Tadalafil is an active pharmaceutical ingredient in the Drugs Used In Erectile Dysfunction group (G04BE). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
GBOfficial regulatory label· revised October 4, 2024[1]
Treatment of erectile dysfunction in adult males. In order for tadalafil to be effective for the treatment of erectile dysfunction, sexual stimulation is required. Tadalafil is not indicated for use by women.
How to take
GB
CACanada· Health Canada
95 products
Uses
CAOfficial regulatory label· revised March 22, 2025[2]
USOfficial regulatory label· revised October 16, 2024[3]
4 ). 1 Erectile Dysfunction Tadalafil tablets are indicated for the treatment of erectile dysfunction (ED). 2 Benign Prostatic Hyperplasia Tadalafil tablets are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).
3 Erectile Dysfunction and Benign Prostatic Hyperplasia Tadalafil tablets are indicated for the treatment of ED and the signs and symptoms of BPH (ED/BPH). 3 )] .
How to take
EUEuropean Union· EMA
5 products
Uses
EUOfficial regulatory label· revised May 8, 2026[4]
1). Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease. Paediatric population Treatment of paediatric patients aged 2 years and above with pulmonary arterial hypertension (PAH) classified as WHO functional class II and III.
How to take
EU
Drug interactions
Known interactions involving Tadalafil. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 384. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[1]MHRA (UK) · PLGB363900314 · revised October 4, 2024
[2]Health Canada (DPD) · 02435896 · revised March 22, 2025
[3]FDA DailyMed · 00cbc656-768d-49… · revised October 16, 2024 [PDF]
[4]European Medicines Agency · EMEA/H/C/004297 · revised May 8, 2026
[5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
Posology Erectile dysfunction in adult men In general, the recommended dose is 10 mg taken prior to anticipated sexual activity and with or without food. In those patients in whom tadalafil 10 mg does not produce an adequate effect, 20 mg might be tried.
It may be taken at least 30 minutes prior to sexual activity. The maximum dose frequency is once per day. Tadalafil 10 and 20 mg is intended for use prior to anticipated sexual activity and it is not recommended for continuous daily use.
, at least twice weekly) a once daily regimen with the lowest doses of tadalafil might be considered suitable, based on patient choice and the physician's judgement. In these patients, the recommended dose is 5mg taken once a day at approximately the same time of day.
5mg once a day based on individual tolerability. The appropriateness of continued use of the daily regimen should be reassessed periodically. Special populations Elderly men Dose adjustments are not required in elderly patients. Men with renal impairment Dose adjustments are not required in patients with mild to moderate renal impairment.
For patients with severe renal impairment, 10 mg is the maximum recommended dose. 2). Men with hepatic impairment For the treatment of erectile dysfunction using on-demand tadalafil the recommended dose of tadalafil is 10 mg taken prior to anticipated sexual activity and with or without food.
There is limited clinical data on the safety of tadalafil in patients with severe hepatic impairment (Child-Pugh class C); if prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician.
There are no available data about the administration of doses higher than 10mg of tadalafil to patients with hepatic impairment. 2). Men with diabetes Dose adjustments are not required in diabetic patients. Paediatric population There is no relevant use of tadalafil in the paediatric population with regard to the treatment of erectile dysfunction.
Method of administration Oral use.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised October 4, 2024[1]
Summary of the safety profile The most commonly reported adverse reactions in patients taking tadalafil for the treatment of erectile dysfunction or benign prostatic hyperplasia were headache, dyspepsia, back pain and myalgia, in which the incidences increase with increasing dose of tadalafil.
The adverse reactions reported were transient, and generally mild or moderate. The majority of headaches reported with tadalafil once-a-day dosing are experienced within the first 10 to 30 days of starting treatment. Tabulated summary of adverse reactions The table below lists the adverse reactions observed from spontaneous reporting and in placebo-controlled clinical trials (comprising a total of 8022 patients on tadalafil and 4422 patients on placebo) for on-demand and once-a-day treatment of erectile dysfunction and the once-a-day treatment of benign prostatic hyperplasia.
Frequency convention:
Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very Rare (<1/10,000) and Not known (cannot be estimated from the available data). 4). (2) Postmarketing surveillance reported adverse reactions not observed in placebo-controlled clinical trials.
