Active ingredient
- tadalafil
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
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: PL35533/0068 .
Tadalafil 20mg film-coated tablets
Package leaflet: Information for the patient
Tadalafil 20mg film-coated tablets
Tadalafil
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
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
1 What Tadalafil is and what it is used for
Tadalafil is a treatment for adult men with erectile dysfunction. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity. Tadalafil has been shown to significantly improve the ability of obtaining a hard erect penis suitable for sexual activity.
Tadalafil contains the active substance tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Following sexual stimulation Tadalafil works by helping the blood vessels in your penis to relax, allowing the flow of blood into your penis. The result of this is improved erectile function. Tadalafil will not help you if you do not have erectile dysfunction.
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.
2 What you need to know before you take Tadalafil
Do not take Tadalafil if you:
Warnings and precautions
Talk to your doctor or pharmacist 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.
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.
Tadalafil is not intended for use by women.
Children and adolescents
Tadalafil is not intended for use by children and adolescents under the age of 18.
Other medicines and Tadalafil
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:
Tadalafil with drink and alcohol
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.
Fertility
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.
Driving and using machines
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.
Tadalafil contains lactose
If you have been told by your doctor you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3 How to take Tadalafil
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.
The recommended starting dose is one 10mg tablet before sexual activity. However, you have been given the dose of one 20mg tablet as your doctor has decided that the recommended dose of 10mg is too weak.
You may take a Tadalafil tablet at least 30 minutes before sexual activity.
Tadalafil may still be effective up to 36 hours after taking the tablet.
Do not take Tadalafil more than once a day.
Tadalafil 10mg and 20mg is intended for use prior to anticipated sexual activity and is not recommended for continuous daily use.
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 and 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.
If you take more Tadalafil than you should
Contact your doctor. You may experience side effects described in section 4.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4 Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. These effects are normally mild to moderate in nature.
If you experience any of the following side effects stop using the medicine and seek medical help immediately:
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.
Reporting of side effects
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).
By reporting side effects you can help provide more information on the safety of this medicine.
5 How to store Tadalafil
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.
Store in the original package in order to protect from moisture. This medicine does not require any special 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.
6 Contents of the pack and other information
What Tadalafil contains
What Tadalafil looks like and contents of the pack
Tadalafil 20mg is a light yellow to yellow round coated tablet with ‘L339’ imprinted one side.
Tadalafil 20mg is available in blister packs containing 2, 4, 8, 10 or 12 tablets.
Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer
Alternative manufacturer
This leaflet was last revised in 04/2017.
1010354-P4.1
4 Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, UK
+44 (0)1730 231148
+44 (0)1730 231148