Antidol 1 g effervescent powder
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Antidol 1 g effervescent powder
Paracetamol
Follow exactly the instructions for taking this medicine as contained in this leaflet or as advised by your doctor or pharmacist.
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Keep this leaflet, as you may need to read it again.
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If you need advice or further information, consult your pharmacist.
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If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
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You should consult a doctor if your condition worsens or if you do not improve after 5 days.
Leaflet Contents
- What Antidol is and what it is used for
- What you need to know before taking Antidol
- How to take Antidol
- Possible side effects
- How to store Antidol
- Contents of the pack and other information
1. What Antidol is and what it is used for
Antidol belongs to a group of medicines called analgesics and antipyretics.
This medicine is used for the symptomatic relief of mild to moderate occasional pain, such as headaches, toothaches, muscle pain (contractures), or back pain (lumbago), as well as for feverish 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
Do not take Antidol
- If you are allergic to paracetamol or to any of the other components of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Antidol.
Paracetamol should be used with special caution in the following situations:
- Do not take more medicine than recommended in section 3, How to take Antidol.
- If you have liver problems, including liver problems due to excessive alcohol consumption (3 or more alcoholic drinks per day).
- If you have glucose-6-phosphate dehydrogenase deficiency.
- If you suffer from anorexia, bulimia, cachexia, or chronic malnutrition.
- If you are dehydrated or have hypovolemia.
- If you are taking antiepileptic medication, you should consult your doctor before taking this medicine, as concomitant use may reduce efficacy and increase the hepatotoxicity of paracetamol, especially with high-dose paracetamol treatments (see further in section "Other medicines and Antidol").
- If you have Gilbert's disease (also known as Meulengracht's disease).
- If you have heart failure, respiratory failure, or anemia; in these cases, treatment should be administered under medical supervision and only for short periods.
- If you have asthma and are sensitive to acetylsalicylic acid.
- Paracetamol may cause serious skin reactions, such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of serious skin reactions, and treatment should be discontinued at the first sign of skin rash or any other sign of hypersensitivity.
- The total daily dose of paracetamol must not exceed 3 g.
- Avoid taking this medicine simultaneously with other medicines containing paracetamol, such as cold and flu remedies, as high doses may cause liver damage. Do not use more than one paracetamol-containing medicine without consulting your doctor. If an overdose occurs, seek medical help immediately (see "If you take more Antidol than you should").
- If you have kidney problems, you should not take this medicine due to its 1 g paracetamol content. Patients with liver, heart, or lung disease, or anemia, should consult their doctor before taking this medicine.
- If you have serious illnesses 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). A serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients in these conditions when paracetamol is used at regular doses over a prolonged period or when taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.
Administration of paracetamol doses higher than recommended carries a risk of severe liver damage.
Medicines containing paracetamol should not be taken for more than a few days or at high doses unless directed by your doctor. If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsens or new symptoms appear, stop treatment and consult your doctor.
Prolonged use of analgesics or inappropriate use of high doses may cause headaches, which should not be treated with higher doses of the medicine.
Children and adolescents
Due to the paracetamol dose, this medicine should not be used in children or adolescents under 16 years of age (and weighing less than 50 kg). Ask your pharmacist about available formulations that allow appropriate dosing for these patients.
Interference with laboratory tests
If you are scheduled for any laboratory tests (including blood, urine, etc.), inform your doctor that you are taking this medicine, as it may alter test results.
Paracetamol may alter analytical values for uric acid and glucose.
Other medicines and Antidol
Tell 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, dose adjustments or discontinuation of treatment may be necessary:
- 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 to lower blood cholesterol levels: Cholestyramine
- Medicines used to increase urine output (loop diuretics such as furosemide)
- Medicines used in the treatment of gout: (probenecid)
- 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
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), which requires urgent treatment (see section 2).
Taking Antidol with food, drinks, and alcohol
Taking 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 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 effective 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; therefore, women who are breastfeeding should consult their doctor or pharmacist before using this medicine.
Driving and using machines
The effect of paracetamol on the ability to drive and operate machinery is negligible or none.
Antidol contains sodium and sodium benzoate (E-211)
The maximum recommended dose of this medicine contains 438 mg of sodium (present in table salt). This corresponds to 21.9% of the maximum daily sodium intake recommended for an adult.
Consult your doctor or pharmacist if you need one or more sachets daily for a prolonged period, especially if you have been advised to follow a low-salt (sodium) diet.
This medicine contains 150 mg of benzoic acid salt per sachet.
3. How to take Antidol
Follow exactly the administration instructions for this medicine provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine is taken orally by dissolving the contents of the sachet in a glass of water.
Recommended dose:
Adults and adolescents over 16 years of age (and weighing more than 50 kg):
1 sachet (1 g of paracetamol) every 6–8 hours, up to 3 times a day.
Do not exceed 1 gram of paracetamol per dose under any circumstances. Do not take more than 3 g of paracetamol in 24 hours, divided into 3 doses.
This medicine should only be taken when symptoms such as pain or fever appear. As symptoms subside, treatment should be discontinued.
The use of high daily doses of paracetamol over prolonged periods should be avoided, 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, consult your doctor and re-evaluate the clinical situation.
Elderly patients: Your doctor will determine the appropriate dosing frequency and whether dose reduction is necessary.
Patients with liver disease: Should take only the amount of medicine prescribed by their doctor, with a minimum interval of 8 hours between doses.
They should not take more than 2 grams of paracetamol in 24 hours, divided into several doses.
Chronic alcoholics: Should take care not to exceed 2 g of paracetamol in 24 hours.
Patients with kidney disease: This medicine is not suitable for patients with moderate or severe kidney disease according to the recommended dosing guidelines.
Use in children and adolescents
Due to the paracetamol content per sachet (1 g), this medicine must not be used in patients under 16 years of age (see section 2).
If you take more Antidol than you should
Contact your doctor or pharmacist immediately.
In case of overdose or accidental ingestion, go immediately to a medical center or call the Poison Information Service (telephone 91 562 04 20), indicating the medicine and the amount ingested. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.
If you have ingested an overdose, you should go quickly 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 of overdose is most effective if started within 4 hours after ingestion of the medicine.
Patients undergoing treatment with barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.
If you forget to take Antidol
Do not take a double dose to make up for missed doses.
If you forget to take a dose of paracetamol when it was due, take it as soon as you remember, and then wait the recommended time between doses before taking the next one.
If you stop taking Antidol
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Possible adverse effects of paracetamol are:
Rare adverse effects (may affect up to 1 in 1,000 patients): malaise, drop in blood pressure (hypotension), and increased blood transaminase levels.
Very rare adverse effects (may affect up to 1 in 10,000 patients): 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).
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 serious illness who are using paracetamol (see section 2).
Very rare cases of severe skin reactions have been reported.
Paracetamol may damage the liver when taken at 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 can also report them directly via 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
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 refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and unused medicines. 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 1 g of paracetamol.
- The other components are: sodium hydrogen carbonate, anhydrous citric acid, mannitol (E-421), sodium benzoate (E-211), anhydrous sodium carbonate, povidone, sodium saccharin, and lemon flavouring.
Appearance of Antidol and contents of the pack
White, homogeneous effervescent powder, presented in single-dose sachets.
Each pack contains 10 sachets.
Marketing Authorisation Holder and Manufacturer
Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) - Spain
Date of the most recent review of this leaflet: February 2025
Detailed information about this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/
You can access detailed information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/67964/P_67964.html
QR code to: https://cima.aemps.es/cima/dochtml/p/67964/P_67964.html