Novagra 50 mg 1 tablet — Made in India — Free Delivery

Product description

Novagra is recommended for the treatment of erectile dysfunction, which is defined as the inability to achieve and maintain an erection of the penis necessary for successful intercourse.

For the effective action of the preparation NOVAGRO, sexual arousal is needed.

Compound

active substance: sildenafil; 1 tablet contains sildenafil citrate, equivalent to sildenafil 25 mg or 50 mg or 100 mg; excipients: calcium hydrogen phosphate, microcrystalline cellulose, croscarmellose sodium, povidone, colloidal silicon dioxide, magnesium stearate, instakot IC-S-091 (pink).

Sildenafil is an oral preparation for the treatment of erectile dysfunction. With sexual arousal, the preparation restores reduced erectile function by increasing blood flow to the penis.

Sildenafil causes a mild and short-term decrease in blood pressure, in most cases it has no clinical manifestations. These reductions in blood pressure are in good agreement with the vasodilating effect of sildenafil, possibly as a result of increased levels of cGMP in vascular smooth muscle. Single oral administration of sildenafil in doses up to 100 mg in healthy volunteers did not result in any clinically significant changes in the ECG.

Contraindications

Hypersensitivity to the active substance or to any of the excipients of the preparation. Simultaneous use with nitric oxide donors (such as amyl nitrite) or nitrates in any form is contraindicated, since it is known that sildenafil affects the metabolic pathways of nitric oxide / cyclic guanosine monophosphate (cGMP) and potentiates hypotensive effect of nitrates. Medicines for the treatment of erectile dysfunction, including sildenafil, are contraindicated in men who are not recommended for sexual activity (for example, patients with severe cardiovascular disorders such as unstable angina and severe heart failure). Patients with vision loss in one eye due to non-arterial anterior ischemic neuropathy of the optic nerve, regardless of whether this pathology is associated with previous use of PDE-5 inhibitors or not. Patients with the following diseases: severe liver dysfunction, arterial hypotension (blood pressure below 90/50 mm), 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 the retinal PDE), since the safety of sildenafil has not been studied in such patient subgroups.

Method of administration and dosage

The preparation is administered orally.

For the effective action of the preparation NOVAGRO, sexual arousal is needed.

Adults.

The recommended dose of NOVAGRO is 50 mg and is applied as needed approximately 1:00 before intercourse. Depending on the effectiveness and tolerability of the preparation, the dose can be increased to 100 mg or reduced to 25 mg. The maximum recommended dose is 100 mg.

The maximum recommended frequency of use of the preparation is 1 time per day. When using the preparation  NOVAGRO during a meal, the effect of the preparation may occur later than when it is used on an empty stomach.

Overdose

In studies with a single dose of sildenafil up to 800 mg, adverse reactions were similar to those observed with sildenafil at lower doses, but were more common and more severe. The use of sildenafil at a dose of 200 mg led to an increase in efficacy, but caused an increase in the incidence of adverse reactions (headache, hot flashes, dizziness, dyspepsia, nasal congestion, visual disturbances).

In case of overdose, if necessary, resort to the usual supportive measures. An acceleration of the clearance of sildenafil during hemodialysis is unlikely due to the high degree of binding of the preparation to blood plasma proteins and the lack of elimination of sildenafil in the urine.

Adverse Reactions

The safety profile of NOVAGRO is based on data obtained from 8691 patients who received the preparation in recommended doses during 67 placebo-controlled clinical trials. The most commonly reported adverse reactions were headache, hot flashes, dyspepsia, visual disturbances, nasal congestion, dizziness, and color disturbance.

Attention! Reporting suspected adverse reactions following registration of a medicinal product is essential. This allows continuous monitoring of the balance between benefits and risks associated with the use of this preparation. Physicians should report any suspected adverse reactions as required by law.

Application features

Application during pregnancy or lactation

The preparation is not intended for use by women.

In reproductive toxicity studies in rats and rabbits, no corresponding side effects were observed with oral administration of sildenafil.

Children

NOVAGRO is not indicated for use in children under the age of 18.

The ability to influence the reaction rate when driving or driving other mechanisms

Studies of the effect of the preparation on the ability to drive vehicles or work with other mechanisms have not been conducted.

Since in clinical studies with sildenafil, cases of dizziness and visual disturbances have been reported, before driving a vehicle or working with mechanisms, it is necessary to find out the individual reaction to the use of NOVAGRO.

Interaction with other medicinal products and other types of interactions

Effects of other medicines on sildenafil.

Grapefruit juice is a weak inhibitor of CYP3A4 in the intestinal wall and can lead to a moderate increase in plasma levels of sildenafil.

A single use of antacids (magnesium hydroxide / aluminum hydroxide) does not affect the bioavailability of sildenafil.

Although studies of specific interaction with all preparations have not been conducted, according to population pharmacokinetic analysis, the pharmacokinetics of sildenafil did not change when used simultaneously with preparations belonging to the group of CYP2C9 inhibitors (tolbutamide, warfarin, phenytoin), the group of CYP2D6 inhibitors (such as selective reverse inhibitors seizure of serotonin, tricyclic antidepressants), a group of thiazide and thiazide-like diuretics, loop and potassium-sparing diuretics, ACE inhibitors, calcium antagonists, beta-adrenergic receptor antagonists or inducers of CYP450 metabolism (such as rifampicin, barbiturates).

Effects of sildenafil on other medicines.

Sildenafil (50 mg) would not lead to an increase in bleeding time caused by the use of acetylsalicylic acid (150 mg).

Sildenafil (50 mg) did not potentiate the hypotensive effect of alcohol in healthy volunteers at an average maximum blood ethanol level of 80 mg / dL.

Sildenafil did not affect the pharmacokinetic parameters of HIV protease inhibitors, saquinavir and ritonavir, which are substrates of CYP3A4.

Storage conditions

Store in its original packaging at a temperature not exceeding 25 ° C. Keep out of the reach of children.

Shelf life is 2 years.

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