SINTRINE Chewable tablet Ref.[115332] Active ingredients: Montelukast

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2025  Publisher: Sandoz SA (Pty) Ltd<sup>1</sup>, Waterfall 5-lr, Magwa Crescent West, Waterfall City, Jukskei View, 2090 Marketed by sanofi aventis south africa (pty) ltd. 1 Company Reg. No.: 1990/001979/07

Product name and form

Sintrine 4 (chewable tablets).

Sintrine 5 (chewable tablets).

Pharmaceutical Form

Sintrine 4: Oval pink to slightly speckled pink tablet with odour of cherry, encoded “4” on one side.

Sintrine 5: Round pink to slightly speckled pink tablet with odour of cherry, encoded “5” on one side.

Qualitative and quantitative composition

Each Sintrine 4 chewable tablet contains 4,16 mg of montelukast sodium equivalent to 4 mg montelukast.

Each Sintrine 5 chewable tablet contains 5,20 mg of montelukast sodium equivalent to 5 mg montelukast.

Contains sugar.

Each Sintrine 4 chewable tablet contains sweetener (aspartame 0,96 mg) and mannitol 155,92 mg.

Each Sintrine 5 chewable tablet contains sweetener (aspartame 1,20 mg) and mannitol 194,90 mg.

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

Aspartame
Cherry flavour
Cellulose microcrystalline
Croscarmellose sodium
Hydroxypropylcellulose, type EXF
Magnesium stearate
Mannitol
Red ferric oxide (E172)

Pack sizes and marketing

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, Waterfall 5-lr, Magwa Crescent West, Waterfall City, Jukskei View, 2090

Marketed by sanofi aventis south africa (pty) ltd.

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

Marketing authorization dates and numbers

Sintrine 4: 44/10.2.2/0485
Sintrine 5: 44/10.2.2/0486

18 May 2012

Drugs

Drug Countries
SINTRINE South Africa
 
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