Antidol Infantil 100 mg/ml oral solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Antidol Infantil 100 mg/ml oral solution
paracetamol
Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.
- Always follow exactly the instructions for administering 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 effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or if you do not improve after 3 days in case of fever, or if pain in children persists for more than 3 days (2 days in case of sore throat).
Contents of the leaflet
- What Antidol Infantil is and what it is used for
- What you need to know before taking Antidol Infantil
- How to take Antidol Infantil
- Possible side effects
- How to store Antidol Infantil
- Contents of the pack and other information
1. What Antidol Infantil is and what it is used for
Antidol Infantil belongs to a group of medicines called analgesics and antipyretics.
This medicine is used for febrile conditions and for the relief of mild to moderate pain in children weighing between 3 and 32 kg (approximately from 0 to 10 years of age).
2. What you need to know before taking Antidol Infantil
Do not take Antidol Infantil
- If you are allergic (hypersensitive) to paracetamol or to any of the other components of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor, pharmacist, or nurse before starting to take this medicine.
- Do not exceed the recommended dose stated in section 3.
- In patients with liver, kidney, heart, or lung disease, and in patients with anemia (reduced hemoglobin levels in the blood, due to a decrease in red blood cells or otherwise), consult your doctor before taking this medicine.
- In children with chronic malnutrition or dehydration, as this may increase liver toxicity.
- Consumption of alcoholic beverages may cause paracetamol to cause liver damage.
- If pain or fever persists for more than 3 days (2 days for sore throat), worsens, or new symptoms appear, treatment should be stopped and you should consult your doctor. Avoid prolonged treatment.
- 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). 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
You must consult your doctor before administering this medicine to children under 2 years of age.
Other medicines and Antidol Infantil
Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines. In particular, if you are taking medicines containing any of the following active substances, a dose adjustment or discontinuation of treatment may be necessary:
- Antibiotics (chloramphenicol).
- Oral anticoagulants (acenocoumarol, warfarin).
- Oral contraceptives and estrogen treatments.
- Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
- Antituberculosis agents (isoniazid, rifampicin).
- Barbiturates (used as sleep inducers, sedatives, and anticonvulsants).
- Activated charcoal, used for diarrhea or treatment of gas.
- Cholestyramine (used to lower blood cholesterol levels).
- Medicines used to treat gout (probenecid and sulfinpyrazone).
- Medicines used to relieve spasms or contractions of the stomach, intestines, and bladder (anticholinergics).
- Metoclopramide and domperidone (used to prevent nausea and vomiting).
- Propranolol, used in the treatment of high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias).
- Zidovudine (used in the treatment of patients infected with the human immunodeficiency virus, HIV, which causes AIDS).
- 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).
Interference with laboratory tests
If you are scheduled to undergo any laboratory tests (including blood or 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 Infantil with food, drinks, and alcohol
This medicine may be administered diluted with water, milk, or fruit juice. The use of paracetamol in patients who habitually consume alcohol (three or more alcoholic drinks per day) may cause liver damage.
Pregnancy, breastfeeding, and fertility
Consult your doctor or pharmacist before using any medicine. In women, although controlled studies are lacking, teratogenic effects have not been demonstrated. Nevertheless, as a general rule, its use during the first trimester of pregnancy is not recommended. If necessary, Antidol Infantil may be used during pregnancy. Use the lowest possible dose that reduces pain or fever, and use it for the shortest possible duration. Contact your doctor if pain or fever do not subside or if you need to take the medicine more frequently. Paracetamol passes into breast milk; therefore, women who are breastfeeding should consult their doctor before using this medicine.
Driving and using machines
No effects affecting the ability to drive or operate machinery have been reported.
Antidol Infantil contains propylene glycol (E-1520), azorubine (E-122), and sodium.
This medicine contains 8.87 mg of propylene glycol (E-1520) per ml. If the infant is less than 4 weeks old, consult your doctor or pharmacist, especially if the infant has been given other medicines containing propylene glycol or alcohol.
This medicine may cause allergic reactions because it contains azorubine (E-122).
This medicine contains less than 1 mmol of sodium (23 mg) per ml; this is essentially “sodium-free”.
3. How to take Antidol Infantil
Follow exactly the dosing instructions for the medicine provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
This medicine is administered orally.
It is intended for short-term use in children weighing between 3 and 32 kg (approximately 0 to 10 years of age).
Use in children
For children under 2 years of age, the dose must always be determined by your doctor.
The paracetamol dose depends on the child's weight; the approximate age is provided for informational purposes only. The recommended daily dose of paracetamol is approximately 60 mg/kg/day, divided into 4 or 6 doses per day, i.e., 15 mg/kg every 6 hours or 10 mg/kg every 4 hours.
