Antidol 500 mg granules
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Antidol 500 mg granules
Paracetamol
Read the entire leaflet carefully before you start taking this medicine, as 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 or pharmacist.
- 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 effects not listed in this leaflet. See section 4.
- You should consult a doctor if you get worse or do not improve after 3 days of fever or 5 days of pain.
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 in adults and adolescents weighing over 44 kg (from 12 years of age) for the symptomatic treatment of mild to moderate occasional pain, such as headache, dental pain, muscle pain (muscle spasms), or back pain (lumbago), and for the relief of fever.
2. What you need to know before starting to take Antidol
Do not take Antidol
- If you are allergic to the active substance or to any of the other components of this medicine (listed in section 6).
Warnings and precautions
- Do not exceed the recommended dose stated in section 3, How to take Antidol. Taking more than the recommended dose does not increase pain relief but may cause liver damage. Symptoms of liver damage may not appear until several days later. If you have taken more paracetamol than indicated in this leaflet, it is important that you consult your doctor as soon as possible.
- Avoid using this medicine together with other medicines containing paracetamol, such as cold and flu remedies, as high doses may lead to liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.
- You should consult your doctor or pharmacist before starting to take this medicine.
- If you suffer from kidney, liver, heart, or lung disease, or if you have anemia (reduced hemoglobin levels in the blood, with or without a reduction in red blood cells).
- If you suffer from chronic malnutrition or dehydration.
- If you are being treated with medicines for epilepsy, you should consult your doctor before taking this medicine, as the combination may reduce effectiveness and increase the hepatotoxicity of paracetamol, especially when high doses of paracetamol are used.
- If you are an aspirin-sensitive asthmatic.
- Chronic alcoholics should take care not to exceed 2 g of paracetamol in 24 hours.
- 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 chronic malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). 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 difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.
Children and adolescents
Do not use in children weighing less than 44 kg (approximately under 12 years of age), as it does not allow for dosing lower than one sachet per dose (500 mg).
For children and adolescents under 12 years of age, consult your doctor or pharmacist, as other formulations with appropriate doses may be available for these patients.
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 medicines containing any of the following active substances, a dose reduction or discontinuation of treatment may be necessary:
- Ethyl alcohol
- Oral anticoagulants (acenocoumarol, warfarin)
- Anticonvulsants (phenytoin, phenobarbital, methylphenobarbital, primidone)
- Isoniazid
- Rifampicin
- Lamotrigine
- Metoclopramide and domperidone (used to prevent nausea and vomiting)
- Probenecid
- Propranolol, used in the treatment of high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias)
- Ion-exchange resins (cholestyramine)
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), which requires urgent treatment (see section 2).
Interference with laboratory tests:
If you are scheduled for any laboratory tests (including blood and urine tests), inform your doctor that you are taking this medicine, as it may alter the results of these tests.
Paracetamol may affect the analytical results of uric acid and glucose measurements.
Use of Antidol with food, drinks, and alcohol
The use of paracetamol in patients who habitually consume alcohol (3 or more alcoholic drinks per day) may cause liver damage.
Taking this medicine with food does not affect its efficacy.
Pregnancy and breastfeeding
If you are pregnant or think you might be pregnant, consult your doctor before taking this medicine. Taking medicines during pregnancy may be harmful to the embryo or fetus and should be monitored by your doctor.
If necessary, paracetamol 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 is excreted in breast milk; therefore, women who are breastfeeding should consult their doctor or pharmacist before using this medicine.
Driving and operating machinery
The effect of this medicine on the ability to drive and operate machinery is negligible or none.
Antidol contains aspartame (E-951), sodium, and sucrose
- This medicine contains 23.62 mg of aspartame (E-951) per sachet. Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.
- This medicine contains 115 mg of sodium (a main component of table/cooking salt). This corresponds to 5.75% of the maximum daily recommended sodium intake for an adult.
- This medicine contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine. It may cause dental caries.
