• Impotence (erectile dysfunction).
• Relieving the urinary symptoms of an enlarged prostate gland (benign prostatic hyperplasia). Only Tadalafil 5mg tablets have a licence for this use.

• Tadalafil tablets may be taken with or without food. The tablets should be swallowed whole with a drink of water.
• Tadalafil 10mg and 20mg tablets are intended for use on an 'as needed' basis for erectile dysfunction. With these strength tablets the dose should be taken at least 30 minutes before intended sex. One dose can produce an erection in response to sexual stimulation for up to 36 hours. These tablets should be taken no more than once a day, and should not be taken every day on a continuous basis.
• If Tadalafil 10mg or 20mg tablets work for you, but you anticipate taking Tadalafil on a regular basis (to have sexual activity at least twice a week), Tadalafil once-a-day tablets may be an appropriate option for you. These tablets contain a lower dose of tadalafil (2.5mg or 5mg) and are designed to be taken once a day, every day, allowing you to get an erection and have sex whenever you wish. Tadalafil 2.5mg and 5mg tablets should not be taken more than once a day.
• If you are taking Tadalafil 5mg tablets for an enlarged prostate gland, or erectile dysfunction and an enlarged prostate gland, you should take one tablet once a day, at the same time each day.

• Tadalafil should not be taken more than once a day.
• This medicine may cause dizziness and so may affect your ability to drive or operate machinery safely. Do not drive or operate machinery until you know how this medicine affects you and you are sure it won't affect your performance.
• If this medicine is taken with alcohol it may cause a drop in blood pressure that might make you feel dizzy. In addition, alcohol can impair sexual performance.
• You should avoid drinking grapefruit juice while taking this medicine, as it may increase the level of this medicine in your blood and hence increase the risk of side effects.
• If you get an erection that lasts longer than four hours (priapism), consult a doctor immediately. Treatment of this condition should not be delayed more than six hours, as this can cause damage to the erectile tissue in the penis and irreversible erectile dysfunction.
• If you experience a sudden, partial decrease or loss of vision in one or both eyes you should stop taking this medicine and consult your doctor immediately.

• Decreased kidney function.
• Decreased liver function.
• Disease involving the heart and blood vessels (cardiovascular disease).
• Men taking medicines for high blood pressure (see end of factsheet for more information).
• Conditions such as sickle cell disease, bone marrow cancer (multiple myeloma) or leukaemia, in which there is an increased risk of prolonged erections (priapism).
• Men with a physical abnormality of the penis, such as severe curvature, scarring or Peyronie's disease.

• Women.
• Children and adolescents under 18 years of age.
• Conditions in which sexual activity is not advisable, for example severe heart disorders.
• Men with angina not well controlled by medical treatment (unstable angina).
• Men with angina that occurs during sex.
• Men who have had a heart attack in the last three months.
• Men who have had a stroke in the last six months.
• Men with mild to severe heart failure in the last six months.
• Men with abnormal heart beats (arrhythmias) not controlled by treatment.
• Uncontrolled high blood pressure (hypertension).
• Low blood pressure (hypotension).
• Men taking any form of nitrate medications, eg glyceryl trinitrate (see end of factsheet for more examples).
• Men who have ever experienced an eye condition called non-arteritic anterior ischemic optic neuropathy (NAION). This condition causes a sudden, partial decrease or loss of vision in one or both eyes due to damage to the optic nerve. It can be temporary or permanent. Talk to your doctor if you have ever experienced this.
• Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (Tadalafil tablets contain lactose).
• Tadalafil once-a-day dosing is not recommended for men with severely decreased kidney function or kidney failure. This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

• Read the package insert and/or patient product information sheet that comes with your prescription.

•Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.
• Headache.
• Flushing.
• Nasal congestion.
• Indigestion (dyspepsia).
• Heartburn (reflux).
• Back pain.
• Pain in the muscles (myalgia).
• Dizziness.
• Blurred vision.
• Eye pain.
• Abdominal pain.
• Increased heart rate (tachycardia).
• Awareness of your heartbeat (palpitations).
• Decrease in blood pressure (hypotension). This is more common in men taking medicines to treat high blood pressure (antihypertensives).
• Increase in blood pressure (hypertension).
• Chest pain.
• Shortness of breath.
• Nosebleeds.
• Rash.
• Sweating.
• Prolonged erections (see warning section above).
• Fainting.
• Migraine.
• Temporary memory loss.
• Swelling of the face.
• Swelling of the eyelids.
• Red eyes.
• Sudden decrease or loss of hearing.
• Heart attack, stroke or mini-stroke (in most cases these events were reported in men who had pre-existing risk factors for heart disease).
• Irregular heartbeat (ventricular arrhythmia).
• Seizures.
• Hives (urticaria).
• Severe blistering skin reaction affecting the tissues of the eyes, mouth, throat and genitals (Stevens-Johnson Syndrome). An eye condition called non-arteritic anterior ischemic optic neuropathy (NAION). This condition causes a sudden, partial decrease or loss of vision in one or both eyes due to damage to the optic nerve. It can be temporary or permanent. See warning section above. .

•It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start taking this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to make sure that the combination is safe. Tadalafil must not be taken with any form of nitrate medication, as this combination can produce a severe drop in blood pressure that can cause dizziness, fainting, or even a heart attack. Nitrate medications include the following:
• glyceryl trinitrate, isosorbide mononitrate or isosorbide dinitrate (these are used for angina or heart failure - if you experience chest pain after taking Tadalafil DO NOT take a nitrate medicine to treat it)
• nicorandil
• amyl nitrate (also known as 'poppers'). If tadalafil is taken by people who are taking medicines for high blood pressure (antihypertensives), the combination may potentially cause an extra drop in blood pressure. This is unlikely to be significant, but you should be aware that if it does occur it may make you feel dizzy. If you are taking Tadalafil every day you should tell your doctor if you feel dizzy because the doses of your blood pressure medicines may need adjusting. This is more likely to occur in people taking alpha-blocker medicines such as doxazosin, some of which are used to treat an enlarged prostate gland as well as high blood pressure. Tadalafil is not recommended for men taking doxazosin. The use of tadalafil with other treatments for erectile dysfunction is not recommended, as the safety of such combinations has not yet been established. The medicines listed below may reduce the breakdown of tadalafil by the liver, which could increase the risk of its side effects. Ask your doctor for advice if you are prescribed any of these, as you may need to take a lower tadalafil dose:
• the antibiotic medicines clarithromycin and erythromycin
• the antifungal medicines ketoconazole and itraconazole
• the HIV protease inhibitors ritonavir and saquinavir. The following medicines speed up the breakdown of tadalafil by the liver, and it could therefore be less effective in people taking any of these medicines:
• carbamazepine
• phenobarbital
• phenytoin
• rifampicin. If tadalafil is taken by people taking theophylline there may be a small increase in heart rate. This is unlikely to be significant, but you should tell your doctor if you are taking theophylline.

•Read the package insert and/or patient product information sheet that comes with your prescription.
• Most medications should be stored in a dry place away from heat and humidity.
• Some medications also have special instructions for storage. Check for special instructions on your prescription label.
• If your medication needs to be protected from light, it should be stored in a container that filters out light, such as a clean film canister.
• If your medication needs to be refrigerated, and you do not have a fridge available (for example, if you are working outside or on the road all day), try using a cooler with an ice pack. An ordinary cooler found at hardware or sporting goods stores will do.

•Consult your doctor for further instructions and also read the package insert and/or patient product information sheet that comes with your prescription.