Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Ebastine
ZUELLIG PHARMA SDN BHD
Ebastine
10 Tablets; 20 Tablets; 30 Tablets; 50 Tablets; 100 Tablets
Industrias Farmaceuticas Almirall, S.A. (IFA)
KESTINE ® FILM-COATED TABLETS Ebastine (10mg, 20mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What _Kestine_ is used for 2. How _Kestine_ works 3. Before you use _Kestine_ 4. How to use _Kestine_ 5. While you are using it 6. Side effects 7. Storage and Disposal of _Kestine_ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT _KESTINE_ IS USED FOR Kestine is indicated for the symptomatic treatment of allergic conditions such as seasonal and perennial allergic rhinitis with or without allergic conjunctivitis (runny nose, itchy nose or eyes, watery eyes, sneezing, etc.), and chronic urticaria (Kestine 10mg only). HOW _KESTINE_ WORKS Kestine belongs to a group of drugs known as antihistamines (antiallergics). BEFORE YOU USE _KESTINE _ - _When you must not use it_ _ _ If you are allergic to ebastine or any of the other ingredients of this medicine (included in section Product Description). If you or your child is under 12 years of age. _ _ _Pregnancy and lactation _ If you are pregnant or breast-feeding, think you might be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medicine. _Pregnancy _ Due to insufficient data to ensure the perfect safety of this drug when administered during pregnancy, its use is not recommended in pregnant women. _ _ _Breast-feeding_ It is not known whether the drug passes into human milk, and therefore it is not recommended for women who are breast-feeding. _ _ - _Before you start to use it _ Ask your doctor or pharmacist for advice before taking Kestine. _ _ This medicine should be used with precaution: • If you have a history of heart disease, cardiac discomfort or palpitations, tell your doctor. • if you suffer from severe liver disease, tell your doctor (see "How to use Kestine"). • Kestine can cause dry mouth. At long term treatment it is therefore important to have a good mouth hygiene to prevent risk for caries (the teeth should be cleaned with fluoride con Baca dokumen lengkap
Ebastine Kestine ® 10 mg Film-coated Tablet Antihistamine FORMULATION: Each Ebastine (Kestine®) Film -coated tablet contains: Ebastine ……………………………….......….. 10mg Excipients: microcrystalline cellulose, pregelatinised maize starch, lactose monohydrate, croscarmellose sodium, magnesium stearate, hypromellose, macrogol 6000 and titanium dioxide. PHARMACEUTICAL FORM AND CONTENT OF PACKAGE: Round, white film -coated tablets with one side marked E10. Boxes containing 10 (1x10), 20 (2x10) 30 (3x10), 50 (5x10) and 100 (10x10) tablets in PVC/Aluminium blisters. Not all the presentations are available in all markets. INDICATION: Ebastine (Kestine®) is indicated in the treatm ent of allergic rhinitis (seasonal and perennial) with or without allergic conjunctivitis and chronic idiopathic urticaria. MECHANISM OF ACTION: Ebastine (Kestine®) produces rapid and prolonged inhibition of the effects induced by histamines, showing a strong af finity for binding to H1 receptors. After oral administration, neither ebastine (Kestine®) nor it’s metabolites cross the blood- brain barrier. This characteristic is consistent with the low sedation observed in the results of experiments in which the effects of ebastine (Kestine®) on the central nervous system were studied. The in vitro and in vivo data demonstrate that ebastine (Kestine®) is a powerful antagonist with a prolonged effect and highly selective of the histamine H1 receptors, free of CNS side effects and anticholinergic effects. PHARMACOKINETIC PROPERTIES: Ebastine is rapidly absorbed after oral intake and undergoes a very significant intestinal and hepatic first -pass effect. It is almost completely transformed into its pharmacologically active acid metabolite, carebastine. After a single oral 10 mg dose, the peak plasma concentration is reached after 2 to 4 hours, with levels ranging from 80 to 100 ng/ml. In vitro studies in human liver microsomes show that ebastine is metabolised pri marily to carebastine via cytochrome CYP3A4. The half -life Baca dokumen lengkap