País: Malàisia
Idioma: anglès
Font: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DESLORATADINE
ORGANON MALAYSIA SDN. BHD.
DESLORATADINE
500Tablet Tablets; 100Tablet Tablets; 10Tablet Tablets
Organon Heist bv
_Consumer Medication Information Leaflet _ _(RiMUP) _ AERIUS ® TABLET 5MG Desloratadine 5 mg 1 Copyright 2023 Organon group of companies. All rights reserved. WHAT IS IN THIS LEAFLET 1. What _AERIUS TABLET _ is used for 2. How _AERIUS TABLET_ _ _ works 3. Before you use _AERIUS _ _TABLET_ _ _ 4. How to use _AERIUS _ _TABLET_ _ _ 5. While you are using _AERIUS _ _TABLET_ _ _ 6. Side effects 7. Storage and Disposal of _AERIUS TABLET_ _ _ 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT _AERIUS TABLET _ IS USED FOR _AERIUS TABLET _ relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites). These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red or watery eyes. _AERIUS TABLET _ is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy). These symptoms include itching and hives. Relief of these symptoms lasts a full day and helps you to resume your normal daily activities and sleep. HOW _AERIUS TABLET _ WORKS _AERIUS TABLET _ is an antiallergy medicine that does not make you drowsy. It helps control your allergic reaction and its symptoms. BEFORE YOU USE _AERIUS _ _TABLET_ _ _ _ _ - _When you must not use it _ • Do not use _AERIUS _ if you are allergic (hypersensitive) to desloratadine, to any of the other ingredients of _AERIUS TABLET _ or to loratadine. - _Before you start to use it _ Talk to your doctor or pharmacist before taking _AERIUS TABLET _ if you have medical or familial history of seizures. _ _ Efficacy and safety of _AERIUS _ _TABLET _ in children under 12 years of age have not been established. PREGNANCY AND BREAST-FEEDING • Ask your doctor or pharmacist for advice before taking any medicine during pregnancy and breast-feeding. • If you are pregnant or nursing a baby, taking _AERIUS TABLET _ is not recommended. IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS OF _AERIUS TABLET_ Llegiu el document complet
Copyright 2023 Organon group of companies. All rights reserved. LPC-OG4117-MTL-112017a AERIUS ® TABLETS Brand of desloratadine DESCRIPTION: Each AERIUS Tablet contains 5.0 mg of desloratadine. AERIUS Tablet is a light blue round tablet, embossed with elongated letters 'S' and 'P' on one side and plain on the other. Inactive Ingredients: dibasic calcium phosphate dihydrate, microcrystalline cellulose, corn starch, talc, Dye Opadry II Blue, Dye Opadry Clear, carnauba wax, white wax and purified water. ACTIONS: Desloratadine is a non-sedating long-acting histamine antagonist with potent, selective peripheral H 1 -receptor antagonist activity. Desloratadine has demonstrated antiallergic, antihistaminic, and anti-inflammatory activity. PRECLINICAL TOXICOLOGY: Desloratadine is the primary active metabolite of loratadine. Preclinical studies conducted with desloratadine and loratadine demonstrated that there are no qualitative or quantitative differences in the toxicity profile of desloratadine and loratadine at comparable levels of exposure to desloratadine. Preclinical data with desloratadine reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, and toxicity to reproduction. The lack of carcinogenic potential was demonstrated in studies conducted with loratadine. CLINICAL PHARMACOLOGY PHARMACODYNAMIC PROPERTIES: After oral administration, desloratadine selectively blocks peripheral histamine H 1 -receptors because the drug is effectively excluded from entry to the central nervous system (CNS). In addition to antihistaminic activity, desloratadine has demonstrated antiallergic and anti- inflammatory activity from numerous _in vitro _ (mainly conducted on cells of human origin) and _in vivo _ studies. These studies have shown that desloratadine inhibits the broad cascade of events that initiate and propagate allergic inflammation, including, Copyright 2023 Organon group of companies. All rights reserved. • the release of proinflammatory cytokin Llegiu el document complet