ANTIDOL 650 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Antidol 650 mg Coated Tablets

Paracetamol

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if the fever does not improve after 3 days or the pain after 5 days.

Contents of the Package Leaflet

1. What is Antidol and what is it used for
2. What you need to know before taking Antidol
3. How to take Antidol
4. Possible side effects
5. Storage of Antidol
6. Contents of the pack and further information

1. What is Antidol and what is it used for

Paracetamol is effective in reducing pain and fever.

This medicine is used for the symptomatic relief of occasional mild or moderate pain, such as headaches, dental pain, muscular pain (cramps) or back pain (lumbago), as well as in febrile states, in adults and adolescents over 14 years old.

You should consult a doctor if your condition worsens or if the fever persists after 3 days or the pain after 5 days.

2. What you need to know before taking Antidol

Do not take Antidol

• 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 Antidol:

• Do not take more medicine than recommended in section 3 "How to take Antidol". A higher dose than recommended does not provide greater pain relief, but it does increase the risk of serious liver damage. Symptoms of liver damage usually appear a few days later. Therefore, it is essential that you contact your doctor as soon as possible if you have taken more than the recommended dose.
• The simultaneous use of this medicine with other medicines that contain paracetamol, such as flu and cold medicines, should be avoided, as high doses can lead to 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 grams of paracetamol in 24 hours.
• If you have liver problems, including liver problems due to excessive alcohol consumption (3 or more alcoholic beverages per day).
• If you have kidney problems.
• If you have a deficiency of glucose-6-phosphate dehydrogenase.
• If you have anorexia, bulimia, cachexia, or chronic malnutrition.
• If you suffer from dehydration or hypovolemia.
• If you are taking a medicine to treat epilepsy, you should consult your doctor before taking this medicine, as it can decrease the effectiveness and increase the hepatotoxicity of paracetamol, especially in high-dose treatments (see below in this section "Other medicines and Antidol").
• If you have Gilbert's disease (also known as Meulengracht's disease).
• If you have heart, respiratory, or anemia failure. In these situations, administration should be carried out under surveillance and only for short periods.
• If you have asthma and are sensitive to acetylsalicylic acid.
• Paracetamol can cause severe skin reactions, such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of severe skin reactions and the use of the medicine should be discontinued at the first sign of skin rash or any other sign of hypersensitivity.
• If you have severe diseases, such as severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), 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 together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling of discomfort (nausea) and vomiting.

The administration of paracetamol doses higher than recommended implies a very serious risk of liver injury. Medicines that contain paracetamol should not be taken for more than a few days or in high doses unless indicated by your doctor.

Prolonged use of analgesics or inadequate use of high doses can cause headaches, which should not be treated with higher doses of the medicine.

Interference with laboratory tests

If you are going to have any laboratory tests (including blood, urine, etc.), inform your doctor that you are taking this medicine, as it may alter the results.

Paracetamol may alter the values of analytical determinations of uric acid and glucose.

Children

Due to the amount of paracetamol it contains, this medicine should not be used in children under 14 years old or weighing less than 50 kg.

Other medicines and Antidol

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 taking any of the following medicines, it may be necessary to modify the dose of one of them or interrupt treatment:

• Medicines to prevent blood clot formation: oral anticoagulants (acenocoumarol, warfarin).
• Medicines to treat epilepsy: antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medicines to treat tuberculosis: isoniazid, rifampicin.
• Medicines to treat depression and convulsions: barbiturates (used as hypnotics, sedatives, and anticonvulsants).
• Medicines to lower cholesterol levels in the blood: cholestyramine.
• Medicines used to increase urine elimination (loop diuretics such as furosemide).
• Medicines used to treat gout: probenecid and sulfinpyrazone.
• Medicines used to prevent nausea and vomiting: metoclopramide and domperidone.
• Medicines used to treat high blood pressure and heart rhythm disorders (arrhythmias): propranolol.
• The simultaneous use of more than one medicine that contains paracetamol can lead to overdose.
• Flucloxacillin (antibiotic), due to a serious risk of alteration of blood and fluids (called metabolic acidosis with high anion gap) that should be treated urgently (see section 2).

