País: Nova Zelanda
Idioma: anglès
Font: Medsafe (Medicines Safety Authority)
Montelukast sodium 4.16mg equivalent to 4 mg motelukast
Apotex NZ Ltd
Montelukast sodium 4.16 mg (= 4 mg motelukast)
4 mg
Chewable tablet
Active: Montelukast sodium 4.16mg equivalent to 4 mg motelukast Excipient: Aspartame Cherry flavour 501027 AP0551 Croscarmellose sodium Iron oxide red Magnesium stearate Mannitol Microcrystalline cellulose
Blister pack, Aluminium/Aluminium, 4 tablets
Prescription
Prescription
Apotex Pharmachem Inc
APO-Montelukast is indicated in adult and paediatric patients 2 years of age and older for the prophylaxis and chronic treatment of asthma, including the prevention of day- and night-time symptoms and the prevention of exercise-induced bronchospasm.
Package - Contents - Shelf Life: Blister pack, Aluminium/Aluminium - 4 tablets - 24 months from date of manufacture stored at or below 25°C protect from light and moisture - Blister pack, Aluminium/Aluminium - 14 tablets - 24 months from date of manufacture stored at or below 25°C protect from light and moisture - Blister pack, Aluminium/Aluminium - 28 tablets - 24 months from date of manufacture stored at or below 25°C protect from light and moisture - Bottle, plastic, HDPE with PP cap - 14 tablets - 24 months from date of manufacture stored at or below 25°C protect from light and moisture - Bottle, plastic, HDPE with PP cap - 28 tablets - 24 months from date of manufacture stored at or below 25°C protect from light and moisture - Bottle, plastic, HDPE with PP cap - 100 tablets - 24 months from date of manufacture stored at or below 25°C protect from light and moisture
2012-03-22
APO-MONTELUKAST TABLETS 1 APO-MONTELUKAST TABLETS _Contains the active ingredient montelukast sodium _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE TAKING YOUR MEDICINE. ASK YOUR DOCTOR OR PHARMACIST IF YOU DO NOT UNDERSTAND ANYTHING OR ARE WORRIED ABOUT TAKING YOUR MEDICINE. This leaflet answers some common questions about Montelukast. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the last page. Some more recent information on the medicine may be available. Speak to your pharmacist or doctor to obtain the most up to date information on the medicine. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. KEEP THIS LEAFLET WITH THE MEDICINE. You may want to read it again. WHAT THIS MEDICINE IS USED FOR Montelukast is used to treat: • asthma, including preventing asthma symptoms during the day and night. It also prevents the narrowing of airways triggered by exercise. • seasonal and year-round allergies, including daytime and nighttime symptoms, including nasal congestion, runny nose, nasal itching, and sneezing; nasal congestion upon awakening, difficulty going to sleep, and nighttime awakenings; tearing, itchy, red, and puffy eyes. Montelukast can be used in children 2 years of age and older, teenagers and adults. Montelukast tablets are not used to treat an acute attack of asthma. If an acute attack occurs, follow your doctor’s instructions for that situation. Asthma is a lung disease and has the following characteristics: • narrowed airways causing breathing to become difficult • inflamed airways, which means the lining of airways become swollen • sensitive airways that react to many things, such as cigarette smoke, pollen, or cold air. Symptoms of asthma include coughing, wheezing and chest tightness. Not all people Llegiu el document complet
NEW ZEALAND DATA SHEET APO-MONTELUKAST Please refer to Medsafe website (www.medsafe.govt.nz) for the most recent datasheet Page 1 1 PRODUCT NAME Apo-Montelukast (10mg tablets) Apo-Montelukast (4mg & 5mg chewable tablets) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains montelukast as sodium equivalent to 4mg, 5mg and 10mg of montelukast. EXCIPIENT OF KNOWN EFFECT Apo-Montelukast 10mg tablets contain lactose. LACTOSE If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product. Apo-Montelukast 4mg and 5mg chewable tablets contain aspartame. ASPARTAME Contains a source of phenylalanine. May be harmful for people with phenylketonuria. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Apo-Montelukast 10 mg: Beige coloured, rounded square shaped, biconvex film coated tablets, with engraved “APO” on one side and “M10” on the other side. Apo-Montelukast 4mg (Chewable Tablets): Pink coloured, oval shaped, biconvex tablets, engraved with “APO” on one side and “M 4” on the other side. Apo-Montelukast 5mg (Chewable Tablets): Pink coloured, round shaped, biconvex tablets, engraved with “APO” on one side and “M 5” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Montelukast is indicated in adult and paediatric patients 2 years of age and older for the prophylaxis and chronic treatment of asthma, including the prevention of day- and night-time symptoms and the prevention of exercise-induced bronchospasm. Montelukast is indicated in adults and paediatric patients 2 years of age and older for the relief of daytime and nighttime symptoms of seasonal allergic rhinitis and perennial allergic rhinitis. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSE Montelukast should be taken once daily. For asthma, the dose should be taken in the evening. For allergic rhinitis, the time of administration may be individualised to suit patient needs. Patients with both asthma and allergic rhinitis shou Llegiu el document complet