Bilobil forte capsules

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

ginkgo biloba dry extract

Available from:

KRKA d.d.

ATC code:

N06DX02

INN (International Name):

ginkgo biloba dry extract

Dosage:

80mg

Pharmaceutical form:

capsules

Units in package:

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

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2016-05-24

Summary of Product characteristics

1.3.1
Ginkgo leaf dry extract
SPC, Labeling and Package Leaflet
AM
SmPCPIL158540_1
09.10.2020 – Updated: 09.10.2020
Page 1 of 5
1.
NAME OF THE MEDICINAL PRODUCT
Bilobil
®
forte 80 mg capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 80 mg of extract (as dry, refined and
quantified) from _Ginkgo biloba_ L., folium
(Ginkgo leaf) (35–67:1), corresponding to:
-
17.6–21.6 mg of flavonoids expressed as flavone glycosides,
-
2.24–2.72 mg of ginkgolides A, B, C and
-
2.08–2.56 mg of bilobalide.
Excipients:
Each capsule contains 125.4 mg of lactose, 4 mg of glucose and 0.029
mg of azorubine (E122).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule.
Pink 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 forte capsules are recommended for:
-
Symptomatic treatment of mild cognitive impairment in patients with
dementia (primary
degenerative dementia, vascular dementia or mixed dementia),
-
The treatment of primary peripheral circulatory disorders of the lower
extremities (stage II on
Fontaine classification).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Symptomatic treatment of cognitive impairment (dementia):
1 capsule three times daily.
Initial disturbances of blood perfusion of the lower extremities:
1 capsule 2 times daily, in the morning and in the evening.
Swallow the capsule with some liquid.
For a longer-lasting effect, you are recommended to take the capsules
for at least three months,
especially if you are elderly. You may repeat the treatment after
consulting your doctor.
4.3
CONTRAINDICATIONS
Hypersensitivity to ginkgo extract or any of the excipients.
Acute stroke.
CONFIDENTIAL
Bilobil forte 80 mg capsule, hard
VOL: 1; P: 14 / 51
1.3.1
Ginkgo leaf dry extract
SPC, Labeling and Package Leaflet
AM
SmPCPIL158540_1
09.10.2020 – Updated: 09.10.2020
Page 2 of 5
Acute myocardial infarction.
Acute stage of gastric ulcer, duodenal ulce