EUGRA

POSOLOGY AND METHOD OF ADMINISTRATION

DOSAGE AND ADMINISTRATION

Posology

Use in adults

The recommended dose is 50 mg taken as needed approximately one hour before sexual activity.

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. The maximum recommended dosing frequency is once per day.

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 25 mg dose should be considered.

Hepatic impairment

Since sildenafil clearance is reduced in patients with hepatic impairment (e.g. cirrhosis) a 25 mg dose should be considered.

Use in patients taking other medicinal products:

Based on the severity of interactions in patients receiving sildenafil concomitantly with ritonavir (see Interaction with other medicinal products and other forms of interaction), a maximum single dose of 25 mg of sildenafil within a 48-hour period should not be exceeded.

A starting dose of 25 mg should be considered in patients receiving concomitant treatment with CYP3A4 inhibitors  (erythromycin, saquinavir, ketoconazole, itraconazole) (see Interaction with other medicinal products and other forms of interaction).

In order to minimise the potential of developing postural hypotension in patients receiving alpha-blocker treatment, patients should be stabilised on alpha-blocker therapy prior to initiating  sildenafil treatment. In addition, initiation of sildenafil at a dose of 25 mg should be considered (see Special warnings and precautions for use and Interaction with other medicinal products and other forms of interaction).

Paediatric population:

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

Elderly:
Dosage adjustments are not required in elderly patients.

Method of administration

For oral use.

CONTRAINDICATIONS

Hypersensitivity to the active substance or to any of the excipients listed in Excipients.

Consistent with its known effects on the nitric oxide/cyclic guanosine monophosphate (cGMP) pathway, sildenafil was shown to potentiate the hypotensive effects of nitrates, and its co-administration with nitric oxide donors or nitrates in any form is therefore contraindicated (see Interaction with other medicinal products and other forms of interaction).

The co-administration of PDE5 inhibitors, including sildenafil, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES

There is no data studies on the effects on the ability to drive and use machines.

As dizziness and altered vision were reported in clinical trials with sildenafil, patients should be aware of how they react to sildenafil, before driving or operating machinery.

Shelf-life

36  months from the date of manufacture.  Do not use after the expiry date.

PVC/Al blister. Box of 01 blister x 4 film-coated tablets