Antidol 1 g tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Antidol 1g tablets
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor, pharmacist, or nurse.
This medicine is available without a prescription. However, to achieve the best results, it must be used carefully.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, consult your pharmacist.
- If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.
- You should consult your doctor if you worsen or if fever persists beyond 3 days of treatment, or if pain persists beyond 5 days.
Contents of the leaflet
- What Antidol 1g is and what it is used for
- What you need to know before taking Antidol 1g
- How to take Antidol 1g
- Possible adverse effects
- How to store Antidol 1g
- Contents of the pack and other information
1. What Antidol 1g is and what it is used for
Paracetamol belongs to a group of medicines called analgesics and antipyretics.
Paracetamol is used for the treatment of moderate pain and febrile conditions in adults and adolescents aged 16 years and older (or with a body weight above 50 kg).
2. What you need to know before taking Antidol 1g
Do not take Antidol 1g
If you are allergic (hypersensitive) to paracetamol, or to any of the other components of this medicine (listed in section 6).
Take special care with Antidol 1g
- Do not take more medicine than the recommended dose stated in section 3, "How to take Antidol 1g".
- The simultaneous use of this medicine with other medicines containing paracetamol, such as cold and flu remedies, should be avoided, as high doses may cause liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.
- If you are an asthmatic patient who is sensitive to acetylsalicylic acid, consult your doctor before taking this medicine.
- If you have liver, kidney, heart, or lung disease, or if you have anemia (reduced hemoglobin levels in the blood, with or without a reduction in red blood cells), consult your doctor before taking this medicine.
- If you are being treated with medications for epilepsy, consult your doctor before taking this medicine, as concomitant use may reduce efficacy and increase the hepatotoxicity of paracetamol, especially with high-dose paracetamol regimens.
- Chronic alcoholics should take care not to exceed 2 g of paracetamol in 24 hours.
- If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or new symptoms appear, consult your doctor and re-evaluate the clinical situation.
- For adolescents under 16 years of age, consult your doctor or pharmacist, as other formulations with appropriate doses are available for this patient group.
- If you have serious 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 cautious. A serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients under these conditions 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 breathing difficulty with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.
Other medicines and Antidol 1g
Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.
Paracetamol may interact with the following medicines:
- 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: cholestyramine.
- Medicines used to increase urine elimination (loop diuretics such as furosemide).
- Medicines used for gout treatment: probenecid and sulfinpyrazone.
- Medicines used to prevent nausea and vomiting: metoclopramide and domperidone.
- Medicines used for high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias): propranolol.
Also inform your doctor or pharmacist if you are taking:
- flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (called metabolic acidosis with high anion gap) that requires urgent treatment (see section 2).
Do not use with other analgesics (pain-relieving medicines) without consulting your doctor.
As a general rule for any medicine, it is advisable to systematically inform your doctor or pharmacist if you are taking any other medicine. In patients on oral anticoagulants, paracetamol may occasionally be used as the analgesic of choice.
Interference with diagnostic tests:
If you are scheduled to undergo any diagnostic tests (including blood and urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter the results of these tests.
Taking Antidol 1g with food, drinks, and alcohol
Using paracetamol in patients who regularly consume alcohol (3 or more alcoholic drinks per day: beer, wine, spirits, etc.) 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
If necessary, this medicine may be used during pregnancy. Use the lowest possible dose that relieves pain or fever, and take it for the shortest possible duration. Contact your doctor if pain or fever does not improve or if you need to take the medicine more frequently.
Small amounts of paracetamol may pass into breast milk; therefore, it is recommended that you consult your doctor or pharmacist before taking this medicine.
Driving and use of machines
The effect of paracetamol on the ability to drive and operate machinery is negligible or none.
This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; hence, it is essentially "sodium-free".
3. How to take Antidol 1g
Follow these instructions unless your doctor has given you different ones. Remember to take your medicine. Paracetamol is to be taken orally.
The usual dose is:
Adults and adolescents over 16 years of age:
The usual dose is 1 tablet (1 g of paracetamol) 3 times a day. Doses should be spaced at least 4 hours apart. Do not exceed 3 grams (3 tablets) in 24 hours.
High daily doses of paracetamol should be avoided for prolonged periods, as this increases the risk of adverse effects such as liver damage.
If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or new symptoms appear, discontinue treatment and consult your doctor.
Patients with liver disease: must consult their doctor before taking this medicine.
They should take the amount prescribed by their doctor, with a minimum interval of 8 hours between doses.
They must not take more than 2 paracetamol tablets in 24 hours, divided into 2 doses.
Patients with kidney disease: must consult their doctor before taking this medicine. Take a maximum of 500 mg per dose.
Due to the dosage, 1 g of paracetamol is not indicated for this group of patients.
Elderly patients: should consult their doctor.
Use in children and adolescents:
Do not use in children and adolescents under 16 years of age.
If you feel the effect of paracetamol is too strong or too weak, inform your doctor or pharmacist. When lower doses than 1 g of paracetamol per administration are required, other paracetamol formulations suitable for the required dosage should be used.
If you take more Antidol 1g than you should
Contact your doctor or pharmacist immediately.
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, go immediately to a medical facility 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 taking the medicine.
Patients undergoing treatment with barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount ingested.
If you forget to take Antidol 1g
Do not take a double dose to make up for missed doses. Simply take the missed dose as soon as you remember, then take the following doses at the recommended intervals (at least 4 hours apart).
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Rare adverse effects (occurring in up to 1 in 1,000 people) are: malaise, low blood pressure (hypotension), and increased blood transaminase levels.
Very rare adverse effects (occurring in up to 1 in 10,000 people) are: 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 rarely, severe skin reactions have been reported.
Paracetamol may damage the liver when taken at high doses or during prolonged treatment.
Adverse effects with unknown frequency (cannot be estimated from available data): A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who are using paracetamol (see section 2).
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 can also report them directly through the Spanish Pharmacovigilance System for 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 1g
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point located at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.
6. Contents of the pack and other information
Composition of Antidol 1g
The active substance is paracetamol. Each tablet contains 1 g of paracetamol.
The other components are: sodium carboxymethyl starch (Type A) (from potato), pregelatinized corn starch, povidone K30 (E1201), stearic acid (E570), and crospovidone (E1202).
Appearance of the product and contents of the pack
Antidol 1g is presented as tablets for oral administration.
The tablets are oblong, biconvex, white in colour, with a score line on one side and marked "PC" on the other side.
The packs contain 10 tablets, packed in PVC/PVDC/Aluminium blisters.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) – Spain
Manufacturer:
SAG Manufacturing S.L.U
Crta. N-I, Km 36,
San Agustín de Guadalix,
28750 Madrid
Spain
or
Galenicum Health, S.L.U.
Sant Gabriel, 50,
Esplugues de Llobregat
08950 Barcelona
Spain
Date of the most recent revision of this leaflet: February 2025
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/