Sinecod for children

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

butamirate (butamirate citrate)

Available from:

Novartis Consumer Health S.A.

INN (International Name):

butamirate (butamirate citrate)

Dosage:

5mg/ml

Pharmaceutical form:

drops oral

Prescription type:

OTC

Summary of Product characteristics

Novartis Consumer Health SA
CH-1260 Nyon, Switzerland
Global Regulatory Affairs
Global Labelling & Compliance
SINECOD
®
Oral drops
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:
6
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
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CLINICAL PARTICULARS
..............................................................................................
3
_ _
4.1
_ _
Therapeutic indications
............................................................................................
3
_ _
4.2
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Posology and method of administration
.................................................................. 3
_ _
4.3
_ _
Contraindications
.....................................................................................................
3
_ _
4.4
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Special warnings and precautions for use
................................................................ 3
_ _
Due to the presence of sorbitol, drops should not be taken to patients
with rare
hereditary disorders associated with intolerance to fructose.
.................................. 4
_ _
It is necessary to consult a doctor if the cough persists for more
than 7 days. .................... 4
_ _
This drug contains a small amount of ethanol (2.81 mg / ml), less than
100 mg per
dose.
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