Product Information: Cialis - Tadalafil

Product Information
The world's latest version of Viagra!

Cialis® is Eli-Lilly's answer to Pfizer's Viagra®.

Cialis® contains Tadalafil and it "works" in the same way as Viagra®, that is it inhibits an enzyme known as Phosphodiesterase type-5 (PDE5), an enzyme that naturally occurs in erectile tissue. PDE5 can break down cyclic GMP, (the substance that is produced during sexual arousal and causes vascular and muscular changes that eventual lead to an erection).

Therefore, men who produce too little cyclic GMP have problems obtaining and maintaining an erection, and men who produce too much PDE5 have problems obtaining and maintaining an erection.

The benefits of Cialis® over Viagra® lie in its ability to work faster, and last longer. Whilst Viagra® on-average, takes effect within 60-minutes and works for 4-hours, in trials Cialis® was effective on-average within 30-minutes and lasted for 12-hours, in some cases Cialis® was still effective up-to 24-hours later.

Cialis® is contraindicated with organic nitrates. These are drugs that are often used to treat heart conditions such as hypotensive conditions, (low blood pressure). Cialis® appears to potentiate the effects of nitrates and therefore the two must not be taken concurrently. Furthermore, caution is advised for any patient using Cialis® who has a heart problem, even if they are not using nitrates for the condition.

Cialis® dosages are usually 10mg (maximum 20mg), taken up to one hour before sexual intercourse. These dosages have produced side effects such as headache, flushing and dyspepsia. There have been some reports of disturbances, dizziness, and nasal congestion. Other rarer adverse effects reported include diarrhoea, muscle pain, skin rashes, and urinary or respiratory-tract infection.

Manufacturers Insert

CIALIS® 20mg / TADALAFIL

Cialis 20mg film-coated tablets

The active substance is tadalafil. Each tablets of Cialis contains 20mg of tadalafil. The other ingredients are:
Tablet Core: lactose monohydrate, croscarmellose sodium, hydroxyproplycellulose, microcrystalline cellulose, sodium laurilsulfate, magnesium stearate.
Film-Coat: lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), iron oxide yellow (E172), talc.

WHAT CIALIS IS AND WHAT IS IT USED FOR:
Cialis comes as yellow film-coated tablets. They are in the shape of almonds and have "C 20" marked on one side. These tablets are available in blister packs containing 2, 4 or 8 tablets.

Cialis is a treatment for men with erectile dysfunction. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity.

Cialis 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.

BEFORE YOU TAKE CIALIS

DO NOT TAKE CIALIS:
- if you 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 drugs. If you are taking any form of nitrate or are unsure tell you doctor.
- If you have serious heart disease or have had a recent heart attack.
- If you have had a recent stroke.
- If you have low blood pressure or uncontrolled high blood pressure.
- If you are (hypersensitive) allergic to tadalafil or any of the other ingredients of Cialis.

Take Special care with Cialis
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. The following are reasons why Cialis may also not be suitable for you. If any of them apply to you, talk to your doctor before you take the medicine:

- you have sickle cell anemia (an abnormality of red blood cells), multiple myeloma (cancer of the bone marrow), leukemia (cancer of the blood cells) or any deformation of your penis.
- You have a serious liver or kidney problem.
- Take other medicines:

As a general rule, always tell your doctor if you are taking or have recently taken any other medicine, even those not prescribed, because occasionally they might interact. This is particularly important if you are treated with nitrates as you should not take Cialis if you are taking these medicines. Do not take Cialis with other medicines if your doctor tells you that you may not. You should not use Cialis together with any other treatments for erectile dysfunction. Cialis is not intended for use by women or by children under the age of 18.

Driving and using machines:
As dizziness has been reported in men taking Cialis in clinical studies, you should be aware of how you react to Cialis before you drive or operate machinery.

Information for men intolerant of lactose, one of the ingredients of Cialis:

Cialis contains lactose and should not be taken by patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.

HOW TO TAKE CIALIS
Always take Cialis exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

The recommended starting dose is one 10mg tablet before sexual activity. If the effect of this dose is too weak your doctor may increase the dose to 20mg. 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 any point in time from 30 minutes to 12 hours before sexual activity. Cialis may still be effective up to 24 hours after taking the tablet. 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. You should NOT take Cialis more than once a day. Daily use of Cialis is strongly discouraged.

If you take more Cialis than you should:

Tell your doctor.

POSSIBLE SIDE EFFECTS
Like all medicines, Cialis can have side effects. These effects are normally mild to moderate in nature. The most common undesirable effects are headache and indigestion. Less commonly reported side effects are back pain, muscle aches, nasal congestion, facial flushing and dizziness. Uncommon effects are swelling of the eyelids, eye pain and red eyes. If you have any of these side effects and they are troublesome, sever, or do not go away, tell your doctor.

Allergic reactions (including skin rashes) could occur. In rare instances it is possible that a prolonged and possibly painful erection may occur after taking Cialis. If you have such an erection, which lasts continuously for more than 4 hours, you should contact a doctor immediately.

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

Heart attack, stroke and irregular heartbeats have been reported rarely in men taking Cialis. Most, but not all of these men had known heart problems before taking this medicine. It is not possible to determine whether these events were directly related to Cialis.

Effects were seen in one animal species that might indicate impairment of fertility. Subsequent studies in man suggest that this effect is unlikely in humans.

STORING CIALIS
Keep out of reach and sight of children. Store in the original package. Do not use after the expiry date stated on the carton and blister.