(3) More commonly reported when tadalafil is given to patients who are already taking antihypertensive medicinal products. Description of selected adverse reactions A slightly higher incidence of ECG abnormalities, primarily sinus bradycardia, has been reported in patients treated with tadalafil once a day as compared with placebo.
Most of these ECG abnormalities were not associated with adverse reactions. Other special populations Data in patients over 65 years of age receiving tadalafil in clinical trials, either for the treatment of erectile dysfunction or the treatment of benign prostatic hyperplasia, are limited.
In clinical trials with tadalafil taken on demand for the treatment of erectile dysfunction, diarrhoea was reported more frequently in patients over 65 years of age. In clinical trials with tadalafil 5mg taken once a day for the treatment of benign prostatic hyperplasia, dizziness and diarrhoea were reported more frequently in patients over 75 years of age.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.
GBOfficial regulatory label· Warnings and precautions· revised October 4, 2024[1]
Before treatment with tadalafil tablets A medical history and physical examination should be undertaken to diagnose erectile dysfunction or benign prostatic hyperplasia and determine potential underlying causes, before pharmacological treatment is considered.
Prior to initiating any treatment for erectile dysfunction, physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. 3). 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. Cardiovascular Serious cardiovascular events, including myocardial infarction, sudden cardiac death, unstable angina pectoris, ventricular arrhythmia, stroke, transient ischaemic attacks, chest pain, palpitations and tachycardia, have been reported either post marketing and/or in clinical trials.
Most of the patients in whom these events have been reported had pre-existing cardiovascular risk factors. However, it is not possible to definitively determine whether these events are related directly to these risk factors, to tadalafil, to sexual activity, or to a combination of these or other factors.
In patients receiving concomitant antihypertensive medicinal products, tadalafil may induce a blood pressure decrease. When initiating daily treatment with tadalafil, appropriate clinical considerations should be given to a possible dose adjustment of the antihypertensive therapy.
5). The combination of tadalafil and doxazosin is not recommended. Vision Visual defects, including Central Serous Chorioretinopathy (CSCR)and cases of NAION have been reported in connection with the intake of tadalafil and other PDE5 inhibitors.
Most cases of CSCR resolved spontaneously after stopping tadalafil. Analyses of observational data suggest an increased risk of acute NAION in men with erectile dysfunction following exposure to tadalafil or other PDE5 inhibitors. 3).
Decreased or sudden hearing loss Cases of sudden hearing loss have been reported after the use of tadalafil. Although other risk factors were present in some cases (such as age, diabetes, hypertension and previous hearing loss history) patients should be advised to stop taking tadalafil and seek prompt medical attention in the event of sudden decrease or loss of hearing.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised October 4, 2024[1]
1. In clinical studies, tadalafil was shown to augment the hypotensive effects of nitrates. This is thought to result from the combined effects of nitrates and tadalafil on the nitric oxide/cGMP pathway. 5). Tadalafil must not be used in men with cardiac disease for whom sexual activity is inadvisable.
Physicians should consider the potential cardiac risk of sexual activity in patients with pre-existing cardiovascular disease. 4). 5).
This is not medical advice. Consult a qualified healthcare professional.
INDICATIONS AND CLINICAL USE AURO-TADALAFIL (tadalafil) is indicated for the treatment of erectile dysfunction (ED) in men. AURO-TADALAFIL is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).
AURO-TADALAFIL is indicated for the treatment of ED and the signs and symptoms of benign prostatic hyperplasia (ED/BPH).
Geriatrics (>65 years of age):
No dose adjustment is warranted based on age alone. However, a greater sensitivity to medications in some older individuals should be considered. (See WARNINGS AND PRECAUTIONS, Use in the Elderly, and DOSAGE AND ADMINISTRATION).
Pediatrics (<18 years of age):
Tadalafil has not been evaluated in individuals less than 18 years old. AURO-TADALAFIL is not indicated for use in pediatric patients. Page 4 of
Side effects & warnings
CAOfficial regulatory label· Adverse reactions· revised March 22, 2025[2]
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.
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.
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 […]
CAOfficial regulatory label· Warnings and precautions· revised March 22, 2025[2]
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.
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.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
CAOfficial regulatory label· Contraindications· revised March 22, 2025[2]
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.
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 […]
This is not medical advice. Consult a qualified healthcare professional.
