国: アルメニア
言語: 英語
ソース: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
sildenafil (sildenafil citrate)
KRKA d.d.
G04BE03
sildenafil (sildenafil citrate)
50mg
tablets orodispersible
(1/1x1/) in blister, (4/1x4/) in blister
Prescription
Registered
2021-02-12
1 1. NAME OF THE MEDICINAL PRODUCT Vizarsin® Q-Tab® 50 mg orodispersible tablets Vizarsin® Q-Tab® 100 mg orodispersible tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains 50 mg or 100 mg sildenafil. Excipients with known effect: _Vizarsin® Q-Tab® 50 mg orodispersible tablets_ Each orodispersible tablet contains 0.75 mg aspartame. _Vizarsin® Q-Tab® 100 mg orodispersible tablets_ Each orodispersible tablet contains 1.5 mg aspartame. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Orodispersible tablet. Vizarsin® Q-Tab® 50 mg orodispersible tablets: White to almost white, round, slightly biconvex tablets, with possible darker spots. Vizarsin® Q-Tab® 100 mg orodispersible tablets: White to almost white, round, slightly biconvex tablets, with possible darker spots. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vizarsin® Q-Tab® 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 Vizarsin® Q-Tab® to be effective, sexual stimulation is required. 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 Vizarsin® Q-Tab® 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 2 renal impairment (creatinine clearance = 30-80 ml/min). Since sildenafil clearance is reduced in patients with severe renal impairment (creatinine clearance <30 ml/min) a 25 mg 完全なドキュメントを読む