Country: Armenia
Bahasa: Inggeris
Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
ginkgo biloba extract
Beaufour Ipsen Industrie
N06DX02
ginkgo biloba extract
40mg
tablets film-coated
(30/3x10/) blisters, (90/6x15/) blisters
OTC
Registered
2015-02-06
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT TANAKAN, coated tablets 40 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ginkgo _(Ginkgo biloba L.)_ (quantified extract) containing 24 % of ginkgo heterosides and 6 % of ginkgolides‐ bilobalide ................................................. 40.00 mg For one coated tablet. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Coated tablet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ‐ Treatment aimed at symptomatic management of chronic pathological cognitive and neurosensorial deficit in the elderly patient (excluding Alzheimer's disease and other dementia). ‐ Symptomatic treatment of intermittent claudication in chronic obliterating arteriopathies of the lower limbs (stage 2). N.B. This indication relies on double blind clinical trials versus placebo, showing an increase in the walking perimeter of at least 50% in 50 to 60% of patients treated versus 20 to 40% of patients following only health and dietetic rules. ‐ Adjunct treatment of losses in acuity and troubles of the visual field presumed to be of vascular origin. ‐ Adjunct treatment of losses in auditive acuity and of certain syndromes of vertigo and/or tinnitus presumed to be of vascular origin. ‐ Improvement of Raynaud's phenomenon. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral route. 3 tablets per day, spread through the day. Tablets should be taken with a half‐glass of water, during meals. 4.3 CONTRAINDICATIONS This medicine is contra‐indicated in the following circumstance : Hypersensitivity to one of the components of the tablet, age under 18, erosive gastritis, stomach or duodenal ulcer in acute period, acute brain disorders, acute myocardial infarction, pregnancy and lactation, low blood coagulability, galactosemia, lactase insufficiency, lactose intolerance, glucose or galactose malabsorption. 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE _SPECIAL WARNINGS _ Since this medicinal product contains lactose, it is contra‐indic Baca dokumen lengkap