USOfficial regulatory label· revised October 16, 2024[3]
2 DOSAGE AND ADMINISTRATION Do not split tadalafil tablets; entire dose should be taken.
Tadalafil tablets for use as needed:
ED: Starting dose: 10 mg as needed prior to sexual activity. Increase to 20 mg or decrease to 5 mg based upon efficacy/tolerability. Improves erectile function compared to placebo up to 36 hours post dose. 1 ). 5 mg taken once daily, without regard to timing of sexual activity.
2 ). 5 ). 1 Tadalafil Tablets for Use as Needed for Erectile Dysfunction The recommended starting dose of tadalafil tablets for use as needed in most patients is 10 mg, taken prior to anticipated sexual activity. The dose may be increased to 20 mg or decreased to 5 mg, based on individual efficacy and tolerability.
The maximum recommended dosing frequency is once per day in most patients. Tadalafil tablets for use as needed were shown to improve erectile function compared to placebo up to 36 hours following dosing. Therefore, when advising patients on optimal use of tadalafil tablets, this should be taken into consideration.
5 mg, taken at approximately the same time every day, without regard to timing of sexual activity. The tadalafil tablets dose for once daily use may be increased to 5 mg, based on individual efficacy and tolerability. 3 Tadalafil Tablets for Once Daily Use for Benign Prostatic Hyperplasia The recommended dose of tadalafil tablets for once daily use is 5 mg, taken at approximately the same time every day.
When therapy for BPH is initiated with tadalafil and finasteride, the recommended dose of tadalafil tablets for once daily use is 5 mg, taken at approximately the same time every day for up to 26 weeks. 4 Tadalafil Tablets for Once Daily Use for Erectile Dysfunction and Benign Prostatic Hyperplasia The recommended dose of tadalafil tablets for once daily use is 5 mg, taken at approximately the same time every day, without regard to timing of sexual activity.
5 Use with Food Tadalafil tablets may be taken without regard to food. 6 Use in Specific Populations Renal Impairment Tadalafil Tablets for Use as Needed Creatinine clearance 30 to 50 mL/min: A starting dose of 5 mg not more than once per day is recommended, and the maximum dose is 10 mg not more than once in every 48 hours.
7 )] . 7 )] . 5 mg is recommended. An increase to 5 mg may be considered based on individual response. 7 )] . Hepatic Impairment Tadalafil tablets for Use as Needed Mild or moderate (Child Pugh Class A or B): The dose should not exceed 10 mg once per day.
The use of tadalafil tablets once per day has not been extensively evaluated in patients with hepatic impairment and therefore, caution is advised. 6 )] .
Tadalafil tablets for Once Daily Use Mild or moderate (Child Pugh Class A or B):
Tadalafil tablets for once daily use has not been extensively evaluated in patients with hepatic impairment. Therefore, caution is advised if tadalafil tablets for once daily use is prescribed to these patients. 6 )] . 1 )] . 2 )] . 2 )] .
2 )] . 2 )] .
This is not medical advice. Consult a qualified healthcare professional.
Most-reported reactions to the US regulator (12 mo to June 4, 2026): 4,990 reports total. [5]
Headache 554
Dyspnoea 511
Diarrhoea 427
Fatigue 421
Nausea 353
Cough 334
Dizziness 298
Drug Ineffective 223
Off Label Use 205
Product Dose Omission Issue 197
Vomiting 191
Hypotension 169
Side effects & warnings
USOfficial regulatory label· Adverse reactions· revised October 16, 2024[3]
1 ). To report SUSPECTED ADVERSE REACTIONS, contact VKT Pharma Pvt. 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Tadalafil was administered to over 9000 men during clinical trials worldwide. In trials of tadalafil tablets for once daily use, a total of 1434, 905, and 115 were treated for at least 6 months, 1 year, and 2 years, respectively. For tadalafil tablets for use as needed, over 1300 and 1000 subjects were treated for at least 6 months and 1 year, respectively.
4% in placebo treated patients. 8% in placebo-treated patients. 6% in placebo-treated patients. Adverse reactions leading to discontinuation reported by at least 2 patients treated with tadalafil included headache, upper abdominal pain, and myalgia.
The following adverse reactions were reported ( see Table 4). 0% Additional, less frequent adverse reactions (<1%) reported in the controlled clinical trials of tadalafil tablets for BPH or ED and BPH included: gastroesophageal reflux disease, upper abdominal pain, nausea, vomiting, arthralgia, and muscle spasm.
