Flebaven tablets film-coated

Ülke: Ermenistan

Dil: İngilizce

Kaynak: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktif bileşen:

diosmin, hesperidin

Mevcut itibaren:

KRKA-RUS LLC

ATC kodu:

C05CA53

INN (International Adı):

diosmin, hesperidin

Doz:

450mg+ 50mg

Farmasötik formu:

tablets film-coated

Paketteki üniteler:

(32/2x16/), (64/4x16/) and (96/6x16/) in blister

Reçete türü:

OTC

Yetkilendirme durumu:

Registered

Yetkilendirme tarihi:

2017-11-07

Ürün özellikleri

1.3.1
Diosmin + Hesperidin
SPC, Labeling and Package Leaflet
AM
SmPCPIL157877_1
30.09.2020 – Updated: 30.09.2020
Page 1 of 4
1.
NAME OF THE MEDICINAL PRODUCT
Flebaven
®
500 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 500 mg of micronised purified
flavonoid fraction (90% (450 mg) of
diosmin and 10% (50 mg) mg of other flavonoids, calculated as
hesperidin).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Pale orange pink, biconvex, capsule shaped film-coated tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of symptoms of chronic venous and lymphatic insufficiency,
such as heavy legs, leg pain,
feeling of heaviness, leg tiredness, early morning restless legs.
Symptomatic therapy of hemorrhoids.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
-
Venous and lymphatic insufficiency: 2 tablets daily, one with lunch
and one with dinner.
-
Acute hemorrhoidal attack: 6 tablets daily, 3 in the morning and 3 in
the evening for 4 days,
followed by 4 tablets daily, 2 in the morning and 2 in the evening,
for 3 days.
Method of administration
For oral use.
The tablets should be taken with meals.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Administration of this medicine is no substitute for the specific
treatment of other anal disorders. The
treatment must be short-term. If the symptoms do not disappear
rapidly, proctological examination
should be performed and the treatment reviewed.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
CONFIDENTIAL
VOL: 1; P: 21 / 160
1.3.1
Diosmin + Hesperidin
SPC, Labeling and Package Leaflet
AM
SmPCPIL157877_1
30.09.2020 – Updated: 30.09.2020
Page 2 of 4
None reported.
4.6
FERTILITY, PREGNANCY AND LACTATION
Pregnancy
Experimental studies in animals have not demonstrated any teratogenic
effect in animals. Furthermore,
no adverse