BIODRAMINA INFANTIL 12.5 mg ORAL SOLUTION

Introduction

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.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 7 days of treatment.

Contents of the leaflet

1. What is Biodramina Infantil and what is it used for
2. What you need to know before taking Biodramina Infantil
3. How to take Biodramina Infantil
4. Possible side effects
5. Storage of Biodramina Infantil
6. Package contents and additional information

1. What is Biodramina Infantil and what is it used for

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.

2. What you need to know before taking Biodramina Infantil

Do not take Biodramina Infantil if:

• You are allergic (hypersensitive) to dimenhydrinate, diphenhydramine, or any of the other components of this medicine (listed in section 6).
• You have porphyria (a rare, usually hereditary disorder in which large amounts of porphyrin are eliminated in feces and urine).
• You have asthma attacks.

Warnings and precautions

Consult your doctor or pharmacist before taking Biodramina Infantil:

• If you have asthma, severe respiratory diseases (chronic obstructive pulmonary disease, emphysema, chronic bronchitis), as it may cause thickening of secretions and alter expectoration.
• If you have a disease that causes abnormal increased activity of the thyroid gland (hyperthyroidism), increased intraocular pressure (glaucoma), prostate enlargement (prostatic hypertrophy), hypertension, or any disease that causes obstruction of the urinary or gastrointestinal tract.
• If you have seizures with convulsive movements, with or without loss of consciousness (epilepsy).
• If you are over 65 years old, dry mouth, urinary retention, nausea, sedation, confusion, and low blood pressure (hypotension) may occur.
• If you are taking any medication that can cause ear toxicity, as symptoms of these toxic effects, such as ringing in the ears, dizziness, or vertigo, may be masked.
• If you have any liver or kidney disease, stomach or duodenal ulcer, or stomach inflammation (gastritis), you should consult your doctor before taking this medicine.
• If you have or have had heart diseases (cardiac arrhythmia).
• If you suspect you may have symptoms of appendicitis, such as nausea, vomiting, or abdominal cramps, it is recommended to consult a doctor to rule out the presence or absence of appendicitis, as dimenhydrinate may make it difficult to diagnose this disease.

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:

• Substances with a depressant effect on the central nervous system, such as anesthetics, barbiturates, benzodiazepines, opioid analgesics, as dimenhydrinate may enhance their sedative effect.
• Aminoglycoside antibiotics and other medicines that can cause ear toxicity (see "Warnings and precautions" section).
• Tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs), antiparkinsonian agents, neuroleptics (for treating schizophrenia), as dimenhydrinate may enhance the adverse effects of these medicines. Gastrointestinal symptoms should be monitored, as paralytic ileus (absence of intestinal movements) may occur.
• Medicines that can cause photosensitivity (skin reactions due to sensitivity to sunlight).

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

-may produce allergic reactions (possibly delayed) because it contains methylparahydroxybenzoate (E-218).

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3. How to take Biodramina Infantil 12.5 mg oral solution

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:

• Children from 2 to 6 years old: 1 to 2 sachets (12.5-25 mg of dimenhydrinate). If necessary, repeat the dose every 6 to 8 hours. Do not take more than 6 sachets per day (75 mg of dimenhydrinate in 24 hours).

• Children from 7 to 12 years old: 2 to 4 single-dose sachets (25-50 mg of dimenhydrinate). If necessary, repeat the dose every 6 to 8 hours. Do not take more than 12 sachets per day (150 mg of dimenhydrinate in 24 hours).

• Children under 2 years old: should not be used in children under 2 years old.

• Patient with liver disease: should consult their doctor before taking this medicine, as it may be necessary to reduce the dose.

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.

If you take more Biodramina Infantil than you should

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.

4. Possible side effects

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:

• Nausea, vomiting, constipation, diarrhea, stomach pain.
• Lack of appetite and dry mouth.
• Drowsiness and sedation (drowsiness).
• Headache, dizziness, and vertigo.
• Increased viscosity of mucus in the bronchi, making breathing difficult.
• Urinary retention and impotence.
• Glaucoma (increased intraocular pressure).
• Dilated pupils, blurred vision, or double vision.
• Allergic reactions on the skin and sensitivity to sunlight, after intense exposure, which may cause hives, itching, and skin redness.
• Decrease in the blood of the number of red blood cells, white blood cells, leukocytes, and platelets.
• Porphyria (rare, usually hereditary disorder in which large amounts of porphyrin are eliminated in feces and urine).
• Hypertension or hypotension (increased or decreased blood pressure).
• Tachycardia, palpitations, and/or cardiac arrhythmias.
• Hyperexcitability may occur, especially in young children, with symptoms such as insomnia, nervousness, confusion, tremors, irritability, euphoria, delirium, palpitations, and even convulsions.

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.

5. Storage of Biodramina Infantil 12.5 mg oral solution

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.

6. Package contents and additional information

Composition of Biodramina Infantil

• The active ingredient is dimenhydrinate. Each 2.5 ml sachet contains 12.5 mg of dimenhydrinate.
• The other ingredients (excipients) are: propylene glycol (E-1520), methylparahydroxybenzoate (E-218), sucrose, sodium saccharin (E-954), sodium cyclamate (E-952), tutti-frutti flavor, sodium chloride, and purified water.

Appearance of the product and package contents

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.

Marketing authorization holder

URIACH CONSUMER HEALTHCARE S.L.

Av. Generalitat 163-167

08174 Sant Cugat del Vallès

(Barcelona-Spain)

Manufacturer

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/