Back pain or myalgia was reported at incidence rates described in Tables 1 through 4. In tadalafil clinical pharmacology trials, back pain or myalgia generally occurred 12 to 24 hours after dosing and typically resolved within 48 hours.
The back pain/myalgia associated with tadalafil treatment was characterized by diffuse bilateral lower lumbar, gluteal, thigh, or thoracolumbar muscular discomfort and was exacerbated by recumbency. In general, pain was reported as mild or moderate in severity and resolved without medical treatment, but severe back pain was reported with a low frequency (<5% of all reports).
, codeine) was used. 5% of all subjects treated with tadalafil tablets for on demand use discontinued treatment as a consequence of back pain/myalgia. 3% of patients, respectively. Diagnostic testing, including measures for inflammation, muscle injury, or renal damage revealed no evidence of medically significant underlying pathology.
Incidence rates for tadalafil tablets for once daily use for ED, BPH and BPH/ED are described in Tables 2, 3 and 4. In studies of tadalafil tablets for once daily use, adverse reactions of back pain and myalgia were generally mild or moderate with a discontinuation rate of <1% across all indications.
5 )] . 1% of patients). The following section identifies additional, less frequent events (<2%) reported in controlled clinical trials of tadalafil tablets for once daily use or use as needed. A causal relationship of these events to tadalafil tablets is uncertain.
2 Postmarketing Experience The following adverse reactions have been identified during post approval use of tadalafil tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
These events have been chosen for inclusion either due to their seriousness, reporting frequency, lack of clear alternative causation, or a combination of these factors. Cardiovascular and Cerebrovascular — Serious cardiovascular events, including myocardial infarction, sudden cardiac death, stroke, chest pain, palpitations, and tachycardia, have been reported postmarketing in temporal association with the use of tadalafil.
Most, but not all, of these patients had preexisting cardiovascular risk factors. Many of these events were reported to occur during or shortly after sexual activity, and a few were reported to occur shortly after the use of tadalafil tablets without sexual activity.
Others were reported to have occurred hours to days after the use of tadalafil tablets and sexual activity. 1 )] . Body as a Whole — hypersensitivity reactions including urticaria, Stevens-Johnson syndrome, and exfoliative dermatitis Nervous — migraine, seizure and seizure recurrence, transient global amnesia Ophthalmologic — visual field defect, retinal vein occlusion, retinal artery occlusion Non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported rarely postmarketing in temporal association with the use of PDE5 inhibitors, including tadalafil tablets.
4 )] . Otologic — Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with the use of PDE5 inhibitors, including tadalafil tablets. In some of the cases, medical conditions and other factors were reported that may have also played a role in the otologic adverse events.
In many cases, medical follow-up information was limited. 5 )] . 3 )] .
USOfficial regulatory label· Warnings and precautions· revised October 16, 2024[3]
5 WARNINGS AND PRECAUTIONS Evaluation of erectile dysfunction and BPH should include an appropriate medical assessment to identify potential underlying causes, as well as treatment options. 1 ). 9 ). Tadalafil tablets are not recommended in combination with alpha-blockers for the treatment of BPH because efficacy of the combination has not been adequately studied and because of the risk of blood pressure lowering.
Caution is advised when tadalafil tablets are used as a treatment for ED in men taking alpha-blockers. 2 ) Patients should seek emergency treatment if an erection lasts >4 hours. 3 ). Patients should stop tadalafil tablets and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non-arteritic anterior ischemic optic neuropathy (NAION).
Tadalafil tablets should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION. 2 ). 5 ). 14 ). 1 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.
1 )] . , aortic stenosis and idiopathic hypertrophic subaortic stenosis) can be sensitive to the action of vasodilators, including PDE5 inhibitors. The following groups of patients with cardiovascular disease were not included in clinical safety and efficacy trials for tadalafil tablets, and therefore until further information is available, tadalafil tablets are not recommended for the following groups of patients: myocardial infarction within the last 90 days unstable angina or angina occurring during sexual intercourse New York Heart Association Class 2 or greater heart failure in the last 6 months uncontrolled arrhythmias, hypotension (<90/50 mm Hg), or uncontrolled hypertension stroke within the last 6 months.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
USOfficial regulatory label· Contraindications· revised October 16, 2024[3]
4 CONTRAINDICATIONS Administration of tadalafil tablets to patients using any form of organic nitrate is contraindicated. 1 ). 2 ). 3 ). 1 Nitrates Administration of tadalafil tablets to patients who are using any form of organic nitrate, either regularly and/or intermittently, is contraindicated.
