Sinecod syrup

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

butamirate (butamirate citrate)

Available from:

GlaxoSmithKline Consumer Healthcare S.A.

ATC code:

R05DB13

INN (International Name):

butamirate (butamirate citrate)

Dosage:

1,5mg/ml

Pharmaceutical form:

syrup

Units in package:

glass bottle 200ml and measuring cup

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2019-03-25

Summary of Product characteristics

Novartis Consumer Health SA
CH-1260 Nyon, Switzerland
Global Regulatory Affairs
Global Labelling & Compliance
SINECOD
®
syrup
Butamirate citrate
CORE SUMMARY OF PRODUCT CHARACTERISTICS (SMPC)
Author(s):
Jean-Michel Casado, Helena Beauvallon
Document status:
FINAL
GLC approval date:
11 Jun 2009
GLC tracking ID:
Amendment date(s):
Release date:
Next update date:
Jun 2014
Number of pages:
7
Property of Novartis
Confidential
May not be used, divulged, published or otherwise disclosed
without the consent of Novartis
Novartis Consumer Health SA
CONFIDENTIAL
Page 2
Core SmPC
GLC: 11 Jun 2009
Sinecod
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 precautions for use
................................................................ 3
4.5
Interaction with other medicinal products and other forms of
interaction .............. 4
4.6
Pregnancy and lactation
...........................................................................................
4
4.7
Effects on ability to drive and use machines
........................................................... 4
4.8
Undesirable effects
..................................................................................................
4
4.9
Overdose
............................................................................