Cialis 20 mg Film-Coated Tablets

CIALIS contains the active substance tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. CIALIS 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.

Do not take CIALIS if you:

• are hypersensitive (allergic) to tadalafil or any of the other ingredients of CIALIS (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 had a heart attack.
• have chest pains during or after sexual activity, have abnormal heart rhythm or heart failure.
• had a stroke.
• have low blood pressure or uncontrolled high blood pressure.
• have a severe liver problem.
• If you 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.
• If you 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.

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. The recommended dose is a 20 mg CIALIS (one tablet) before sexual activity. CIALIS tablets are for oral use. Swallow the tablet whole with some water. You may take CIALIS with or without food. You may take a CIALIS tablet at least 16 minutes before sexual activity. CIALIS may still be effective up to 36 hours after taking the tablet. 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. You should NOT take CIALIS more than once a day. CIALIS 20 mg is intended for use prior to anticipated sexual activity and is not recommended for continuous daily use. 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. 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 “6.04 Adverse Drug Reaction Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. 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).