מדינה: ארמניה
שפה: אנגלית
מקור: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
sildenafil (sildenafil citrate)
Fareva Amboise
G04BE03
sildenafil (sildenafil citrate)
25mg
tablets film-coated
(4/1x4/) in blister
Prescription
Registered
2022-02-02
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT VIAGRA 25 mg film-coated tablets VIAGRA 50 mg film-coated tablets VIAGRA 100 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains sildenafil citrate equivalent to 25, 50 or 100 mg of sildenafil. Excipient with known effect VIAGRA 25 mg tablets Each tablet contains 0.9 mg lactose (as monohydrate). VIAGRA 50 mg tablets Each tablet contains 1.7 mg lactose (as monohydrate). VIAGRA 100 mg tablets Each tablet contains 3.5 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. VIAGRA 25 mg tablets Blue, rounded diamond-shaped tablets, marked “PFIZER” on one side and “VGR 25” on the other. VIAGRA 50 mg tablets Blue, rounded, diamond-shaped tablets, marked “PFIZER” on one side and “VGR 50” on the other. VIAGRA 100 mg tablets Blue, rounded diamond-shaped tablets, marked “PFIZER” on one side and “VGR 100” on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS VIAGRA 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 VIAGRA to be effective, sexual stimulation is required. 3 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _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 VIAGRA is taken with food, the onset of activity may be delayed compared to the fasted state (see section 5.2). Special populations _ _ _Elderly _ Dosage adjustments are not required in elderly patients (≥ 65 years old). _ Renal impairment _ The dosing recommendations described in ‘Use in adults’ apply to patients with mild to moderate renal impairment (creatini קרא את המסמך השלם