LIFANED Film-coated tablet Ref.[115341] Active ingredients: Sildenafil

Posology

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.

The following factors are associated with increased plasma levels of LIFANED:

Age >65 years (40% increase in AUC), hepatic impairment (e.g. cirrhosis, 80%), severe renal impairment (creatinine clearance <30 mL/min, 100%), and concomitant use of potent cytochrome P450 3A4 inhibitors (erythromycin 182%, saquinavir 210%, ketoconazole, itraconazole, 200%, ritonavir 1 000%).

Special populations

Use in patients with mild to moderately impaired renal function

A starting dose of 25 mg should not be exceeded.

Use in patients with mild to moderately impaired hepatic function

Since LIFANED clearance is reduced in patients with hepatic impairment (e.g. cirrhosis), a starting dose of 25 mg should not be exceeded.

Use in elderly patients

Healthy elderly volunteers (65 years or over) had a reduced clearance of LIFANED. A starting dose of 25 mg should be considered in patients older than 65 years of age.

Use in patients using potent CYP 3A4 inhibitors

Given the extent of the interaction with patients receiving concomitant therapy with cytochrome P450 3A4 inhibitors (e.g. ritonavir, erythromycin, saquinavir, ketoconazole, itraconazole), LIFANED should not be used concomitantly with these medicines (see section 4.3).

LIFANED was shown to potentiate the hypotensive effects of nitrates and its administration in patients who use nitric oxide donors or nitrates in any form is therefore contraindicated.

Use in children

LIFANED is not indicated for use in children.

Method of administration

LIFANED tablets are for oral administration.

In single dose volunteer studies of doses up to 800 mg, adverse reactions were similar to those seen at lower doses, but the incidence rates and severities were increased. Doses of 200 mg did not result in increased efficacy but the incidence of adverse reactions (headache, flushing, dizziness, dyspepsia, nasal congestion, altered vision) was increased. In cases of overdose, supportive measures should be adopted as required. Renal dialysis is not expected to accelerate clearance as sildenafil is highly bound to plasma proteins and not eliminated in the urine.

3 years.

Store at or below 30°C.

Protect from moisture.

Keep the blister strips in the outer carton until required for use.

Clear PVC/Aluminium blister strips placed in an outer carton.

Pack size: 2, 4, 8 or 12 tablets.

Not all pack sizes may be marketed.

No special requirements.