Land: Armenien
Sprache: Englisch
Quelle: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
ebastine
Industrias Farmaceuticas Almirall S.A.
R06AX22
ebastine
10mg
tablets film-coated
(5/1x5/) in blister, (10/1x10/) in blister
Prescription
Registered
2020-11-13
1/7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Kestine 10 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg of ebastine. EXCIPIENT WITH KNOWN EFFECT:_ _Each film-coated tablet contains 88.5 mg of lactose. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. The film-coated tablets are white to almost white, round, engraved with “E/10” on one side. The engraved line is not intended for breaking the tablet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Kestine is indicated in the symptomatic treatment of: • allergic rhinitis (seasonal and perennial) associated or not with allergic conjunctivitis • urticaria of different etiology including idiopathic chronic urticaria 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology _ ADULTS AND CHILDREN OVER 12 YEARS OF AGE The recommended dose is 10 mg of ebastine once daily. If the effect is not sufficient, it is advised to take two tablets of Kestine 10 mg, once daily. ELDERLY PATIENTS It is no necessary to adjust the dose. RENAL INSUFFICIENCY It is not necessary to adjust the dose in patients with mild, moderate or severe renal insufficiency. HEPATIC INSUFFICIENCY It is not necessary to adjust the dose in patients with mild or moderate hepatic impairment (Child-Pugh Classes A and B). There is no experience with doses over 10 mg in patients with 2/7 severe hepatic insufficiency (Child-Pugh Class C); therefore, the dose of 10 mg of ebastine/day should not be exceeded in these patients. Treatment may be prolonged until symptoms disappear. _Method of administration _ For oral use. The tablets may be taken with or without food and with a glass of water. 4.3 CONTRAINDICATIONS Known hypersensitivity to the active substance or to any excipient listed in section 6.1. Pregnancy, lactation period, children under 12 years of age, deficit of lactase, intolerance of lactose, malabsorption of glucose-galactose. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Adm Lesen Sie das vollständige Dokument