Torfil 2.5/Torfil 5/Torfil 10/Torfil 20 Special Precautions

Evaluation of erectile dysfunction and benign prostatic hyperplasia should include an appropriate medical assessment to identify potential underlying causes as well as treatment options.
Patients with Cardiovascular Disease: Treatments for erectile dysfunction, including tadalafil is not recommended in patients with cardiac diseases for whom sexual activity is inadvisable. PDE5 inhibitors have vasodilatory properties which lead to transient decreases in blood pressure. In the event when a patient who has taken tadalafil needs nitrate administration deemed medically necessary for life-threatening situation, at least 48 hours must elapse after the last dose of tadalafil before nitrate is considered. Patients with severely impaired autonomic control of blood pressure may be sensitive to the effects of vasodilators, including PDE5 inhibitors.
Prolonged erection and Priapism: Cases of prolonged erection lasting greater than 4 hours and priapism (painful erection lasting greater than 6 hours) have been associated with the use of PDE5 inhibitors, including tadalafil. Patients with erection lasting for 4 hours or more must seek immediate medical attention. If neglected, it may result to penile tissue damage leading to permanent loss of potency. Caution must be exercised with the use of tadalafil in patients present with risk factors to priapism (sickle cell anemia, multiple myeloma, or leukemia) and in patients with anatomical deformation of the penis (angulation, cavernosal fibrosis or Peyronie’s disease).
Alpha-blockers and Antihypertensives: Caution is advised when PDE5 inhibitors are co-administered with alpha-blockers. Both substances are vasodilators with blood-pressure lowering effects, this may lead to symptomatic hypotension (e.g., fainting). For patients using tadalafil for erectile dysfunction, ensure that patient is stable on alpha-blocker therapy before administration of Tadalafil to prevent risk of developing symptomatic hypotension. Use of the lowest recommended dose is advised. For patients with BPH, concomitant use of Tadalafil and alpha-blocker is not recommended.
Alcohol: Alcohol and Tadalafil both act as mild vasodilators. When taken in combination, blood pressure-lowering effect of each substance may be increased. This may also increase risk of orthostatic signs and symptoms (increased heart rate, decreased standing BP, dizziness, and headache).
Vision Impairment: Rare reports of sudden loss of vision have been associated with temporal use of PDE5 inhibitors, including Tadalafil. Patient must be advised to discontinue medication and seek medical attention if vision impairment occurs as this may be a sign of NAION. NAION (non-arteritic anterior ischemic optic neuropathy) is a cause of decreased vision including permanent loss of vision. In the event of a sudden loss of vision, patients should be advised by their physician to stop use of tadalafil and must seek medical attention immediately. Patients with known hereditary degenerative retinal disorders (e.g., retinitis pigmentosa,) are contraindicated with the use of tadalafil.
Sudden Hearing Loss: Sudden hearing loss usually accompanied by tinnitus and dizziness have been reported with the temporal use of PDE5 inhibitors. Patient should discontinue medication and seek medical attention if this occurs.
Combination with Other Agent for Treatment of Erectile dysfunction: Determination of potential underlying cause and application of appropriate treatment after thorough medical assessment must be included in evaluating erectile dysfunction. There are no established studies regarding the combination of tadalafil with other agents for treatment of erectile dysfunction. Therefore, co-administration is not recommended.
Sexually Transmitted Disease: The use of tadalafil offers no protection against sexually transmitted disease.
Bleeding: Caution is advised in patients with bleeding disorders or significant active peptic ulceration.
Patient with Other Urological Conditions: In some cases, Benign Prostatic Hyperplasia and prostate cancer may coexist. Consideration is given to patients with other urological conditions prior to initiating treatment for BPH as that may cause similar symptoms.
Renal Impairment: Tadalafil is not recommended for patients with creatinine clearance less than 30 mL/min.
Hepatic Impairment: Caution is advised for patients with mild to moderate hepatic impairment if prescribed with once daily use of tadalafil. It is not recommended in patient with severe hepatic impairment.
Effects on Ability to Drive and Use Machine: Tadalafil has negligible influence on the ability to drive or use machines. Although the frequency of reports of dizziness in placebo and tadalafil arms in clinical trials was similar, patients should be aware of how they react to Tadalafil, before driving or using machines.
