BIODRAMINA 20 mg CHEWABLE MEDICATED LOZENGES

Introduction

Package Leaflet: Information for the User

Biodramina 20 mg Medicinal Chews

Dimenhydrinate

Read the entire package leaflet carefully before starting to take this medication, as 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.

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 6 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 (hypersensitive) 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 attacks.
• This medication should not be administered to children under 6 years old, as there is a risk of choking, like with any chewing gum.

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 thyroid gland activity (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 a history of 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 low blood pressure (hypotension).
• If you are taking any medication that can cause ear toxicity, as it may mask symptoms of those toxic effects, such as ringing in the ears, dizziness, or vertigo.
• If you have any liver or kidney disease, stomach or duodenal ulcers, or 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 or disorders (cardiac arrhythmia, myocardial ischemia, ...).
• If you suspect you may have symptoms of appendicitis, such as nausea, vomiting, or abdominal cramps, you should consult a doctor to rule out appendicitis, as dimenhydrinate may interfere with the diagnosis of this disease.
• It is recommended to avoid exposure to high temperatures and follow proper hygiene and dietary measures, such as adequate 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 6 years old.

Taking Biodramina with other medications

Tell your doctor or pharmacist if you are taking or have recently taken any other medications.

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 a depressant effect on the central nervous system
• Antibiotics from the aminoglycoside group
• Antidepressants, such as monoamine oxidase inhibitors (MAOIs)
• Antiparkinsonian medications
• Neuroleptics (used to calm agitation and neuromuscular hyperactivity)
• Ototoxic medications (which can affect the ear) (see Warnings and Precautions section).
• 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, drinks, and alcohol

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

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 medication.

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

Breastfeeding women should not take this medication without consulting their doctor or pharmacist first, 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.

Biodramina contains aspartame (E-951), glucose, sucrose, and sorbitol (E-420).

• This medication contains 3 mg of aspartame (E-951) per chewable tablet. Aspartame contains a source of phenylalanine, which can be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates due to the body's inability to eliminate it correctly.

• This medication contains glucose and sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.
• This medication contains 285 mg of sorbitol (E-420) per chewable tablet. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor before taking this medication.

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 6 years old: 1 or 2 chewable tablets (corresponding to 20 or 40 mg of dimenhydrinate) per dose. If necessary, repeat the dose every 6 or 8 hours. Do not take more than 7 chewable tablets (140 mg of dimenhydrinate) per day, and always spread them out over several doses.

Children under 6 years old: Should not be used in children under 6 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 previously, the first dose should be taken when symptoms appear. If the motion sickness persists, wait at least 6 hours between doses.

The chewable tablet should be chewed for 5-10 minutes. After this time, it should be spat out, not swallowed.

If your symptoms worsen or persist for more than 7 days, you should 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 respiratory and cardiac 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 ingested.

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 precision:

• Nausea, vomiting, constipation, diarrhea, stomach pain.
• Lack of appetite and dry mouth.
• It may cause temporary numbness of the mouth and tongue.
• Drowsiness and sedation (drowsiness).
• Headache, dizziness, and vertigo.
• Increased mucus viscosity 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 blood red blood cell count, white blood cell count, leukocytes, and platelets.
• Porphyria (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.
• 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 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 Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Biodramina

Keep this medication out of the sight and reach of children.

Store below 25°C.

Do not use this medication after the expiration date stated 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 your 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 chewable tablet contains 20 milligrams of dimenhydrinate.
• The other components (excipients) are: core:aspartame (E-951), gum base, dextrin, semi-synthetic solid glycerides, light magnesium oxide, magnesium stearate (E-572), levomenthol, sodium saccharin (E-954), sucrose, anhydrous colloidal silica, sorbitol (E-420), talc, white beeswax, methacrylic acid-methyl methacrylate copolymer (Eudragit S), peppermint flavor. Coating:calcium carbonate, liquid glucose, methacrylate copolymer (Eudragit E), macrogol 35000, emulsifying wax, potassium dihydrogen phosphate, povidone (E-1201), titanium dioxide (E-171), magnesium stearate (E-572), levomenthol, peppermint essence, povidone 25, sucrose, talc.

Product Appearance and Package Contents

Biodramina are round, white, medicinal chewable tablets.

They come in packages containing 6 and 12 chewable 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:December 2024

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