• 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.

1. What CIALIS is and what it is used for
2. What you need to know before you take CIALIS
3. How to take CIALIS
4. Possible side effects
5 How to store CIALIS
6. Contents of the pack and other information

• 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. This is a group of medicines (“nitrates”) used in the treatment of angina pectoris (“chest pain”). CIALIS 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 recently had a heart attack within the last 90 days.
• recently had a stroke within the last 6 months.
• have low blood pressure or uncontrolled high blood pressure.
• 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 CIALIS, have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.

Talk to your doctor before taking CIALIS.

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 CIALIS for benign prostatic hyperplasia. CIALIS does not treat prostate cancer.

Before taking the tablets, tell your doctor if you have:

• 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 CIALIS 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 non-nerve-sparing prostatectomy).

If you experience sudden decrease or loss of vision or your vision is distorted, dimmed while you are taking CIALIS, stop taking CIALIS 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 CIALIS and contact your doctor immediately.

CIALIS is not intended for use by women.

CIALIS 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 CIALIS if you are already taking nitrates.

Some medicines may be affected by CIALIS or they may affect how well CIALIS 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.
• riociguat.
• a 5- alpha reductase inhibitor (used to treat benign prostatic hyperplasia).
• medicines such as ketoconazole tablets (to treat fungal infections) and 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.

Information on the effect of alcohol is in section 3. Grapefruit juice may affect how well CIALIS will work and should be taken with caution. Talk to your doctor for further information.

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.

Some men taking CIALIS in clinical studies have reported dizziness. Check carefully how you react to the tablets before driving or using machines.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

The recommended dose is one 5 mg tablet taken once a day at approximately the same time of the day. Your doctor may adjust the dose to 2.5 mg based on your response to CIALIS. This will be given as a 2.5mg tablet.

Do not take CIALIS more than once a day.

When taken once a day CIALIS 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 CIALIS may be useful to men who anticipate having sexual activity two or more times per week.

It is important to note that CIALIS 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 dose is one 5 mg 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 5 mg tablet taken once a day.

Do not take CIALIS 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 CIALIS more than once a day.

• allergic reactions including rashes (frequency uncommon).
• chest pain - do not use nitrates but seek immediate medical assistance (frequency uncommon).
• priapism, a prolonged and possibly painful erection after taking CIALIS (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), distorted, dimmed, blurred central vision or sudden decrease of vision (frequency not known).

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, website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

• The active substance is tadalafil. Each tablet contains 5 mg of tadalafil.
• The other ingredients are:
  Tablet core: lactose monohydrate (see end of section 2), croscarmellose sodium, hydroxypropylcellulose, microcrystalline cellulose, sodium laurilsulfate, magnesium stearate, see section 2 “CIALIS contains lactose”.
  Film-coat: lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), iron oxide yellow (E172), talc.

CIALIS 5 mg is a light yellow film-coated tablet in the shape of an almond and has "C 5" marked on one side.

CIALIS 5 mg is available in blister packs containing 14, 28 or 84 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Manufacturer:

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: