BIODRAMINA Medicated chewing-gum Ref.[51123] Active ingredients: Dimenhydrinate

Source: Medicines Authority (MT)  Revision Year: 2013  Publisher: J. Uriach & Cรญa. S.A., Av. Camรญ Reial 51-57, 08184 Palau-solitร  i Plegamans, Barcelona, Spain

4.1. Therapeutic indications

Prevention and symptomatic treatment of motion sickness due to sea, overland or air travel.

4.2. Posology and method of administration

For oral use. Always use the lowest effective dose.

Adults and children older than 6 years

1 chewing-gum when the first symptoms appear. Treatment may be repeated after 1-3 hours. In order to attain full effect, the chewing-gum should be chewed for 5-10 minutes and should not be swallowed.

It starts to take effect after 2-3 minutes, as the active ingredient directly enters the blood stream through the oral mucosa. Consequently, Biodramina chewing-gum enables immediate treatment if the disorder should appear unexpectedly.

4.9. Overdose

Accident massive swallowing can produce the following as dominant signs: excitation with agitation, hallucinations, ataxia, intermittent clonic convulsions, coma, respiratory collapse and death.

Frequent signs are: fixed and dilated pupils, reddening of the skin, and hyperthermia.

In case of overdose, symptomatic and maintenance treatment should be implemented.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Not required.

6.5. Nature and contents of container

Blister aluminium – PVC/PVDC containing 6 or 12 chewing-gums.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements.

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