Leaflet: information for the user

Antidol 500 mg coated tablets

Paracetamol

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

Follow exactly the administration instructions for the medicine contained in this leaflet or those 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 any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if your fever worsens or does not improve after 3 days or if your pain persists for 5 days.

1. What isAntidoland what it is used for

2. What you need to know before starting to takeAntidol

3. How to takeAntidol

4. Possible side effects

5. Storage ofAntidol

6. Contents of the pack and additional information

Paracetamol is effective in reducing pain and fever.

This medication is used for symptomatic relief of occasional mild or moderate pains, such as headaches, dental pain, muscle pain (contractures) or back pain (lumbago), as well as in febrile states, in adults and adolescents over 12 years old.

Consult a doctor if the fever worsens or persists after 3 days or the pain lasts for 5 days.

Do not take Antidol

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Antidol.

• Do not take more medication than recommended in section 3 “How to take Antidol”.
• Avoid taking this medication with other medications that contain paracetamol, such as cold and flu medications, as high doses may cause liver damage. Do not take more than one medication that contains paracetamol without consulting your doctor.
• Chronic alcoholics should be careful not to take more than 2 grams (4 tablets) of paracetamol in 24 hours.
• Patients with kidney, liver, heart, or lung diseases and patients with anemia should consult their doctor before taking this medication.
• Patients undergoing treatment for epilepsy should consult their doctor before taking this medication, as it may reduce the effectiveness and increase the hepatotoxicity of paracetamol, especially with high doses of paracetamol.
• Asthmatic patients sensitive to acetylsalicylic acid should consult their doctor before taking this medication.
• If you have severe diseases, such as severe renal insufficiency or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have chronic malnutrition, alcoholism, or are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (a blood and fluid anomaly) has been reported in patients in these situations when using paracetamol at regular doses for a prolonged period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe respiratory distress with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Interference with analytical tests

Inform your doctor if you are to undergo any analytical tests (including blood and urine tests) as this medication may alter the results.

Children

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

Other medications and Antidol

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

Particularly, if you are using any of the following medications, as it may be necessary to modify the dose of one of them or interrupt treatment:

• Blood thinners: oral anticoagulants (acenocoumarol, warfarin).
• Medications for treating epilepsy: antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medications for treating tuberculosis: isoniazid, rifampicin.
• Medications for treating depression and seizures: barbiturates (used as hypnotics, sedatives, and anticonvulsants).
• Medications to lower blood cholesterol levels: cholestyramine.
• Medications used to increase urine elimination (diuretics such as furosemide).
• Medications used to treat gout: probenecid and sulfinpyrazone.
• Medications used to prevent nausea and vomiting: metoclopramide and domperidone.
• Medications used to treat high blood pressure (hypertension) and heart rhythm disorders (arrhythmias): propranolol.
• The simultaneous use of more than one medication that contains paracetamol may lead to intoxication.

Inform your doctor or pharmacist if you are taking:

• Flucloxacillin (antibiotic), due to a severe risk of blood and fluid imbalance (metabolic acidosis with high anion gap) that must be treated urgently (see section 2).

Taking Antidol with food, drinks, and alcohol

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

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

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, Antidol can be used during pregnancy. 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.

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

Driving and operating machinery

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

Antidol contains hydrogenated ricin oil.

This medication may cause stomach discomfort and diarrhea due to the presence of hydrogenated ricin oil.

Antidol contains sodium.

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

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

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

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

If pain persists for more than 5 days (2 days for throat pain), fever for more than 3 days, or if pain or fever worsen or other symptoms appear, treatment should be interrupted and your doctor consulted.

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 12 years 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.

Patients with liver disease:Before taking this medication, they must consult their doctor. They should take the amount of medication 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.

Patients with kidney disease:Before taking this medication, 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 1 tablet per dose (500 mg of paracetamol).

Senior patients:They should consult their doctor.

Always take the smallest effective dose.

When requiring administration of doses less than 500 mg of paracetamol per dose, other presentations of paracetamol should be used that adapt to the required dosage.

This medication is administered orally. Tablets should be taken with a glass of liquid, preferably water. They can be taken with or without food. To quickly relieve pain, take the medication without food.

The groove is only for breaking the tablet if it is difficult to swallow whole.

If it is estimated that the action of this medication is too strong or too weak, inform your doctor or pharmacist.

Use in children and adolescents:

Children and adolescents under 12 years old cannot take this medication.

If you take more Antidol than you should:

The symptoms of overdose may be: dizziness, vomiting, loss of appetite, yellowish discoloration of the skin and eyes (jaundice), and abdominal pain.

If you have taken an overdose, you should immediately go to a medical center, even if you do not notice the symptoms, as they often do not appear until 3 days after the overdose, even in cases of severe poisoning.

The treatment of an overdose is more effective if it is initiated within 4 hours of the excessive intake of the medication.

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, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Antidol:

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

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

The possible adverse effects of Antidol are:

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 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).

Severe skin reactions have been reported very rarely.

Unknown Frequency(cannot be estimated from available data): headache induced by analgesic abuse; a serious disease that can make the blood more acidic (metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

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

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 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 packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Antidol

• The active principle is paracetamol. Each tablet contains 500 mg of paracetamol.
• The other components are:

Core:magnesium stearate, povidone (E-1201), cornstarch, anhydrous colloidal silica, microcrystalline cellulose (E-460), hydrogenated ricin oil, and sodium carboxymethyl starch (type A) (from potato).

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

Appearance of Antidol and content of the packaging

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

They are presented in PVC/ALU blisters.

Each package contains 10 and 20 coated tablets.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Park Areta

31620 Huarte (Navarra) – Spain

Last review date of this leaflet:April 2025

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