Cialis Film-Coated Tablets

CIALIS contains the active substance tadalafil. CIALIS 5 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. It is important to note that CIALIS does not work if there is no sexual stimulation.
• CIALIS 5 is also used to treat
• Benign prostatic hyperplasia (BPH) - BPH means that the prostrate has become enlarged and it is not cancerous.

Do not take CIALIS if you:

• are hypersensitive (allergic) to tadalafil or any of the other ingredients of CIALIS (listed in section 6.1).
• 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 have had a heart attack.
• have had a stroke.
• have low blood pressure or uncontrolled high blood pressure.
• have a severe kidney problem.
• are also using any of the following medicines: azole antifungals such as ketoconazole, itraconazole, voriconazole, ritonavir and other protease inhibitors.
• have had previous experience of a decrease or loss of hearing in one or both ears, with or without dizziness.
• have ever had an experience of partial, sudden, temporary or permanent decrease or loss of vision in one or both eyes.
• are taking any guanylate cyclase stimulators such as riociguat. This group of medicines is used to treat pulmonary hypertension. CIALIS used together with these medicines may cause low blood pressure.

Warnings and precautions

Take special care with CIALIS: Sexual activity carries a possible risk if you have heart disease because it puts an extra strain on your heart. If you have a heart problem, you should tell your doctor. In case of chest pain occurring during or after sexual activity you should NOT use nitrates, but you should seek immediate medical assistance. If you experience long erections lasting 4 hours or more, talk to your doctor immediately as this can result in permanent tissue damage. Before taking CIALIS, 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.

CIALIS is not intended for use by women or by children or adolescents under the age of 18.

Do not share medicines prescribed for you with any other person. Always take CIALIS exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Do not take CIALIS more than once a day.

For the treatment of erectile dysfunction:

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

For the treatment benign prostatic hyperplasia:

The recommended dose is one 5 mg tablet taken once a day at approximately the same time of the day. CIALIS tablets are for oral use. Swallow the tablet whole with a glass of water. You may take CIALIS with or without food. When taken once a day, CIALIS allows you to obtain an erection, when sexually stimulated, at any time point during the next 24 hours of the day.

It is important to note that CIALIS does not work if there is no sexual stimulation. Drinking alcohol may affect your ability to get an erection. Drinking alcohol may temporarily lower your blood pressure. If you have taken or are planning to take CIALIS, avoid excessive drinking since this may increase the risk of dizziness when standing up. Your doctor will tell you how long your treatment with CIALIS will last. If you have the impression that the effect of CIALIS is too strong or too weak, tell your doctor or pharmacist.

Paediatric population

CIALIS should not be used in children.

If you take more CIALIS than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison center.

If you forget to take CIALIS

Do not take a double dose to make up for forgotten doses. If you have any further questions on the use of CIALIS, ask your doctor or pharmacist.

CIALIS can have side effects. Not all side effects reported for CIALIS are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking CIALIS, please consult your doctor, pharmacist or other healthcare professional for advice.

If any of the following happens, stop taking CIALIS and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Difficulty breathing
• Severe skin rash or itching
• Swollen tongue or lips

These are all very serious side effects. If you have them, you may have had a serious reaction to CIALIS. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Chest pain
• An erection that lasts longer than 4 hours
• Sudden loss of vision

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects

• Headache
• Reddening of the face (flushing)
• Stuffy nose
• Discomfort in your stomach
• Back pain, pain in your muscles or any part of your body

Less frequent side effects

• Dizziness
• Loss of consciousness or numbness on one side of the body
• Fainting, severe headache (migraine), sudden memory loss
• Blurred vision or loss of vision, eye pain, swelling of eyelids, redness or itching of the eye
• Ringing in ears, loss of hearing
• Changes in heart rhythm, chest pain or feeling of pressure in chest
• Low or high blood pressure
• Difficulty breathing, nose bleeds
• Stomach pain, nausea, vomiting, heartburn or burning sensation in your throat
• Rash, sweating
• Blood in urine
• Prolonged erections, blood in the sperm or bleeding from the penis
• Chest pain, tiredness, swelling of the legs or face

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who- umc.org) found on SAHPRA website. Alternatively, report suspected adverse events to the company at [email protected]. By reporting side effects, you can help provide more information on the safety of CIALIS.

Store all medicines out of reach of children. Store at or below 25 °C. Store in original package. Do not use CIALIS after the expiry date stated on the carton and blister. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).