Maxigra Max 50 mg x 2 film-coated tablets

Directions for use: use w/o doctor's instructions.
See package insert for detailed directions for use.

Storage: Store at ambient temperature

Sildenafil

Zakłady Farmaceutyczne Polpharma S.A.

Zakłady Farmaceutyczne Polpharma S.A.,
19 Pelplińska street,
83-200 Starogard Gdański,
PL

Before administering drug treatment, the patient should use the questionnaire included in the package to assess whether his/her use of the drug product is appropriate. The questionnaire can be found in the "Patient's Guide". If the use of pharmacological treatment is decided by the doctor, the patient's subject and physical examination should be conducted to diagnose erectile dysfunction and determine its causes. Cardiovascular risk factors. Since there is a risk of cardiovascular dysfunction associated with sexual activity, when pharmacological treatment is decided by a physician, it is advisable to assess the patient's cardiovascular status before starting any treatment for erectile dysfunction. Sildenafil, exhibiting the property of vasodilation, causes a slight, transient reduction in blood pressure. Before prescribing sildenafil, the doctor should assess whether the patient may be susceptible to vasodilator effects, especially during sexual activity. Increased sensitivity to vasodilators is demonstrated in patients with impaired outflow of blood from the left ventricle (such as aortic outlet stenosis or hypertrophic cardiomyopathy with narrowing of the outflow tract) and with the rare multiple atrophy syndrome, characterized by severe impairment of blood pressure control by the autonomic nervous system. Maxigra Max potentiates the hypotensive effect of nitrates. Following the marketing of sildenafil, cases have been reported of time-related severe cardiovascular disorders, such as myocardial infarction, unstable angina, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, transient ischemic attack, hypertension or hypotension. Most of these patients who developed the above disorders were in a group with risk factors for cardiovascular disease. Many of these side effects occurred during or shortly after sexual intercourse. In isolated cases, there were patients in whom the above disorders occurred shortly after sildenafil use before sexual activity occurred. It is not possible to clearly determine the relationship between the above events and the factors that may have caused them. Priapism. Drug products for the treatment of erectile dysfunction, including sildenafil, should be used with caution in patients with anatomical penile deformities (such as kinking, fibrosis of the corpora cavernosa or Peyronie's disease) and diseases predisposing to priapism (such as sickle cell anemia, multiple myeloma or leukemia). Following the approval of sildenafil, cases of prolonged erections and priapism have been reported. If an erection persists for more than 4 hours, the patient should seek immediate medical attention. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may occur. Concomitant use with other PDE5 inhibitors or other treatments for erectile dysfunction. To date, the safety and efficacy of concomitant use of sildenafil with other PDE5 inhibitors, therapies for pulmonary arterial hypertension (TNP) with sildenafil (REVATIO), or other treatments for erectile dysfunction have not been studied. Such combinations are not recommended. Visual disturbances. Spontaneous cases of visual disturbances have been reported in association with sildenafil and other PDE5 inhibitors. Cases of non-arteritis-related anterior ischemic neuropathy of the optic nerve, a rare condition, have been reported spontaneously and in observational studies in association with taking sildenafil and other PDE5 inhibitors. If any sudden visual disturbance occurs, the patient should stop taking Maxigra Max and consult a physician immediately. Concomitant use with ritonavir. Concomitant use of sildenafil and ritonavir is not recommended. Concomitant use with alpha-blockers. Caution should be exercised when sildenafil is taken by patients taking alpha-blockers, as concomitant use may lead to symptomatic hypotension in a small number of susceptible patients. This most often occurs within 4 hours of taking sildenafil. To reduce the risk of orthostatic hypotension, the condition of a patient taking alpha-blockers should be hemodynamically stable before starting sildenafil treatment; consider starting therapy with the lowest commercially available dose of 25 mg of sildenafil. In the event that drug therapy is decided by the doctor, he should inform the patient what to do if symptoms of orthostatic hypotension occur. Effects on bleeding. In vitro studies conducted on human platelets have shown that sildenafil enhances the anticoagulant effect of sodium nitroprusside. There is no information on the safety of sildenafil in patients with coagulation disorders or active peptic ulcer disease. Therefore, sildenafil should be used in these patients only after careful consideration of the possible benefits and risks. Women. Maxigra Max medicinal product is not indicated for use in women. Sodium. The product contains less than 1 mmol (23 mg) of sodium per tablet, that is, the product is considered "sodium free."