TADALAFIL (Systemic)

Some commonly used brand names are:

In the U.S.?

• Cialis

Category

• Impotence therapy agent(systemic)

Description

Tadalafil ((tah-DAL-a-fil) )is a medicine used to treat erectile dysfunction in men. Erectile dysfunctionis a condition where the penis does not harden and expand when a man is sexuallyexcited, or when he cannot keep an erection. When a man is sexually stimulated,his body's normal response is to increase blood flow to his penis. This resultsin an erection. Tadalafil helps increase blood flow to the penis and may helpmen with erectile dysfunction get and keep an erection satisfactory for sexualactivity. Once a man has completed sexual activity, blood flow to his penisdecreases, and his erection goes away.

This medicine is available only with your doctor's prescription, in thefollowing dosage forms:

Oral
• Tablets (U.S.)

Before Using This Medicine

In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. This is a decision you and your doctor will make. For tadalafil, the followingshould be considered:

Allergies?Tell your doctor if you have ever had any unusualor allergic reaction to tadalafil. Also tell your doctor and pharmacist ifyou are allergic to any other substances, such as foods, preservatives, ordyes.

Pregnancy?Tadalafil is for use in men only. Tadalafil hasnot been studied in pregnant women. Tadalafil has not been shown to causebirth defects or other problems in animals.

Breast-feeding?Tadalafil is for use in men only. It is not knownwhether tadalafil passes into human breast milk.

Children?Tadalafil is not for use in children.

Older adults?This medicine has been tested in a limited numberof patients 65 years of age or older and has not been shown to cause differentside effects or problems in older people than it does in younger adults.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingtadalafil, it is especially important that your doctor and pharmacist knowif you are taking any of the following:

• Erectile dysfunction medicines?These medicines should not beused at the same time as tadalafil because the safety of using these medicinesin combination has not been proven.

• Nitrates (medicine used to treat chest pain [e.g., nitroglycerin])?Thesemedicines should not be used at the same time as tadalafil because they cancause very low blood pressure and serious side effects.

• Alcoholic beverages?Drinking alcohol can cause an increasedchance of some side effects.

• Alpha blockers, other than tamsulosin 0.4 mg taken once a day (medicinefor high blood pressure)?These medicines should be used with cautionwhen taken at the same time as tadalafil because they can cause very low bloodpressure and serious side effects.

• Erythromycin (e.g., Apo-erythro) or
• Itraconazole (e.g., Sporanox) or
• Ketoconazole (e.g., Nizoral) or
• Grapefruit juice or
• Ritonavir (e.g., Norvir) or
• Saquinavir (e.g., Fortovase, Invirase)?These medicines or foodmay increase your chance of getting side effects.

Other medical problems?The presence of other medicalproblems may affect the use of tadalafil. Make sure you tell your doctor ifyou have any other medical problems, especially:

• Age greater than 50 years or
• Coronary artery disease or
• Diabetes or
• Hyperlipidemia (excess of lipids in the blood) or
• Hypertension (high blood pressure) or
• Low cup to disc ratio (?crowded disc?) or
• Smoking?These conditions may increase risk for a serious eyeproblem called NAION.

• Angina (reoccurring chest pain) or
• Arrhythmia (irregular heartbeat) or
• Hypotension (low blood pressure) or
• Hypertension (high blood pressure) or
• Stroke (recent history of) or
• Heart attack (within the last 3 months) or
• Heart failure (within the last 6 months) or
• Retinal disorders (rare hereditary eye problem)?Tadalafil hasnot been studied in patients with these medical conditions and should notbe used.

• Kidney disease (severe)?Tadalafil should be used with cautionin these patients and a lower dose may be needed.

• Liver disease?Tadalafil should not be used in patients withserious liver disease; in patients with less serious liver disease, tadalafilshould be used with caution and a lower dose may be needed.

• Abnormal penis, including curved penis and birth defects of the penis?Chanceof problems occurring may be increased and this medicine should be used withcaution in these patients

• Bleeding disorders or
• Stomach ulcers?Chance of problems occurring may be increased;it is not known if the medicine is safe for use in these patients.

• Heart disease, underlying?Chance of low blood pressure occurringis greater; tadalafil should be used carefully in these patients.

• Heart blood flow problems?These conditions may cause you tobe more sensitive to tadalafil.

• Sickle-cell anemia (blood disorder) or
• Bone marrow cancer or
• Leukemia (blood related cancer)?Tadalafil should be used withcaution in these patients as problems with prolonged erection of the penismay occur.

• NAION (serious eye condition) in one or both eyes, previously?Mayincrease your chance of getting NAION again.

Proper Use of This Medicine

Specialpatient directions come with tadalafil. Read the directionscarefully before you start using tadalafil and each time you get a refillof your medicine.

Use tadalafil exactly as directed by your doctor.Do not use more of it and do not use it more often than your doctor ordered.If too much is used, the chance of side effects or other problems is increased.

