국가: 말레이시아
언어: 영어
출처: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
MONTELUKAST SODIUM
PAHANG PHARMACY SDN. BHD.
MONTELUKAST SODIUM
28 mcg/mL
KRKA, d.d., Novo mesto
MONKASTA FILM-COATED TABLETS Montelukast (10mg) _Consumer Medication Information Leaflet (RiMUP)_ _ _ 1 WHAT IS IN THIS LEAFLET 1. What _Monkasta _is used for 2. How _Monkasta_ works 3. Before you use _Monkasta_ 4. How to use _Monkasta_ 5. While you are using it 6. Side effects 7. Storage and Disposal of _Monkasta_ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT _MONKASTA_ IS USED FOR Monkasta is used for the treatment of adult patients and adolescents, aged 15 years and older with asthma, who are not adequately controlled on their asthma medications and need additional therapy. For patients with asthma and seasonal allergies, Monkasta also treats your seasonal allergy symptoms. Monkasta also helps prevent asthma symptoms in adult patients and adolescents, aged 15 years and older, which are triggered by exercise. HOW _MONKASTA_ WORKS The active ingredient in Monkasta 10 mg tablets is montelukast, which is a leukotriene receptor antagonist. It blocks naturally occurring chemicals in the lungs called leukotrienes which cause narrowing of the airways and inflammation in the lungs, which can lead to asthma symptoms. Leukotrienes also contribute to the symptoms of allergy. Blocking leukotrienes reduces the symptoms of seasonal allergy (also known as seasonal allergic rhinitis or hay fever). BEFORE YOU USE _MONKASTA _ - _When you must not use it _ Do not take Monkasta if you are allergic (hypersensitive) to montelukast or any of the other ingredients of Monkasta. Monkasta 10 mg tablets are not recommended for use in children under 15 years of age. _ _ - _Before you start use it _ Patients should be advised never to use oral montelukast to treat acute asthma attacks and to keep their usual appropriate rescue medication for this purpose readily available. If an acute attack occurs, a short-acting inhaled beta-agonist should be used. Patients should seek their doctor's advice as soon as possible if they need more inhalations of short-acting beta-agonists than usual. Montelu 전체 문서 읽기
1.3.1 Montelukast sodium SPC, Labeling and Package Leaflet MY SmPCPIL136740_6 31.07.2019 – Updated: 07.07.2021 Page 1 of 6 NAME OF THE MEDICINAL PRODUCT Monkasta film-coated tablets 10 mg QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg montelukast (equivalent to 10.4 mg montelukast sodium). Excipient: 10 mg tablets lactose 81.94 mg PHARMACEUTICAL FORM Film-coated tablet. The film-coated tablets are apricot-coloured, round, slightly biconvex, with bevelled edges. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS For the prophylaxis and chronic treatment of asthma in adults and paediatric patients 12 months of age and older. Monkasta is indicated if adults 15 years of age and older for the relief of daytime and night-time symptoms of seasonal allergic rhinitis. POSOLOGY AND METHOD OF ADMINISTRATION Monkasta should be taken once daily. For the treatment of asthma, the dose should be taken in the evening. For seasonal allergic rhinitis, the time of administration may be individualised to suit patient needs. Adults 15 years of Age and Older with Asthma and/or Seasonal Allergic Rhinitis The dosage for adults 15 years of age and older is one l0 mg tablet daily. _General recommendations_ The therapeutic effect of Monkasta on parameters of asthma control occurs within one day. Monkasta may be taken with or without food. Patients should be advised to continue taking Monkasta even if their asthma is under control, as well as during periods of worsening asthma. Monkasta should not be used concomitantly with other products containing the same active ingredient, montelukast. 1.3.1 Montelukast sodium SPC, Labeling and Package Leaflet MY SmPCPIL136740_6 31.07.2019 – Updated: 07.07.2021 Page 2 of 6 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 impairment. The dosage is the same for both male and female patients. _Therapy with Monkasta in relation to other treatment 전체 문서 읽기