SILPEMAR 25 Milligram Film Coated Tablet
Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Preparatomtale
(SPC)
08-06-2024
Noen dokumenter for dette produktet er ikke tilgjengelig for øyeblikket, du kan sende en forespørsel til kundeservicen vår, og vi vil varsle deg så snart vi kan få dem.
Send forespørsel.
Send forespørsel.
Aktiv ingrediens:
SILDENAFIL CITRATE
Tilgjengelig fra:
Vaia S.A.
INN (International Name):
SILDENAFIL CITRATE
Dosering :
25 Milligram
Legemiddelform:
Film Coated Tablet
Resept typen:
Product subject to prescription which may not be renewed (A)
Autorisasjon status:
Withdrawn
Autorisasjon dato:
2012-11-21
Preparatomtale
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Silpemar 25mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25mg of sildenafil (as citrate).
Excipient with known effect:
Each tablet contains 0.0004mg sunset yellow (E110).
For a full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Blue, oval, convex coated tablet plain on one side, debossed with “3781” on the other side and dimensions of
approximately 9.3 x 6.7mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for
satisfactory sexual performance.
In order for sildenafil to be effective, sexual stimulation is required.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral use.
_Use in adults_
The recommended dose is 50mg taken as needed approximately one hour before sexual activity. Based on efficacy and
toleration, the dose may be increased to 100mg or decreased to 25mg. The maximum recommended dose is 100 mg.
The maximum recommended dosing frequency is once per day. If sildenafil is taken with food, the onset of activity
may be delayed compared to the fasted state (see Section 5.2).
_Use in the elderly_
Dosage adjustments are not required in elderly patients.
_Use in patients with impaired renal function_
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
25mg dose should be considered. Based on efficacy and toleration, the dose may be increased to 50mg and 100mg.
_Use in patients with impaired hepa
Les hele dokumentet
