Venosmil capsules

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

hidrosmin

Available from:

FAES FARMA S.A.

ATC code:

C05CA05

INN (International Name):

hidrosmin

Dosage:

200mg

Pharmaceutical form:

capsules

Units in package:

(60/6x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2023-02-06

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
VENOSMIL 200 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 200 mg hidrosmin.
For the list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
Hard, orange gelatine capsules containing a fine yellow powder.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
VENOSMIL is a medicinal product indicated for:
-
Treatment of the symptoms related to slight venous insufficiency in
adults.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
4.2.1. Posology
_Adults _
One 200 mg capsule three times a day.
_Paediatric population _
The use of Venosmil is not recommended in children.
4.2.2. Method of administration
Oral route.
Once removed from the blister, the capsule must be taken immediately.
It can be taken with water or
another drink to aid swallowing.
If symptoms do not improve in two weeks the clinical situation should
be reevaluated.
If necessary, treatment can be continued at the same daily dose for up
to 2-3 months.
4.3. CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in Section 6.1.
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Patients must be advised that they must not use the medicinal product
for long periods without medical
supervision.
4.4.1. PAEDIATRIC POPULATION
The use of Venosmil is not recommended in children.
4.5.
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
No specific studies have been made of possible pharmacokinetic and/or
pharmacodynamic interactions
between hidrosmin and other medications or foods.
4.6.
FERTILITY, PREGNANCY AND LACTATION
_4.6.1._
_ _
_PREGNANCY _
No clinical data are available for Venosmil capsules as regards the
use of hidrosmin in pregnant
women.
Animal studies have shown no direct or indirect hazardous effects on
pregnancy, foetal development,
delivery or postnatal development.
However, as a precautionary measure, the use of Venosmil is not
recommended during pregnancy
unless, in the physician's opinion, the