ANTIDOL 1 G ORAL SOLUTION
SpainIt is used to relieve occasional mild to moderate pain (such as headache, dental, muscular, or back pain) and to reduce fever.
Frequently asked questions
Who can take this medication?
It is indicated for adults and adolescents over 15 years of age weighing more than 50 kg.
What is the recommended dose of Antidol?
The dose for adults and adolescents over 15 years of age (weighing more than 50 kg) is 1 sachet every 6 to 8 hours, up to a maximum of 3 sachets per day. If you have liver disease, you must follow the specific dose instructed by your doctor, which must not exceed 2 sachets in 24 hours.
How should the medication be administered?
It is taken orally. The contents of the sachet may be taken directly or diluted in a liquid, preferably water. Once the sachet is opened, all its contents must be consumed.
When should I not take Antidol?
Do not take it if you are allergic to paracetamol or any of its components. You should also not use it if you are under 15 years of age or weigh less than 50 kg.
What precautions should I take with other medications or alcohol?
Do not take this medication along with others containing paracetamol, as high doses can damage the liver. You must inform your doctor if you are taking anticoagulants, medications for epilepsy, tuberculosis, depression, or blood pressure, among others. Additionally, regular alcohol consumption can increase the risk of liver damage.
What are the possible side effects of Antidol?
It may cause rare effects such as discomfort, low blood pressure, or increased transaminases. In very rare cases, it may cause kidney disease, skin rashes, yellowing of the skin (jaundice), blood disorders, or severe skin reactions. The use of high or prolonged doses can damage the liver.
What should I do if I take more than the recommended dose?
You must consult a doctor or pharmacist immediately. In case of overdose, go immediately to a medical center or call the Toxicological Information Service, even if you do not show symptoms, as these may take up to 3 days to appear.
Instructions for use
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Antidol 1 g oral solution
Paracetamol
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
Follow exactly the instructions for administration provided 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 adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.
- You should consult a doctor if symptoms worsen or if fever persists for more than 3 days or pain for more than 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
This medicine contains paracetamol. Paracetamol is effective in reducing pain and fever.
It is used for the relief of mild to moderate occasional pain, such as headache, dental pain, muscle pain (cramps), or back pain (lumbago), and in febrile conditions, in adults and adolescents over 15 years of age and weighing more than 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 ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor, pharmacist, or nurse before starting to take Antidol.
- Do not take more medicine than the recommended dose stated in section 3, How to take Antidol.
- The simultaneous use of this medicine with other medicines containing paracetamol (e.g. 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.
- Chronic alcoholics should take care not to exceed 2 g of paracetamol in 24 hours.
- Patients with kidney, liver, heart, or lung disease, or those with anemia (reduced hemoglobin levels in the blood, with or without a reduction in red blood cells), or patients suffering from chronic malnutrition or dehydration, should consult their doctor before taking this medicine.
- If you are being treated with medication 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.
- Asthmatic patients who are sensitive to acetylsalicylic acid should consult their doctor before taking this medicine.
- 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 aware that a serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients under these circumstances 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, malaise (nausea), and vomiting.
Children and adolescents
Due to the dosage, this medicine is not recommended for children and adolescents under 15 years of age or weighing less than 50 kg.
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, inform your doctor 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 to treat epilepsy: Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
- Medicines to treat tuberculosis: (isoniazid, rifampicin).
- Medicines to treat depression and seizures: Barbiturates (used as hypnotics, sedatives, and anticonvulsants).
- Medicines to lower blood cholesterol levels: (cholestyramine).
- Medicines used to increase urine output (loop diuretics such as furosemide).
- Medicines used to treat 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.
Also inform your doctor or pharmacist if you are taking:
- Flucloxacillin (an antibiotic), due to a serious risk of blood and fluid disturbances (called high anion gap metabolic acidosis) 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 treatment. In the case of treatment with oral anticoagulants, paracetamol may occasionally be administered as the analgesic of choice.
Interference with laboratory tests
If you are due to have any laboratory tests (including blood and urine tests, etc.), inform your doctor that you are taking this medicine, as it may alter test results.
Paracetamol may alter the analytical values of uric acid and glucose measurements.