2 )] . 2 Hypersensitivity Reactions Tadalafil tablets are contraindicated in patients with a known serious hypersensitivity to tadalafil (tadalafil tablets or ADCIRCA ® ). 2 )] . 3 Concomitant Guanylate Cyclase (GC) Stimulators Do not use tadalafil tablets in patients who are using a GC stimulator, such as riociguat.
PDE5 inhibitors, including tadalafil may potentiate the hypotensive effects of GC stimulators.
This is not medical advice. Consult a qualified healthcare professional.
Treatment should only be initiated and monitored by a physician experienced in the treatment of PAH. Posology Adults The recommended dose is 40 mg (two x 20 mg film-coated tablets) taken once daily. Paediatric population (age 2 years to 17 years) The recommended once daily doses based on age and weight categories in paediatric patients are shown below.
3 Paediatric patient’s age and/or weight Recommended daily dose and dosing regimen Age ≥ 2 years old Body weight ≥ 40 kg 40 mg (two 20 mg tablets) once daily Body weight < 40 kg 20 mg (one 20 mg tablet or 10 mL of oral suspension (OS), 2 mg/mL tadalafil*) once daily * Oral suspension is available for administration to paediatric patients who require 20 mg and are not able to swallow tablets.
For patients < 2 years old no PK or efficacy data are available from clinical trials. The most appropriate dose of Tadalafil in children aged between 6 months to < 2 years has not been established. Therefore, Tadalafil is not recommended in this age subset.
Delayed dose, missed dose, or vomiting If there is a delay in the administration of Tadalafil, but yet within the same day, the dose should be taken with no changes to the subsequent dose schedules. Patients should not take an extra dose if a dose is missed.
Patients should not take an extra dose if vomiting occurs. Special populations Elderly patients Dose adjustments are not required in elderly patients. Renal impairment Adults and paediatric population (2 to 17 years, weighing at least 40 kg) In patients with mild to moderate renal impairment a starting dose of 20 mg once per day is recommended.
The dose may be increased to 40 mg once per day, based on individual efficacy and tolerability. 2). Paediatric population (2 to 17 years, weighing less than 40 kg) In patients < 40 kg and with mild to moderate renal impairment a starting dose of 10 mg once per day is recommended.
The dose may be increased to 20 mg once per day, based on individual efficacy and tolerability. 2). Hepatic impairment Adults and paediatric population (2 to 17 years, weighing at least 40 kg) Due to limited clinical experience in patients with mild to moderate hepatic cirrhosis (Child-Pugh Class A and B), a starting dose of 20 mg once per day may be considered.
Paediatric population (2 to 17 years, weighing less than 40 kg) In patients < 40 kg and with mild to moderate hepatic impairment, a starting dose of 10 mg once per day may be considered. For patients of all ages, if tadalafil is prescribed, a careful individual benefit/risk assessment should be undertaken by the prescribing physician.
2). Paediatric population (age < 2 years) Dosing and efficacy of tadalafil has not been established for children aged < 2 years. 1. 4 Method of administration Talmanco is for oral use. The film-coated tablets should be swallowed whole with water, with or without food.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
EUOfficial regulatory label· Adverse reactions· revised May 8, 2026[4]
Summary of the safety profile The most commonly reported adverse reactions, occurring in ≥ 10 % of patients in the tadalafil 40 mg treatment arm, were headache, nausea, back pain, dyspepsia, flushing, myalgia, nasopharingitis and pain in extremity.
The adverse reactions reported were transient, and generally mild or moderate. Adverse reaction data are limited in patients over 75 years of age. 5 mg to 40 mg once daily and 82 patients were treated with placebo. The duration of treatment was 16 weeks.
The overall frequency of discontinuation due to adverse events was low (tadalafil 11 %, placebo 16 %). Three hundred and fifty seven (357) patients who completed the pivotal study entered a long-term extension study. Doses studied were 20 mg and 40 mg once daily.
9 Tabulated list of adverse reactions The table below lists the adverse reactions reported during the placebo-controlled clinical trial in patients with PAH treated with tadalafil. Also included in the table are some adverse reactions which have been reported in clinical trials and/or post marketing with tadalafil in the treatment of male erectile dysfunction.
