CIALIS® (tadalafil) tablets

Generic name: Tadalafil

Tadalafil Tablets

This information does not take the place of talking with your healthcare provider. You and your healthcare provider should talk about CIALIS when you start taking it and at regular checkups. If you do not understand the information, or have questions, talk with your healthcare provider or pharmacist.

What are tadalafil / Cialis tablets?

CIALIS (Tadalafil) is a prescription medicine taken by mouth for the treatment of erectile dysfunction (ED) in men.

ED is a condition where the penis does not fill with enough blood to harden and expand when a man is sexually excited, or when he cannot keep an erection. A man who has trouble getting or keeping an erection should see his healthcare provider for help if the condition bothers him. CIALIS helps increase blood flow to the penis and may help men with ED get and keep an erection satisfactory for sexual activity. Once a man has completed sexual activity, blood flow to his penis decreases, and his erection goes away. Tadalafil does not cure ED or increase a man's sexual desire. Tadalafil is only for men with ED and is not for women or children. Tadalafil should only be used under a healthcare provider's care.

Some form of sexual stimulation is needed for an erection to happen with CIALIS.

CIALIS does not:

• cure ED

• increase a man's sexual desire

• protect a man or his partner from sexually transmitted diseases, including HIV. Speak to your healthcare provider about ways to guard against sexually transmitted diseases.

• serve as a male form of birth control

CIALIS is only for men over the age of 18 who have ED, including men with diabetes or who have undergone prostatectomy CIALIS is not for women or children.

CIALIS must be used only under a healthcare provider's care.

What conditions should I have / tell my doctor before I take this medicine?

Health care providers need to know if you have any of these conditions:

• breast-feeding
• bleeding disorder
• diabetes
• gastroesophageal reflux disease (GERD) or frequent heartburn
• angina, irregular heart beats, heart disease, a history of heart attack, or any heart problems
• pregnant or trying to get pregnant
• low or high blood pressure
• stroke
• intestinal or stomach ulcers
• high cholesterol
• eye or vision problems or a retinitis pigmentosa - rare genetic eye disease
• HIV infection
• kidney disease or require dialysis
• liver disease
• sickle cell disease
• an unusual or allergic reaction to tadalafil, other medicines, foods, dyes, or preservatives
• Peyronie's disease, anatomical deformity of the penis, or ever had an erection that lasted more than 4 hours

How should I use Cialis?

• Take Cialis pills by mouth.

• Take CIALIS exactly as your healthcare provider prescribes it. Your healthcare provider will prescribe the dose that is right for you.

• Some men can only take a low dose of CIALIS or may have to take it less often, because of medical conditions or medicines they take.

• Do not change your dose or the way you take CIALIS without talking to your healthcare provider. Your healthcare provider may lower or raise your dose, depending on how your body reacts to CIALIS and your health condition.

• CIALIS may be taken with or without meals.

• If you take too much CIALIS, call your healthcare provider or emergency room right away.

There are two ways to take CIALIS: CIALIS for use as needed:

• Do not take CIALIS more than one time each day.

• Take one CIALIS tablet before you expect to have sexual activity. You may be able to have sexual activity at 30 minutes after taking CIALIS and up to 36 hours after taking it. You and your healthcare provider should consider this in deciding when you should take CIALIS before sexual activity. Some form of sexual stimulation is needed for an erection to happen with CIALIS.

• Your healthcare provider may change your dose of CIALIS depending on how you respond to the medicine, and on your health condition.

OR

CIALIS for once daily use:

• Do not take CIALIS more than one time each day.

• Take one CIALIS tablet every day at about the same time of day. You may attempt sexual activity at any time between doses.

• If you miss a dose, you may take it when you remember but do not take more than one dose per day.

• Some form of sexual stimulation is needed for an erection to happen with CIALIS.

• Your healthcare provider may change your dose of CIALIS depending on how you respond to the medicine, and on your health condition.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed. At this time, this medicine is not for use in children.

What Should I Avoid While Taking CIALIS?

• Do not use other ED medicines or ED treatments while taking CIALIS.

• Do not drink too much alcohol when taking CIALIS (for example, 5 glasses of wine or 5 shots of whiskey). Drinking too much alcohol can increase your chances of getting a headache or getting dizzy, increasing your heart rate, or lowering your blood pressure.

What if I miss a dose of Cialis?

Since Cialis is used as needed, you are not likely to be on a dosing schedule.

If you take Cialis every day and you miss a dose, take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

Can Other Medicines Affect CIALIS / TADANAFIL?

Do not take tadalafil if you are taking the following medications:

• nitroglycerin-type drugs for the heart or chest pain such as amylnitrite, isosorbide dinitrate, isosorbide mononitrate, nitroglycerin, even if these are only taken occasionally

• medicines called alpha blockers. These include Hytrin® (terazosin), Flomax® (tamsulosin), Cardura® (doxazosin mesylate), Minipress® (prazosin ) or Uroxatral® (alfuzosin). Alpha blockers are sometimes prescribed for prostate problems or high blood pressure. If CIALIS is taken with certain alpha blockers, your blood pressure could suddenly drop. You could get dizzy or faint.

