INSTRUCTION

the drug for medical use

KAMAHRA JELLY

(KAMAGRA JELLY)

Ingredients:

active ingredient: 5 g gel contains 50 mg or kamagra oral jelly 100 mg (as kamagra oral jelly citrate);

Excipients: sucrose, sodium methylparahydroxybenzoate (E 219), sodium propilparahidroksybenzoat (E 217), acesulfame potassium, sodium chloride, propylene glycol, sorbitol (E 420), sodium carboxymethylcellulose, citric acid, dye quinoline yellow (E 104), pineapple flavor, purified water.

Pharmaceutical form. Gel for oral delivery.

Pharmacotherapeutic group. Drugs used in erectile dysfunction. Sildenafil. ATS ID G04B E03.

Clinical characteristics.

Pokazannya.Likuvannya erectile dysfunction, defined as the inability to achieve and maintain an erection of the penis, necessary for successful intercourse.

For effective action kamagra oral jelly required sexual stimulation.

Drug.

Use of kamagra oral jelly is contraindicated in patients with known hypersensitivity to active substance or any excipient.

Due to the impact of exchange of nitric oxide / cGMP, kamagra oral jelly enhances the hypotensive effect of nitrates in their single or prolonged use, so it is a joint appointment with nitric oxide donors, organic nitrates or organic nitrites in any form continuously or periodically contraindicated.

Preparations for the treatment of erectile dysfunction, including kamagra oral jelly, should not be used for patients for whom sexual activity is not desirable (eg, patients with severe cardiovascular disease such as unstable angina or severe heart failure).

Acceptance of kamagra oral jelly is contraindicated for patients who have lost eyesight in one eye due nearterialnu anterior ischemic optic neuropathy, regardless of whether it happened because of previous inhibitors FDE5 or not.

Safety of kamagra oral jelly not studied in these subgroups of patients because these patients the drug contraindicated in: patients with severe liver dysfunction, and arterial hypotension (blood pressure <90/50 mmHg. Cent.), With recent stroke or myocardial infarction and known hereditary retinal degenerative diseases such as pigmentosa retynit (lower part of such patients have a genetic disease of retinal phosphodiesterase).

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Dosage and Administration.

Kamahra jelly intended for oral administration. To implement the necessary effect cyldenafilu sexual arousal.

Application adults. The recommended dose for adults is 50mg, you accept, if necessary, about 1 hour before sexual activities. Given the efficacy and tolerability, dose can be increased to 100 mg. The maximum recommended dose is 100mg. The maximum recommended frequency of acceptance once a day. The activity of kamagra oral jelly may be expressed through a longer term at a reception with food intake compared with an empty stomach.

Application of the elderly. For elderly patients dosage change is needed.

Adverse reactions.

Adverse events were transient, mild to moderate. During the study the frequency and severity increased with increasing doses. The nature of side effects in studies of variable dose, which largely reflects the recommended dosage regimen, was similar to the fixed-dose studies. The most common side effects were headache and hot flashes.

Very common side displays - Frequency more than 1 / 10:

Since the nervous system - headache.

In the cardiovascular system - vasodilatation (hot flushes).

FAQ - 1/100-1/10 frequency:

Since the nervous system - dizziness.

From the side view - abnormal vision (misting vision, sensitivity to light), hromatopsiya (moderate degree, transient, especially color vision).

In the cardiovascular system: palpitatsiya (feeling heartbeat).

From the respiratory system - rhinitis (nasal congestion).

From the digestive tract - dyspepsia.

In applying the drug in doses that exceed recommended, adverse effects were similar, but occur more often.

Application of kamagra oral jelly did not influence the frequency of myocardial infarction and mortality rate from cardiovascular diseases.

In post-registration period, there were atypical or malorozpovsyudzheni reactions while receiving the drug:

Immune system - hypersensitivity reactions (including skin rash);

nervous system - an epileptic seizure, recurrent epileptic attack;

Cardiovascular - tachycardia, arterial hypotension, syncope, epistaxis;

digestive tract - vomiting;

Disorders of view - eye pain, redness of eyes;

reproductive system - prolonged erections and / or priapizm.

Overdose.

In studies on healthy volunteers at times the reception of the drug in doses up to 800 mg adverse effects were similar to those observed at lower doses of kamagra oral jelly, but their frequency of occurrence and severity increased.

In cases of overdose, if necessary zastosovuvyut symptomatic therapy. It should be noted that dialysis does not accelerate the withdrawal of the drug, kamagra oral jelly as tightly bound to plasma proteins and excreted in urine.

Features application.

A diagnosis of erectile dysfunction, determine possible causes of disease and the appointment of adequate treatment is necessary to carefully examine the patient's medical history and perform a thorough medical examination.

For the effectiveness of kamagra oral jelly medications required sexual stimulation.

