FENISTIL Oral drops, solution Ref.[51023] Active ingredients: Dimetindene

Source: Υπουργείο Υγείας (CY)  Revision Year: 2020  Publisher: GlaxoSmithKline Καταναλωτικά Προϊόντα Υγείας Ελλάς Μονοπρόσωπη Ανώνυμη Εταιρεία, διακριτικός τίτλος «GSK CH Ελλάς Μονοπρόσωπη Α.Ε.», 274 Kifissias Ave. , Halandri, 152 32 Athens, Greece Tel.: 210 6882100 ...

Product name and form

Fenistil 1 mg/ml, Oral Drops.

Pharmaceutical Form

Oral drops, solution.

Clear, Colourless to slightly brown yellowish solution.

Qualitative and quantitative composition

Each ml of Fenistil Drops contains 1 mg of dimethindene maleate.

Dimetindene maleate: C20H24N2 . C4H4O4
2-(2-dimethylaminoethyl)3[2-(2-pyridyl)ethyl]-(1H)-indene maleate

For excipients, see Section 6.1.

Active Ingredient Description
Dimetindene

Dimetindene is an antihistaminic of the alkylamine group. Its action is the result of the capture of histamine Η1 subunits. It has mild anticholinergic and sedative action.

List of Excipients

Disodium phosphate dodecahydrate
Citric acid monohydrate
Benzoic acid
Disodium edentate
Saccharin sodium
Propylene glycol
Purified water

Pack sizes and marketing

Amber glass bottle with a polyethylene dropper and a polypropylene guarantee cap, which contains 10 or 20 ml.

Not all pack sizes may be marketed.

Marketing authorization holder

GlaxoSmithKline Καταναλωτικά Προϊόντα Υγείας Ελλάς Μονοπρόσωπη Ανώνυμη Εταιρεία, διακριτικός τίτλος «GSK CH Ελλάς Μονοπρόσωπη Α.Ε.», 274 Kifissias Ave. , Halandri, 152 32 Athens, Greece
Tel.: 210 6882100

Marketing authorization dates and numbers

9662

3 December 1984/27 February 2009

Drugs

Drug Countries
FENISTIL Austria, Cyprus, Germany, Spain, Croatia, Israel, Lithuania, Malta, Netherlands, Poland, Romania, Turkey

© 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.