Composition

active ingredient: sildenafil;

1 chewable tablet contains sildenafil citrate 70.24 mg, equivalent to sildenafil 50 mg;

1 chewable tablet contains sildenafil citrate 140.48 mg equivalent to sildenafil 100 mg;

Excipients: potassium polacrylin; purified water; potassium hydroxide or hydrochloric acid; magnesium stearate; colloidal silicon dioxide anhydrous; aspartame (E 951); croscarmellose sodium; mint flavour; lactose monohydrate; povidone K-30.

Indications

Konegra Deluxe is recommended for use in men with erectile dysfunction, which is defined as the inability to achieve or maintain an erection of the penis necessary for successful sexual intercourse.

For effective action of Konegra Deluxe, sexual arousal is required.

Contraindications

- Hypersensitivity to the active substance or any of the excipients of the drug.

- Concomitant use with nitric oxide donors (such as amyl nitrite) or nitrates in any form is contraindicated, as sildenafil is known to affect the nitric oxide/cyclic guanosine monophosphate (cGMP) metabolism pathway and potentiate the antihypertensive effect of nitrates.

- The simultaneous use of PDE5 inhibitors (including sildenafil) with guanylate cyclase stimulants, such as riociguat, is contraindicated as it can lead to symptomatic hypotension (see section ""Interaction with Other Drugs and Other Interactions"").Conditions in which sexual activity is not recommended (for example, severe cardiovascular disorders such as unstable angina or severe heart failure).

- Loss of vision in one eye due to non-arterial anterior ischaemic optic neuropathy, regardless of whether this pathology is associated with previous use of PDE5 inhibitors or not.

- Presence of diseases such as severe hepatic impairment, arterial hypotension (blood pressure below 90/50 mm Hg), recent stroke or myocardial infarction, and known hereditary degenerative retinal diseases such as retinitis pigmentosa (a small number of such patients have genetic disorders of retinal phosphodiesterases), as the safety of sildenafil has not been studied in such subgroups of patients.

Routes of Administration and Dosage Take orally.

The drug should be taken orally. The tablet should be chewed before swallowing.

For effective action of Conegra Deluxe, sexual arousal is required.

Adults. The recommended dose of Conegra Deluxe is 50 mg; if necessary, use approximately one hour before sexual activity. Depending on the efficacy and tolerability of the drug, the dose may be increased to 100 mg or decreased to 25 mg*. The maximum recommended dose is 100 mg per day. If Conegra Deluxe is taken with food, the effect of the drug may occur later than when it is taken on an empty stomach.

Elderly patients. There is no need for dose adjustment in elderly patients (≥ 65 years).

Patients with renal impairment. For patients with mild to moderate renal impairment (creatinine clearance 30-80 ml/min), the recommended dose is the same as that given above in the section "Adults".

Since sildenafil clearance is reduced in patients with severe renal insufficiency (creatinine clearance < 30 ml/min), a dose of 25 mg* should be considered. Depending on the efficacy and tolerability of the drug, the dose can be gradually increased to 50 mg and 100 mg if necessary.

Patients with hepatic impairment. Since sildenafil clearance is reduced in patients with hepatic impairment (e.g. cirrhosis), a dose of 25 mg* should be considered. Depending on the efficacy and tolerability of the drug, the dose can be gradually increased to 50 mg and 100 mg if necessary.

Patients taking other medicinal products. If patients are concomitantly using CYP3A4 inhibitors (except for ritonavir, which is not recommended for use with sildenafil, see sections "Precautions for Use" and "Interaction with Other Drugs and Other Interactions"), an initial dose of 25 mg* should be considered.

In order to minimise the possible development of postural hypotension in patients taking α-adrenergic receptor blockers, the condition of such patients should be stabilised with α-adrenergic receptor blockers before starting sildenafil. Consideration should also be given to the possibility of using an initial dose of 25 mg* (see sections "Precautions for Use" and "Interaction with Other Drugs and Other Interactions").

* - use medicinal products with the active ingredient sildenafil in the appropriate dosage.

Children.Conegra Deluxe is not indicated for use in persons under 18 years of age.

This information about medicinal products, including prescription drugs, is intended for information purposes only and is not a guide for self-diagnosis and/or treatment.
The use of medicinal products is possible only as prescribed by a physician and after prior consultation with him/her. Self-medication can be harmful to your health.