SINTRINE Film-coated tablet Ref.[115334] Active ingredients: Montelukast

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2025  Publisher: Sandoz SA (Pty) Ltd<sup>1</sup>, Magwa Crescent West, Waterfall City, Jukskei View, 2090, Tel: 011 347 6600 Marketed by Sanofi Aventis South Africa (Pty) Ltd. 1 Company Reg. No.: 1990/001979/07

Product name and form

SINTRINE 10 (film-coated tablets).

Pharmaceutical Form

A beige, round, biconvex, coated tablet, that is plain on both sides.

Qualitative and quantitative composition

Each SINTRINE 10 film-coated tablet contains montelukast sodium equivalent to 10 mg montelukast.

Contains sugar (lactose monohydrate 89,10 mg per tablet).

Active Ingredient

Montelukast is an orally active compound which binds with high affinity and selectivity to the CysLT1 receptor. Τhe CysLT type-1 (CysLT1) receptor is found in the human airway (including airway smooth muscle cells and airway macrophages) and on other pro-inflammatory cells (including eosinophils and certain myeloid stem cells). CysLTs have been correlated with the pathophysiology of asthma and allergic rhinitis.
List of Excipients

Tablet core:

Cellulose microcrystalline
Croscarmellose sodium
Hydroxypropylcellulose type EF
Lactose monohydrate
Magnesium stearate

Film-coating layer:

Opadry beige (II) composed of ferric oxide red (E172), ferric oxide yellow (E172), macrogol 400, polyvinyl alcohol, talc and titanium dioxide (E171)

Pack sizes and marketing

Sintrine 10 film-coated tablets are packed as 10, 14, 20, 28, 30, 35 or 50 tablets in: OPA/Al/PVC/Aluminium blisters or white, opaque polyethylene containers and tamper evident polypropylene closures with desiccant insert.

Not all packs may be marketed.

Marketing authorization holder

Sandoz SA (Pty) Ltd1, Magwa Crescent West, Waterfall City, Jukskei View, 2090, Tel: 011 347 6600

Marketed by Sanofi Aventis South Africa (Pty) Ltd.

1 Company Reg. No.: 1990/001979/07

Marketing authorization dates and numbers

44/10.2.2/0203

18 May 2012

Drugs

Drug Countries
SINTRINE South Africa
 
Next: Usage >

© 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.

⇈