Biodramina 50 mg tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Biodramina 50 mg Tablets
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 this medicine as described in this leaflet or as 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 any 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 your condition worsens or does not improve after 7 days.
Contents of the leaflet:
- What Biodramina is and what it is used for
- What you need to know before taking Biodramina
- How to take Biodramina
- Possible adverse effects
- How to store Biodramina
- 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 means 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 from 7 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 to dimenhydrinate, diphenhydramine, or 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.
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 impair expectoration.
- If you have a condition causing abnormally increased activity of the thyroid gland (hyperthyroidism), increased intraocular pressure (glaucoma), prostate enlargement (prostatic hypertrophy), hypertension, or any disease causing urinary tract or gastrointestinal obstruction.
- If you have 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, 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 make diagnosis of this condition more difficult.
- 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 rays) while taking this medicine.
Children
Do not use this medicine in children under 2 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 using any of the following medicines, it may be necessary to adjust the dose of Biodramina or avoid taking it:
- 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 due to have any allergy testing, including skin tests, it is recommended to stop treatment 72 hours before the test to avoid altering the test results.
Taking Biodramina with food, drinks, and alcohol
Alcohol consumption is not recommended during treatment with this medicine.
It is recommended to take this medicine with food or milk.
Pregnancy, breastfeeding, and fertility
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 may be dangerous 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 capacity at the recommended doses.
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, ask your doctor or pharmacist.
The recommended doses are:
Adults and children over 12 years of age: 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 aged 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 aged 2 to 6 years: It is recommended to administer Biodramina Infantil 25 mg film-coated tablets to this population group.
Children under 2 years of age: 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 1–2 hours beforehand). If not taken previously, the first dose should be taken when symptoms appear. If dizziness persists, allow at least 4 to 6 hours between doses.
It is advisable to take the tablets 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 than you should
If you have taken more Biodramina than you should, 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 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.
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, Biodramina may produce adverse effects, although not everyone experiences 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, whose frequency cannot be accurately determined:
- Nausea, vomiting, constipation, diarrhea, stomach pain.
- Loss of appetite and dry mouth.
- Drowsiness and sedation (drowsiness).
- 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 sensitivity to sunlight after intense exposure, which may result in 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 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 mentioned 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 out of sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the packaging 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 containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and unused medicines. This helps protect the environment.
6. Contents of the pack and other information
Composition of Biodramina
- The active substance is dimenhydrinate. Each tablet contains 50 mg of dimenhydrinate.
- The other components (excipients) are: pregelatinized corn starch, microcrystalline cellulose, calcium sulfate dihydrate, magnesium stearate, quinoline yellow (E104).
Appearance of the product and contents of the pack
Biodramina tablets are round, yellow, and have a score line on one side.
The tablet can be divided into equal halves.
They are available in packs 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 most recent review of this leaflet: October 2013
Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/