ERIGRA 100 Tablet

 Treatment of men with 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.

Dosage and administration

 The recommended dose is 50mg taken as needed approximately 1 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 100mg. 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 patients: Dosage adjustments are not required in elderly patients (≥65 years old).

 Paediatric population: Sildenafil is not indicated for individuals below 18 years of age.

 Method of administration: For oral use.

 Hypersensitivity to the active substance or to any of the excipients like Silica colloidal anhydrous, Lactose monohydrate, Providone K-30, Aspartame (E951), Croscarmellose sodium, Peppermint flavour, Magnesium stearate.

 In patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure.

Immune system disorders

Rare: Hypersensitivity reactions

Nervous system disorders

Very common: Headache

Common: Dizziness

Uncommon: Somnolence, hypoaesthesia

Rare: Cerebrovascular accident, syncope

Not known: Transient ischaemic attack, seizure recurrence

Eye disorders

Common: Visual disorders, visual colour distortion

Uncommon: Conjunctival disorders, eye disorders, lacrimation disorders, other eye disorders, other eye disorders.

 Nicorandil is a hybrid potassium channel activator and nitrate. Doe to the nitrate component it has the potential to have serious interaction with sildenafil.

 Sildenafil is a weak inhibitor of the CYP450 isoforms 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4. Given sildenafil peak plasma concentrations of approximately 1µM after recommended doses, it is unlikely that Sildenafil will after the clearance of substrates of these isoenzymes.

 There are no data on the interaction of sildenafil and non-specific phosphodiesterase inhibitors such as theophylline or dipyridamole.

Contraindicated.

 A medical history and physical examination should be undertaken to diagnose erectile dysfunction and determine potential underlying causes, before pharmacological treatment is considered. Decreased gastric acidity due to lansoprazole might be expected to increase gastric counts of bacteria normally present in the gastrointestinal tract. Treatment with lansoprazole may lead to a slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter.

 For patients expected to be an prolonged treatment or who take PPIs with digoxin or drugs that may cause hypomagnesaemia (e.g., diuretics), health care professionals should consider measuring magnesium levels before starting PPI treatment and periodically during treatment.

Cardiovascular risk factors

 Prior to initiating any treatment for erectile dysfunction, physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity.

Effects on vision

 Cases of visual defects have been reported spontaneously in connection with the intake of sildenafil and other PDE5 inhibitors.

Priapism

 Agents for the treatment of erectile dysfunction, including sildenafil, should be used with caution in patients with anatomical deformation of the penis.

Sildenafil citrate, a specific phosphodiesterase-5 inhibitor which is present in the feto-placental circulation. Sildenafil citrate vasodilators the feto-placental circulation via a cGMP dependent mechanism involving increased responsiveness to NO.