GLEMONT IR 10 Tablets 10 mg

Country: Tanzania

Language: English

Source: Tanzania Medicinces & Medical Devices Authority

Active ingredient:

Montelukast Sodium

Available from:

Glenmark Pharmaceuticals Limited, INDIA

ATC code:

Bronchodilators and other anti-asthmatics excl. R0

INN (International Name):

Montelukast Sodium

Dosage:

10 mg

Pharmaceutical form:

Tablets

Manufactured by:

Glenmark Pharmaceuticals Limited, INDIA

Product summary:

Physical description: Round beige colored, biconvex film coated tablets engraved with 'G' on one side and '392' on other side; Local technical representative: Phillips Pharmaceuticals (Tanzania) Limited (2404)

Authorization status:

Registered/Compliant

Authorization date:

2020-09-25

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Glemont- IR 10
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains:
Montelukast sodium equivalent to Montelukast………... 10 mg
Also includes Lactose monohydrate and titanium dioxide
Excipient with known effect:
Each tablet contains 89.30 mg of Lactose monohydrate
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablets.
Description:
Round, Beige colored, biconvex film-coated tablets engraved with “G’ on one side and
‘392’ on other side.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Montelukast is indicated in the treatment of asthma as add-on therapy in those patients
with mild to moderate persistent asthma who are inadequately controlled on inhaled
corticosteroids and in whom “as needed” short acting β-agonists provide inadequate
clinical control of asthma. In those asthmatic patients in whom montelukast is indicated
in asthma, montelukast can also provide symptomatic relief of seasonal allergic rhinitis.
Montelukast is also indicated in the prophylaxis of asthma in which the predominant
component is exercise-induced bronchoconstriction.
4.2 Posology and Method of Administration
The dosage for adults and adolescents 15 years of age and older with asthma, or with
asthma and concomitant seasonal allergic rhinitis, is one 10 mg tablet daily to be taken
in the evening.
General recommendations. The therapeutic effect of montelukast on parameters of
asthma control occurs within one day. Montelukast may be taken with or without food.
Patients should be advised to continue taking montelukast even if their asthma is under
control, as well as during periods of worsening asthma. Montelukast should not be used
concomitantly with other products containing the same active ingredient, montelukast.
No dosage adjustment is necessary for the elderly, or for patients with renal
insufficiency, or mild to moderate hepatic impairment. There are no data on patients
with severe hepatic