Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Accord Healthcare Limited, Sage House, 319, Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom
Montelukast 10 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. 7.9 × 7.9 mm beige coloured, rounded square, biconvex, film coated tablet debossed “M10” on one side and plain on other side. |
Each film-coated tablet contains montelukast sodium 10.4 mg equivalent to 10 mg montelukast.
Excipient(s) with known effect: Contain 130.95 mg of Lactose monohydrate per tablet.
For a full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Montelukast |
Montelukast is an orally active compound which binds with high affinity and selectivity to the CysLT1 receptor. ฮคhe 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: Lactose monohydrate Film coat: Hydroxypropylcellulose (LF) (E463) |
Montelukast 10 mg tablets are packed in OPA-Al-PVC/Al blister.
Pack size: Packs of 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 100, 140 and 200 tablets in blister.
Not all pack sizes may be marketed.
Accord Healthcare Limited, Sage House, 319, Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom
PL 20075/0182
03/11/2016
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