Use of Antidol with food, drinks, and alcohol
The use of paracetamol in patients who habitually consume alcohol (three or more alcoholic drinks per day – beer, wine, liquor, etc.) may cause liver damage. |
Taking this medicine with food does not affect its effectiveness.
Pregnancy, breastfeeding, and fertility
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.
Taking medicines during pregnancy may be dangerous for the embryo or fetus and should be monitored by your doctor.
Paracetamol passes into breast milk; therefore, women who are breastfeeding should consult their doctor or pharmacist before taking this medicine.
Driving and using machines
The influence of paracetamol on the ability to drive and operate machinery is none or negligible.
Antidol contains propylene glycol (E-1520), sodium, and azorubine (E-122).
This medicine contains 88.7 mg of propylene glycol per sachet.
This medicine contains less than 23 mg of sodium (1 mmol) per sachet, which means it is essentially "sodium-free".
This medicine may cause allergic reactions because it contains azorubine. It may provoke asthma, especially in patients allergic to acetylsalicylic acid.
3. How to take Antidol
Follow exactly the instructions for use provided in this leaflet or those given by your doctor. If in doubt, consult your doctor or pharmacist.
Recommended dose:
Adults and adolescents over 15 years of age and weighing more than 50 kg:
Take 1 g of paracetamol (1 sachet) every 6–8 hours, 3 times a day. Do not exceed 3 g of paracetamol (3 sachets) in 24 hours.
Always take the lowest effective dose.
This medicine should only be taken when pain or fever occurs. As these symptoms subside, treatment should be discontinued.
Prolonged use of high daily doses of paracetamol 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, treatment should be stopped and a doctor consulted.
For sore throat, this medicine should not be taken for more than 2 consecutive days without consulting a doctor.
Patients with kidney disease:
This medicine does not conform to the recommended dosing for these patients.
Patients with liver disease:
You must consult your doctor before starting to take this medicine.
They should take the amount of medicine prescribed by their doctor, with a minimum interval of 8 hours between doses.
They must not take more than 2 g of paracetamol (2 sachets) in 24 hours, divided into several doses.
Method of administration
This medicine is taken orally.
The contents of the sachet can be taken directly or diluted in a liquid, preferably water. Once the sachet is opened, the entire contents should be consumed.
If you take more Antidol than you should
Consult your doctor or pharmacist immediately. In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.
Symptoms of overdose may include: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.
If you have ingested an overdose, you must go immediately to a medical center even if you do not have symptoms, as these often do not appear until 3 days after the overdose has occurred, even in cases of severe poisoning.
Treatment of 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.
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 may cause adverse effects, although not everyone experiences them.
Rare adverse effects (may affect up to 1 in 1,000 people): malaise, low blood pressure (hypotension), and increased blood transaminase levels.
Very rare adverse effects (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), hypoglycaemia (low blood sugar), and severe skin reactions.
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).
Paracetamol may cause liver damage when taken at high doses or during prolonged treatment.
Reporting of adverse effects
If you experience any adverse effect, consult your doctor or pharmacist, even if it is an effect not listed in this leaflet. You can also report them directly via the Spanish System of Pharmacovigilance of Human Medicines: 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 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. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, 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: macrogol 400, glycerol (E-422), sodium saccharin, strawberry flavour, raspberry flavour (contains propylene glycol (E-1520)), taste-masking agent (azorubine (E-122)) and purified water.
Appearance of Antidol and contents of the pack
Red translucent oral solution, free from suspended particles, with a characteristic strawberry/raspberry odour.
Each pack contains 10 unit-dose sachets with 10 ml of solution each, packed in a laminate complex of PET/ALU/PET/PE.
Marketing Authorisation Holder
Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) – Spain
Manufacturer
Farmalider, S.A.
C/Aragoneses, 2
28108 Alcobendas, Madrid - Spain
or
Edefarm, S.L.
Polígono Industrial Enchilagar del Rullo, 117
46191 Villamarchante, Valencia - Spain
or
Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) – 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 Medical Devices (AEMPS) http://www.aemps.gob.es/
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The original data is available in the language of the country of manufacture.
Data source: Online Medicines Information Centre (CIMA) — AEMPS
Data last verified: September 21, 2026