Tadalafil relaxes muscles within thepenis. This allows increased blood flow into the penis, necessary toachieve and maintain an erection.

Tadalafil is used to treat erectile dysfunction (impotence).

Tadalafil may also be used for purposes other than those listed in this medication guide.

* Taking tadalafil with any of thesemedications may cause very low blood pressure, possibly resulting indizziness, fainting, stroke, or heart attack.

* Contact your doctor orseek emergency medical attention for any erection that lasts longerthan 4 hours. A sustained erection can damage the penis.

* Refrain from furthersexual activity and notify your doctor it you develop dizziness,nausea, or angina (pain, tightness, discomfort, numbness, or tinglingin the chest, arms, neck, or jaw) during sexual activity.

* Tadalafil is usually taken whenneeded before sexual activity. The effects of tadalafil may last for upto 36 hours or more. Your doctor will determine how often you can taketadalafil. Do not take tadalafil more often than is directed by yourdoctor.

Special precautions

Before taking tadalafil, tell your doctor if you

• have heart problems such as angina, heart failure, irregular heartbeats, or have had a heart attack;

• have low blood pressure or high blood pressure that is not controlled;

• have had a stroke;

• have liver problems;

• have kidney problems;

• have ever had blood cell problems such as sickle cell anemia, multiple myeloma, or leukemia;

• have a bleeding disorder;

• have a stomach ulcer;

• have retinitis pigmentosa (an inherited condition of the eye);

• have a physical deformity of the penis such as Peyronie's disease;

• Had an erection that lasted longer than 4 hours.

* Taking tadalafil with any of thesemedications may cause very low blood pressure, possibly resulting indizziness, fainting, stroke, or heart attack.

* You may not be able to taketadalafil, or you may require a dosage adjustment or special monitoringduring treatment if you have any of the conditions listed above.

* Although tadalafil is not indicatedfor use by women, it is in the FDA pregnancy category B. This meansthat tadalafil is not expected to be harmful to an unborn baby.Tadalafil should not be taken by women.

* It is not known whether tadalafil passes into breast milk. Tadalafil should not be taken by women.

* If you are over 65 yearsof age, you may be more likely to experience side effects fromtadalafil. Your doctor may prescribe a lower dose of this medication.

Side effects

If you experience any ofthe following serious side effects, stop taking tadalafil and seekemergency medical attention or contact your doctor immediately:

• an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

• chest pain or irregular heartbeats;

• dizziness, nausea, or angina (pain, tightness, discomfort, numbness, or tingling in the chest, arms, neck, or jaw);

• swelling of the ankles or legs;

• shortness of breath;

• prolonged or severe dizziness; or

• A prolonged (lasting longer than 4 hours) or painful erection.

Other, less serious side effects may bemore likely to occur. Continue to take tadalafil and talk to yourdoctor if you experience

• headache;

• indigestion;

• back pain;

• muscle aches;

• flushing;

• stuffy or runny nose; or

• Temporary blue tint in vision or difficulty telling the difference between the colors blue and green (uncommon).

Side effects other thanthose listed here may also occur. Talk to your doctor about any sideeffect that seems unusual or that is especially bothersome.

Keep all appointments with your doctor.

Don’t let anyone else take your medicines.