Antidol 500 mg film-coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Antidol 500 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 instructions for administration of this medicine as described in this leaflet or as directed 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 adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or if fever does not improve after 3 days or pain does not improve after 5 days.
Contents of the leaflet
- What Antidol is and what it is used for
- What you need to know before taking Antidol
- How to take Antidol
- Possible adverse effects
- How to store Antidol
- Contents of the pack and other information
1. What Antidol is and what it is used for
Paracetamol is effective in reducing pain and fever.
This medicine is used for the symptomatic relief of mild to moderate occasional pain, such as headaches, toothaches, muscle pain (muscle strains), or back pain (lumbago), as well as for feverish conditions, in adults and adolescents over 12 years of age.
You should consult a doctor if symptoms worsen or if fever persists beyond 3 days or pain beyond 5 days.
2. What you need to know before taking Antidol
Do not take Antidol
- 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 Antidol.
- Do not take more medicine than the recommended dose stated in section 3 “How to take Antidol”.
- Avoid using this medicine together with other medicines containing paracetamol, such as cold and flu remedies, 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 grams (4 tablets) of paracetamol in 24 hours.
- Patients with kidney, liver, heart or lung disease, or 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 the effectiveness of paracetamol and increase its hepatotoxic potential, especially with high-dose paracetamol regimens.
- Asthmatic patients who are sensitive to acetylsalicylic acid should consult their doctor before taking this medicine.
- If you have serious medical 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), be aware that a serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients in these situations when paracetamol is used at regular doses over 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.
Interference with laboratory tests
If you are due to have any laboratory tests (including blood and urine tests), inform your doctor that you are taking this medicine, as it may affect test results.
Children
Due to the amount of paracetamol it contains, this medicine must not be given to children (under 12 years of age).
Other medicines and Antidol
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, as it may be necessary to adjust the dose or discontinue treatment:
- 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: colestyramine.
- 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.
- Taking more than one medicine containing paracetamol simultaneously may lead to cases of poisoning.
Also inform your doctor or pharmacist if you are taking:
- Flucloxacillin (antibiotic), due to a serious risk of blood and fluid disturbances (called metabolic acidosis with high anion gap) that requires urgent treatment (see section 2).
Taking Antidol with food, drinks and alcohol
Using paracetamol in patients who habitually consume alcohol (3 or more alcoholic drinks: beer, wine, spirits, etc., per day) may cause liver damage.
Taking this medicine with food does not affect its effectiveness.
Pregnancy and breastfeeding
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.
If necessary, Antidol may be used during pregnancy. 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 does not improve or if you need to take the medicine more frequently.
Paracetamol passes into breast milk, so women who are breastfeeding should consult their doctor or pharmacist before taking this medicine.
Driving and using machines
The effect of this medicine on the ability to drive and operate machinery is negligible or none.
Antidol contains hydrogenated castor oil.
This medicine may cause stomach discomfort and diarrhoea as it contains hydrogenated castor oil.
Antidol contains sodium.
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; therefore, it is essentially “sodium-free”.
3. How to take Antidol
Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
High daily doses of paracetamol should be avoided over prolonged periods, as this increases the risk of adverse effects such as liver damage.
Doses should be repeated as long as symptoms persist. This medicine is intended for the treatment of pain or fever. As symptoms subside, treatment should be discontinued.
If pain persists for more than 5 days (2 days for sore throat), fever lasts more than 3 days, or if pain or fever worsen or new symptoms appear, treatment must be stopped and a doctor consulted.
Adults:
The recommended dose is 1 tablet every 4–6 hours as needed. If necessary, 2 tablets may be taken every 6–8 hours, up to a maximum of 6 tablets per day. Do not exceed 3 grams of paracetamol in 24 hours.
Adolescents aged 12 to 18 years (weighing 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 medicine, consult your doctor. Take only the amount prescribed by your doctor, with a minimum interval of 8 hours between doses. Do not exceed 2 grams or 4 tablets of 500 mg paracetamol in 24 hours.
Patients with kidney disease: Before taking this medicine, consult your doctor, who will determine whether the minimum interval between doses should be 6 or 8 hours. Take no more than 1 tablet per dose (500 mg of paracetamol).
Elderly patients: Should consult their doctor.
Always take the lowest effective dose.
When doses lower than 500 mg of paracetamol per administration are required, other formulations of paracetamol better suited to the required dosage should be used.
This medicine is for oral use. Tablets should be taken with a glass of liquid, preferably water. They may be taken with or without food. For faster pain relief, take the medicine without food.
The score line is intended only for splitting the tablet if you have difficulty swallowing it whole.
If you feel that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.
Use in children and adolescents
Children and adolescents under 12 years of age must not take this medicine.
If you take more Antidol than you should
Symptoms of overdose may include: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.
If you have taken an overdose, seek immediate medical attention even if you do not have symptoms, as symptoms often do not appear until 3 days after the overdose, even in cases of severe poisoning.
Treatment for overdose is most effective if started within 4 hours of excessive intake.
Patients undergoing treatment with barbiturates or chronic alcoholics may be more susceptible to the toxic effects of a paracetamol overdose.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 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.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
The possible adverse effects of Antidol are:
Rare (may affect up to 1 in 1,000 people): malaise, hypotension (low blood pressure), and increased blood transaminase levels.
Very rare (may affect up to 1 in 10,000 people): kidney disorders, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, haemolytic anaemia), and hypoglycaemia (low blood sugar).
Very rare cases of severe skin reactions have been reported.
Frequency not known (cannot be estimated from available data): headache caused by analgesic abuse; a serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who use paracetamol (see section 2).
Paracetamol may damage the liver when taken in high doses or during prolonged treatment.
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 System for Pharmacovigilance of Human Medicines: https://www.notificaram.es. By reporting adverse 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 expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Antidol
- The active substance is paracetamol. Each tablet contains 500 mg of paracetamol.
- The other components are:
Core: magnesium stearate, povidone (E-1201), corn starch, colloidal anhydrous silica, microcrystalline cellulose (E-460), hydrogenated castor 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 contents of the pack
Oblong, film-coated white tablets, scored on one side and marked with the code “antidol” on the other.
They are presented in PVC/ALU blisters.
Each pack contains 10 or 20 film-coated tablets.
Only certain pack 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 most recent revision of this leaflet: April 2025
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/