Fenistil gel

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

dimetindene (dimetindene maleate)

Available from:

Novartis Consumer Health S.A.

INN (International Name):

dimetindene (dimetindene maleate)

Dosage:

1mg/g

Pharmaceutical form:

gel

Prescription type:

OTC

Summary of Product characteristics

Global Drug Regulatory Affairs
Fenistil® Gel
Dimethindene maleate 0.1 %
Novartis Consumer Health SA CH-1260 Nyon, Switzerland
SUMMARY OF PRODUCT CHARACTERISTICS
Author: Alain Bossy
Document type: Core SPC
Document status: Final
Release date: June 26, 2001,
supersedes
version of August 24, 1995
Number of pages: 14
Property of Novartis Consumer Health SA
Confidential
May not be used, divulged, published or otherwise disclosed
without the consent of Novartis Consumer Health SA
Novartis Consumer Health SA
CONFIDENTIAL
Page
2
Summary of Product Characteristics
Fenistil Gel
CONTENTS
1. NAME OF THE MEDICINAL
PRODUCT
................................................................
3
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
.......................................
3
3. PHARMACEUTICAL
FORM
....................................................................................
3
4. CLINICAL
PARTICULARS
......................................................................................
3
4.1. Therapeutic
indications
....................................................................................
3
4.2. Posology and method of
administration
............................................................
3
4.3.
Contra-indications............................................................................................
3
4.4. Special
warnings
and
special
precautions for
use
..............................................
3
4.5. Interactions with other
medicinal
products and other forms of
interaction
.........
3
4.6. Pregnancy and lactation
...................................................................................
3
4.7. Effects on
ability
to drive and use
machines...................................................... 4
4.8.
Undesirable
effects...........................................................................................
4
4.9.
Overdose
.........................................................................................................
4
5.
PHARMACOLOGICAL
PROPERTIES
.............................