Fenistil gel gel

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

dimetindene (dimetindene maleate)

Available from:

GlaxoSmithKline Consumer Healthcare S.A.

ATC code:

D04AA13

INN (International Name):

dimetindene (dimetindene maleate)

Dosage:

1mg/g

Pharmaceutical form:

gel

Units in package:

aluminium tube 30g

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2019-11-27

Summary of Product characteristics

GSK Consumer Healthcare S.A.,
Switzerland.
CONFIDENTIAL
Summary of Product Characteristics
Fenistil Gel
1
Global Drug Regulatory Affairs
Fenistil Gel
Dimethindene maleate 0.1 %
SUMMARY OF PRODUCT CHARACTERISTICS
Document type: Core SPC
Document status: Final
Release date: October 03, 2019
Number of pages: 6
GSK Consumer Healthcare S.A.,
Switzerland.
CONFIDENTIAL
Summary of Product Characteristics
Fenistil Gel
2
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.
Contraindications............................................................................................
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
.....................................................................
4
5.1.
Pharmacodynamic
properties............................................................................
4
5.2.
Phar