البلد: أرمينيا
اللغة: الإنجليزية
المصدر: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
clemastine (clemastine fumarate)
SmithKline Beecham S.A. Ctra. de Ajalvir
R06AA04
clemastine (clemastine fumarate)
1mg
tablets
(20/1x20/) in blister, (60/3x20/) in blister
OTC
Registered
2021-06-29
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Tavegyl 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 tablet contains: _ active ingredient_ – 1 mg of clemastine equivalent to 1.34 mg of clemastine fumarate. Excipient with known effect: lactose monohydrate. _For the full list of excipients, see Section 6.1. _ 3. DOSAGE FORM Tablets. Whitish round flat bevelled-edged tablets. Scored on one side and coded “OT”. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Tavegyl is indicated for the relief of hay fever (allergic rhinoconjunctivitis) and other allergic rhinitis, urticaria of various genesis, itching, puritic dermatoses and insect stings and bites. Tavegyl is also indicated as an adjuvant in acute and chronic eczema, contact dermatitis and drug eruptions. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION _POSOLOGY _ _ For adults and children over 12 years_: 1 tablet in the morning and in the evening, unless otherwise instructed by a doctor. You should not take more than 6 tablets during 24 hours. The highest single dose is 2 tablets at a time. _For children from 6 to 12 years_: 1/2 to 1 tablet in the morning and evening. Maximum duration of use: should not be taken for more than 14 days without consulting a doctor. Do not exceed the recommended dose. _METHOD OF ADMINISTRATION _ For oral administration. The tablets should be taken with water before meals. 4.3. CONTRAINDICATIONS Hypersensitivity to clemastine or other similar antihistamines or to any of the excipients. Tavegyl should not be given to patients suffering from porphyria. Tavegyl in tablet form should not be given to children below 6 year of age. 4.4. WARNINGS AND PRECAUTIONS Use with caution in elderly patients, who are more likely to experience adverse effects such as paradoxical excitation. Avoid use in elderly patients with confusion. Do not exceed recommended dosage and duration of use without consulting a doctor (See _Posology and Method of Administration_). Antihistamines should be used with caution in patients with: ep اقرأ الوثيقة كاملة