Read this information carefully before using this medicine.
Ask your doctor or pharmacist if you need further information.
Registration number: XXXXXXX
Trade name: Impaza
Composition: Each orodispersible tablet contains:
Active ingredient: Affinity purified antibodies to endothelial NO-synthase 3 mg (water-ethanol mixture or the active substance dilutions).
*Weight of lactose saturated with water-ethanol mixture of dilutions of the active substance with concentration not more than 10-15 ng/g.
Excipients: lactose, microcrystalline cellulose, magnesium stearate.
White to off-white, round, flat, scored on one side and beveled tablets, marked «MATERIA MEDICA» on one side and «IMPAZA» on the other.
Drugs used in erectile dysfunction.
ATC codes: G04BE
Pharmacodynamics: IMPAZA enhances the activity of endothelial nitric oxide (NO) synthase, restores production of NO by the endothelium under sexual stimulation, increases concentration of cyclic guanosine monophosphate (cGMP) in smooth muscles and facilitates their relaxation, which leads to increased blood inflow to the cavernous bodies. The abovementioned effects enable the beginning of erection which is sufficient in strength and duration.
Due to positive influence on central mechanisms of erection the medicine increases libido (sexual drive) and intercourse satisfaction.
Long-term use of the medicine contributes to an increase in total serum testosterone levels (in cases of partial androgen deficiency).
Pharmacokinetics: The sensitivity of contemporary physicochemical methods (gas-liquid chromatography, high performance liquid chromatography and mass spectrometry) does not allow assessing the content of ultralow doses of antibodies in biological fluids, organs and tissues; that makes technically impossible to investigate the pharmacokinetic properties of Impaza.
Erectile disturbances (erectile dysfunction) of various origin. Vegetative disorders related to male climacterial period (weakness, rapid fatigue, decrease in physical activity, decrease in libido etc.)
Individual hypersensitivity to components of the medicine.
Posology and method of administration
One tablet per intake (the tablet should be held in the mouth until it is completely dissolved, not during the meal).
Regular intake. To stabilize sexual potency (the ability for sexual intercourse) except cases of underlying organic causes, a 12 week treatment course is recommended. During the course the drug is taken with frequency from once on alternate days to 2 times per day, preferably in the evening hours.
If necessary, the therapeutic courses both for potency stabilization and treatment of symptoms of male climacterial period may be repeated at 3-6 months intervals.
On-demand use. In order to stimulate erection, 2 tablets should be taken 1-2 hours before intercourse.
There is no relevant indication for use of IMPAZA by children.
No side effects have been reported for the drug used in accordance with the specified indications in the recommended doses.
Individual hypersensitivity to components of the medicine is possible.
Inform doctors of any unwanted effects related to drug use.
No cases of overdose have been reported.
Dyspepsia caused by excipients is possible in accidental overdose.
Effects on ability to drive and use machines
Impaza has no influence on the ability to drive and use machines.
Interaction with other medicinal products and other forms of interaction
IMPAZA can be used by patients suffering from coronary heart disease (angina pectoris of 1-2 functional class) and taking nitrates. IMPAZA can be co-administered with betaadrenergic blocking agents, diuretics, ACE inhibitors, calcium channel blockers.
Special warnings and precautions for use
Medicine contains lactose. Patients with rare hereditary problems of galactose intolerance, the lactase deficiency or glucose-galactose malabsorption should not take this medicine.
IMPAZA is not indicated for use by women.
No correction therapy for hepatic and renal failure.
Use in Pregnancy and lactation
There were no special clinical studies of IMPAZA on woman in period of pregnancy or lactation.
Nature and contents of container
20 orodispersible tablets in PVC/Aluminum blister. 1 blister is inserted into a cardboard box with leaflet.
Store in dry light-protected place at temperature below 300C.
Store in the original package.
Keep out of reach of children.
3 years since the manufacturing date. Do not use after the expiry date indicated on the package.
Specification: Manufacturer’s standard (In house).
ООО «NPF «MATERIA MEDICA HOLDING»
9, 3rd Samotyochny per., Moscow, Russia, 127473
Tel/fax: +7 (495) 684-43-33
Date of last revision: 2 of September 2011