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

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

Product name and form

BIODRAMINA Chewing-gum.

Pharmaceutical Form

Medicated chewing-gum.

Convex white chewing-gum.

Qualitative and quantitative composition

Each tablet contains: Dimenhydrinate 20 mg.

Excipients, see section 6.1.

Active Ingredient Description
Dimenhydrinate

Dimenhydrinate is a theoclate salt of the ethanolamine derivative diphenhydramine. It exhibits reversible competitive antagonism with histamine for the capture of H1 receptors. It has anticholinergic (antimuscarinic) properties that explain the anti-emetic action of the drug in cases of labyrinthial irritation (nausea, vertigo), and the central suppression it causes.
List of Excipients

Base gum
Sodium saccharin
Aspartame
Menthol
Colloidal dioxide silica
White wax
Magnesium stearate
Magnesium oxide
Menthe flavour
Dextrin
Witepsol
Talc
Dextrose
Sucrose
Sorbitol
Monobasic potassium phosphate
Magnesium stearate
Wax E
Povidone
Eudragit E
Eudragit S
Titanium dioxide
Glucose
Polyethylenglycol
Calcium carbonate

Pack sizes and marketing

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

Not all pack sizes may be marketed.

Marketing authorization holder

J. Uriach & Cía. S.A., Av. Camí Reial 51-57, 08184 Palau-solità i Plegamans, Barcelona, Spain

Marketing authorization dates and numbers

MA13100101

6th August 2007 / 6th February 2013

Drugs

Drug Countries
BIODRAMINA Spain, Malta
 
Next: Usage >

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.

⇈