is used at regular doses for 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, feeling unwell (nausea), and vomiting.

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 medical advice sought.

Children and adolescents

Children under 12 years of age should not take this medicine. Other formulations more suitable for this patient group are recommended.

Other medicines and Paracetamol Benel 500 mg

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

In particular, if you are taking any of the following medicines, dosage adjustments or discontinuation of treatment may be necessary:

• Medicines to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin)

• Medicines for epilepsy: Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)

• Medicines for tuberculosis: (isoniazid, rifampicin)

• Medicines for depression and seizures: Barbiturates (used as hypnotics, sedatives and anticonvulsants)

• Medicines 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.

Do not use with other analgesics (pain-relieving medicines) without consulting your doctor.

Inform your doctor or pharmacist if you are taking:

Flucloxacillin (antibiotic), due to a serious risk of blood and fluid disorder (called metabolic acidosis) that requires urgent treatment (see section 2).

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 administered as the analgesic of choice.

Interference with diagnostic tests:

If you are due to have any laboratory 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 these tests.

Taking Paracetamol Benel 500 mg with food, drinks and alcohol

Taking this medicine with food does not affect its effectiveness.

Pregnancy, breastfeeding, and fertility

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.

Taking medicines during pregnancy may be dangerous for the embryo or fetus and should be monitored by your doctor.

Paracetamol may be used during pregnancy if necessary. 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 do not improve, or if you need to take the medicine more frequently.

Breastfeeding

Paracetamol passes into breast milk; therefore, women who are breastfeeding should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

The influence of paracetamol on the ability to drive and operate machinery is none or negligible.

3. How to take Paracetamol Benel 500 mg

Follow these instructions unless your doctor has given you different ones. Remember to take your medicine. Paracetamol is to be taken orally.

The normal dose is:

Adults and children aged 12 years and older, or with body weight above 40 kg:

Take 1 tablet every 4–6 hours as needed, up to a maximum of 6 tablets per day. Do not exceed 3 grams of paracetamol in 24 hours. Doses should be spaced at least 4 hours apart.

Children: It is necessary to adhere to the dosages defined according to body weight. The child's age in relation to weight is provided for informational purposes only.

The recommended daily dose of paracetamol is approximately 60 mg/kg/day, divided into 4 or 6 doses, i.e., 15 mg/kg every 6 hours or 10 mg/kg every 4 hours.

• Children aged 12 years and older (or weighing more than 40 kg): take one 500 mg tablet up to 4 times a day.

The maximum daily dose must not exceed 4 tablets (2 g).

Patients with liver disease: Before taking this medicine, you must consult your doctor. You should take the amount prescribed by your doctor, with a minimum interval of 8 hours between doses. You must not take more than 2 grams or 4 tablets of 500 mg paracetamol in 24 hours.

Patients with kidney disease: Before taking this medicine, you must consult your doctor. Take a maximum of 500 mg per dose.

Elderly patients: You should consult your doctor.

Use in children and adolescents:

Do not use in children under 12 years of age.

Prolonged use of high daily doses of paracetamol should be avoided, 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 new symptoms appear, you should stop treatment and consult your doctor.

If you feel that the effect of paracetamol is too strong or too weak, inform your doctor or pharmacist.

Whole, split, or crushed tablets should be taken with a glass of liquid, preferably water.

If you take more Paracetamol Benel 500 mg than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medication and the amount ingested.

If an overdose has been taken, you must go immediately to a medical center even if there are no symptoms, as symptoms often do not appear until three days after the overdose, even in cases of severe poisoning. Symptoms of overdose may include dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

Treatment of overdose is most effective when started within 4 hours of taking the medication.

Patients undergoing treatment with barbiturates or who suffer from chronic alcoholism may be more susceptible to paracetamol overdose.

If you forget to take Paracetamol Benel 500 mg

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

If you stop treatment with Paracetamol Benel 500 mg

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

4. Possible adverse effects

Like all medicines, Paracetamol may produce adverse effects, although not everyone experiences them.

This medicine may cause the following adverse effects:

• Rare (may affect up to 1 in 1,000 patients): malaise, low blood pressure (hypotension), and increased blood transaminase levels.
• Very rare (may affect up to 1 in 10,000 patients): kidney disorders, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, haemolytic anaemia), hypoglycaemia (low blood sugar), and severe skin reactions. Paracetamol may cause liver damage when taken in high doses or during prolonged treatment.
• 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 are using paracetamol (see section 2).

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 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 Benel 500 mg

No special storage conditions are required.

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

Do not use this medicine after the expiry date stated on the packaging, following "EXP". The expiry date refers to the last day of the month indicated.

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

6. Contents of the pack and other information

Composition of Paracetamol Benel 500 mg tablets

• The active substance is paracetamol.
• The other components are: pregelatinized corn starch (gluten-free), stearic acid, povidone, crospovidone, microcrystalline cellulose and vegetable-source magnesium stearate.

Appearance of the medicinal product and contents of the pack

Paracetamol Benel 500 mg is presented as oral tablets, in packs of 10 and 20 tablets in blister packs, and packs of 20 tablets in bottles. The tablets are scored, allowing them to be divided into equal doses.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Farmalider S.A.

C/ La Granja 1

28108 Alcobendas, Madrid, Spain

Manufacturer

Toll Manufacturing Services S.L

C/ Aragoneses, 2.

28108 Alcobendas (Madrid)

Spain

“or”

ROVI PHARMA INDUSTRIAL SERVICES, S.A.

Vía Complutense, 140,

Alcalá de Henares,

28805 (Madrid) Spain

Date of the most recent revision of this package leaflet: March 2025.

Detailed and up-to-date 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/