Biodramina 6 chicles View larger

Biodramina 6 chicles

Chewing gum for the prevention and treatment of symptoms of dizziness caused by travel by car, plane or boat, such as nausea and vomiting in adults and children from 6 years old

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 1. What it is Biodramina and what it is used
Dimenhydrinate is the active ingredient of this medicine and acts against nausea produced by the means of locomotion.
It is indicated for the prevention and treatment of symptoms of dizziness caused by transportation by land, sea or air, such as nausea, vomiting and / or dizziness in adults and children over 6 years old.
You should consult a doctor if worsens or does not improve after 7 days.


 2. What you need to know before you start taking Biodramina
Do not take Dramamine if:
- If you are allergic (hypersensitive) to dimenhydrinate, diphenhydramine or any of the other ingredients of this medicine (listed in section 6).
- Have porphyria (rare disorder, usually inherited, in which large amount of porphyrin excreted in feces and urine).
- Have asthma attacks.
- This medicine should not be given to children under 6 years old, since, as with any gum, there is a risk of being swallowed by children.

Warnings and Precautions
- If you have asthma, severe respiratory diseases (chronic obstructive pulmonary disease, emphysema, chronic bronchitis), as thickening may occur and alter secretions expectoration.
- If you have a disease in which an abnormal increase in activity of the thyroid gland (hyperthyroidism), increased intraocular pressure (glaucoma) occurs, presents an enlarged prostate (prostatic hypertrophy), hypertension or any disease that causes obstruction urinary tract or gastrointestinal tract.
- If you suffer from crises that appear convulsive movements, with or without loss of consciousness (epilepsy).
- If you are over 65 dry mouth, urinary retention, nausea, sedation, confusion and lowering the pressure (hypotension) may occur.
- If you are using a medicine that causes toxicity in the ear as it may be masked symptoms of these toxic effects, such as ringing in the ears, dizziness or vertigo.
- If you have a disease or liver or kidney disorder, stomach ulcer or duodenal ulcer or stomach inflammation (gastritis) should consult their doctor before taking this medicine.
You should consult your doctor before taking this medicine if you have or have had heart diseases or disorders (cardiac arrhythmia, myocardial ischemia, ...).
If you suspect you may have appendicitis symptoms such as nausea, vomiting or abdominal cramping, you should go to a doctor for it can rule out the presence or absence of appendicitis, as dimenhydrinate may hinder the diagnosis of this disease.
It is recommended to avoid exposure to very high temperatures and follow a hygienic and dietary appropriate measures such as adequate ventilation and hydration.
Avoid exposure to sunlight (even when cloudy), and sunlamps (U.V.A rays). while taking this medication.

Children
Do not use this medicine in children under 6 years old.

Taking with other medicines Biodramina
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.
In particular, if you are using any of the following medications may be necessary to modify the dose of Dramamine or not to take:
- Anesthetics and other substances with depressant action of Central Nervous System
- Antibiotics aminoglycoside group
- Antidepressants such as monoamine oxidase inhibitors (MAOIs)
- Anti-Parkinson
- Neuroleptics (used to calm agitation and neuro-muscular hyperactivity)
- Ototoxic medicines (which can affect the ear) (see section Precautions).
- Medicines that may cause photosensitivity (skin reactions due to sensitivity to sunlight).

Interference with diagnostic tests:
If you are going to perform some allergy test: including skin tests (skin) it is recommended to discontinue treatment 72 hours before the test, not to alter the results of it.

Taking Biodramina with food, drink and alcohol
Alcohol consumption is not recommended during the time you are taking this medicine.

Pregnancy and lactation
If you are pregnant or breast-feeding, you think you may be pregnant or planning to become pregnant. consult your doctor or pharmacist before using this medicine.
Medicine use during pregnancy can be dangerous for the embryo or fetus, and should be monitored by your doctor.
Women who are breastfeeding should not take this medication without consulting your doctor or pharmacist, because this medication passes into breast milk.

Driving and using machines:
Do not drive or operate machinery because this medicine causes sleepiness or decreased responsiveness to the recommended doses.

Biodramina contains aspartame, glucose, sucrose and sorbitol.
- This medicine may be harmful for people with phenylketonuria, because it contains aspartame, a source of phenylalanine.
- This medicine contains glucose. If your doctor has told you have an intolerance to some sugars, contact your doctor before taking this medicine. It can cause tooth decay.
- This medicine contains sucrose. If your doctor has told you have an intolerance to some sugars, contact your doctor before taking this medicine. It can cause tooth decay
- This medicine contains sorbitol. If your doctor has told you have an intolerance to some sugars, contact your doctor before taking this medicine.


