Maa: Armenia
Kieli: englanti
Lähde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
sildenafil (sildenafil citrate)
KRKA d.d.
G04BE03
sildenafil (sildenafil citrate)
25mg
tablets film-coated
(1/1x1/) in blister, (4/1x4/) in blister
Prescription
Registered
2021-02-12
1 1. NAME OF THE MEDICINAL PRODUCT Vizarsin® 25 mg film-coated tablets Vizarsin® 50 mg film-coated tablets Vizarsin® 100 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains sildenafil citrate equivalent to 25 mg, 50 mg or 100 mg sildenafil. Excipient with known effect: _Vizarsin® 25 mg film-coated tablets _ Each film-coated tablet contains 1.9 mg lactose (as monohydrate). _Vizarsin® 50 mg film-coated tablets _ Each film-coated tablet contains 3.8 mg lactose (as monohydrate). _Vizarsin® 100 mg film-coated tablets _ Each film-coated tablet contains 7.6 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Vizarsin® 25 mg film-coated tablets: white to off white, oval shaped, biconvex film coated tablets, engraved with sign 25 on one side Vizarsin® 50 mg film-coated tablets: white to off white, oval shaped, biconvex film coated tablets, engraved with sign 50 on one side Vizarsin® 100 mg film-coated tablets: white to off white, oval shaped, biconvex film coated tablets, engraved with sign 100 on one side 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vizarsin® 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® 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® is taken with food, the onset of activity may be delayed compared to the fasted state (see section 5.2). 2 Special populations _Elderly _ Dosage adjustments are not required in elderly patients (≥ 65 years old). _Renal impairment: _ The Lue koko asiakirja