The solution dose is measured in milliliters (ml) (100 mg/ml) using the 5 ml oral syringe provided in the package.
For administration of 15 mg/kg every 6 hours, the dosing schedule is as follows:
Child's weight | Age (indicative) | Volume in ml | mg of paracetamol |
Up to 4 kg | from 0 to 3 months | 0.6 ml | 60 mg |
Up to 8 kg | from 4 to 11 months | 1.2 ml | 120 mg |
Up to 10.5 kg | from 12 to 23 months | 1.6 ml | 160 mg |
Up to 13 kg | from 2 to 3 years | 2.0 ml | 200 mg |
Up to 18.5 kg | from 4 to 5 years | 2.8 ml | 280 mg |
Up to 24 kg | from 6 to 8 years | 3.6 ml | 360 mg |
Up to 32 kg | from 9 to 10 years | 4.8 ml | 480 mg |
For direct calculation, the child's weight in kg may also be multiplied by 0.15; the result is the number of ml of the medicine to be administered.
These doses may be repeated every 6 hours.
If the desired effects are not achieved within 3-4 hours after administration, the dosing interval may be shortened to every 4 hours, in which case 10 mg/kg should be administered.
Paracetamol administration is dependent on the presence of pain or fever symptoms. As these symptoms subside, the medication should be discontinued.
Instructions for correct administration of the medicine
1.- Open the bottle following the instructions indicated on the cap (on first opening, the seal will break).
2.- Insert the oral syringe by pressing it into the hole in the pierced cap.
3.- Invert the bottle and withdraw the required dose.
4.- Administer directly or dilute with water, milk, or fruit juice.
5.- The oral syringe should be washed with water after each use.
Close the bottle tightly after each administration.
If you take more Antidol Infantil than you should
If you have taken more paracetamol than you should, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.
If an overdose has been ingested, seek immediate medical attention 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.
An overdose of paracetamol is considered to occur when a single dose exceeding 6 g is ingested in adults, or more than 100 mg per kg of body weight in children. Treatment for overdose is most effective if initiated within 4 hours of ingestion of the medicine.
Patients undergoing treatment with barbiturates or those suffering from chronic alcoholism may be more susceptible to paracetamol overdose.
In general, symptomatic treatment will be provided.
If you forget to take Antidol Infantil
Do not take a double dose to make up for a missed dose. If you have missed a dose, take it as soon as possible and then continue with your regular schedule. However, if the next dose is due shortly, skip the missed dose and take the next dose at the scheduled time.
If you stop using Antidol Infantil
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Adverse reactions to paracetamol are generally rare or very rare.
Rare (may affect up to 1 in 1,000 people): malaise, increased levels of hepatic transaminases, and low blood pressure.
Very rare (may affect up to 1 in 10,000 people): severe skin reactions, liver disorders (such as jaundice), decreased blood glucose, blood disorders (thrombocytopenia, agranulocytosis, leucopenia, neutropenia, haemolytic anaemia), cloudy urine, and kidney disorders.
Liver damage may very rarely occur at high doses or with prolonged treatment. Very rare cases of severe skin reactions have been reported.
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 serious illness who are using paracetamol (see section 2).
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may 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 Infantil
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle after EXP. The expiry date refers to the last day of the month indicated.
This medicine does not require special storage conditions. The shelf life after opening is 12 months.
Medicines must not be disposed of via wastewater drains or household waste. Dispose of empty containers and unused medicines at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Antidol Infantil
- The active substance is paracetamol. Each ml of solution contains 100 mg of paracetamol.
- The other components (excipients) are: macrogol 400, glycerol (E-422), sodium saccharin, strawberry flavour, raspberry flavour (contains propylene glycol (E-1520)), taste masker (contains potato maltodextrin), cochineal red A (E-122), and purified water.
Appearance of the medicinal product and contents of the pack
Red translucent solution, free from suspended particles, with a characteristic strawberry/raspberry odour.
Packs containing a plastic (PET) bottle of 30, 60 and 90 ml with a child-resistant screw cap, plus an oral syringe with a capacity of 5 ml, graduated in 0.1 ml increments.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) – Spain
Manufacturers
Edefarm, S.L.
Polígono Industrial Enchilagar del Rullo, 117,
Villamarchante, 46191 Valencia
Spain
or
Farmalider, S.A.
C/ Aragoneses, 2
28108 Alcobendas – Madrid
Spain
or
Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) – Spain
Date of the most recent revision of the package leaflet: February 2025
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): https://www.aemps.es/