Bilobil capsules

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

ginkgo biloba folies dry extract

Available from:

KRKA d.d.

ATC code:

N06DX02

INN (International Name):

ginkgo biloba folies dry extract

Dosage:

40mg

Pharmaceutical form:

capsules

Units in package:

(20/2x10/) in blister, (60/6x10/) in blister

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2023-03-10

Summary of Product characteristics

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