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AURO-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 ..........................……................... 4 ADVERSE REACTIONS ....................................…………................... 9 DRUG INTERACTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Tadalafil was administered to over 9000 subjects (aged 19 to 86 years) during clinical trials worldwide. In trials of tadalafil for Once-a-Day use, a total of 1434, 905, and 115 subjects were treated for at least 6 months, 1 year, and 2 years, respectively.
For tadalafil On -Demand, over 1300 and 1000 subjects were treated for at least 6 months and 1 year, respectively. In these studies, the adverse events reported with tadalafil were generally mild or moderate, transient, and decreased with continued dosing.
A. 1%). 8%). In controlled Phase 2/3 clinical trials, the following adverse events were reported: Table 1. Adverse Events Reported by >2% of Patients with ED Treated with tadalafil, and More Frequent on Drug than Placebo, in Phase 2/3 Clinical Trials.
3%). 1%). 1%) in clinical trials. Adverse events reported over a 24 week treatment duration in one placebo-controlled clinical study were generally similar to those reported in the 12 week clinical studies. Additional common (≥2%) adverse events included nasopharyngitis, gastroenteritis, upper respiratory tract infection, gastroesophageal reflux disease and hypertension.
B. 6% in placebo-treated patients.
The following adverse events were reported in patients with BPH (Table 2):
Page 10 of 51 Table 2: Adverse Events Reported by ≥2% of Patients with BPH Treated with tadalafil 5 mg Once-a-Day, and More Frequent on Drug than Placebo. 2% in patients treated with tadalafil Once-a-Day, tamsulosin, and placebo, respectively.
4 mg/day, and More Frequent on Drug than Placebo. 5% in placebo-treated patients.
The following adverse events were reported in patients with ED and BPH (Table 4):
Table 4: Adverse Events Reported by ≥2% of patients with ED/BPH, Treated with Tadalafil 5 mg Once –a -Day and More Frequent on Drug than Placebo Adverse Event Tadalafil Once-a-Day (5 mg) (N=208) Placebo (N=200) Headache 6% 3% Back pain 3% 2% Nasopharyngitis 2% 2% Additional reported adverse events which occurred in <2% of patients receiving tadalafil Once –a -Day for treatment of BPH or ED/BPH included pain in extremity, myalgia, gastroesophageal reflux disease, upper abdominal pain, nausea, vomiting, arthralgia and muscle spasm.
Before taking AURO-TADALAFIL talk to your doctor if you: have or had any of the following conditions: Heart disease or previously had a heart attack: Sexual activity carries a possible risk to patients with heart disease because it puts extra strain on your heart.
Before you start any treatment for erectile dysfunction, ask your doctor if your heart is healthy enough to handle the extra strain of having sex. If you have chest pains, dizziness or nausea during sex, stop exerting yourself and tell your doctor you have had this problem.
Stroke. Low blood pressure or uncontrolled high blood pressure. Liver or kidney problem. Sickle cell anemia (an abnormality of red blood cells), multiple myeloma (cancer of the bone marrow), or leukemia (cancer of the blood cells).
Peptic ulcer or other bleeding disorders. Deformation of the penis. Ever had severe loss of vision, including a condition called Non-Arteritic Ischemic Optic Neuropathy (NAION). The specific type of vision decrease or loss known as NAION has been reported rarely after the intake of tadalafil or other PDE5 inhibitors.
Vision decrease or loss may be partial or complete, in one or very occasionally in both eyes. While in some cases the condition may improve over time, it can also be irreversible. If you are taking AURO-TADALAFIL and experience temporary or permanent loss or change in vision, stop taking AURO-TADALAFIL and immediately call your doctor.
Hearing problems: Sudden decrease or loss of hearing has been reported with the use of PDE5 inhibitors, including tadalafil, although it is not known if it is due to drug or other factors. Lactose or milk sugar intolerance. AURO-TADALAFIL contains a small amount of lactose (about 250 mg).
AURO-TADALAFIL is not recommended to be used in combination with alpha blockers if you have symptoms of BPH. AURO-TADALAFIL does not protect against sexually transmitted diseases including HIV/ AIDS. Long-term studies have shown that tadalafil therapy may decrease sperm concentration in some men.
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.
AURO-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 AURO-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 AURO-TADALAFIL before nitrate administration is considered.
In such circumstances, nitrates should only be administered under close medical supervision with appropriate hemodynamic monitoring. Hypersensitivity Reactions AURO-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 AURO-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 AURO-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.
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.
The following section identifies additional, less frequent events (<2%) reported in controlled clinical trials of tadalafil for once daily use or use as needed. A causal relationship of these Page 11 of 51 events to tadalafil is uncertain.
Excluded from this list are those events that were minor, those with no plausible relation to drug use, and reports too imprecise to be meaningful: Body as a Whole — asthenia, face edema, fatigue, pain, peripheral edema. Cardiovascular — angina pectoris, chest pain, hypotension, myocardial infarction, postural hypotension, palpitations, syncope, tachycardia.
