Torfil 2.5/Torfil 10/Torfil 20 Special Precautions

2.5 mg: 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 leads to transient decreases in blood pressure.
Torfil 2.5: 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.
Torfil 10/Torfil 20: 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.
Prolonged erection and Priapism: Torfil 2.5: 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).
Torfil 10/Torfil 20: 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).
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.
Torfil 2.5: Alpha-blockers 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).
Visual 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 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.
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.
Torfil 10/Torfil 20: Alpha-adrenergic Receptors 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 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.