Cialis
(Tadalafil)

What Cialis is and what it is used for

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. CIALIS has been shown to significantly improve the ability of obtaining a hard erect penis suitable for sexual activity. CIALIS contains the active substance tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Following sexual stimulation CIALIS works by helping the blood vessels in your penis to relax, allowing the flow of blood into your penis. The result of this is improved erectile function. CIALIS will not help you if you do not have erectile dysfunction. 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.

How to take Cialis

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. CIALIS tablets are for oral use in men only. Swallow the tablet whole with some water. The tablets can be taken with or without food. The recommended starting dose is one 10 mg tablet before sexual activity. If the effect of this dose is too weak your doctor may increase the dose to 20 mg. CIALIS tablets are for oral use. You may take a CIALIS tablet at least 30 minutes before sexual activity. CIALIS may still be effective up to 36 hours after taking the tablet. Do not take CIALIS more than once a day. CIALIS 10 mg and 20 mg is intended for use prior to anticipated sexual activity and is not recommended for continuous daily use. 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 and may temporarily lower your blood pressure. If you have taken or are planning to take CIALIS, avoid excessive drinking (blood alcohol level of 0.08 % or greater), since this may increase the risk of dizziness when standing up. If you take more CIALIS than you should Contact your doctor. You may experience side effects described in section 4. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. These effects are normally mild to moderate in nature. 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).
•priapsim, 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).

Other side effects have been reported:

Common (seen in 1 to 10 in every 100 patients)
•headache, back pain, muscle aches, pain in arms and legs, facial flushing, nasal congestion, and indigestion.

Uncommon (seen in 1 to 10 in every 1,000 patients)
•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 and feeling tired.

Rare (seen in 1 to 10 in every 10,000 patients)
•fainting, seizures and passing memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of hearing, hives (itchy red welts on the surface of the skin), penile bleeding, presence of blood in semen and increased sweating. Heart attack and stroke have also been reported rarely in men taking CIALIS. 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 CIALIS 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 and sudden cardiac death. The side effect dizziness has been reported more frequently in men over 75 years of age taking CIALIS. Diarrhoea has been reported more frequently in men over 65 years of age taking CIALIS.

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 national reporting system United Kingdom: Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard or Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL
•Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: [email protected] Malta: ADR Reporting, Website: www.medicinesauthority.gov.mt/adrportal. By reporting side effects you can help provide more information on the safety of this medicine.

How to Store Cialis

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP’. The expiry date refers to the last day of that month. Store in the original package in order to protect from moisture. Do not store above 30°C. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.