• other medicines to treat high blood pressure (hypertension)

• medicines called HIV protease inhibitors, such as ritonavir (Norvir®, Kaletra®)

• ketoconazole (Nizoral^®)

• itraconazole (Sporanox®)

• other medicines or treatments for ED.

Tadalafil may also interact with the following medications:

• bosentan
• certain antibiotics such as clarithromycin, erythromycin, troleandomycin
• certain drugs used for seizures such as carbamazepine, phenytoin, and phenobarbital
• cimetidine
• cisapride
• diltiazem
• grapefruit juice
• medicines for fungal infections (fluconazole, itraconazole, ketoconazole, voriconazole)
• mibefradil
• nicardipine
• certain medicines for the treatment of HIV infection or AIDS
• quinidine
• rifabutin, rifampin or rifapentine
• some drugs for treating depression, anxiety or other mood problems (examples: fluoxetine, fluvoxamine, nefazodone)
• verapamil

Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. CIALIS and other medicines may affect each other. Always check with your healthcare provider before starting or stopping any medicines. Especially tell your healthcare provider if you take any of the mentioned above.

What are the possible side effects of Cialis / Tadalafil?

Call your healthcare provider if you get any side effect that bothers you or one that does not go away.

• changes in hearing such as loss of hearing or ringing in ears
• changes in vision such as loss of vision, blurred vision, eyes being more sensitive to light, or trouble telling the difference between blue and green objects or objects having a blue color tinge to them
• chest pain or palpitations
• difficulty breathing, shortness of breath
• dizziness
• eyelid swelling
• prolonged erection (lasting longer than 4 hours)
• skin rash, itching

In rare instances, men taking PDE5 inhibitors (oral erectile dysfunction medicines, including CIALIS) reported a sudden decrease or loss of vision in one or both eyes. It is not possible to determine whether these events are related directly to these medicines, to other factors such as high blood pressure or diabetes, or to a combination of these. If you experience sudden decrease or loss of vision, stop taking PDE5 inhibitors, including CIALIS, and call a healthcare provider right away.

Sudden loss or decrease in hearing, sometimes with ringing in the ears and dizziness, has been rarely reported in people taking PDE5 inhibitors, including CIALIS. It is not possible to determine whether these events are related directly to the PDE5 inhibitors, to other diseases or medications, to other factors, or to a combination of factors. If you experience these symptoms, stop taking CIALIS and contact a healthcare provider right away.

The most common side effects with CIALIS are:

• back pain
• flushing
• headache
• indigestion
• muscle aches
• stuffy or runny nose

These side effects usually go away after a few hours. Men who get back pain and muscle aches usually get it 12 to 24 hours after taking CIALIS. Back pain and muscle aches usually go away within 2 days.

What Is The Most Important Information I Should Know About CIALIS?

CIALIS can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. You could get dizzy, faint, or have a heart attack or stroke.

Do not take CIALIS if you take any medicines called "nitrates." Nitrates are commonly used to treat angina. Angina is a symptom of heart disease and can cause pain in your chest, jaw, or down your arm.

• Medicines called nitrates include nitroglycerin that is found in tablets, sprays, ointments, pastes, or patches. Nitrates can also be found in other medicines such as isosorbide dinitrate or isosorbide mononitrate. Some recreational drugs called "poppers" also contain nitrates, such as amyl nitrite and butyl nitrite.

• Ask your healthcare provider or pharmacist if you are not sure if any of your medicines are nitrates.

(See "Who should not take CIALIS?") Tell all of your healthcare providers that you take CIALIS. If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took CIALIS.

After taking a single tablet, some of the active ingredient of CIALIS remains in your body for more than 2 days.

The active ingredient can remain longer if you have problems with your kidneys or liver, or you are taking certain other medications (See "Can Other Medicines Affect CIALIS?").

Stop sexual activity and get medical help right away if you get symptoms such as chest pain, dizziness, or nausea during sex. Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease.

See also "What Are The Possible Side Effects Of CIALIS?"

What should I watch for while taking Tadalafil?

If you notice any changes in your vision while taking Cialis / Tadalafil, notify your prescriber or health care professional as soon as possible. Stop using Cialis right away if you have a loss of sight in one or both eyes. Contact your doctor immediately.

Contact your physician immediately if the erection lasts longer than 4 hours or if it becomes painful. This may be a sign of priapism and must be treated immediately to prevent permanent damage.

If you experience symptoms of dizziness, nausea, arm pain or chest pain upon initiation of sexual activity after tadalafil / cialis use, you should refrain from further activity and should discuss the episode with your prescriber or health care professional as soon as possible.

Do not drink alcohol to excess (5 shots of whiskey or 5 glasses of wine) when taking cialis / tadalafil. When taken in excess, alcohol can increase your chances of getting a headache or getting dizzy, increasing your heart rate or lowering your blood pressure.

Do not change the dose of your medication. Please call your prescriber or health care professional to determine if your dose needs to be reevaluated.

Using tadalafil does not protect you or your partner against HIV infection (the virus that causes AIDS) or other sexually transmitted diseases.

How should I store Cialis?

Keep CIALIS and all medicines out of the reach of children.

Store CIALIS at room temperature between 59° and 86°F (15° and 30°C). Throw away any unused medicine after the expiration date.