PROSPECTO : INFORMATION FOR THE USER

Biodramina 50 mg Tablets

Dimenhidrinato

Read this prospect carefully before you start taking this medicine because it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this prospect or those indicated by your doctor or pharmacist.

• Keep this prospect, 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 or pharmacist, even if they are not listed in the prospect. (See section 4).
• You should consult a doctor if you get worse or do not improve after 7 days.

The dimenhidrinate is the active ingredient of 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 transportation, such as nausea, vomiting, and/or dizziness in adults and children 7 years of age and older.

Consult a doctor if symptoms worsen or do not improve after 7 days.

Do not take Biodramina

• If you are allergic to dimenhidrinato, difenhidramina, or any other component of this medication (listed in section 6).
• If you have porphyria (a rare, usually inherited disorder in which a large amount of porphyrin is eliminated in feces and urine).
• If you have asthma attacks.

• 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 an abnormal increase in the 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 or without loss of consciousness (epilepsy).
• If you are over 65 years old, it may cause dry mouth, urinary retention, nausea, sedation, confusion, and hypotension.
• If you are using any medication that causes ototoxicity, as symptoms of these effects may be masked, such as tinnitus, dizziness, or vertigo.
• If you have any liver or kidney disease, stomach or duodenal ulcer, or stomach inflammation (gastritis), consult your doctor before taking this medication.
• Consult your doctor before taking this medication if you have or have had heart diseases (cardiac arrhythmia, myocardial ischemia, etc.).
• 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 dimenhidrinato may make it difficult to diagnose this disease.
• 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 lamps (UVA rays) while taking this medication.

Warnings and precautions

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

Taking Biodramina with other medications

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

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

• Anesthetics and other substances with a depressant effect on the Central Nervous System
• Aminoglycoside antibiotics
• Antidepressants, such as monoamine oxidase inhibitors (MAOIs)
• Antiparkinsonian medications
• Neuroleptics (used to calm agitation and hyperactivity of the neuromuscular system)
• Otototoxic medications (that can affect the ear) (see warnings and precautions section).
• Medications that may cause photosensitivity (skin reactions due to sensitivity to sunlight).

Interference with diagnostic tests:

If you are to undergo any allergy test: including skin tests, it is recommended to suspend treatment 72 hours before starting the test, to avoid altering the results of the test.

Taking Biodramina with food, drinks, and alcohol

It is not recommended to consume alcohol during the time you are taking this medication.

It is recommended to take this medication with food or milk.

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.

The consumption of 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 consulting their doctor or pharmacist first, as this medication passes into breast milk.

Driving and operating machinery

Do not drive or operate hazardous machinery as this medication causes drowsiness or a decrease in reaction time at the recommended doses.

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

The recommended doses are:

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

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

Children 2 to 6 years:it is recommended to administer Biodramina Infantil 25 mg coated tablets to this age group Children under 2 years: This medication should not be used in children under 2 years.

Patients with liver diseases:they 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 half an hour before starting the trip (preferably 1-2 hours before), and if it has not been taken beforehand, the first dose will be taken when symptoms appear. If the dizziness persists, at least 4 or 6 hours should pass between one dose and the next.

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

If symptoms worsen, or if they persist for more than 7 days, you should consult your doctor.

If you take more Biodramina than you should

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

The symptoms of overdose include mainly: dilated pupils, flushed face, excitement, hallucinations, confusion, stomach and intestinal irritation with nausea, vomiting, and diarrhea, movement disorders, convulsions, deep loss of consciousness (coma), sudden decrease in respiratory and heart functions (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 Toxicological Information Service (phone: 91.5620420), indicating the medication and the amount ingested.

Like all medications, Biodramina can produce adverse effects, although not all people will experience them.

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

During the period of use of dimenhidrinato, the following adverse reactions have been observed, whose frequency has not been established with precision:

• Nausea, vomiting, constipation, diarrhea, stomach pain.
• Loss of appetite and dry mouth.
• Drowsiness and sedation (drowsiness).
• Headache, dizziness, and dizziness.
• Increased mucus viscosity in the bronchi, making breathing difficult.
• Urinary retention and impotence.
• Glaucoma (increase in intraocular pressure of the eye).
• Pupil dilation, blurred vision, or double vision.
• Allergic reactions on the skin and sensitivity to sunlight, after intense exposure, which may appear as urticaria, itching, and skin redness.
• Decrease in the blood of the number of red blood cells, white blood cells, leukocytes, and platelets.
• Porphyria (rare disorder, usually inherited, in which a large amount of porphyrin is eliminated in feces and urine).
• Hypertension or hypotension (increase or decrease in blood pressure).
• Tachycardia, palpitations, and/or cardiac arrhythmias.
• It may cause hyperexcitability, especially in children, with symptoms such as insomnia, nervousness, confusion, tremors, irritability, euphoria, delirium, palpitations, and even convulsions.

If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects that do not appear in this prospectus.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is possible adverse effects that do not appear in the prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of sight and reach of children.

Store below 25°C.

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

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Biodramina

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

Appearance of the product and content of the packaging

Biodramina are round tablets, yellow in color, and with a groove on one of their faces.

The tablet can be divided into two equal halves.

They are presented in packaging that contains 4 and 12 tablets.

Holder of the marketing authorization

URIACH CONSUMER HEALTHCARE S.L.

Av. Generalitat 163-167

08174 Sant Cugat del Vallès (Barcelona-Spain)

Responsible for manufacturing:

Noucor Health, S.A.

Av. Camí Reial 51-57

08184 Palau-solità i Plegamans (Barcelona-Spain)

Last review date of this leaflet October 2013

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/