Tadalafil Maxigra 10 mg x 4 tabl.

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

Storage: Store at ambient temperature

Tadalafil

Zakłady Farmaceutyczne Polpharma S.A.

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

Before starting treatment with Tadalafil Maxigra. Before using drug treatment, the patient should use the questionnaire included in the package to assess whether his use of the drug product is appropriate. The questionnaire can be found in the "Patient's Guide". In case the use of pharmacological treatment is decided by a doctor, a medical history and physical examination should be performed to diagnose the patient's erectile dysfunction and determine its potential causes. In case the use of pharmacological treatment is decided by a doctor, it is advisable to assess the patient's cardiovascular status before starting any treatment for erectile dysfunction, as there is a certain degree of risk of cardiac dysfunction associated with sexual activity. Tadalafil has vasodilating properties and causes a mild and transient reduction in blood pressure, and may thus potentiate the hypotensive effect of nitrates. Evaluation of erectile dysfunction should include determining its potential underlying causes and, after a thorough medical evaluation, determining appropriate treatment. It is not known whether Tadalafil Maxigra is effective in patients following pelvic surgery or radical prostatectomy without nerve sparing. Cardiovascular System. Severe cardiovascular side effects such as myocardial infarction, sudden cardiac death, unstable angina, ventricular arrhythmias, stroke, transient ischemic attacks (TIA), chest pain, palpitations and tachycardia have been reported after tadalafil was marketed and/or in clinical trials. Most of the patients who experienced these effects had cardiovascular risk factors. However, it is not possible to determine conclusively whether the reported effects were directly related to these risk factors, tadalafil, sexual activity or a combination of these and other factors. In patients taking α1-adrenergic receptor blockers, concomitant administration of Tadalafil Maxigra may lead to hypotension in some patients. Therefore, concomitant use of tadalafil and doxazosin is not recommended. Sight
Visual disturbances, including central serous chorioretinopathy (CSCR) and cases of non-arteritis-related anterior ischemic optic neuropathy (NAION), have been reported in association with tadalafil and other PDE5 inhibitors. In most cases, CSCR resolved spontaneously after tadalafil discontinuation. Regarding NAION, analyses of observational data indicate an increased risk of acute nonarteritic anterior ischemic neuropathy of the optic nerve in men with erectile dysfunction after use of tadalafil or other PDE5 inhibitors. Because it may be relevant to all patients taking tadalafil, patients should be advised to discontinue taking Tadalafil Maxigra and consult a physician immediately if they experience sudden visual disturbances, impaired visual acuity and/or visual distortion. Deterioration or sudden hearing loss. Cases of sudden hearing loss following tadalafil use have been reported. Although other risk factors (such as age, diabetes, hypertension and a history of hearing loss) have been present in some cases, patients should be advised to discontinue tadalafil use and seek immediate medical advice in the event of sudden deterioration or hearing loss. Renal and hepatic impairment. Because of the increased exposure (AUC) to tadalafil, limited clinical experience and the inability of dialysis to alter clearance, tadalafil Maxigra in a once-daily regimen is not recommended for use in patients with severe renal impairment.
There are limited clinical data on the safety of single doses of tadalafil in patients with severe hepatic insufficiency (Child-Pugh class C). When pharmacological treatment is decided by a physician, the physician should carefully evaluate the benefit-risk ratio before using Tadalafil Maxigra in a patient. Priapism and anatomical deformities of the penis. The patient should seek immediate medical attention if the erection persists for 4 hours or longer. If priapism is not treated immediately, damage to the tissues of the penis and permanent loss of potency may occur.Tadalafil Maxigra should be used with caution in patients with anatomical deformities of the penis (e.g., bowing, fibrosis of the corpora cavernosa, or Peyronie's disease) or in patients with conditions that may predispose to priapism (e.g., sickle cell anemia, multiple myeloma, leukemia). Use with CYP3A4 inhibitors. Caution should be exercised when prescribing Tadalafil Maxigra to patients using potent CYP3A4 inhibitors (ritonavir, saquinavir, ketoconazole, itraconazole and erythromycin), as increased exposure (AUC) to tadalafil has been observed during concomitant use of these medicinal products. Tadalafil Maxigra and other treatments for erectile dysfunction. The safety and efficacy of concomitant use of tadalafil with other PDE5 inhibitors or with other treatments for erectile dysfunction have not been studied. Patients should be advised not to use Tadalafil Maxigra in such combinations. Lactose. The product should not be used in patients with rare hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome. Sodium. The product contains less than 1 mmol (23 mg) of sodium per film-coated tablet, that is, the product is considered "sodium free."