Associated with sexual activity a certain degree of risk due to possible heart attack. So before you start any course of treatment of erectile dysfunction, your doctor should check the status of cardiovascular patients. Drugs designed to treat erectile dysfunction, should not be used in patients for whom sexual activity is not desirable.

Since the introduction of the drug in large medical practices reported serious cardiovascular complications that coincide in time with the intake of kamagra oral jelly. These include myocardial infarction, sudden cardiac death, ventricle fibrillation, cerebrovascular hemorrhage and transient ischemic attack. Most, but not all, of these patients had previous cardiovascular risk factors. Most of these cases were observed during or immediately after sexual pressure, a small part - in a short period after administration of kamagra oral jelly without sexual activity. Other cases occurred over hours or days after use of kamagra oral jelly and sexual stress. Thus, it is impossible to establish a direct relationship of these cases with the use of kamagra oral jelly, sexual activity, with concomitant cardiovascular diseases, combination of these factors or other factors.

In healthy volunteers receiving kamagra oral jelly at times the doses of 100 mg was not revealed clinically significant changes in ECG. The mean maximum reduction of systolic pressure in a horizontal position after oral administration of the drug at a dose of 100 mg was 8.34 mmrt. Art. The changes in diastolic pressure in the horizontal position was 5.3 mmrt. Art. Lower than normal, but short-term blood pressure decreased in patients who were simultaneously taking nitrates.

In studies done kamagra oral jelly medication systemic vasodilative action that resulted in transient reduction of blood pressure. This effect is of little value or do not lead to any effects in most patients. However, the appointment of kamagra oral jelly physician must carefully weigh the risk of undesirable acts vasodilative action in patients with certain concomitant diseases, especially during sexual activity. Increased sensitivity to vasodilators observed in patients with left ventricular obstruction (aortic stenosis, obstructive hypertrophic cardiomyopathy), and with multiple system atrophy symptoms that occur in rare cases and revealed gross violation of autonomous control of blood pressure.

Sildenafil 100 mg once daily oral administration in patients with severe heart disease (stenosis> 70% at least one coronary artery) reduces your average resting systolic pressure and diastolic pressure by 7% and 6% respectively, compared with baseline. The average systolic pulmonary pressure fell by 9%. Sildenafil has not committed any effect on cardiac output and blood flow in coronary arteries stenozovanyh due to improvement (approximately 13%) adenosine-stimulated blood flow reserve (in the coronary arteries with and without stenosis).

In patients with erectile dysfutsiyeyu and stable angina who regularly took antianginal medications (except nitrates) and used generic kamagra oral jelly 100 mg once daily orally, was the increasing duration tredmil-test (19.9 sec. 95% confidence interval 0.9 -38.9 sec.) and the average time of exercise in aggravation of the symptoms of angina, 423.6 and 403.7 sec. compared with placebo.

In patients with hypertensive, simultaneously taking two or more antihypertensive drugs, kamagra oral jelly 100 mg once a day internally improved erections in 71%, increased the number of successful sexual attempts by 62%.

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The number of side effects was the same compared with patients in other groups of patients receiving three or more antihypertensive drugs.

In all studies using FDE5 inhibitors, including kamagra oral jelly, reported nearterialnu anterior ischemic optic nerve neuropathy (NAION), which causes reduction or loss of vision. Most of these patients had risk factors such as reduced ratio of depth / area ("stagnant disc), age older than 50rokiv, diabetes, hypertension, coronary disease, hyperlipidemia and smoking. There was no established causal links between FDE5 inhibitors and appearance of NAION. The doctor should warn patients who had signs of NAION, the possible recurrence of NAION. Patients should be warned about the need to consult your doctor immediately if sudden loss of vision.

In patients with age degeneration of the retina kamagra oral jelly 100 mg once a day internally was well-tolerated and showed no clinical effect in the study of visual fuktsiy in tests (visual acuity, mesh Amslera, color recognition, artificial stream of light, and perimetry in Hamfreya fotostres).

Sildenafil is recommended for use with caution in patients receiving both an alpha blocker used because in some cases this may lead to symptomatic hypotension. To minimize the risk of postural hypotension, should achieve stabilization of the blood pressure with alpha-blockers to use kamagra oral jelly. It should start to use low dose of kamagra oral jelly. In addition, doctors should tell patients what to do in case of symptoms of postural hypotension.

In some patients with congenital pigment retynitom marked genetic defects of retinal phosphodiesterase. There is no information about security purpose kamagra oral jelly patients with pigmented retynitom because this group of patients kamagra oral jelly should be administered with caution.

Studies in human platelets vitrosvidchat that kamagra oral jelly enhances the effect of sodium nitroprusydu inhibit platelet aggregation (donator NO). There is no safety information regarding the appointment of kamagra oral jelly to patients with a predisposition to bleeding or an acute stomach ulcer, so this group of patients kamagra oral jelly should be administered with caution.

