VIAGRA*

1. NAME OF THE MEDICINAL PRODUCT

VIAGRA*

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

VIAGRA 25 mg: Each tablet contains sildenafil citrate equivalent to 25 mg sildenafil.

VIAGRA 50 mg: Each tablet contains sildenafil citrate equivalent to 50 mg sildenafil.

VIAGRA 100 mg: Each tablet contains sildenafil citrate equivalent to 100 mg sildenafil.

For excipients, see Section 6.1

3. PHARMACEUTICAL FORM

Film-coated tablet

Blue, rounded-diamond shaped film-coated tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration, marked "PFIZER" on one side and "VGR 25" "VGR 50", or "VGR 100" on the other.

4.CLINICAL PARTICULARS

4.1 Therapeutic indications

Sildenafil is indicated for the treatment of erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.

In order for sildenafil to be effective, sexual stimulation is required.

4.2 Posology and method of administration

Sildenafil tablets are for oral administration.

Use in adults

For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. Based on effectiveness and toleration, the dose may be increased to a maximum recommended dose of 100 mg or decreased to 25 mg. The maximum recommended daily dose is 100 mg. The maximum recommended dosing frequency is once per day.

Use in patients with impaired renal function

Dosage adjustments are not required in 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.

Use in patients with impaired hepatic function

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

Use in patients using other medications

Given the extent of the interaction with patients receiving concomitant therapy with ritonavir (see section 4.5 Interaction with other medicinal products and other forms of interaction), it is recommended not to exceed a maximum single dose of 25 mg of sildenafil in a 48-hour period.

A starting dose of 25 mg should be considered in patients receiving concomitant treatment with CYP3A4 inhibitors (e.g. erythromycin, saquinavir, ketoconazole, itraconazole). See section 4.5 Interaction with other medicinal products and other forms of interaction.

In order to minimize the potential for developing postural hypotension, patients should be stable on alpha-blocker therapy prior to initiating sildenafil treatment. In addition, initiation of sildenafil at lower doses should be considered (see section 4.4 Special warnings and precautions for use and section 4.5 Interaction with other medicinal products and other forms of interaction).

Use in children

Sildenafil is not indicated for use in children (<18 years old).

Use in elderly men

Dosage adjustments are not required in elderly patients.

4.3 Contraindications

Use of sildenafil is contraindicated in patients with a known hypersensitivity to any component of the tablet. Sildenafil was shown to potentiate the hypotensive effects of acute and chronic nitrates, and its administration to patients who are concurrently using nitric oxide donors, organic nitrates or organic nitrites in any form either regularly or intermittently is therefore contraindicated (see section 4.5 Interaction with other medicinal products and other forms of interaction).

1    2    3    4