Dosing?The dose of tadalafil will be different fordifferent patients. Follow your doctor's orders or thedirections on the label. The following information includes only theaverage doses of tadalafil. If your dose is different,do not change it unless your doctor tells you to do so.

• For oral dosage form (tablets):
  • For treatment of erectile dysfunction:
    • Adults?10 mg as a single dose no more than once a day, takenbefore you think sexual activity may occur. The ability to have sexual activitymay be improved up to 36 hours after taking tadalafil when compared to placebo(sugar pill). If needed, your doctor may change your dose.

Storage?To store this medicine:

• Keep out of the reach of children.
• Do not store in the bathroom, near the kitchen sink, or in otherdamp places. Heat or moisture may cause the medicine to break down.
• Keep the medicine from freezing. Do not refrigerate.
• Do not keep outdated medicine or medicine no longer needed. Ask yourhealth care professional how you should dispose of any medicine you do notuse. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Tadalafil has not been studied with other medicines used fortreatment of erectile dysfunction. Using them together is not recommended.

It is important that you tell all of your healthcareproviders that you take tadalafil. If you need emergency medical carefor a heart problem, it is important that your healthcare provider knows whenyou last took tadalafil.

If you experience a prolonged or painful erection for4 hours or more, contact your doctor immediately. This condition mayrequire prompt medical treatment to prevent serious and permanent damage toyour penis.

This medicine does not protect you against sexually transmitted diseases.Use protective measures and ask your doctor if you have any questions aboutthis.

It is important to tell your doctor about any heart problems you may havenow or may have had in the past. This medicine can cause serious side effectsin patients with heart problems.

Do not drink alcohol to excess (for example, 5 glasses of wine or 5 shotsof whiskey) when taking tadalafil. When taken in excess alcohol can increaseyour chances of getting a headache or getting dizzy, increasing your heartrate, or lowering your blood pressure.

If you experience sudden loss of vision in one or botheyes, stop using tadalafil and contact your doctor immediately.

Side Effects of This Medicine

Along with its needed effects, a medicinemay cause some unwanted effects. Although not all of these side effects mayoccur, if they do occur they may need medical attention.

Check with your doctorimmediately if any of the following side effects occur:

Less common

Arm, back or jaw pain; blurred vision; chest pain or discomfort; chest tightness or heaviness; chills; cold sweats; confusion; dizziness; fainting; faintness, or lightheadedness when getting up from a lying or sitting positionsuddenly; fast or irregular heartbeat; headache; nausea; nervousness; pain or discomfort in arms, jaw, backor neck; pounding in the ears; shortness of breath; slow or fast heartbeat; sweating; unusual tiredness or weakness; vomiting

Rare

Painful or prolonged erection of the penis

Incidence not known

Abdominal or stomach pain; blistering,peeling, loosening of skin; cracks in the skin; decrease or change in vision; difficultyin speaking; double vision; hives or welts; inability to move arms, legs, orfacial muscles; inability to speak; loss of heat from the body; numbnessor tingling of face, hands or feet; red irritatedeyes; red skin lesions, often with a purple center; red, swollen skin; rednessand soreness of eyes; redness of skin; scaly skin; slow speech; sore throat; sores in mouth; swelling of feet or lower legs

Other side effects mayoccur that usually do not need medical attention. These side effects may goaway during treatment as your body adjusts to the medicine. However, checkwith your doctor if any of the following side effects continue or are bothersome.

More common

Acid or sour stomach; belching; heartburn; indigestion; stomach discomfort, upset, or pain

Less common

Bloody nose; burning, crawling, itching,numbness, prickling, "pins and needles" , or tingling feelings; burning feeling in chest or stomach; burning, dry or itching eyes; body aches or pain; congestion; cough; diarrhea; difficulty in moving; difficulty swallowing; dry mouth; dryness or soreness of throat; eye pain; excessive eye discharge; fever; feeling of constant movement of self or surroundings; feeling of warmth redness of the face, neck, armsand occasionally, upper chest; hoarseness; increased erection; itching skin; joint pain; lack or loss of strength; loose stools; muscle achingor cramping; muscle pains or stiffness; nasal congestion; neck pain; pain; pain in arms and/or legs; pain or burning in throat; rash; redness, pain, swelling of eye, eyelid, or inner lining of eyelid; reduced sensitivity to touch; runny nose; sensation of spinning; sleepiness or unusual drowsiness; sleeplessness; sores, ulcers, or white spots on lips or tongue or inside themouth; spontaneous penile erection; stomach upset; swelling of eyelids; swelling or puffiness of eye or face; swollen joints; tearing; tender, swollen glands in neck; tenderness in stomacharea; trouble sleeping; unable to sleep; upper abdominal pain; voice changes; watering of eyes

Other side effectsnot listed above may also occur in some patients. If you notice any othereffects, check with your doctor.

Rare