Impaza^® (Tablets) Instructions for Use

Marketing Authorization Holder

Materia Medica Holding NPF, LLC (Russia)

Contact Information

MATERIA MEDICA HOLDING NPF LLC (Russia)

ATC Code

G04BE (Drugs for the treatment of erectile dysfunction)

Dosage Form

Impaza®

Lozenges: 20 pcs.

Dosage Form, Packaging, and Composition

Lozenges from white to almost white in color, flat-cylindrical in shape, with a score and a bevel; on the flat side with a score, the inscription MATERIA MEDICA is applied, on the other flat side the inscription IMPAZA is applied; the break line (score) is not intended for dividing the tablet into parts.

* EMD – units of modifying action.

Excipients: lactose monohydrate, microcrystalline cellulose, magnesium stearate.

20 pcs. – blister packs (1) – cardboard packs.

Clinical-Pharmacological Group

Erectile dysfunction treatment drug

Pharmacotherapeutic Group

Drugs for the treatment of erectile dysfunction

Pharmacological Action

It increases the activity of endothelial NO synthase, restores the production of nitric oxide (NO) by the endothelium during sexual stimulation, increases the content of cyclic guanosine monophosphate (cGMP) in smooth muscles and promotes their relaxation, which leads to increased blood filling of the cavernous bodies and provides an erection of sufficient strength and duration.

The drug increases libido (sexual desire) and satisfaction with sexual intercourse.

Regular use of the drug helps to increase the testosterone content in the serum (with a moderately reduced initial level).

Clinical efficacy and safety

During clinical trials, the efficacy and safety of the drug Impaza^® were studied in men with erectile dysfunction of different age groups.

The efficacy of the drug Impaza^® was assessed using the International Index of Erectile Function (IIEF), which includes 5 main components: erectile function, satisfaction with sexual intercourse, orgasm, libido and overall satisfaction.

Both in terms of the ability to improve erectile function and in terms of the positive effect on other aspects of sexual function, the drug Impaza^® statistically significantly outperformed placebo.

By the end of 3 months of therapy in the Impaza^® drug group, the achieved results statistically significantly (p<0.001) exceeded both the initial indicators and the data of the control group. Against the background of treatment in the Impaza^® drug group, an increase in the integral indicator “erectile function” by 23.5% was observed, in the placebo group this indicator increased by 5.5% (p<0.001).

In the Impaza^® drug group, a significant (p<0.001) improvement in all integral indicators of the IIEF was also noted by the end of the 1st month; with continued therapy up to 3 months, the positive dynamics increased.

Analysis of the results of the total subjective assessment of the clinical efficacy of treatment by patients showed a significant advantage of the Impaza^® drug group: 16.7% of patients assessed the treatment effect as excellent, 83.3% of patients as good.

Preclinical safety data

Preclinical safety studies, including studies of acute and chronic toxicity, genotoxicity, reproductive toxicity, immunotoxicity, sensitizing and local irritant properties, did not reveal the presence of toxic or potentially hazardous effects of the drug Impaza^® in humans.

Pharmacokinetics

Pharmacokinetic studies are impossible due to the complex composition of the drug.

Indications

The drug Impaza^® is indicated for use in adults

• Erectile dysfunction of various origins.

ICD codes

Dosage Regimen

The recommended dose for adults is 1 tablet per dose.

To improve erection (ability for sexual intercourse), a therapeutic and prophylactic course of at least 12 weeks is recommended, 1 tablet 1-2 times a day. If necessary, course therapy can be repeated after 3-6 months.

Method of administration

The tablet should be kept in the mouth until completely dissolved. The drug should be taken not during meals.

Special patient groups

Dose adjustment in elderly patients is not required.

Dose adjustment in patients with impaired renal function is not required.

Dose adjustment in patients with impaired liver function is not required.

The safety and efficacy of the drug Impaza^® in children and adolescents aged 0 to 18 years have not been established to date. Data are not available.

Adverse Reactions

Possible reactions of increased individual sensitivity to the components of the drug.

Contraindications

• Hypersensitivity to the active substance or to any of the excipients that make up the drug.

Use in Pregnancy and Lactation

According to the registered indication, the drug is not intended for use in women.

Use in Hepatic Impairment

Dose adjustment is not required.

Use in Renal Impairment

Dose adjustment is not required.

Pediatric Use

The use of the drug is contraindicated under the age of 18 years.

Geriatric Use

Dose adjustment is not required.

Special Precautions

Excipients

The drug contains lactose, therefore patients with rare hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take this drug.

Effect on the ability to drive vehicles and mechanisms

No negative effect of the drug Impaza^® on the ability to drive vehicles (including bicycles, scooters) and other potentially dangerous mechanisms was detected.

Overdose

Symptoms: in case of overdose, dyspeptic phenomena are possible due to the excipients that make up the drug.

Treatment is symptomatic.

Drug Interactions

It is possible to use the drug Impaza^® against the background of nitrate intake in patients with coronary artery disease (stable angina pectoris I-II functional class), as well as use together with beta-blockers, diuretics, ACE inhibitors, calcium antagonists.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F). During the period of use of the drug, store the blister pack in the cardboard pack provided by the manufacturer.

Shelf Life

The shelf life is 3 years. Do not use after the expiration date.

Dispensing Status

The drug is available without a prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.