These events have either been assigned a frequency of “Not known,” as the frequency in PAH patients cannot be estimated from the available data or assigned a frequency based on the clinical trial data from the pivotal placebo-controlled study of tadalafil.
Frequency estimate:
Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000) and not known (cannot be estimated from the available data). Very common Common Uncommon Rare Not known1 Immune system disorders Hypersensitivity reactions5 Angioedema Nervous system disorders Headache6 Syncope, Migraine5 Seizures5, Transient amnesia5 Stroke2 (including haemorrhagic events) Eye disorders Blurred vision Non-arteritic anterior ischemic optic neuropathy (NAION), Retinal vascular occlusion, Visual field defect, Central serous chorioretinopathy Ear and labyrinth disorders Tinnitus Sudden hearing loss Cardiac disorders Palpitations2, 5 Sudden cardiac death2, 5, Tachycardia2, 5 Unstable angina pectoris, Ventricular arrhythmia, Myocardial Infarction2 Vascular disorders Flushing Hypotension Hypertension Respiratory, thoracic and mediastinal disorders Nasopharyngitis (including nasal congestion, sinus congestion and rhinitis) Epistaxis Gastrointestinal disorders Nausea, Dyspepsia (including abdominal pain/discomfort3) Vomiting, Gastroesophageal reflux Skin and subcutaneous tissue disorders Rash Urticaria5, Hyperhydrosis (sweating)5 Stevens-Johnson Syndrome, Exfoliative dermatitis Musculoskeletal and connective tissue disorders Myalgia, Back pain, Pain in extremity (including limb discomfort) 10 Very common Common Uncommon Rare Not known1 Renal and urinary disorders Haematuria Reproductive system and breast disorders Increased uterine bleeding4 Priapism5, Penile haemorrhage, Haematospermia Prolonged erections General disorders and administration site conditions Facial oedema, Chest pain2 1 Events not reported in registration trials and cannot be estimated from the available data.
The adverse reactions have been included in the table as a result of postmarketing or clinical trial data from the use of tadalafil in the treatment of erectile dysfunction. 2 Most of the patients in whom these events have been reported had pre-existing cardiovascular risk factors.
3 Actual MedDRA terms included are abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper, and stomach discomfort. 4 Clinical non-MedDRA term to include reports of abnormal/excessive menstrual bleeding conditions such as menorrhagia, metrorrhagia, menometrorrhagia, or vaginal haemorrhage.
5 The adverse reactions have been included in the table as a result of post-marketing or clinical trial data from the use of tadalafil in the treatment of erectile dysfunction; and in addition, the frequency estimates are based on only 1 or 2 patients experiencing the adverse reaction in the pivotal placebo-controlled study of tadalafil.
6 Headache was the most commonly reported adverse reaction. Headache may occur at the beginning of therapy; and decreases over time even if treatment is continued. 5 to 17 years with PAH were treated with tadalafil in clinical trials (H6D-MC-LVHV, H6D-MC-LVIG).
A total of 391 paediatric patients with PAH, from new-born to < 18 years, were treated with tadalafil in an observational post-marketing study (H6D-JETD01). Following tadalafil administration, the frequency, type and severity of adverse reactions in children and adolescents were similar to that seen for adults.
Due to differences in study design, sample size, gender, age range, and doses, safety findings from these trials are detailed separately below. 2 years) with PAH, a total of 17 patients were treated once daily with tadalafil 20 mg (middle-weight cohort, ≥ 25 kg to < 40 kg) or 40 mg (heavy-weight cohort, ≥ 40 kg), and 18 patients were treated with placebo, for 24 weeks.
8 % each). No deaths or SAEs were reported. Of the 35 paediatric patients treated in the short-term, placebo-controlled study, 32 entered the 24 month long-term open-label extension and 26 patients completed the follow-up. No new safety signals were observed.
Uncontrolled pharmacokinetic study in paediatric patients (H6D-MC-LVIG) In a paediatric multiple ascending dose […]
EUOfficial regulatory label· Warnings and precautions· revised May 8, 2026[4]
Cardiovascular diseases The following groups of patients with cardiovascular disease were not included in PAH clinical trials: - Patients with clinically significant aortic and mitral valve disease - Patients with pericardial constriction - Patients with restrictive or congestive cardiomyopathy - Patients with significant left ventricular dysfunction - Patients with life-threatening arrhythmias - Patients with symptomatic coronary artery disease - Patients with uncontrolled hypertension.