Digestive — abnormal liver function tests, dry mouth, dysphagia, esophagitis, gastritis, GGTP increased, loose stools, nausea, upper abdominal pain, vomiting, gastroesophageal reflux disease, hemorrhoidal hemorrhage, rectal hemorrhage.
Musculoskeletal — arthralgia, neck pain. Nervous — dizziness, hypesthesia, insomnia, paresthesia, somnolence, vertigo. Renal and Urinary — renal impairment. Respiratory — dyspnea, epistaxis, pharyngitis. Skin and Appendages — pruritus, rash, sweating.
Ophthalmologic — blurred vision, changes in color vision, conjunctivitis (including conjunctival hyperemia), eye pain, lacrimation increase, swelling of eyelids. Otologic — sudden decrease or loss of hearing, tinnitus. Urogenital — erection increased, spontaneous penile erection.
Post-Market Experience In postmarketing surveillance, adverse events that have been reported very rarely in temporal association in patients taking tadalafil include: Body as a […]
The effect on fertility in men is unknown. AURO-TADALAFIL is not intended for use by women or by children under 18 years of age. 5% of patients). Only your doctor can decide if AURO-TADALAFIL is right for you. If you have ED, you will need to have a physical examination to diagnose your erectile dysfunction and to find out if you can take AURO-TADALAFIL alone or with your other medicines.
If you have urinary problems, you will need to have a physical examination to diagnose your BPH and not a more serious condition such as prostate cancer. INTERACTIONS WITH THIS MEDICATION Tell your doctor or pharmacist if you are taking or have recently taken any other medicine, including the medicine you can buy without prescription and natural health products.
Drugs that may interact with AURO-TADALAFIL include: nitrates (see previous section) rifampin (an antibacterial product used against tuberculosis) ketoconazole or itraconazole (used against fungal infections) erythromycin (an antibacterial product) protease inhibitors such as ritonavir and saquinavir (HIV treatments) You should not use AURO-TADALAFIL together with any other treatments for erectile dysfunction or PDE5 inhibitors for treatment of pulmonary arterial hypertension (PAH), such as ADCIRCA ® (tadalafil) or REVATIO ® (sildenafil).
Tell your doctor if you are taking: medicines to treat high blood pressure alpha-blockers (such as doxazosin) for the treatment of prostate problems. The combination of these medicines with AURO- TADALAFIL may add to the blood-pressure-lowering effect of these drugs.
PROPER USE OF THIS MEDICATION This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
How To Take AURO-TADALAFIL:
Always take AURO-TADALAFIL exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. Do not take a higher dose than the one which your doctor prescribed for you.
IMPORTANT:
PLEASE READ Page 50 of 51 AURO-TADALAFIL tablets are for oral use. Swallow the tablet whole, with some water. You may take AURO-TADALAFIL with or without food. Alcohol consumption may decrease the ability to attain an erection and may also temporarily decrease blood pressure.
There are two different ways of taking AURO-TADALAFIL tablets to treat ED: a 20 mg On-Demand dose taken as needed, or a lower 5 mg daily dose. It may take up to 5 days for AURO-TADALAFIL Once-a-Day to reach steady blood levels. For patients with ED: Try sex at different times to find out what works best for you and your partner.
AURO-TADALAFIL works only if you are sexually stimulated. If you don't get the results you expect ― talk to your doctor or pharmacist.
AURO-TADALAFIL for “On-Demand” Dosing:
The recommended dose is one tablet (20 mg) before sexual activity, as needed. You should NOT take more than the prescribed dose of one AURO-TADALAFIL 10 mg or 20 mg tablet per day. The 10 mg and 20 mg doses are not recommended for continuous daily use.
You can engage in sexual activity within 30 minutes of taking the tablet and up to 36 hours later. The amount of time AURO-TADALAFIL takes to work varies from person to person. 5 mg) Once-a- Day every day, at approximately the same time each day, regardless of when you are planning to have sex.
Treatment of BPH and ED/BPH:
Your doctor may recommend that you take one tablet of AURO-TADALAFIL 5 mg Once-a-Day every day, at approximately the same time each day.
Overdose:
Like all medicines, AURO-TADALAFIL can have some side-effects. These effects are usually mild to moderate in nature. The most common side effects […]
Counselling Patients About Sexually Transmitted Diseases The use of AURO-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.
Page 5 of 51 Consideration of Other Urological Conditions Prior to Initiating Treatment for BPH Prior to initiating treatment with AURO-TADALAFIL for BPH, consideration should be given to other urological conditions that may cause similar symptoms.
In addition, prostate cancer and BPH may coexist. Cardiovascular Sexual activity carries a potential cardiac risk for patients with pre-existing cardiovascular disease. Therefore, treatments for erectile dysfunction, including AURO-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. Page 6 of 51 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 immediately seek medical attention if they experience changes in, sudden decrease or loss of vision in one or both eyes.
Ear/Sudden Hearing Loss Sudden decrease or loss of hearing has been reported in a few number of […]