Torfil 5: Evaluation of erectile dysfunction and benign prostatic hyperplasia should include an appropriate medical assessment to identify potential underlying causes, as well as treatment options. Prior to initiating treatment with Tadalafil for benign prostatic hyperplasia patients should be examined to rule out the presence of carcinoma of the prostate and carefully assessed for cardiovascular conditions. The evaluation of erectile dysfunction should include a determination of potential underlying causes and the identification of appropriate treatment following an appropriate medical assessment. It is not known if Tadalafil is effective in patients who have undergone pelvic surgery or radical non-nerve-sparing prostatectomy. Before prescribing tadalafil tablets, it is important to note the following:
Cardiovascular: Physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Therefore, treatments for erectile dysfunction, including tadalafil tablets, should not be used in men for whom sexual activity is inadvisable as a result of their underlying cardiovascular status. Patients who experience symptoms upon initiation of sexual activity should be advised to refrain from further sexual activity and seek immediate medical attention.
Physicians should discuss with patients the appropriate action in the event that they experience anginal chest pain requiring nitroglycerin following intake of tadalafil tablets. In such a patient, who has taken tadalafil tablets, where nitrate administration is deemed medically necessary for a life-threatening situation, at least 48 hours should have elapsed after the last dose of tadalafil tablets before nitrate administration is considered. In such circumstances, nitrates should still only be administered under close medical supervision with appropriate hemodynamic monitoring. Therefore, patients who experience anginal chest pain after taking tadalafil tablets should seek immediate medical attention. Patients with left ventricular outflow obstruction, (e.g., aortic stenosis and idiopathic hypertrophic subaortic stenosis) can be sensitive to the action of vasodilators, including PDE5 inhibitors. As with other PDE5 inhibitors, tadalafil has mild systemic vasodilatory properties that may result in transient decreases in blood pressure. In a clinical pharmacology study, tadalafil 20 mg resulted in a mean maximal decrease in supine blood pressure, relative to placebo, of 1.6/0.8 mm Hg in healthy subjects. While this effect should not be of consequence in most patients, prior to prescribing tadalafil tablets, physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects. Patients with severely impaired autonomic control of blood pressure may be particularly sensitive to the actions of vasodilators, including PDE5 inhibitors. Do not use tadalafil in patients who are using a GC stimulator, such as riociguat. PDE5 inhibitors, including tadalafil, may potentiate the hypotensive effects of GC stimulators.
Potential for Drug Interactions When Taking Tadalafil Tablets for Once Daily Use: Physicians should be aware that tadalafil tablets for once daily use provides continuous plasma tadalafil levels and should consider this when evaluating the potential for interactions with medications (e.g., nitrates, alpha-blockers, anti-hypertensives and potent inhibitors of CYP3A4) and with substantial consumption of alcohol.
Priapism and Anatomical Deformation of the Penis: There have been rare reports of prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) for this class of compounds. Priapism, if not treated promptly, can result in irreversible damage to the erectile tissue. Patients who have an erection lasting greater than 4 hours, whether painful or not, should seek emergency medical attention. Tadalafil tablets should be used with caution in patients who have conditions that might predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia), or in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie's disease).
Vision: Physicians should advise patients to stop use of all phosphodiesterase type 5 (PDE5) inhibitors, including tadalafil, and seek medical attention in the event of a sudden loss of vision in one or both eyes. Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a rare condition and a cause of decreased vision, including permanent loss of vision. Physicians should consider whether their patients with underlying NAION risk factors could be adversely affected by use of PDE5 inhibitors. Individuals who have already experienced NAION are at increased risk of NAION recurrence. Therefore, PDE5 inhibitors, including tadalafil, should be used with caution in these patients and only when the anticipated benefits outweigh the risks. Patients with known hereditary degenerative retinal disorders, including retinitis pigmentosa, were not included in the clinical trials, and use in these patients is not recommended.
Sudden Hearing Loss: Physicians should advise patients to stop taking PDE5 inhibitors, including tadalafil, and seek prompt medical attention in the event of sudden decrease or loss of hearing. These events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to the intake of PDE5 inhibitors, including tadalafil. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors.
Alpha-blockers and Antihypertensives: Physicians should discuss with patients the potential for tadalafil to augment the blood-pressure lowering effect of alpha-blockers and antihypertensive medications. Caution is advised when PDE5 inhibitors are co-administered with alpha-blockers. PDE5 inhibitors, including tadalafil, and alpha-adrenergic blocking agents are both vasodilators with blood-pressure-lowering effects. When vasodilators are used in combination, an additive effect on blood pressure may be anticipated. In some patients, concomitant use of these two drug classes can lower blood pressure significantly, which may lead to symptomatic hypotension (e.g., fainting).
