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APO-TADALAFIL is a brand name for Tadalafil, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ....................................................................................... 3 CONTRAINDICATIONS .......................................................................................................... 4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Nitrates Tadalafil has been shown to potentiate the hypotensive effects of nitrates. This is thought to result from the combined effects of nitrates and tadalafil on the nitric oxide/ cGMP pathway. , oral, sublingual, transdermal, by inhalation), either regularly and/or intermittently, is contraindicated, due to the risk of developing potentially life-threatening hypotension.
Tadalafil should not be prescribed to patients for whom nitrates are prescribed, even though the patient may not have actually used the nitrate therapy. In a patient prescribed tadalafil, where nitrate administration is deemed medically necessary in a life-threatening situation, at least 48 hours should have elapsed after the last dose of tadalafil before nitrate administration is considered.
In such circumstances, nitrates should only be administered under close medical supervision with appropriate hemodynamic monitoring. Hypersensitivity Reactions Tadalafil should not be used in patients with a known hypersensitivity to tadalafil or any component of the tablet (see DOSAGE FORMS, COMPOSITION AND PACKAGING).
Non-Arteritic Anterior Ischaemic Optic Neuropathy Tadalafil is contraindicated in patients with previous episode of non-arteritic anterior ischaemic optic neuropathy (NAION) (see WARNINGS AND PRECAUTIONS). Co-administration with Guanylate Cyclase Stimulators The co-administration of PDE5 inhibitors, including tadalafil, with guanylate cyclase stimulators, such as riociguat, is contraindicated because it could lead to potentially life-threatening episodes of symptomatic hypotension or syncope.
WARNINGS AND PRECAUTIONS General The evaluation of erectile dysfunction and lower urinary tract symptoms should include a determination of potential underlying causes and the identification of appropriate treatment following an appropriate medical assessment.
Counselling Patients About Sexually Transmitted Diseases The use of tadalafil offers no protection against sexually transmitted diseases. Counselling patients about the protective measures necessary to guard against sexually transmitted diseases, including Human Immunodeficiency Virus (HIV) should be considered.
Consideration of Other Urological Conditions Prior to Initiating Treatment for BPH Prior to initiating treatment with tadalafil for BPH, consideration should be given to other urological conditions that may cause similar symptoms. In addition, prostate cancer and BPH may coexist.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Tadalafil in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Page 5 of 50 Cardiovascular Sexual activity carries a potential cardiac risk for patients with pre-existing cardiovascular disease. Therefore, treatments for erectile dysfunction, including tadalafil, should not be used in men with cardiac disease for whom sexual activity is inadvisable.
, aortic stenosis and idiopathic hypertrophic subaortic stenosis) can be sensitive to the action of vasodilators, including PDE5 inhibitors. , nitrates, alpha-blockers, antihypertensives and potent inhibitors of CYP3A4). Sexual Function/Prolonged Erection Priapism was not reported in clinical trials with tadalafil.
However, priapism has been reported rarely in post-marketing surveillance with PDE5 inhibitors, including tadalafil. The incidence of priapism may increase when PDE5 inhibitors are used in combination with intrapenile injections containing vasoactive agents.
Patients who experience erections lasting 4 hours or more should be instructed to seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result. Tadalafil 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).
Long-term human studies with subjects 45 years or older have shown that tadalafil therapy may decrease sperm concentration in some patients, but the clinical relevance of this to human fertility is unknown. Ophthalmology/Eye Postmarketing reports of sudden loss of vision have occurred rarely, in temporal association with the use of PDE5 inhibitors, including tadalafil (see ADVERSE REACTIONS, Post-Market Experience).
An approximate 2 to 4-fold increased risk of acute Non-Arteritic Ischemic Optic Neuropathy (NAION) has been suggested from analyses of observational data in men with ED within 1 to 4 days (5 half-lives) of episodic PDE5 inhibitor use, including tadalafil.
There is an increased risk of NAION in patients who have already experienced NAION. The use of PDE5 inhibitors, including tadalafil, is contraindicated in patients with a previous episode of NAION (see CONTRAINDICATIONS). Physicians should instruct patients to stop taking tadalafil and and immediately seek medical attention if they experience changes in, sudden decrease or loss of vision in one or both eyes.
Page 6 of 50 Ear/Sudden Hearing Loss Sudden decrease or loss of hearing has been reported in a few number of postmarketing and clinical trials with the use of PDE5 […]