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Zoltan


Each film-coated tablet contains 50 mg Sildenafil (as sildenafil citrate).

Excipient with known effect:

Each 50 mg film-coated tablet contains 3.7 mg lactose monohydrate.

Sildenafil is indicated in adult men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.

KSh135 KSh170

Use in adults

The recommended dose is 50mg taken as needed approximately one hour before sexual activity. Based on efficacy and tolerability, 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.

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 25mg dose should be considered. Based on efficacy and tolerability, the dose may be increased step-wise to 50mg and 100mg as necessary.

Hepatic impairment

Since sildenafil clearance is reduced in patients with hepatic impairment (e.g. cirrhosis) a 25mg dose should be considered. Based on efficacy andtolerability, the dose may be increased step-wise to 50mg and 100mg as necessary.

Paediatric population

Sildenafil is not indicated for individuals below 18 years of age.

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