MONTELUKAST Film-coated tablet Ref.[7322] Active ingredients: Montelukast

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

Product name and form

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.

Qualitative and quantitative composition

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
Cellulose microcrystalline
Low substituted hydroxypropylcellulose (LH-11) (E463)
Croscarmellose sodium
Magnesium stearate

Film coat:

Hydroxypropylcellulose (LF) (E463)
Hypromellose 6CPS (A)
Titanium dioxide (E171)
Macrogol 6000
Iron oxide yellow (E172)
Iron oxide red (E172)

Pack sizes and marketing

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.

Marketing authorization holder

Accord Healthcare Limited, Sage House, 319, Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

Marketing authorization dates and numbers

PL 20075/0182

03/11/2016

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