PARACETAMOL BENEL 500 mg TABLETS

Introduction

Package Leaflet: Information for the User

Paracetamol Benel 500 mg Tablets

Read this package leaflet carefully before starting to take this medicine, as it contains important information for you.

Follow the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor, pharmacist, or nurse.

Contents of the Package Leaflet:

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. Storage of Paracetamol Benel 500 mg
6. Package Contents and Additional Information

1. What Paracetamol Benel 500 mg is and what it is used for

Paracetamol belongs to the group of medicines called analgesics and antipyretics. Paracetamol is used to treat mild to moderate pain and febrile conditions in adults and children over 12 years old (or with a body weight over 40 kg).

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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 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 Benel 500 mg.

• Do not take more than the recommended dose in section 3.
• Avoid taking this medicine simultaneously with other medicines that contain paracetamol, such as flu and cold medicines, as high doses can cause liver damage. Do not use more than one medicine that contains paracetamol without consulting your doctor.
• Chronic alcoholics should be cautious not to take more than 2 g/day of paracetamol.

• Patient with kidney, heart, or lung diseases, and patients with anemia, should consult their doctor before taking this medicine.
• When being treated with any medicine for epilepsy, consult your doctor before taking this medicine, as the efficacy of paracetamol may be decreased and hepatotoxicity may be increased, especially with high doses of paracetamol.
• Asthmatic patients sensitive to acetylsalicylic acid should consult their doctor before taking this medicine.

During treatment with Paracetamol Benel, inform your doctor immediately if:

• You have severe diseases, such as severe renal insufficiency 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 severe disease called metabolic acidosis (an anomaly in blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken with flucloxacillin. Symptoms of metabolic acidosis may include: severe respiratory distress with deep and rapid breathing, drowsiness, feeling of discomfort (nausea) and vomiting.

If the pain persists for more than 5 days, the fever for more than 3 days, or if the pain or fever worsens or other symptoms appear, you should interrupt the treatment and consult your doctor.

Children and Adolescents

Children under 12 years old should not take this medicine. The use of other presentations more suitable for the treatment of this group of patients is recommended.

Other Medicines and Paracetamol Benel 500 mg

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

In particular, if you are using any of the following medicines, it may be necessary to modify the dose of some of them or interrupt the treatment:

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

• Medicines for treating epilepsy: Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Medicines for treating tuberculosis: (isoniazid, rifampicin)
• Medicines for treating depression and convulsions: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medicines for lowering cholesterol levels in the blood: (cholestyramine)
• Medicines used to increase urine elimination (loop diuretics such as furosemide)
• Medicines used for the treatment of gout (probenecid and sulfinpyrazone)
• Medicines used to prevent nausea and vomiting: Metoclopramide and domperidone
• Medicines used for the treatment of high blood pressure and heart rhythm disorders (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 anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).

As a general rule for any medicine, it is recommended to systematically inform your doctor or pharmacist if you are being treated with another medicine. In the 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 have any analytical test (including blood tests, urine tests, skin tests that use 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 efficacy.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Taking medicines during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

If necessary, paracetamol 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 medicine more frequently.

Breastfeeding

Paracetamol passes into breast milk, so breastfeeding women should consult their doctor or pharmacist before taking this medicine.

Driving and Using Machines

The influence of paracetamol on the ability to drive and use machines is negligible or non-existent.

3. How to Take Paracetamol Benel 500 mg

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

The normal dose is:

Adults and children over 12 years old, or with a 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. The doses should be spaced at least 4 hours apart.

Children: It is necessary 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 over 12 years old (or with a body weight over 40 kg): take 1 tablet of 500 mg up to 4 times a day.

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

Patient 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 each dose. They should not take more than 2 grams or 4 tablets of 500 mg of paracetamol in 24 hours.

Patient with kidney disease: before taking this medicine, they must consult their doctor. Take a maximum of 500 mg per dose.

Elderly patients: should consult their doctor.

Use in children and adolescents:

Do not use in children under 12 years old.

High daily doses of paracetamol should be avoided during prolonged periods, as the risk of side effects such as liver damage increases.

If the pain persists for more than 5 days, the fever for more than 3 days, or if the pain or fever worsens or other symptoms appear, you should interrupt the treatment and consult your doctor.

If you think the action of paracetamol is too strong or too weak, inform your doctor or pharmacist.

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

If you take more Paracetamol Benel 500 mg than you should

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

If you have ingested an overdose, you should go to a medical center immediately, even if you do not have symptoms, as they often do not appear until three days after taking 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 more effective if started within 4 hours after taking the medicine.

Patient being treated with barbiturates or suffering 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 taking Paracetamol Benel 500 mg

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

4. Possible Side Effects

Like all medicines, Paracetamol can cause side effects, although not everyone gets them.

This medicine can cause the following side effects:

• Rare (may affect up to 1 in 1,000 patients): discomfort, low blood pressure (hypotension), and increased levels of transaminases in the blood.
• Very rare (may affect up to 1 in 10,000 patients): kidney disease, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, hemolytic anemia), and hypoglycemia (low blood sugar) and severe skin reactions. Paracetamol can damage the liver when taken in high doses or for prolonged periods.
• Frequency not known (cannot be estimated from available data): a severe disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing 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 expiration date stated on the package, after "EXP". The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packages and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Paracetamol Benel 500 mg Tablets

• The active ingredient is paracetamol.
• The other ingredients are: pregelatinized cornstarch (gluten-free), stearic acid, povidone, crospovidone, microcrystalline cellulose, and vegetable magnesium stearate.

Appearance of the Product and Package Contents

Paracetamol Benel 500 mg is presented in the form of tablets for oral administration, in packages of 10 and 20 tablets packaged in blisters and packages of 20 tablets packaged in bottles. The tablets are scored, which allows 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 Last Revision of this Package Leaflet:March 2025.

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