Since there are no clinical data on the safety of tadalafil in these patients, the use of tadalafil is not recommended. Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD).
Since there are no clinical data on administration of tadalafil to patients with veno-occlusive disease, administration of tadalafil to such patients is not recommended. Should signs of pulmonary oedema occur when tadalafil is administered, the possibility of associated PVOD should be considered.
Tadalafil has systemic vasodilatory properties that may result in transient decreases in blood pressure. Physicians should carefully consider whether their patients with certain underlying conditions, such as severe left ventricular outflow obstruction, fluid depletion, autonomic hypotension or patients with resting hypotension, could be adversely affected by such vasodilatory effects.
5). Therefore, the combination of tadalafil and doxazosin is not recommended. Vision Visual defects, including Central Serous Chorioretinopathy (CSCR), and cases of NAION have been reported in connection with the intake of tadalafil and other PDE5 inhibitors.
Most cases of CSCR resolved spontaneously after stopping tadalafil. Regarding NAION, analyses of observational data suggest an increased risk of acute NAION in men with erectile dysfunction following exposure to tadalafil or other PDE5 inhibitors.
3). 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. Decreased or sudden hearing loss Cases of sudden hearing loss have been reported after the use of tadalafil.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
EUOfficial regulatory label· Contraindications· revised May 8, 2026[4]
1. Acute myocardial infarction within the last 90 days. Severe hypotension (< 90/50 mm Hg). In clinical trials, tadalafil was shown to augment the hypotensive effects of nitrates. This is thought to result from the combined effects of nitrates and tadalafil on the nitric oxide/cGMP pathway.
5). 5). 4).
This is not medical advice. Consult a qualified healthcare professional.
Renal and hepatic impairment Due to increased tadalafil exposure (AUC), limited clinical experience and the lack of ability to influence clearance by dialysis, once-a-day dosing of tadalafil is not recommended in patients with severe renal impairment.
There is limited clinical data on the safety of single-dose administration of tadalafil in patients with severe hepatic insufficiency (Child-Pugh Class C). Once-a-day administration has not been evaluated in patients with hepatic insufficiency.
If tadalafil is prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician. Priapism and anatomical deformation of the penis 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 with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie's disease) or in patients who have conditions which may predispose them to priapism (such as sickle cell anaemia, multiple myeloma or leukaemia).
5). Tadalafil tablets and other treatments for erectile dysfunction The safety and efficacy of combinations of tadalafil and other PDE5 inhibitors or other treatments for erectile dysfunction have not been studied. The patients should be informed not to take tadalafil in such combinations.
5 mg film-coated tablet contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. Sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
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 […]
As with other PDE5 inhibitors, tadalafil has mild systemic vasodilatory properties that may result in transient decreases in blood pressure. 2 )] . 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. 3 )] . 3 Prolonged Erection 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).
4 Effects on the Eye 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, that has been reported rarely postmarketing in temporal association with the use of all PDE5 inhibitors.
8 cases per 100,000 in males aged ≥50. An observational case-crossover study evaluated the risk of NAION when PDE5 inhibitor use, as a class, occurred immediately before NAION onset (within 5 half-lives), compared to PDE5 inhibitor use in a prior time period.
34). 20). Other risk factors for NAION, such as the presence of "crowded" optic disc, may have contributed to the occurrence of NAION in these studies. 2 )] . 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.
Individuals with "crowded" optic disc are also considered at greater risk for NAION compared to the general population; however, evidence is insufficient to support screening of prospective users of PDE5 inhibitors, including tadalafil, for this uncommon condition.
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. 5 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. 2 )] . 2 )] . Caution is advised when PDE5 inhibitors are coadministered 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.
, fainting).
Consideration should be given to the following:
ED Patients should be stable on alpha-blocker therapy prior to initiating a PDE5 inhibitor. Patients who demonstrate hemodynamic instability on alpha-blocker therapy alone are at increased risk of symptomatic hypotension with concomitant use of PDE5 inhibitors.
In those patients who are stable on alpha-blocker therapy, PDE5 inhibitors should be initiated at the lowest recommended dose. In those patients already taking an optimized dose of PDE5 inhibitor, alpha-blocker therapy should be initiated at the lowest dose.
Stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure when taking a PDE5 inhibitor. Safety of combined use of PDE5 inhibitors and alpha-blockers may be affected by other variables, including intravascular volume depletion and other antihypertensive drugs.
1 )] . BPH The efficacy of the coadministration of an alpha-blocker and tadalafil tablets for the treatment of BPH has not been adequately studied, and due to the potential vasodilatory effects of combined use resulting in blood pressure lowering, the combination of tadalafil tablets and alpha-blockers is not recommended for the treatment of BPH.
)] . Patients on alpha-blocker therapy for BPH should discontinue their alpha-blocker at least one day prior to starting tadalafil tablets for once daily use for the treatment of BPH. 7 Renal Impairment Tadalafil Tablets for Use as Needed Tadalafil tablets should be limited to 5 mg not more than once in every 72 hours in patients with creatinine clearance less than 30 mL/min or end-stage renal disease on hemodialysis.
The starting dose of tadalafil tablets in patients with creatinine clearance 30 – 50 mL/min should be 5 mg not more than once per day, and the maximum dose should be limited to 10 mg not more than once in every 48 hours. 7 )] . 7 )] .
BPH and ED/BPH 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.
3 )] . 8 Hepatic Impairment Tadalafil Tablets for Use as Needed In patients with mild or moderate hepatic impairment, the dose of tadalafil tablets should not exceed 10 mg. 6 )] . Tadalafil Tablets for Once Daily Use 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. 6 )] . 9 Alcohol Patients should be made aware that both alcohol and tadalafil tablets, 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. 2 )] . 10 Concomitant Use of Potent Inhibitors of Cytochrome P450 3A4 (CYP3A4) Tadalafil is metabolized predominantly by CYP3A4 in the liver.
2 )] . 7 )] . 11 Combination With Other PDE5 Inhibitors or Erectile Dysfunction Therapies The safety and efficacy of combinations of tadalafil tablets and other PDE5 inhibitors or treatments for erectile dysfunction have not been studied.
Inform patients not to take tadalafil tablets with other PDE5 inhibitors, including ADCIRCA. 12 Effects on Bleeding Studies in vitro have demonstrated that tadalafil is a selective inhibitor of PDE5. PDE5 is found in platelets. When administered in combination with aspirin, tadalafil 20 mg did not prolong bleeding time, relative to aspirin alone.
Tadalafil tablets have not been administered to patients with bleeding disorders or significant active peptic ulceration. Although tadalafil tablets have not been shown to increase bleeding times in healthy subjects, use in patients with bleeding disorders or significant active peptic ulceration should be based upon a careful risk-benefit assessment and caution.
13 Counseling Patients About Sexually Transmitted Diseases The use of tadalafil tablets offers no protection against sexually transmitted diseases. Counseling patients about the protective measures necessary to guard against sexually transmitted diseases, including Human Immunodeficiency Virus (HIV) should be considered.
14 Consideration of Other Urological Conditions Prior to Initiating Treatment for BPH Prior to initiating treatment with tadalafil tablets for BPH, consideration should be given to other urological conditions that may cause similar symptoms.
In addition, prostate cancer and BPH may coexist.
Although other risk factors were present in some cases (such as age, diabetes, hypertension, previous hearing loss history and associated connective tissue diseases) patients should be advised to seek prompt medical attention in the event of sudden decrease or loss of hearing.
Renal and hepatic impairment Due to increased tadalafil exposure (AUC), limited clinical experience, and the lack of ability to influence clearance by dialysis, tadalafil is not recommended in patients with severe renal impairment.
Patients with severe hepatic cirrhosis (Child-Pugh Class C) have not been studied and, therefore, dosing of tadalafil is not recommended. Priapism and anatomical deformation of the penis Priapism has been reported in men treated with PDE5 inhibitors.
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 with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie's disease), or in patients who have conditions which may predispose them to priapism (such as sickle cell anaemia, multiple myeloma or leukaemia).
5). 5). Treatments for erectile dysfunction The safety and efficacy of combinations of tadalafil and other PDE5 inhibitors or other treatments for erectile dysfunction have not been studied. Patients should be informed not to take tadalafil with these medicinal products.
6 Prostacyclin and its analogues The efficacy and safety of tadalafil co-administered with prostacyclin or its analogues has not been studied in controlled clinical trials. Therefore, caution is recommended in case of co-administration.
1). Excipents with known effects Talmanco tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.