国: アルメニア
言語: 英語
ソース: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
hidrosmin
FAES FARMA
C05CA05
hidrosmin
200mg
capsules
(60/6x10/) blisters
Prescription
Registered
2017-07-31
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 完全なドキュメントを読む