SILDENAFIL ASPEN 50 Milligram Film Coated Tablet
Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
Lastnosti izdelka
(SPC)
10-06-2024
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Aktivna sestavina:
SILDENAFIL CITRATE
Dostopno od:
Aspen Pharma Trading Limited
INN (mednarodno ime):
SILDENAFIL CITRATE
Odmerek:
50 Milligram
Farmacevtska oblika:
Film Coated Tablet
Tip zastaranja:
Product subject to prescription which may not be renewed (A)
Status dovoljenje:
Withdrawn
Datum dovoljenje:
2013-04-11
Lastnosti izdelka
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sildenafil Aspen 50mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg of sildenafil (as citrate)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Sildenafil Aspen 50 mg film-coated tablets
Blue, round (diameter approx. 9.6 mm), biconvex, film coated tablets, debossed with ‘8’ Bisect ‘7’ on one side and
plain on the other side. The tablet can be divided into equal doses.
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 Aspen to be effective, sexual stimulation is required.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral use.
USE IN ADULTS:
The recommended dose is 50 mg taken as needed approximately one hour before sexual activity. Based on efficacy and
toleration, 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 Sildenafil Aspen 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 25
mg dose should be considered. Based on efficacy and toleration, the dose may be increased to 50 mg
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