PLETAL (Cilostazol) Tablets
Patient Information about PLETAL (PLAY-tal)
Generic name: cilostazol
(sil-OS-tah-zol)

Please read this leaflet before you start taking PLETAL and each time you renew it in case anything has changed. This leaflet does not replace careful discussions with your doctor. You and your doctor should discuss PLETAL when you start taking it and at regular check-ups. You should follow your doctor’s advice about when to have check-ups.

What is PLETAL for?

PLETAL may improve the symptoms of patients with a medical condition called intermittent claudication.

What is intermittent claudication?

Intermittent claudication is pain in the legs that occurs with walking and disappears with rest. It occurs because narrowing or blockage of the arteries decreases blood flow to the legs. The decreased blood flow does not supply enough oxygen to the leg muscles during exercise.

What treatments are available for intermittent claudication?

The three main treatments available for intermittent claudication are:

• Exercise. Your doctor may advise an exercise program.

• Medication. Your doctor may prescribe a medication such as PLETAL. (See Who should not take PLETAL?)

• Surgery. Your doctor may recommend a surgical procedure to bypass the blocked segment of the artery. Another procedure is called a percutaneous transluminal angioplasty. In this procedure, a catheter (a flexible tube) is inserted into the artery to lessen the blockage.

Who should not take PLETAL?

• Patients who have, or who develop, congestive heart failure (shortness of breath, swelling of the legs and other symptoms due to heart disease) must not take PLETAL. In patients with congestive heart failure, long-term use (several months or more) of other drugs similar to PLETAL has increased the risk of death. It is important that you discuss with your doctor whether you have heart failure.

How does PLETAL work?

• How PLETAL works is not clear. Its main effects are to dilate (widen) the arteries supplying blood to the legs and to decrease the ability of platelets in the blood to stick together. Platelets are particles that circulate in the blood and play a role in clotting.

• PLETAL may improve the symptoms of patients with intermittent claudication, allowing them to walk longer before leg pain occurs.

• Improvement in symptoms may not occur immediately. However, if you have not noticed any benefit from PLETAL after 12 weeks, you and your doctor may wish to discuss other forms of treatment.

What other important information should I know before taking PLETAL?

• Although drugs similar to Pletal have increased the risk of death in patients with congestive heart failure, they have not been studied in people without heart failure. It is not known if drugs similar to Pletal would increase the risk of death in patients without congestive heart failure. Pletal was studied in about 1,374 patients with claudication who had not had a recent heart attack or stroke or serious chest pain. In these patients treated for 3-6 months, the death rate was similar in the Pletal and placebo groups (less than 1%). These studies were too small to be sure there is not some increased risk of death with longer use or in patients who are sicker than people in the clinical studies. You should discuss this with your physician.

• Sometimes blood vessel disease of the legs causes pain at rest or breakdown of skin in the leg. PLETAL has not been shown to work in patients with these problems.

• Follow your doctor’s advice about how to take PLETAL.

• You should take PLETAL twice a day, at least one half-hour before or two hours after breakfast and dinner. Take PLETAL at about the same times each day.

• Do not share PLETAL with anyone else. It was prescribed only for you.

• Keep PLETAL and all drugs out of the reach of children.

Can PLETAL be taken with other drugs or foods?

Certain drugs and foods can increase the amount of PLETAL in the blood. Because of this, your doctor may adjust your dose of PLETAL or even stop it if you are taking or are going to take one of the following medications.

Drugs Interacting with Pletal

• Do not take PLETAL with grapefruit juice. You can take PLETAL with other citrus juices.

This list does not include every drug that may interact with PLETAL. Therefore, you should tell your doctor about all medications that you are taking, including vitamins, herbal supplements and over-the-counter drugs you can buy without a prescription. You should also check with your doctor before taking a new medication after you have begun PLETAL.

What are the possible side effects of PLETAL?

PLETAL may cause side effects including headache, diarrhea, abnormal stools, increased heart rate, and palpitations.

You should discuss side effects with your doctor before taking PLETAL and any time you think you are having a side effect.

This provides only a summary of information about PLETAL. If you have any questions about PLETAL, talk to your doctor.

1/14/99