3. How to take Antidol
Follow exactly the instructions for administering this medicine as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
This medicine is taken orally.
Open the sachet and pour the contents directly into the mouth. The granules disperse immediately in saliva and are then swallowed.
It may be taken with or without food.
The recommended dose is:
Adults: 1 sachet (500 mg of paracetamol) every 4–6 hours as needed. If necessary, 2 sachets of 500 mg may be taken every 6–8 hours.
Do not take more than 3 g of paracetamol (6 sachets) in 24 hours. Doses should be spaced at least 4 hours apart.
Always take the lowest effective dose.
This medicine should only be taken when pain or fever occurs. As symptoms subside, treatment should be discontinued.
Avoid using high daily doses of paracetamol 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.
For sore throat, do not take this medicine for more than 2 consecutive days without consulting a doctor.
Use in children and adolescents
Adolescents over 44 kg (from 12 years of age): the recommended dose is 1 sachet (500 mg of paracetamol) every 4–6 hours as needed, not exceeding 5 sachets in 24 hours.
Children:
Do not use in children weighing less than 44 kg (approximately 12 years of age). Other formulations more suitable for this patient group are recommended.
Patients with liver or kidney disease: must consult their doctor before taking this medicine. If your doctor prescribes this medicine, you must wait at least 8 hours between doses.
If you take more Antidol than you should
Contact your doctor or pharmacist immediately.
If you have taken an overdose, go immediately to a medical center even if there are no symptoms, as symptoms often do not appear until 3 days after the overdose, even in cases of severe poisoning.
Symptoms of overdose may include: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.
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, go immediately to a medical center or call the Toxicology Information Service (telephone 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 missed doses.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The following adverse effects have been reported according to the frequencies detailed below:
Renal and urinary disorders
Rare (may affect up to 1 in 1,000 people): kidney disorders; cloudy urine
Skin and subcutaneous tissue disorders
Rare (may affect up to 1 in 1,000 people): allergic dermatitis (skin rash)
Very rare (may affect up to 1 in 10,000 people): very rare cases of serious skin reactions have been reported.
Hepatobiliary disorders
Rare (may affect up to 1 in 1,000 people): jaundice (yellowing of the skin)
Blood and lymphatic system disorders
Rare (may affect up to 1 in 1,000 people): blood disorders (agranulocytosis, leucopenia, neutropenia, thrombocytopenia, haemolytic anaemia)
Metabolism and nutrition disorders
Rare (may affect up to 1 in 1,000 people): hypoglycaemia (low blood sugar)
Frequency not known (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 use paracetamol (see section 2).
Paracetamol may cause liver damage when taken at high doses or during prolonged treatment.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
Reporting of adverse effects
If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products (www.notificaram.es).
5. Storage of Antidol
Keep this medicine out of the sight and reach of children.
No special storage conditions are required.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be handed over to the SIGRE collection point at your pharmacy. Ask your pharmacist how to 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 sachet contains 500 mg of paracetamol.
The other components are calcium carbonate, sodium hydrogen carbonate, anhydrous citric acid, anhydrous sodium citrate, aspartame (E-951), mask it (containing sucrose and aspartame (E-951)), mannitol (E-421), lemon flavour, amorphous silica, glycerol (E-422) diestearate type 1, sodium croscarmellose, sodium carboxymethylstarch (type A) (from potato), ethylcellulose, hydroxypropyl methylcellulose and polyethylene glycol 400.
Appearance of the medicine and contents of the pack
White granules with a strong lemon odour, packed in single-dose sachets.
Packed in boxes of 10 and 20 sachets.
Only some pack sizes may be marketed.
Marketing Authorization Holder
Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra)
Manufacturer responsible
Farmalider, S.A.
C/Aragoneses, 2
28108 Alcobendas, Madrid
or
Edefarm, S.L
Polígono Industrial Enchilagar del Rullo, 117
46191 Villamarchante, Valencia
Spain
Date of the most recent revision of this package leaflet: April 2025
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/