Vizarsin Q-Tab tablets orodispersible

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

sildenafil (sildenafil citrate)

Available from:

KRKA d.d.

ATC code:

G04BE03

INN (International Name):

sildenafil (sildenafil citrate)

Dosage:

100mg

Pharmaceutical form:

tablets orodispersible

Units in package:

(1/1x1/) in blister, (4/1x4/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2021-02-12

Summary of Product characteristics

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