Riik: Armeenia
keel: inglise
Allikas: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
ginkgo biloba folies dry extract
KRKA d.d.
N06DX02
ginkgo biloba folies dry extract
40mg
capsules
(20/2x10/) in blister, (60/6x10/) in blister
OTC
Registered
2023-03-10
PI_Text037267_2 – Updated: Page 1 of 6 1. NAME OF THE MEDICINAL PRODUCT Bilobil ® 40 mg capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule, hard, contains 40 mg of extract (as dry extract, refined and quantified) from _ Ginkgo _ _biloba_ L_., _folium (Ginkgo leaf) (35 - 67 : 1), corresponding to: - 8.8 to 10.8 mg of flavonoids expressed as flavone glycosides, - 1.12 to 1.36 mg of ginkgolides A, B, C and - 1.04 to 1.28 mg of bilobalide. First extraction solvent: Acetone 60% m/m. Excipients with known effect: Each hard capsule contains 62.7 mg lactose, 0.015 mg azorubine (E122) and 2 mg glucose. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule. Violet-brown capsules. The capsule contains a light to dark brown powder with visible darker particles and possible small clods. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Bilobil capsules are a herbal medicinal product that is recommended for symptomatic treatment: - in disturbances of cerebral circulation and function (syndrome of dementia in primary degenerative dementia, in vascular dementia or in a mixed form of both) manifested as decline in memory and intellectual capacity, vertigo, tinnitus, indisposition, headache and sleep disorders, general malaise; - in initial disturbances of blood perfusion of the extremities, manifested as cold feet, tingling, numbness or pain on walking. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION DISTURBANCES OF CEREBRAL CIRCULATION AND FUNCTION (SYNDROME OF DEMENTIA IN PRIMARY DEGENERATIVE DEMENTIA, IN VASCULAR DEMENTIA OR IN A MIXED FORM OF BOTH): The recommended dose is 3 capsules once to twice daily. INITIAL DISTURBANCES OF BLOOD PERFUSION OF THE EXTREMITIES: The recommended dose is 1 capsule three times daily. The capsules should be swallowed whole with some liquid. They may be taken without regard to meals. Concomitant intake of alcoholic beverages is not advised. The first signs of improvement are usually observed after one month. For a longer-lasting effect, it is recommended, es Lugege kogu dokumenti