What the official label says. If a doctor prescribed it, follow the prescription. Your pack's leaflet comes first if it is different.
Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: erectile dysfunction (ED) ( 1.1 ) the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2 ) ED and the signs and symptoms of BPH (ED/BPH) ( 1.3 ) If tadalafil is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks ( 1.4 ). 1.1 Erectile Dysfunction Tadalafil tablets are indicated for the treatment of erectile dysfunction (ED). 1.2 Benign Prostatic Hyperplasia Tadalafil tablets are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). …
Four strengths of yellow colored, oval-shaped, film coated tablets, debossed on both side as below: 2.5 mg tablets debossed with “2.5” on one side and “V” on other side 5 mg tablets debossed with “5” on one side and “V” on other side 10 mg tablets debossed with “10” on one side and “V” on other side 20 mg tablets debossed with “20” on one side and “V” on other side Tablets: 2.5 mg, 5 mg, 10 mg, 20 …
Of the total number of subjects in ED clinical studies of tadalafil, approximately 19 percent were 65 and over, while approximately 2 percent were 75 and over. Of the total number of subjects in BPH clinical studies of tadalafil (including the ED/BPH study), approximately 40 percent were over 65, while approximately 10 percent were 75 and over. …
Tadalafil tablets can potentiate the hypotensive effects of nitrates, alpha-blockers, antihypertensives or alcohol ( 7.1 ). CYP3A4 inhibitors (e.g. ketoconazole, ritonavir) increase tadalafil exposure ( 2.7 , 5.10 , 7.2 ) requiring dose adjustment: Tadalafil tablets for use as needed: no more than 10 mg every 72 hours Tadalafil tablets for once daily use: dose not to exceed 2.5 mg CYP3A4 inducers (e.g. rifampin) decrease tadalafil exposure ( 7.2 ). 7.1 Potential for Pharmacodynamic Interactions with Tadalafil Tablets Nitrates — Administration of tadalafil tablets to patients who are using any form of organic nitrate, is contraindicated. …
Evaluation of erectile dysfunction and BPH should include an appropriate medical assessment to identify potential underlying causes, as well as treatment options. Before prescribing tadalafil tablets, it is important to note the following: Patients should not use tadalafil tablets if sex is inadvisable due to cardiovascular status ( 5.1 ). Use of tadalafil tablets with alpha-blockers, antihypertensives or substantial amounts of alcohol (≥5 units) may lead to hypotension ( 5.6 , 5.9 ). …
Most common adverse reactions (≥2%) include headache, dyspepsia, back pain, myalgia, nasal congestion, flushing, and pain in limb ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact VKT Pharma Pvt. Ltd at 1 844-387-1231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 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. …
8.1 Pregnancy Risk Summary Tadalafil tablets are not indicated for use in females. There are no data with the use of tadalafil tablets in pregnant women to inform any drug-associated risks for adverse developmental outcomes. In animal reproduction studies, no adverse developmental effects were observed with oral administration of tadalafil to pregnant rats or mice during organogenesis at exposures up to 11 times the maximum recommended human dose …
Single doses up to 500 mg have been given to healthy subjects, and multiple daily doses up to 100 mg have been given to patients. Adverse events were similar to those seen at lower doses. In cases of overdose, standard supportive measures should be adopted as required. Hemodialysis contributes negligibly to tadalafil elimination.
Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.
Products with Tadalafil as the active ingredient. Names differ between countries.
Other countries: check your pack's registration number and we point you to your regulator.
A recall usually affects certain batches only. Compare the lot number on your pack.
Type the registration number on the pack, or scan it with your camera.
Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: erectile dysfunction (ED) ( 1.1 ) the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2 ) ED and the signs and symptoms of BPH (ED/BPH) ( 1.3 ) If tadalafil is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks ( 1.4 ). 1.1 Erectile Dysfunction Tadalafil tablets are indicated for t (From the official U.S. FDA label.)
Follow your prescription or the leaflet in your pack. The official label says: 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. Not to be taken more than once per day ( 2.1 ). Tadalafil tablets for once d…
Usually yes. Tadalafil is a prescription medicine in most countries. Rules differ by country.
Tadalafil is sold under names such as Alyq, Entadfi, Tadliq, Opsynvi, Cialis, Adcirca. Brand names differ between countries.
The official label lists: Most common adverse reactions (≥2%) include headache, dyspepsia, back pain, myalgia, nasal congestion, flushing, and pain in limb ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact VKT Pharma Pvt. Ltd at 1 844-387-1231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adver… Tell your doctor about any side effect that bothers you or does not go away.
Tadalafil tablets are not indicated for use in pediatric patients. Safety and efficacy in patients below the age of 18 years have not been established. A randomized, double-blind, placebo-controlled trial in pediatric patients (7 to 14 years of age) with Duchenne muscular dystrophy, who received tadalafil 0.3 mg/kg, tadalafil 0.6 mg/kg, or placebo daily for 48 weeks failed to d… Always use the dose for the child's age or weight on the pack or prescription.
8.1 Pregnancy Risk Summary Tadalafil tablets are not indicated for use in females. There are no data with the use of tadalafil tablets in pregnant women to inform any drug-associated risks for adverse developmental outcomes. In animal reproduction studies, no adverse developmental effects were observed with oral administration of tadalafil to pregnant rats or mice during organo… Ask your doctor or midwife first.
The official label says: Use of tadalafil tablets with alpha-blockers, antihypertensives or substantial amounts of alcohol (≥5 units) may lead to hypotension ( 5.
Tadalafil tablets can potentiate the hypotensive effects of nitrates, alpha-blockers, antihypertensives or alcohol ( 7.1 ). CYP3A4 inhibitors (e.g. ketoconazole, ritonavir) increase tadalafil exposure ( 2.7 , 5.10 , 7.2 ) requiring dose adjustment: Tadalafil tablets for use as needed: no more than 10 mg every 72 hours Tadalafil tablets for once daily use: dose not to exceed 2.5… Use the free interaction checker before combining medicines.
Single doses up to 500 mg have been given to healthy subjects, and multiple daily doses up to 100 mg have been given to patients. Adverse events were similar to those seen at lower doses. In cases of overdose, standard supportive measures should be adopted as required. Hemodialysis contributes negli… Get medical help right away.
Scan the registration number on your pack with PillVera (NAFDAC number in Nigeria, NDC in the United States, DIN in Canada), check the expiry date and buy only from licensed pharmacies.
This page shows what official sources say, in plain words. It is not medical advice: your prescription and your doctor or pharmacist come first. Brand names, strengths and rules differ between countries.