BIODRAMINA 50 mg TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Biodramina 50 mg Tablets

Dimenhydrinate

Read the package leaflet carefully before starting to take this medication because it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package 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 package leaflet. (See section 4).
• You should consult a doctor if your symptoms worsen or do not improve after 7 days.

Contents of the package leaflet:

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

1. What Biodramina is and what it is used for

Dimenhydrinate is the active ingredient in this medication and acts against motion sickness caused by transportation.

It is indicated for the prevention and treatment of symptoms of motion sickness caused by land, sea, or air travel, such as nausea, vomiting, and/or dizziness in adults and children over 7 years old.

You should consult a doctor if your symptoms worsen or do not improve after 7 days.

2. What you need to know before taking Biodramina

Do not take Biodramina

• If you are allergic to dimenhydrinate, diphenhydramine, or any of the other components of this medication (listed in section 6).
• If you have porphyria (a rare, usually inherited disorder in which large amounts of porphyrin are eliminated in feces and urine).

• If you have asthma.

Warnings and precautions

• 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), enlarged prostate (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 medication.
• You should consult your doctor before taking this medication if you have or have had heart diseases (cardiac arrhythmia, myocardial ischemia, ...).
• 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.
• It is recommended to avoid exposure to very high temperatures and follow adequate hygienic-dietary measures, such as proper ventilation and hydration.
• Avoid exposure to the sun (even on cloudy days) and ultraviolet lamps (UVA rays) while taking this medication.

Children

Do not use this medication in children under 2 years old.

Taking Biodramina with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

In particular, if you are taking any of the following medications, it may be necessary to modify the dose of Biodramina or not take it:

• Anesthetics and other substances with central nervous system depressant action
• Antibiotics of the aminoglycoside group
• Antidepressants, such as monoamine oxidase inhibitors (MAOIs)
• Antiparkinsonian medications
• Neuroleptics (used to calm agitation and neuromuscular hyperactivity)
• Ototoxic medications (that can affect the ear) (see warnings and precautionssection).
• Medications 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 with food, beverages, and alcohol

It is not recommended to consume alcohol while taking this medication.

It is recommended to take this medication with food, water, or milk to minimize gastric irritation.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Taking medications during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

Women who are breastfeeding should not take this medication without first consulting their doctor or pharmacist, as this medication passes into breast milk.

Driving and using machines

Do not drive or operate hazardous machinery, as this medication can cause drowsiness or decreased reaction time at recommended doses.

3. How to take Biodramina

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended doses are:

Adults and children over 12 years old: 1 or 2 tablets (50-100 mg of dimenhydrinate) per dose. If necessary, repeat the dose every 4-6 hours. Do not take more than 8 tablets (400 mg of dimenhydrinate) per day, divided into several doses.

Children from 7 to 12 years old: half a tablet to 1 tablet (25-50 mg of dimenhydrinate). If necessary, repeat the dose every 6 to 8 hours. Do not take more than 3 tablets (150 mg of dimenhydrinate) per day, divided into several doses.

Children from 2 to 6 years old: it is recommended to administer Biodramina Infantil 25 mg film-coated tablets to this population.

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 medication, as it may be necessary to reduce the dose.

This medication is taken orally.

It is recommended to take the first dose at least 30 minutes before starting the trip (preferably 1-2 hours before), and if not taken beforehand, the first dose should be taken when symptoms appear. If the motion sickness persists, wait at least 4 or 6 hours between doses.

It is recommended to take the tablets with food, water, or milk to minimize gastric irritation.

If the symptoms worsen or persist for more than 7 days, consult a doctor.

If you take more Biodramina than you should

If you have taken more Biodramina than you should, consult your doctor or pharmacist immediately.

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

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service (phone: 91.5620420), indicating the medication and the amount taken.

4. Possible side effects

Like all medications, Biodramina can cause side effects, although not everyone will experience 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 can cause hives, itching, and redness of the skin.
• Decrease in the number of red blood cells, white blood cells, leukocytes, and platelets in the blood.
• Porphyria (a rare, usually inherited 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 children, with symptoms such as insomnia, nervousness, confusion, tremors, irritability, euphoria, delirium, palpitations, and even convulsions.

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet.

Reporting side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in the package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Biodramina

Keep out of sight and reach of children.

Store below 25°C.

Do not use this medication after the expiration date shown on the box after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Biodramina composition

• The active ingredient is dimenhydrinate. Each tablet contains 50 mg of dimenhydrinate.
• The other components (excipients) are: pregelatinized cornstarch, microcrystalline cellulose, calcium sulfate dihydrate, magnesium stearate, quinoline yellow (E104).

Product appearance and package contents

Biodramina are round, yellow tablets with a score line on one side.

The tablet can be divided into two equal halves.

They are available in packages containing 4 and 12 tablets.

Marketing authorization holder

URIACH CONSUMER HEALTHCARE S.L.

Av. Generalitat 163-167

08174 Sant Cugat del Vallès (Barcelona-Spain)

Manufacturer

Noucor Health, S.A.

Av. Camí Reial 51-57

08184 Palau-solità i Plegamans (Barcelona-Spain)

Date of the last revision of this package leaflet: October 2013

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS): http://www.aemps.gob.es/