The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL35533/0066 .
Tadalafil 5mg film-coated tablets
Tadalafil 5mg film-coated tablets
1. What Tadalafil is and what it is used for
2. What you need to know before you take Tadalafil
3. How to take Tadalafil
4. Possible side effects
5. How to store Tadalafil
6. Contents of the pack and other information
This medicine contains the active substance tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.
Tadalafil 5mg is used to treat adult men with:
Talk to your doctor before taking Tadalafil.
Be aware that sexual activity carries a possible risk to patients with heart disease because it puts an extra strain on your heart. If you have a heart problem you should tell your doctor.
Since benign prostatic hyperplasia and prostate cancer may have the same symptoms, your doctor will check you for prostate cancer before starting treatment with Tadalafil for benign prostatic hyperplasia.
Tadalafil does not treat prostate cancer.
Before taking the tablets, tell your doctor if you have:
It is not known if Tadalafil is effective in patients who have had:
If you experience sudden decrease or loss of vision, stop taking Tadalafil and contact your doctor immediately.
Decreased or sudden hearing loss has been noted in some patients taking tadalafil. Although it is not known if the event is directly related to tadalafil, if you experience decreased or sudden hearing loss, stop taking Tadalafil and contact your doctor immediately.
Tadalafil is not intended for use by women.
Tadalafil is not intended for use by children and adolescents under the age of 18.
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Do not take Tadalafil if you are already taking nitrates.
Some medicines may be affected by Tadalafil or they may affect how well Tadalafil will work. Tell your doctor or pharmacist if you are already taking:
Information on the effect of alcohol is in section 3.
Grapefruit juice may affect how well Tadalafil will work and should be taken with caution. Talk to your doctor for further information.
A reduction in sperm was seen in some men and reduced sperm development was seen during testing, in dogs. These effects are unlikely to lead to a lack of fertility.
Some men taking Tadalafil in clinical studies have reported dizziness. Check carefully how you react to the tablets before driving or using machines. If you experience side effects which may affect your ability to drive or operate machinery safely, then do not do either of these activities until the effects have completely disappeared.
If you have been told by your doctor you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Tadalafil tablets are for oral use in men only. Swallow the tablet whole with some water. The tablets can be taken with or without food.
Drinking alcohol may temporarily lower your blood pressure. If you have taken or are planning to take Tadalafil, avoid excessive drinking (blood alcohol level of 0.08% or greater which equates to approximately 4 units of alcohol for a man of average weight), since this may increase the risk of dizziness when standing up.
The recommended dose is one 5mg tablet taken once a day at approximately the same time of the day. Your doctor may adjust the dose to 2.5mg based on your response to Tadalafil. This will be given as a 2.5mg tablet.
When taken once a day Tadalafil allows you to obtain an erection, when sexually stimulated, at any time point during the 24 hours of the day. Once a day dosing of Tadalafil may be useful to men who anticipate having sexual activity two or more times per week.
It is important to note that Tadalafil does not work if there is no sexual stimulation. You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.
Drinking alcohol may affect your ability to get an erection.
The recommended dose is one 5mg tablet taken once a day at approximately the same time of the day.
If you have benign prostatic hyperplasia and erectile dysfunction, the dose remains one 5mg tablet taken once a day.
Do not take Tadalafil more than once a day.
Contact your doctor. You may experience side effects described in section 4.
Take your dose as soon as you remember but do not take a double dose to make up for a forgotten tablet. You should not take Tadalafil more than once a day.
It is important to keep taking Tadalafil as prescribed unless your doctor tells you to stop your treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. These effects are normally mild to moderate in nature.
Other side effects have been reported:
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1000 people)
Heart attack and stroke have also been reported rarely in men taking Tadalafil. Most of these men had known heart problems before taking this medicine.
Partial, temporary, or permanent decrease or loss of vision in one or both eyes has been rarely reported.
Some additional rare side effects (may affect up to 1 in 1000 people) have been reported in men taking Tadalafil that were not seen in clinical trials. These include:
The side effect dizziness has been reported more frequently in men over 75 years of age taking Tadalafil. Diarrhoea has been reported more frequently in men over 65 years of age taking Tadalafil.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme (website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store). By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP’.
The expiry date refers to the last day of that month.
This medicine does not require any special temperature storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Tadalafil 5mg is a yellow to light yellow round film-coated tablet with ‘337’ imprinted on one side.
Tadalafil 5mg is available in blister packs containing 14, 28 or 84 tablets.
Not all pack sizes may be marketed.
This leaflet was last revised in 01/2023.