SILDENAFIL ASPEN 25 Milligram Film Coated Tablet
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
04-06-2024
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Active ingredient:
SILDENAFIL CITRATE
Available from:
Aspen Pharma Trading Limited
INN (International Name):
SILDENAFIL CITRATE
Dosage:
25 Milligram
Pharmaceutical form:
Film Coated Tablet
Prescription type:
Product subject to prescription which may not be renewed (A)
Authorization status:
Withdrawn
Authorization date:
2013-04-11
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sildenafil Aspen 25mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25 mg of sildenafil (as citrate)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Sildenafil Aspen 25 mg film-coated tablets
Blue, round (diameter approx. 7.1 mm), biconvex, film coated tablets, debossed with ‘86’on one side and plain on the
other side.
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 and 100 mg.
USE IN PATIENTS WITH IMPAIRED HEPATIC FUNCTION:
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