Tadalafil SUN 20 mg film-coated tablets

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

Do NOT take Tadalafil if you

• are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6)
• are taking any form of organic nitrate or nitric oxide donors such as amyl nitrite (nitrates) used in the treatment of angina pectoris (chest pain). Tadalafil has been shown to increase the effects of these medicines. If you are taking any form of nitrate or are unsure tell your doctor.
• have serious heart disease or have had a heart attack within the last 90 days
• have had a stroke within the last 6 months
• have low blood pressure or uncontrolled high blood pressure
• have ever had loss of vision because of non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “stroke of the eye”
• are taking riociguat. This drug is used to treat pulmonary arterial hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high blood pressure in the lungs secondary to blood clots). PDE5 inhibitors, such as Tadalafil, have been shown to increase the blood pressure lowering effects of this medicine. If you are taking riociguat or are unsure tell your doctor.

Warnings and precautions

Tell your doctor before taking Tadalafil if you have:

• a heart problem. Sexual activity carries a possible risk to patients with heart disease because it puts an extra strain on your heart.
• sickle cell anaemia (an abnormality of red blood cells)
• multiple myeloma (cancer of the bone marrow)
• leukaemia (cancer of the blood cells)
• any deformation of your penis
• a serious liver problem
• a severe kidney problem.

It is not known if Tadalafil is effective in patients who have had:

• pelvic surgery
• removal of all or part of the prostate gland in which nerves of the prostate are cut (radical nonnerve-sparing prostatectomy).

Contact your doctor immediately and stop taking Tadalafil if you experience:

• sudden decrease or loss of vision
• decreased or sudden hearing loss. This has been noted in some patients taking tadalafil. Although it is not known if the event is directly related to tadalafil.

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, used to treat angina pectoris (chest pain)
• riociguat, used to treat high blood pressure in the lungs.

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:

• an alpha blocker (used to treat high blood pressure or urinary symptoms associated with benign prostatic hyperplasia)
• other medicines to treat high blood pressure
• a 5- alpha reductase inhibitor (used to treat benign prostatic hyperplasia)
• medicines such as ketoconazole tablets (to treat fungal infections)
• protease inhibitors for treatment of AIDS or HIV infection
• phenobarbital, phenytoin and carbamazepine (anticonvulsant medicines)
• rifampicin, erythromycin, clarithromycin or itraconazole
• other treatments for erectile dysfunction.

Tadalafil with drink and alcohol

Information on the effect of alcohol is given 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

When dogs were treated there was reduced sperm development in the testes. A reduction in sperm was seen in some men. 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.

Tadalafil contains lactose:

If you have an intolerance to some sugars, contact your doctor before taking this medicine.

If you take more Tadalafil than you should

Contact your doctor. You may experience side effects described in section 4.

If you experience any of the following side effects stop using the medicine and seek medical help immediately:

• allergic reactions including rashes (frequency uncommon)
• chest pain - do not use nitrates but seek immediate medical assistance (frequency uncommon)
• priapism, prolonged and possibly painful erection after taking Tadalafil (frequency rare). If you have such an erection, which lasts continuously for more than 4 hours you should contact a doctor immediately.
• sudden loss of vision (frequency rare)
• sudden decrease or loss of hearing (frequency rare).

Other side effects have been reported:

Common (may affect up to 1 in 10 people)

• headache
• back pain
• muscle aches
• pain in arms and legs
• facial flushing
• nasal congestion
• indigestion.

Uncommon (may affect up to 1 in 100 people)

• dizziness
• stomach ache
• feeling sick
• being sick (vomiting)
• reflux
• blurred vision
• eye pain
• difficulty in breathing
• presence of blood in urine
• prolonged erection
• pounding heartbeat sensation
• a fast heart rate
• high blood pressure
• low blood pressure
• nose bleeds
• ringing in the ears
• swelling of the hands, feet or ankles
• feeling tired.

Rare (may affect up to 1 in 1,000 people)

• fainting
• seizures and passing memory loss
• swelling of the eyelids
• red eyes
• hives (itchy red welts on the surface of the skin)
• penile bleeding
• presence of blood in semen
• increased sweating.

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 have been reported in men taking Tadalafil that were not seen in clinical trials. These include:

• migraine
• swelling of the face
• serious allergic reaction which causes swelling of the face or throat
• serious skin rashes
• some disorders affecting blood flow to the eyes
• irregular heartbeats
• angina
• sudden cardiac death.

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 the Yellow Card Scheme at: 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.

What Tadalafil contains

• The active substance is tadalafil. Each tablet contains 20 mg of tadalafil.
• The other ingredients are:
  Tablet core: lactose monohydrate (see end of section 2), microcrystalline cellulose, crospovidone type A, hydroxypropylcellulose (353-658 cps), poloxamer 188, colloidal silica anhydrous, magnesium stearate.
  Film-coat: opadry II yellow: lactose monohydrate, hypromellose 2910/15, macrogol 6000, titanium dioxide (E171), iron oxide yellow (E172), talc.

What Tadalafil looks like and contents of the pack

Tadalafil 20 mg is a yellow coloured, 14.30 x 7.95 mm oval shaped, biconvex, film-coated tablet, 5.975 mm thick, debossed with "20" on one side and “S” on the other side.

Tadalafil 20 mg is available in blister packs containing 2, 4, 8, 10, 12, 28, 56, 84 or 98 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer