Liberize 50mg Tablets

Each tablet contains sildenafil citrate equivalent to 50 mg of sildenafil.

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

Posology

Use in adults

The recommended dose is one 50 mg tablet taken with water approximately one hour before sexual activity. The maximum recommended dosing frequency is once per day. If Liberize is taken with food, the onset of activity may be delayed compared to the fasted state (see section 5.2).

Patients should be advised that they may need to take Liberize a number of times on different occasions (a maximum of one 50 mg tablet per day), before they can achieve a penile erection satisfactory for sexual activity. If after several attempts on different dosing occasions patients are still not able to achieve a penile erection sufficient for satisfactory sexual activity, they should be advised to consult a doctor.

For the POM product only: Based on efficacy and tolerability, the dose may be increased to 100 mg or decreased to 25 mg. The maximum recommended dose is 100 mg.

Special populations

Elderly

Dosage adjustments are not required in elderly patients (= 65 years old).

Renal Impairment

No dosage adjustments are required for patients with mild to moderate renal impairment.

However since sildenafil clearance is reduced in individuals with severe renal impairment (creatinine clearance <30ml/min), individuals previously diagnosed with severe renal impairment must be advised to consult their doctor before taking Liberize, since a 25 mg tablet may be more suitable for them (see section 4.4 for further information).

Hepatic Impairment

Sildenafil clearance is reduced in individuals with hepatic impairment (e.g. cirrhosis). Individuals previously diagnosed with mild to moderate hepatic impairment must be advised to consult their doctor before taking Liberize, since a 25 mg tablet may be more suitable for them (see section 4.4 for further information). The safety of sildenafil has not been studied in patients with severe hepatic impairment, and its use is therefore contraindicated (see section 4.3).

Paediatric population

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

Use in patients taking other medicinal products

Pharmacokinetic analysis of clinical trial data indicated a reduction in sildenafil clearance when co-administered with CYP3A4 inhibitors (such as ritonavir, ketoconazole, itraconazole, erythromycin, cimetidine).

With the exception of ritonavir, for which co-administration with sildenafil is contraindicated (see section 4.3), individuals receiving concomitant treatment with CYP3A4 inhibitors must be advised to consult their doctor before taking Liberize, since a 25 mg tablet may be more suitable for them (see section 4.4 for further information).

In order to minimise the potential of developing postural hypotension in patients receiving alpha blocker treatment (e.g. alfuzosin, doxazosin or tamsulosin), patients should be stabilised on alpha blocker therapy prior to initiating sildenafil treatment. Thus, patients taking alpha blockers must be advised to consult their doctor before taking Liberize since a 25 mg tablet may be more suitable for them (see sections 4.4 and 4.5).

Method of administration

For oral use.