


Ask a doctor about a prescription for BIODRAMINA INFANTIL 12.5 mg ORAL SOLUTION
Leaflet: information for the user
Biodramina Infantil 12.5 mg oral solution
Dimenhydrinate
Read this leaflet carefully before starting to take this medicine, as it contains important information for you
Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.
Contents of the leaflet
Dimenhydrinate is the active ingredient of this medicine and acts against motion sickness caused by means of transportation.
It is indicated in children from 2 to 12 years old for the prevention and treatment of symptoms of motion sickness caused by land, sea, or air travel, such as nausea, vomiting, and/or dizziness.
Warnings and precautions
Consult your doctor or pharmacist before taking Biodramina Infantil:
Cross-sensitivity (allergy) may occur with other antihistamines.
Sedation or drowsiness may occur in some patients.
It is recommended to avoid exposure to high temperatures and follow adequate hygiene and dietary measures, such as proper ventilation and hydration.
Avoid exposure to the sun (even on cloudy days) and ultraviolet radiation lamps (UVA rays) while taking this medicine.
Children
Do not use this medicine in children under 2 years old.
Other medicines and Biodramina Infantil
Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medicine.
In particular, if you are taking any of the following medicines, it may be necessary to modify the dose of Biodramina Infantil or not take it:
Interference with diagnostic tests
If you are going to undergo an allergy test, including skin tests, it is recommended to stop treatment 72 hours before starting the test to avoid altering the results.
Taking Biodramina Infantil with food, drinks, and alcohol
Alcohol consumption is not recommended during the time you are taking this medicine.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
This medicine is intended exclusively for administration in children.
Taking medicines during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.
Breastfeeding women should not take this medicine without first consulting their doctor or pharmacist, as this medicine passes into breast milk and may inhibit milk production.
Driving and using machines
Do not drive or operate hazardous machinery, as this medicine can cause drowsiness or decreased reaction capacity at the recommended doses.
Biodramina Infantil contains methylparahydroxybenzoate (E-218), sucrose, propylene glycol (E-1520), and sodium
Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
The recommended dose is:
This medicine is taken orally.
It is recommended to take the first dose at least half an hour before starting the trip (preferably 1 or 2 hours before), and if not taken previously, the first dose will be taken when symptoms appear.
If motion sickness persists, at least 6 hours should pass between one dose and the next.
It is recommended to take this medicine with food, water, or milk to minimize gastric irritation.
If symptoms worsen or persist for more than 7 days, you should consult your doctor.
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service (telephone: 91 562 04 20), indicating the medicine and the amount ingested.
The symptoms of overdose include mainly: dilated pupils, red face, excitement, hallucinations, confusion, stomach and intestinal irritation with nausea, vomiting, and diarrhea, alterations in movement, convulsions, deep loss of consciousness (coma), sudden decrease in respiratory and cardiac function (cardiorespiratory collapse), and death. Symptoms may take more than 2 hours to appear after the overdose.
Like all medicines, Biodramina Infantil can cause side effects, although not everyone gets them.
Side effects are usually mild and temporary, especially at the beginning of treatment.
During the use of dimenhydrinate, the following adverse reactions have been observed, whose frequency could not be established with accuracy:
Reporting of side effects
If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiration date stated on the carton and blister pack after EXP. The expiration date is the last day of the month indicated.
This medicine does not require special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Place the blisters and any unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of blisters and unused medicines. This will help protect the environment.
Composition of Biodramina Infantil
Biodramina Infantil is a clear, colorless or slightly yellowish oral solution with a tutti-frutti flavor and aroma.
It is presented in packs containing 12 sachets of 2.5 ml.
Laboratorios Alcalá Farma, S.L.
Avenida de Madrid, 82
28802 Alcalá de Henares
Madrid
Date of the last revision of this leaflet:April 2021
Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/
Discuss dosage, side effects, interactions, contraindications, and prescription renewal for BIODRAMINA INFANTIL 12.5 mg ORAL SOLUTION – subject to medical assessment and local rules.