Biodramina Infantil 12.5 mg oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Biodramina Infantil 12.5 mg oral solution

Dimenhydrinate

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the instructions for administration of the medicine contained in this leaflet or those 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 adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 7 days of treatment.

Contents of the leaflet

1. What Biodramina Infantil is and what it is used for
2. What you need to know before taking Biodramina Infantil
3. How to take Biodramina Infantil
4. Possible adverse effects
5. How to store Biodramina Infantil
6. Contents of the pack and other information

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

Dimenhydrinate is the active substance in this medicine and acts against motion sickness caused by means of transportation.

It is indicated in children aged 2 to 12 years 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 starting to take 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 disorder, usually hereditary, characterized by excessive excretion of porphyrins in feces and urine).
• You are experiencing asthma attacks.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Biodramina Infantil:

• If you have asthma or severe respiratory diseases (chronic obstructive pulmonary disease, emphysema, chronic bronchitis), as thickening of secretions may occur and affect expectoration.
• If you have a condition involving abnormally increased activity of the thyroid gland (hyperthyroidism), increased intraocular pressure (glaucoma), enlarged prostate (prostatic hypertrophy), hypertension, or any illness causing urinary or gastrointestinal obstruction.
• If you suffer from seizures involving convulsive movements, with or without loss of consciousness (epilepsy).
• If you are over 65 years of age, dry mouth, urinary retention, nausea, sedation, confusion, and low blood pressure (hypotension) may occur.
• If you are taking any medication that causes ototoxicity (ear toxicity), as symptoms of such 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 inflammation of the stomach (gastritis), you should consult your doctor before taking this medicine.
• If you have or have had heart conditions or disorders (cardiac arrhythmia).
• If you suspect you may have symptoms of appendicitis such as nausea, vomiting, or abdominal cramps, it is recommended to see a doctor to rule out the presence of appendicitis, as dimenhydrinate may interfere with the diagnosis of this condition.

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 to follow appropriate hygienic-dietary measures, such as adequate ventilation and hydration.

Avoid exposure to sunlight (even when cloudy) and to ultraviolet radiation lamps (UV-A rays) while taking this medicine.

Children

Do not use this medicine in children under 2 years of age.

Other medicines and Biodramina Infantil

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

In particular, if you are taking any of the following medicines, it may be necessary to adjust the dose of Biodramina Infantil or avoid taking it altogether:

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

Interference with diagnostic tests

If you are due to undergo allergy testing, including skin tests, it is recommended to discontinue treatment at least 72 hours before the test to avoid interference with test results.

Taking Biodramina Infantil with food, drinks, and alcohol

Alcohol consumption is not recommended while taking this medicine.

Pregnancy and breastfeeding

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.

This medicine is intended exclusively for administration to children.

Taking medicines during pregnancy may be harmful to the embryo or fetus and should be supervised by your doctor.

Breastfeeding women should not take this medicine without first consulting a doctor or pharmacist, as this medicine passes into breast milk and may inhibit milk production.

Driving and using machines

Do not drive or operate dangerous machinery, as this medicine may cause drowsiness or reduced reaction capacity at recommended doses.

Biodramina Infantil contains methyl parahydroxybenzoate (E-218), sucrose, propylene glycol (E-1520), and sodium

- This medicine may cause allergic reactions (possibly delayed) as it contains methylparahydroxybenzoate (E-218).

- This medicine contains sucrose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

- This medicine contains 200 mg of propylene glycol (E-1520) per sachet. If the baby is less than 4 weeks old, consult your doctor or pharmacist, particularly if the baby has been given other medicines containing propylene glycol or alcohol.

- This medicine contains less than 1 mmol of sodium (23 mg) per sachet; thus, it is essentially “sodium-free”.

3. How to take Biodramina Infantil 12.5 mg oral solution

Follow exactly the administration instructions provided in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

• Children aged 2 to 6 years: 1 to 2 sachets (12.5–25 mg of dimenhydrinate). If necessary, repeat the dose every 6 to 8 hours. In no case should more than 6 sachets be taken per day (75 mg of dimenhydrinate in 24 hours).

• Children aged 7 to 12 years: 2 to 4 single-dose sachets (25–50 mg of dimenhydrinate). If necessary, repeat the dose every 6 to 8 hours. In no case should more than 12 sachets be taken per day (150 mg of dimenhydrinate in 24 hours).

• Children under 2 years: this medicine must not be used in children under 2 years of age.

• Patients 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 journey (preferably 1 or 2 hours beforehand). If not taken previously, the first dose should be taken when symptoms appear.

If motion sickness persists, at least 6 hours should elapse between doses.

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, 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 medication and the amount ingested.

Symptoms of overdose include mainly: dilated pupils, flushed face, excitement, hallucinations, confusion, stomach and intestinal irritation with nausea, vomiting and diarrhea, movement disturbances, seizures, deep unconsciousness (coma), sudden decrease in respiratory and heart function (cardiorespiratory collapse), and death. Symptoms may take more than 2 hours to appear after the overdose.

4. Possible adverse effects

Like all medicines, Biodramine Junior may cause adverse effects, although not everyone will experience them.

Adverse effects are usually mild and transient, especially at the beginning of treatment.

During the period of use of dimenhydrinate, the following adverse reactions have been observed, the frequency of which cannot be precisely established:

• Nausea, vomiting, constipation, diarrhoea, stomach pain.
• Loss of appetite and dry mouth.
• Drowsiness and sedation.
• Headache, dizziness, and vertigo.
• Increased mucus viscosity in the bronchi, making breathing difficult.
• Urinary retention and sexual impotence.
• Glaucoma (increased intraocular pressure of the eye).
• Pupil dilation, blurred vision or double vision.
• Allergic skin reactions and photosensitivity after intense sun exposure, possibly causing urticaria, itching, and skin redness.
• Decrease in blood levels of red blood cells, white blood cells, leukocytes, and platelets.
• Porphyria (a rare disorder, usually hereditary, characterized by excessive excretion of porphyrins in faeces 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, tremor, irritability, euphoria, delirium, palpitations, and even seizures.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish System of Pharmacovigilance of 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 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 expiry date stated on the packaging and container after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Biodramina Infantil

• The active substance is dimenhydrinate. Each 2.5 ml sachet contains 12.5 mg of dimenhydrinate.
• The other components (excipients) are: propylene glycol (E-1520), methyl 4-hydroxybenzoate (E-218), sucrose, sodium saccharin (E-954), sodium cyclamate (E-952), tutti frutti flavor, sodium chloride, and purified water.

Appearance of the product and contents of the container

Biodramina Infantil is a clear, colorless or slightly yellowish oral solution with a tutti frutti odor and flavor.

It is presented in packages containing 12 sachets of 2.5 ml each.

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 most recent review of this leaflet: April 2021

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.es/