Bilobil forte capsules

Χώρα: Αρμενία

Γλώσσα: Αγγλικά

Πηγή: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Δραστική ουσία:

ginkgo biloba leaf dry extract

Διαθέσιμο από:

KRKA d.d.

Φαρμακολογική κατηγορία (ATC):

N06DX02

INN (Διεθνής Όνομα):

ginkgo biloba leaf dry extract

Δοσολογία:

80mg

Φαρμακοτεχνική μορφή:

capsules

Μονάδες σε πακέτο:

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

Τρόπος διάθεσης:

OTC

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

2021-05-25

Αρχείο Π.Χ.Π.

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 carmoisine (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. If there is no
symptomatic improvement after 3 months, or if pathological symptoms
should intensify, the doctor
should check whether continuation of treatment is still justified.
4.3
CONTRAINDICATIONS
Hypersensitivity to ginkgo extract or any of the excipients (see
section 6.1).
Pregnancy (see section 4.6).
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Before starting treatment with Bilobil forte, it has to be made sure
that the symptoms are not a
consequence of another disease that require