ANTIDOL 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Antidol 500 mg Coated Tablets

Paracetamol

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

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

• Keep this package 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 they are not listed in this package 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. Package Contents and Additional 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, muscle pain (cramps) or back pain (lumbago), as well as in febrile states, in adults and adolescents over 12 years of age.

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".
• Avoid simultaneous use of this medicine with other medicines that contain paracetamol, such as flu and cold medicines, 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 (4 tablets) of paracetamol in 24 hours.
• Patient with kidney, liver, heart, or lung disease, 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 increased, especially with high doses of paracetamol.
• Asthmatic patients sensitive to acetylsalicylic acid should consult their doctor before taking this medicine.
• If you have severe diseases, such as severe kidney 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 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. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling of discomfort (nausea) and vomiting.

Interference with Analytical Tests

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

Children

Due to the amount of paracetamol it contains, children (under 12 years) cannot take this medicine.

Other Medicines and Antidol

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

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

• Medicines to prevent blood clots: 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 seizures: 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.
• Taking more than one medicine that contains paracetamol can lead to overdose.

Also, inform your doctor or pharmacist if you are taking:

• Flucloxacillin (antibiotic), due to a serious risk of alteration of blood and fluids (called metabolic acidosis with high anion imbalance) 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: beer, wine, liquor, etc. per day) may 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.

In case of need, 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 Hydrogenated Castor Oil

This medicine may cause stomach upset and diarrhea because it contains hydrogenated castor oil.

Antidol contains Sodium

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

3. How to take Antidol

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

Avoid using high daily doses of paracetamol for prolonged periods, as the risk of side 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 they disappear, this 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:

The recommended dose is 1 tablet every 4-6 hours as needed. If necessary, 2 tablets can be taken every 6-8 hours, up to a maximum of 6 tablets per day. Do not take more than 3 grams of paracetamol in 24 hours.

Adolescents from 12 to 18 years (43-65 kg):

The recommended dose is 1 tablet every 4-6 hours as needed, up to a maximum of 5 tablets per day.

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 between each intake of 8 hours. 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, who will indicate if the minimum interval between each administration should be 6 or 8 hours. They should take a maximum of one tablet per intake (500 mg of paracetamol).

Elderly Patients:should consult their doctor.

Always take the lowest effective dose.

When lower doses of paracetamol are required, other paracetamol presentations 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 quick 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, tell your doctor or pharmacist.

Use in Children and Adolescents

Children and adolescents under 12 years 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 immediately to a medical center, even if you do not notice symptoms, as they often do not appear until 3 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.

Patient treated with barbiturates or chronic alcoholics may be more susceptible to paracetamol toxicity.

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 taken.

If you forget to take Antidol

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

4. Possible Side Effects

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

Possible side effects of Antidol are:

Rare(may affect up to 1 in 1,000 people): discomfort, hypotension (low blood pressure), and increased transaminase levels 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): headache induced by analgesic abuse; a serious 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 not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) 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 CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Antidol

• The active ingredient is paracetamol. Each tablet contains 500 mg of paracetamol.
• Other ingredients are:

Core:magnesium stearate, povidone (E-1201), corn starch, anhydrous colloidal silica, microcrystalline cellulose (E-460), hydrogenated castor oil, and sodium carboxymethylcellulose (type A) (potato).

Coating:hypromellose 606 (E-464), hypromellose 615 (E-464), and macrogol 6000.

Appearance of Antidol and Package Contents

Oblong, coated tablets, white in color, scored on one side and marked with the code "antidol" on the other.

They come in PVC/ALU blisters.

Each package contains 10 and 20 coated tablets.

Only some package sizes may be marketed.

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 Package Leaflet:April 2025

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