Antidol 500 mg oral solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Antidol 500 mg 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 taking 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 reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions 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 (muscle spasms), or back pain (lumbago), as well as for feverish conditions in adults and children weighing over 33 kg (approximately 10–12 years of age).
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.
-
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 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 effectiveness 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 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 breathing difficulty with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.
Children
For children under 10–12 years of age, consult your doctor or pharmacist, as other formulations with doses appropriate for these patients may be available.
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, your dose may need to be adjusted or treatment interrupted:
- 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 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.
Also inform your doctor or pharmacist if you are taking:
- Flucloxacillin (an 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 (medicines that relieve pain) 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 medication. In the case of treatment with oral anticoagulants, paracetamol may occasionally be used as the analgesic of choice.
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.
Paracetamol may alter the analytical results for uric acid and glucose.
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 efficacy.
Pregnancy, breastfeeding, and fertility
If you are pregnant, 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 44.35 mg of propylene glycol per sachet.
This medicine contains less than 23 mg of sodium (1 mmol) per sachet; hence, 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 dosage instructions for the medicine provided in this leaflet or as directed by your doctor. If in doubt, consult your doctor, pharmacist, or nurse.
Recommended dose:
Adults and adolescents over 15 years of age (and weighing 50 kg):
Take 1 sachet (500 mg paracetamol) every 4-6 hours as needed. If necessary, 2 sachets may be taken every 8 hours.
Do not exceed 3 g of paracetamol (6 sachets) in 24 hours. Doses should be spaced at least 4 hours apart. Always use 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, discontinue treatment and consult your doctor.
For sore throat, do not take this medicine for more than 2 consecutive days without consulting a doctor.
Patients with kidney disease:
You must consult your doctor before taking this medicine. Take a maximum of 1 sachet per dose.
Depending on your condition, your doctor will advise whether you should take the medicine with a minimum interval of 6 or 8 hours between doses.
Patients with liver disease:
Consult your doctor before starting to take this medicine.
You must take the amount prescribed by your doctor, with a minimum interval of 8 hours between doses.
Do not exceed 2 g of paracetamol (4 sachets) in 24 hours, divided into several doses.
Children:
The recommended daily dose of paracetamol is approximately 60 mg/kg/day, divided into 4 or 6 doses per day; that is, 15 mg/kg every 6 hours or 10 mg/kg every 4 hours.
It is necessary to adhere strictly to the dosages based on body weight. The age ranges corresponding to body weight are provided for informational purposes only.
- Children weighing between 33 kg and 42 kg (approximately 10 to 12 years): 1 sachet per dose every 6 hours, up to a maximum of 4 sachets per day.
- Children weighing between 42 kg and 50 kg (approximately 12 to 14 years): 1 sachet per dose every 4-6 hours as needed, up to a maximum of 5 sachets per day.
Do not use for more than 3 consecutive days in children without reassessing the clinical condition.
Do not use in children weighing less than 33 kg (approximately 10-12 years). The use of other formulations more suitable for this patient group is recommended.
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.
Once the sachet is opened, the entire contents should be consumed.
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 Toxicology Information Service (telephone 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 taken an overdose, go immediately to a medical center 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.
If you forget to take Antidol
Do not take a double dose to make up for a missed dose.
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) are: malaise, drop in blood pressure (hypotension), and increased blood transaminase levels.
Very rare adverse effects (may affect 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), hypoglycaemia (low blood sugar), and serious 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 seriously ill patients using 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 an adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: 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.
No special storage conditions are required.
Do not use this medicine after the expiry date stated on the container 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 in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.
6. Contents of the pack and other information
The active substance is paracetamol. Each sachet contains 500 mg 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 (contains potato maltodextrin), azorubine (E-122) and purified water.
Appearance of Antidol and pack contents
Red translucent oral solution, free from suspended particles, with a characteristic strawberry/raspberry odour.
Each pack contains 10 and 20 sachets with 5 ml of solution each, packed in unit-dose sachets made of a laminate structure: PET/ALU/PET/PE.
Only certain pack sizes may be commercially available.
Marketing Authorization 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 review of this leaflet: February 2025
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/