LELIPEL 4 MG (?MONTELUKAST ) 14 ORAL GRANULES?SACHETS

Indications

? Prophylaxis and treatment of chronic asthma in adults and pediatric patients 12 months of age and older

? Prevention of exercise-induced bronchoconstriction in patients 15 years of age and older

? Relieves symptoms of allergic rhinitis (seasonal and perennial) in adults and pediatric patients 6 months of age and older

Dosage And Administration

Dosage: Once daily ? Children aged 6 months to 5 years: 4 mg oral granule package once daily in the evening (do not mix with water, can be mixed with breast milk or semi-solid food)

? May be taken with or without food

? Pediatric patient 6-14 years old: 5mg tablet once daily in the evening.

? Patients aged 15 years and older: 10 mg tablet once daily in the evening

? No dosage adjustment is necessary for the elderly, for patients with renal insufficiency, for mild to moderate hepatic impairment, or for patients of either gender.

Contraindications

Hypersensitivity to active ingredient or any excepients

Drug Interactions

Lelipel has no drug-drug interactions with:

Decongestants, theophylline, prednisone, prednisolone, non steroidal anti inflammatory, sedative hypnotics, contraceptives, warfarin, terfenadine

Lelipel has drug-drug interactions with:

Phenobarbital (but no dosage adjustment is needed)

Side effects

Include headache, abdominal or stomach pain, cough, dental pain, dizziness, fever, heartburn, skin rash, stuffy nose, weakness or fatigue.

Package

? Lelipel tablets 10 mg, are brick-coloured, round in shape, film-coated tablets, available in triplex? blister packages of 20 tablets.

? Lelipel Chewable 5 mg, 1,2 or 3 (Al/opaque PVC/LDPE/PVDC) Blisters, each of 10 chewable tablets.

? Lelipel oral granules 4 mg, are a white, coarse, granular, free-flowing solid in a foil packet available in packages of 14 sachets.

Storage

Store the 10 mg film coated tablets at room temperature (15oc-30oc) protected from moisture.

Store the 5 mg Chewable tablets at room temperature (15oc-30oc) protected from moisture.

Store the 4 mg oral granules at room temperature (15oc-30oc) in the original package