Biodramina 20 mg medicated chewing gum

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Biodramina 20 mg Medicinal Chewing Gums

Dimenhydrinate

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

Follow exactly the instructions for use provided in this leaflet or those given 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 any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. (See section 4).
• You should consult a doctor if you worsen or do not improve after 7 days.

Contents of the 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 adverse effects
5. Storage of Biodramina
6. Contents of the pack and other information

1. What Biodramina is and what it is used for

Dimenhydrinate is the active substance in this medicine and acts against motion sickness caused by various modes of 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 6 years of age.

You should consult a doctor if your condition worsens or does 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 to any of the other ingredients of this medicine (listed in section 6).
• If you have porphyria (a rare disorder, usually hereditary, in which large amounts of porphyrins are excreted in faeces and urine).
• If you are experiencing asthmatic attacks.
• This medicine should not be given to children under 6 years of age, as with any chewing gum, there is a risk that it may be swallowed by children.

Warnings and precautions

• If you have asthma or severe respiratory diseases (chronic obstructive pulmonary disease, emphysema, chronic bronchitis), as thickening of secretions may occur and may affect expectoration.
• If you have a condition characterized by abnormally increased activity of the thyroid gland (hyperthyroidism), increased intraocular pressure (glaucoma), enlarged prostate (prostatic hypertrophy), hypertension, or any illness causing obstruction of the urinary or gastrointestinal tract.
• 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 medicine that causes ear toxicity (ototoxicity), 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.
• You should consult your doctor before taking this medicine if you have or have had heart conditions (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 see a doctor to rule out the presence of appendicitis, as dimenhydrinate may interfere with the diagnosis of this condition.
• It is recommended to avoid exposure to very high temperatures and to follow appropriate hygiene and dietary measures, such as adequate ventilation and hydration.
• Avoid exposure to sunlight (even when cloudy) and to ultraviolet lamps (UV-A rays) while taking this medicine.

Children

Do not use this medicine in children under 6 years of age.

Taking Biodramina with other medicines

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

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

• Anaesthetics and other substances with central nervous system depressant effects
• Antibiotics of the aminoglycoside group
• Antidepressants, such as monoamine oxidase inhibitors (MAOIs)
• Anti-Parkinson agents
• Neuroleptics (used to calm agitation and neuromuscular hyperactivity)
• Ototoxic medicines (which may affect the ear) (see section Warnings and precautions)
• Medicines that may cause photosensitivity (skin reactions due to sensitivity to sunlight)

Interference with diagnostic tests:

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

Taking Biodramina 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.

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

Breastfeeding women should not take this medicine without first consulting their doctor or pharmacist, as this medicine passes into breast milk.

Driving and using machines:

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

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

• This medicine contains 3 mg of aspartame (E-951) per chewing gum. Aspartame contains a source of phenylalanine, which may be harmful in patients with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it properly.

• This medicine contains glucose and sucrose. If your doctor has advised you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

• This medicine contains 285 mg of sorbitol (E-420) per chewing gum. Sorbitol is a source of fructose. If your doctor has advised you (or your child) that you have an intolerance to certain sugars, or if you (or your child) have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which fructose cannot be broken down, consult your doctor (or your child’s doctor) before taking this medicine.

3. How to take Biodramina

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended doses are:

Adults and children over 6 years of age: 1 or 2 chewing gums (corresponding to 20 or 40 mg of dimenhydrinate) per dose. If necessary, repeat the dose every 6 to 8 hours. Do not take more than 7 chewing gums (140 mg of dimenhydrinate) per day, and always spread the doses throughout the day.

Children under 6 years of age: This medicine must not be used in children under 6 years of age.

Patients with liver disease: You should consult your 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 your journey (preferably 1–2 hours before). If you have not taken it beforehand, the first dose should be taken when symptoms appear. If motion sickness persists, allow at least 6 hours to pass between doses.

The chewing gum should be chewed for 5–10 minutes. After this time, it should be spat out and not swallowed.

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

If you take more Biodramina than you should

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

Symptoms of overdose mainly include: dilated pupils, flushed face, excitement, hallucinations, confusion, irritation of the stomach and intestines with nausea, vomiting and diarrhea, movement disorders, convulsions, deep unconsciousness (coma), sudden decrease in respiratory and heart function (cardiorespiratory collapse), and death. Symptoms may not appear until more than 2 hours after the overdose.

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

4. Possible adverse effects

Like all medicines, Biodramine may produce 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, although their frequency could not be established accurately:

• Nausea, vomiting, constipation, diarrhea, stomach pain.
• Loss of appetite and dry mouth.
• May cause transient numbness of the mouth and tongue.
• 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 in the eye).
• Pupil dilation, blurred vision, or double vision.
• Allergic skin reactions and photosensitivity after intense sun exposure, possibly causing urticaria, itching, and redness of the skin.
• 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 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, tremor, irritability, euphoria, delirium, palpitations, and even seizures.

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

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet.

You can also report them directly through the Spanish Pharmacovigilance System for 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

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

Store below 25°C.

Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Biodramina

• The active substance is dimenhydrinate. Each medicated chewing gum 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, butyl methacrylate basic 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.

Appearance of the product and contents of the container

Biodramina is white, round medicated chewing gums.

They are presented in packs containing 6 and 12 chewing gums.

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 most recent review of this leaflet: December 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Care Products (AEMPS) http://www.aemps.gob.es.