Viagra tablets film-coated

Țară: Armenia

Limbă: engleză

Sursă: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredient activ:

sildenafil (sildenafil citrate)

Disponibil de la:

Fareva Amboise

Codul ATC:

G04BE03

INN (nume internaţional):

sildenafil (sildenafil citrate)

Dozare:

25mg

Forma farmaceutică:

tablets film-coated

Unități în pachet:

(4/1x4/) in blister

Tip de prescriptie medicala:

Prescription

Statutul autorizaţiei:

Registered

Data de autorizare:

2022-02-02

Caracteristicilor produsului

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
VIAGRA 25 mg film-coated tablets
VIAGRA 50 mg film-coated tablets
VIAGRA 100 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains sildenafil citrate equivalent to 25, 50 or 100 mg
of sildenafil.
Excipient with known effect
VIAGRA 25 mg tablets
Each tablet contains 0.9 mg lactose (as monohydrate).
VIAGRA 50 mg tablets
Each tablet contains 1.7 mg lactose (as monohydrate).
VIAGRA 100 mg tablets
Each tablet contains 3.5 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
VIAGRA 25 mg tablets
Blue, rounded diamond-shaped tablets, marked “PFIZER” on one side
and “VGR 25” on the other.
VIAGRA 50 mg tablets
Blue, rounded, diamond-shaped tablets, marked “PFIZER” on one side
and “VGR 50” on the other.
VIAGRA 100 mg tablets
Blue, rounded diamond-shaped tablets, marked “PFIZER” on one side
and “VGR 100” 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.
3
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 VIAGRA 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
renal impairment (creatini