Venosmil capsules

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

hidrosmin

Available from:

FAES FARMA

ATC code:

C05CA05

INN (International Name):

hidrosmin

Dosage:

200mg

Pharmaceutical form:

capsules

Units in package:

(60/6x10/) blisters

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2017-07-31

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
VENOSMIL 200 mg hard capsules
VENOSMIL 20 mg/g gel
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_VENOSMIL 200 mg hard capsules _
Each capsule contains 200 mg hidrosmin.
_VENOSMIL 20 mg/g gel _
Each gramme of gel contains 20 mg hidrosmin.
Excipients with known effect: Each gramme of gel contains 1 mg methyl
parahydroxybenzoate (E-
218) and 0.5 mg propyl parahydroxybenzoate (E-216).
For the full list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
VENOSMIL capsules:
Hard, orange gelatine capsules containing a fine yellow powder.
VENOSMIL gel:
Transparent slightly yellowish gel.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
VENOSMIL is a medicinal product indicated for:
-
Short-term
(2-3
months)
relief
from
oedema
and
symptoms
related
to
chronic
venous
insufficiency in adults.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
VENOSMIL capsules: One 200 mg capsule three times a day.
VENOSMIL gel: Three applications per day.
Method of administration
VENOSMIL capsules:
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.
VENOSMIL gel:
Cutaneous use.
For external use only on intact skin.
1.
Unscrew the cap of the tube and perforate the metal opening of the
tube sufficiently using the
back of the cap.
2.
Apply approximately 3-4 cm of product to the skin.
3.
Spread over the affected region by gently rubbing to form a thin layer
of gel.
4.3. CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in Section 6.1.
Venosmil gel must not be applied to mucosa, irritated regions of skin
or to wounds, and must not be
used to treat dermatitis, eczema or urticaria.
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
VENOSMIL gel
-
Use only on intact skin.
-
Avoid contact with the eyes, ears and mouth.
-
Do not apply simultaneously with other medicinal products for
cutaneous use in the same region.
Patients must be advi