Vizarsin tablets film-coated

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:

50mg

Pharmaceutical form:

tablets film-coated

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® 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