Страна: Армения
Език: английски
Източник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
sildenafil (sildenafil citrate)
S Kant Healthcare LTD
G04BE03
sildenafil (sildenafil citrate)
100mg
tablets film-coated
(4/1x4/) in blister, (30) box
Prescription
Registered
2018-05-29
SUMMARY PRODUCT CHARACTERISTICS for: TRO-SILDENAFIL 100 mg film-coated Tablets TROGE ® Register-Nr. HRB 35614 DEPARTMENT FOR SCIENTIFIC RESEARCH AND PRODUCT DEVELOPMENT DEPARTMENT FOR INTERNATIONAL REGULATORY AFFAIRS – March2017 – PRODUCT: TRO-SILDENAFIL 100 MG film-coated tablets SUMMARY OF PRODUCT CHARACTERISTICS TROGE MEDICAL GMBH · HAMBURG · GERMANY 1. NAME OF THE MEDICINAL PRODUCT TRO-SILDENAFIL 100 mg film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 100 mg Sildenafil (in form of Sildenafil citrate) Excipients with known effect Each tablet contains 170 mg of lactose as monohydrate For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM _Film-coated tablets for oral use. _ Description: TRO-SILDENAFIL 100 mg film-coated tablets are blue coloured and diamond shaped. They are embossed with “100” on one side and plain on the other side. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS TRO-SILDENAFIL 100 mg film-coated tablets is indicated in adult men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. In order for TRO-SILDENAFIL 100 mg film-coated tablets to be effective, sexual stimulation is required. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Posology This strength is not suitable for dosages below 100 mg. PRODUCT: TRO-SILDENAFIL 100 MG film-coated tablets SUMMARY OF PRODUCT CHARACTERISTICS TROGE MEDICAL GMBH · HAMBURG · GERMANY Other medicinal products of Sildenafil in adequate strength are available. _Use in Adults _ The recommended dose is 50 mg taken as needed approximately one hour before sexual activity. Based on efficacy and tolerability, the dose may be increased to 100 mg or decreased to 25 mg. The maximum recommended dose is 100 mg. The maximum recommended dosing frequency is once per day. If TRO-SILDENAFIL 100 mg film-coated tablets is taken with food, the onset of activity may be delayed compared to the fasted state (see section 5.2). Special Прочетете целия документ