Viagra

Land: Armenía

Tungumál: enska

Heimild: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Virkt innihaldsefni:

sildenafil (sildenafil citrate)

Fáanlegur frá:

Fareva Amboise Zone Industrielle

INN (Alþjóðlegt nafn):

sildenafil (sildenafil citrate)

Skammtar:

50mg

Lyfjaform:

tablets orodispersible

Gerð lyfseðils:

Prescription

Vara einkenni

1
SUMMARY OF PRODUCT CHARACTERISTICS
VIAGRA® (sildenafil citrate) 50 mg Orodispersible Tablets
1.
NAME OF THE MEDICINAL PRODUCT
VIAGRA 50 mg orodispersible tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains sildenafil citrate equivalent to 50 mg of
sildenafil.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Orodispersible tablet.
Blue, rounded, diamond-shaped tablets, marked “V50” on one side
and plain 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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Use in adults_
Viagra should be taken as needed approximately one hour before sexual
activity. The recommended
dose is 50 mg taken on an empty stomach as concomitant intake with
food delays absorption and
delays the effect of the orodispersible tablet (see section 5.2).
Based on efficacy and tolerability, the dose may be increased to 100
mg. The maximum recommended
dose is 100 mg. For patients requiring a dose increase to 100 mg, two
50 mg orodispersible tablets
should be administered sequentially. The maximum recommended dosing
frequency is once per day.
If a dose of 25 mg is required, the use of the 25 mg film-coated
tablets should be recommended.
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 (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 dose should be considered. Based on efficacy and
tolerability the dose may be
increased step-wise to 50 mg up to 100 mg as necessary.
2
_Hepatic impairment_
Since sildena