Renal and Hepatic Impairment: Due to increased tadalafil exposure (AUC), limited clinical experience, and the lack of ability to influence clearance by dialysis, tadalafil tablets for once daily use is not recommended in patients with creatinine clearance less than 30 mL/min. Tadalafil tablets for once daily use has not been extensively evaluated in patients with mild or moderate hepatic impairment. Therefore, caution is advised if tadalafil tablets for once daily use is prescribed to these patients. Because of insufficient information in patients with severe hepatic impairment, use of tadalafil tablets in this group are not recommended.
Alcohol: Patients should be made aware that both alcohol and tadalafil, a PDE5 inhibitor, act as mild vasodilators. When mild vasodilators are taken in combination, blood-pressure-lowering effects of each individual compound may be increased. Therefore, physicians should inform patients that substantial consumption of alcohol (e.g., 5 units or greater) in combination with tadalafil can increase the potential for orthostatic signs and symptoms, including increase in heart rate, decrease in standing blood pressure, dizziness, and headache.
Concomitant Use of Potent Inhibitors of Cytochrome P450 3A4 (CYP3A4): Tadalafil is metabolized predominantly by CYP3A4 in the liver. The dose of tadalafil tablets for use as needed should be limited to 10 mg no more than once every 72 hours in patients taking potent inhibitors of CYP3A4 such as ritonavir, ketoconazole, and itraconazole. In patients taking potent inhibitors of CYP3A4 and tadalafil tablets for once daily use, the maximum recommended dose is 2.5 mg. Caution should be exercised when prescribing Tadalafil to patients using potent CYP34A inhibitors (ritonavir, saquinavir, ketoconazole, itraconazole, and erythromycin) as increased Tadalafil exposure (AUCC) has been observed if the medicinal products are combined.
Combination With Other PDE5 Inhibitors or Erectile Dysfunction Therapies: The safety and efficacy of combinations of tadalafil and other PDE5 inhibitors or treatments for erectile dysfunction have not been studied. Inform patients not to take tadalafil tablets with other PDE5 inhibitors.
Lactose: Tadalafil tablets contains lacrosse. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Effects on Ability to Drive and Use Machine: Tadalafil has negligible influence on the ability to drive or use machines. Although the frequency of reports of dizziness in placebo and tadalafil arms in clinical trials was similar, patients should be aware of how they react to Tadalafil, before driving or using machines.
Torfil 10/Torfil 20: Patients with Cardiovascular Disease: Treatments for erectile dysfunction, including tadalafil is not recommended in patients with cardiac diseases for whom sexual activity is inadvisable. PDE5 inhibitors have vasodilatory properties which lead to transient decreases in blood pressure. Physicians must consider if their patients pose risk to such vasodilatory effects. Sexual activity poses serious cardiac risks to patients with pre-existing cardiovascular diseases.
Priapism: Cases of priapism have been associated with PDE5 inhibitors, including tadalafil. Patients with erection lasting for 4 hours or more must seek immediate medical attention. If neglected, it may result to penile tissue damage leading to permanent loss of potency. Caution must be exercised with the use of tadalafil in patients present with risk factors to priapism (sickle cell anemia, multiple myeloma, or leukemia) and in patients with anatomical deformation of the penis (angulation, cavernosal fibrosis or Peyronie’s disease).
Alpha-adrenergic Receptor Blockers: Co-administration of tadalafil with alpha-1 blockers such as doxazosin may lead to symptomatic hypotension.
Non-arteritic Anterior Ischemic Optic Neuropathy (NAION): NAION is a cause of decreased vision including permanent loss of vision. In the event of a sudden loss of vision, patients should be advised by their physician to stop use of tadalafil and must seek medical attention immediately.
Combination with Other Agent for Treatment of Erectile dysfunction: Determination of potential underlying cause and application of appropriate treatment after thorough medical assessment must be included in evaluating erectile dysfunction. There are no established studies regarding the combination of tadalafil with other agents for treatment of erectile dysfunction. Therefore, co-administration is not recommended.
Combination with Other PDE5 Inhibitors: Tadalafil has systemic vasodilatory properties which may result in transient decreases in blood pressure.
Hepatic Impairment: No data are available in patients with severe hepatic impairment (Child-Pugh Class C).
Effects on Ability to Drive and Use Machine: Tadalafil has negligible influence on the ability to drive or use machines. Although the frequency of reports of dizziness in placebo and tadalafil arms in clinical trials was similar, patients should be aware of how they react to Tadalafil, before driving or using machines.