Drugs designed to treat erectile dysfunction, should be used with caution in patients with anatomical deformations of the penis (such as anhulyatsiyi, cavernous fibrosis or Peyronie's disease) or patients who have diseases that can lead to priapizmu (such as lunar-cell anemia, multiple myeloma or leukemia).

Safety and efficacy of combinations of kamagra oral jelly with other treatments for erectile dysfunction were not investigated, so apply such combinations is not recommended.

After oral single dose of 100 mg of kamagra oral jelly was not observed any effect on the motility and morphological characteristics of spermatozoa in healthy volunteers.
On a sudden reduction and hearing loss reported in a small number of cases in post-market studies in the application FDE5inhibitoriv inhibitors, including kamagra oral jelly. Most of these patients had risk factors for sudden decrease or loss of hearing. Any causal link inhibition FDE5ta sudden decrease or loss of hearing patients is not established. In the event of sudden decrease or loss of hearing patients should be encouraged to discontinue use of kamagra oral jelly and immediately consult a doctor.

Application patients with renal impairment. Patients with mild renal insufficiency and moderate severity (creatinine clearance of 30 - 80ml/hv) dosage regimen does not change. Because patients with severe renal insufficiency (creatinine clearance <30ml/hv) reduced clearance of kamagra oral jelly, the drug should start with a dose of 25 mg.

Application of the patients with liver dysfunction. As in patients with liver failure cheap generic kamagra oral jelly reduced clearance, such as cirrhosis, the drug should start with a dose of 25 mg.

Use in patients who use other treatments. Given the degree of interaction in patients who receive concomitant therapy ritonavir is not recommended to exceed a maximum single dose of kamagra oral jelly 25 mg over 48 hours. The initial dose of 25 mg should rekomenduvatysya patients receiving concomitant inhibition CYP3A4 (eg erythromycin, sakvinavir, ketoconazole, itraconazole).

To reduce the risk of postural hypotension should achieve stabilization of patients during therapy of alpha-blockers to use kamagra oral jelly. Furthermore, it should start with the least use of drug doses.
Use during pregnancy or breastfeeding.

Sildenafil is not intended to be used by women.

Children.

Sildenafil is not indicated for use by persons under the age of 18rokiv.

Ability to influence the reaction speed when driving or operating other machinery.

Study effects on ability to drive and work with the mechanisms to be evaluated.

Since during clinical studies were observed kamagra oral jelly dizziness and blurred vision, patients need to know your reaction to receiving Kamahry jelly before you drive a car or work with mechanisms.

Interaction with other drugs and other types of interactions.

The influence of other drugs on kamagra oral jelly. Studies in vitro: Sildenafil metabolism is mediated mainly by cytochrome P450 (CYP), namely its isoforms 3A4 (major road) and 2S9 (minor road). Thus, inhibitors of these isoenzymes may reduce kamagra oral jelly withdrawal, and inducers of these isoenzymes may increase its output.

Studies in vivo: Population pharmacokinetic analysis of clinical trial results showed decrease kamagra oral jelly clearance while applying it with inhibitors of CYP 3A4 (eg, ketoconazole, erythromycin, cimetidine). Cimetidine (800mh), inhibitor of cytochrome CYP3A4 R450ta nonspecific inhibitor, with accompanying receiving kamagra oral jelly 50 mg healthy volunteers to cause the increase of its concentration in plasma by 56%.

When administered a single dose of kamagra oral jelly 100mg erythromycin, a specific inhibitor of CYP 3A4 (500 mg twice a day, 5 days), systemic dose of kamagra oral jelly (AUC) increased by 182%. Simultaneous treatment with HIV protease inhibitors sakvinaviru (1200 mg three times a day), who also is an inhibitor of CYP 3A4, led to an increase Smaxsyldenafilu 140%, AUC - to 210%. Sildenafil did not influence the pharmacokinetics sakvinaviru. Strong CYP 3A4 inhibitors such as ketoconazole and itraconazole, can reveal more pronounced effects.

Simultaneous treatment with HIV protease inhibitor ritonavir, which is a highly specific inhibitor of P450, under equilibrium concentrations (500 mg twice daily) with kamagra oral jelly (100 mg once) leads to a 300% increase (4 times) Cmaxsyldenafilu and 1000% increase (in 11 times) AUCsyldenafilu in plasma. Through 24hodyny kamagra oral jelly plasma concentrations were approximately 200nh/ml, while the application of these separately kamagra oral jelly concentration was 5 ng / ml. This is rytonavirzumovlenymy effects of P450 isozymes. Sildenafil does not affect the pharmacokinetics of ritonavir. When the dose of kamagra oral jelly for subjects receiving inhibitor of CYP3A4, was used in accordance with the recommendations in the plasma concentration of kamagra oral jelly was less than 200 nM for every patient, and the drug had a good tolerance.

Acute administration antatsydu (magnesium hydroxide and aluminum hydroxide) did not affect the bioavailability of kamagra oral jelly.