Taking Antidol with food, drinks, and alcohol

The use of paracetamol in patients who habitually consume alcohol (3 or more alcoholic beverages per day) can 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine. The use of medicines during pregnancy can be hazardous to the embryo or fetus and should be controlled by your doctor.

If necessary, Antidol 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.

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 this medicine on the ability to drive and use machines is zero or insignificant.

Antidol contains sodium

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

3. How to take Antidol

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

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

Doses should be repeated as long as symptoms persist. This medicine is intended for the treatment of pain or fever. As these symptoms disappear, the medication should be discontinued.

If the pain persists for more than 5 days (2 days for throat pain), the fever for more than 3 days, or the pain or fever worsens or other symptoms appear, you should interrupt treatment and consult your doctor.

Adults and adolescents over 14 years old (body weight over 50 kg): the recommended dose is 1 tablet every 4-6 hours as needed, up to a maximum of 4 tablets per day. Do not take more than 3 grams of paracetamol in 24 hours.

Adults and adolescents over 14 years old who weigh less than 50 kg: consult your pharmacist. Do not exceed 60 mg/kg/day (maximum 2 g/day).

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 between each dose of 8 hours. Do not take more than 2 grams or 3 tablets of 650 mg of paracetamol in 24 hours.

Patients with kidney disease: due to the dose, 650 milligrams of paracetamol, the medicine is not indicated for this group of patients.

Elderly patients: should consult their doctor.

Always take the lowest effective dose.

When lower doses of paracetamol are required, other presentations of paracetamol that adapt to the required dosage should be used.

This medicine is administered orally. The tablets should be taken with a glass of liquid, preferably water. They can be taken with or without food. For rapid relief of pain, take the medicine without food.

The score line is only for breaking the tablet if you find it difficult to swallow it whole.

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

Use in children and adolescents

Children and adolescents under 14 years old cannot take this medicine.

If you take more Antidol than you should

Symptoms of overdose may be: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

If you have taken an overdose, you should go to a medical center immediately, even if you do not notice symptoms, as they often do not appear until a few days after taking the overdose, even in cases of severe poisoning.

Treatment of overdose is more effective if started within 4 hours of taking the excess medicine.

Patients treated with barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

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 forget to take Antidol

Do not take a double dose to make up for forgotten doses. If you forget to take a dose, take the forgotten dose as soon as you remember, taking the next doses with the indicated separation between doses (at least 4 hours).

If you stop taking Paracetamol

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been reported:

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

Very rare(may affect up to 1 in 10,000 people): 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). Very rare cases of severe skin reactions have been reported.

Frequency not known(cannot be estimated from the available data): analgesic-induced headache; a severe disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

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

Reporting of side effects

If you experience any side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this 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 help provide more information on the safety of this medicine.

5. Storage of Antidol

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

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

Store in the original packaging to protect it from light.

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

6. Contents of the pack and further information

Composition of Antidol

The active ingredient is paracetamol. Each tablet contains 650 mg of paracetamol.

The other ingredients are:

Core: povidone, corn starch, microcrystalline cellulose, hydrogenated castor oil, sodium carboxymethylcellulose type A (potato), anhydrous colloidal silica, magnesium stearate.

Coating: macrogol, hypromellose.

Appearance of the product and packaging contents

Antidol 650 mg is presented in coated tablets for oral administration.

White, oblong, biconvex tablet, scored on one side and with code "A650" on the other side. Dimensions: 17.2 mm ± 0.5 mm x 9.2 mm ± 0.5 mm.

The score line is only for breaking the tablet if you find it difficult to swallow it whole.

The packaging is 20 tablets, packaged in single-dose PVC-PVDC/Aluminum blisters.

Marketing authorization holder and manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Date of the last revision of this leaflet: February 2025

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