 3. How to take Biodramina
Follow exactly the instructions of medicine administration in this leaflet or as 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 pieces (corresponding to 20 or 40 mg of dimenhydrinate) per shot. If necessary, repeat the dose every 6 to 8 hours. Do not take more than 7 gum (140 mg of dimenhydrinate) a day and always in divided doses.
Children under 6 years old should not be used in children under 6 years.
Patients with liver disease: should consult a physician before taking this medication because it may be necessary to reduce the dose.
This medicine is taken orally.
It is recommended that the first take at least half an hour before starting the journey (preferably 1-2 hours before), and should not have taken earlier, the first shot is performed when symptoms appear. If dizziness persists, it will pass at least 6 hours between feedings and the next.
The gum should be chewed for 5-10 minutes. After this time should spitting, should not be swallowed
If symptoms worsen or if they persist more than 7 days, consult your doctor.

If you take more than you should Biodramina
If you have taken Biodramina more than you should, immediately consult your doctor or pharmacist.
Symptoms of overdose mainly include: dilated pupils, flushed face, excitation, hallucinations, confusion, irritation of the stomach and intestines with nausea, vomiting and diarrhea, abnormal movement, convulsions, deep state of unconsciousness (coma), sudden decrease respiratory and heart functions (cardiorespiratory collapse) and death. Symptoms may be delayed more than 2 hours after the overdose.
In case of overdose or accidental ingestion, immediately consult a medical center or call a poison control center (phone: +34 915620420), indicating the medicine and the amount taken.


 4. Possible side effects
Like all medicines, Biodramina can cause side effects, although not everybody gets them
Adverse effects are usually mild and transient, especially at the beginning of treatment.
During the period of use of dimenhydrinate they have been observed following adverse reactions whose frequency has not been able to establish exactly:
- Nausea, vomiting, constipation, diarrhea, stomach pain.
- Lack of appetite and dry mouth.
- Sleep and sedation (sleepiness).
- Headache, dizziness and lightheadedness.
- Increased viscosity of mucus in the bronchi, making breathing difficult.
- Retention of urine and sexual impotence.
- Glaucoma (increased intraocular pressure of the eye).
- Dilated pupils, blurred or double vision.
- Allergic skin reactions and sensitivity to sunlight, after intense exposure, hives, itching and reddening of the skin may appear.
- Decreased number of red blood cells, white blood cells, leukocytes and platelets.
- Porphyria (rare disorder, usually inherited, in which large amount of porphyrin excreted in feces and urine).
- Hypertension or hypotension (increase or decrease in 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 side effects, consult your doctor or pharmacist, even if it comes to possible side effects not listed in this leaflet.

Communication adverse effects:
If you experience any side effects, talk to your doctor or pharmacist, even if it comes to possible side effects not listed in this leaflet.
I could also communicate directly through the Spanish Pharmacovigilance System for Medicinal Products for Human Use: https://www.notificaram.es. By communicating adverse effects you can help provide more information on the safety of this medicine.


 5. Conservation 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 on the carton after EXP. The expiry date is the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Place containers and medicines no longer required at the point SIGRE pharmacy. If in doubt, ask your pharmacist how to dispose of medicines no longer required. This way you will help to protect the environment.


 6. Contents of the pack and other information
Composition Biodramina
- The active substance is dimenhydrinate. Each medicated chewing gum contains 20 milligrams of dimenhydrinate.
- The other ingredients (excipients) are: core: aspartame (E951), gum base, dextrin, glycerides solid semisynthetic, light magnesium oxide, magnesium stearate, levomenthol, sodium saccharin, sucrose, silica colloidal anhydrous, sorbitol, talc , white beeswax, methacrylic acid copolymer and methylmethacrylate (Eudragit S), aroma menta.Recubrimiento: calcium carbonate, liquid glucose, basic butylated methacrylate copolymer (Eudragit E), macrogol 35000, emulsifying wax, dihydrogen potassium phosphate, povidone, titanium dioxide (E171), magnesium stearate, levomenthol, peppermint oil, povidone 25, sucrose, talc.

Holder of the marketing authorization
URIACH-AQUILEA OTC, S.L. Av. Camí Reial 51-57
08184 Palau-solità i Plegamans (Barcelona-Spain)

Responsible for manufacturing:
J. URIACH & Cia., SA Av. Camí Reial 51-57
08184 Palau-solità i Plegamans (Barcelona-Spain)


Source: Spanish Agency for Medicines and Health Products

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