MONKASTA Film-coated tablet Ref.[51138] Active ingredients: Montelukast

Source: Medicines Authority (MT)  Revision Year: 2022  Publisher: TAD Pharma GmbH, Heinz-Lohmann-StraรŸe 5, 27472 Cuxhaven, Germany

Product name and form

Monkasta 10 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

The film-coated tablets are apricot-coloured, round, slightly biconvex, with bevelled edges.

Qualitative and quantitative composition

Each film-coated tablet contains 10 mg montelukast (as montelukast sodium).

Excipient(s) with known effect: Each film-coated tablet contains 81.94 mg lactose.

For the 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, powdered
Cellulose, microcrystalline
Croscarmellose sodium
Magnesium stearate

Film-coating:

Hypromellose (E464)
Titanium dioxide (E171)
Talc
Propylene glycol
Iron oxide, red (E172)
Iron oxide, yellow (E172)

Pack sizes and marketing

Blister (OPA/Alu/PVC//Alu), pack sizes: 7, 10, 14, 20, 28, 30, 49, 50, 56, 84, 90, 98, 100, 140 or 200 film-coated tablets, in a box.

Not all pack sizes may be marketed.

Marketing authorization holder

TAD Pharma GmbH, Heinz-Lohmann-StraรŸe 5, 27472 Cuxhaven, Germany

Marketing authorization dates and numbers

MA982/01002

Date of first authorisation: 17th February 2022

Drugs

Drug Countries
MONKASTA Germany, Estonia, Spain, Croatia, Italy, Lithuania, Malta, Poland, Romania

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