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CILOSTAZOL tablet


  1. Cilostazol Tablets Can Cause Serious Side Effects:
  2. What Are Cilostazol Tablets?
  3. Do Not Take Cilostazol Tablets If You:
  4. Before You Take Cilostazol Tablets, Tell Your Doctor If You:
  5. How Should I Take Cilostazol Tablets?
  6. Cilostazol Tablets May Cause Serious Side Effects, Including:
  7. The Most Common Side Effects Of Cilostazol Tablets Include:
  8. How Should I Store Cilostazol Tablets?
  9. Active Ingredient:
  10. What Are Cilostazol Tablets For?
  11. What Is Intermittent Claudication?
  12. The Three Main Treatments Available For Intermittent Claudication Are:
  13. How Do Cilostazol Tablets Work?
  14. Who Should Not Take Cilostazol Tablets?
  15. How Should Cilostazol Tablets Be Taken?
  16. Can Cilostazol Tablets Be Taken With Other Drugs?
  17. What Are The Possible Side Effects Of Cilostazol Tablets?
  18. Manufactured In India By:
  19. Patient Information
  20. Advise The Patient:
  21. Manufactured For:
  22. Cilostazol Can Cause Serious Side Effects:
  23. What Is Cilostazol?
  24. How Does Cilostazol Work?
  25. Do Not Take Cilostazol If You:
  26. Before You Take Cilostazol, Tell Your Doctor If You:
  27. How Should I Take Cilostazol?
  28. Cilostazol May Cause Serious Side Effects, Including:
  29. Inactive Ingredients:

Cilostazol Tablets Can Cause Serious Side Effects: 

  • Cilostazol tablets stop a protein called phosphodiesterase III from working. Other similar drugs which affect this protein may cause death if you already have heart problems, called class 3 to 4 (III-IV) heart failure.Do nottake cilostazol tablets if you have heart failure of any kind.

What Are Cilostazol Tablets? 

Cilostazol tablets are a prescription medicine used to reduce the symptoms of intermittent claudication and can increase

your ability to walk further distances.

It is not known if cilostazol tablets are safe and effective for use in children.

Do Not Take Cilostazol Tablets If You: 

  • have heart problems (heart failure)
  • are allergic to cilostazol or any of the ingredients in cilostazol tablets.

Before You Take Cilostazol Tablets, Tell Your Doctor If You: 

  • drink grapefruit juice. Taking cilostazol tablets and drinking grapefruit juice can increase the amount of cilostazol tablets causing side effects.
  • have any other medical conditions
  • are pregnant or planning to become pregnant. It is not known if cilostazol tablets will harm your unborn baby.
  • are breastfeeding or planning to breastfeed. It is not known if cilostazol passes into your breast milk. You and your doctor should decide if you will take cilostazol tablets or breastfeed. You should not do both.

Tell your doctor about all the medicines you take,including prescription and over-the-counter medicines,

vitamins and herbal supplements.

Ask your doctor for a list of these medicines if you are not sure. You can ask your pharmacist for a list of

medicines that interact with cilostazol tablets. Know the medicines you take. Keep a list of them to show to your doctor

and pharmacist when you get a new medicine.

How Should I Take Cilostazol Tablets? 

  • Take cilostazol tablets exactly as your doctor tells you to take it.
  • Your doctor will tell you how many cilostazol tablets to take and when to take it.
  • Your doctor may change your dose if needed.
  • Take cilostazol tablets30 minutes beforeyou eator 2 hours afteryou eat.

Cilostazol Tablets May Cause Serious Side Effects, Including: 

  • heart problems.Taking cilostazol tablets may cause you to have heart problems, including a fast heart beat, palpitations, irregular heartbeat, and low blood pressure.
  • severe allergic reactions (anaphylaxis, angioedema).Call your doctor or go to the nearest emergency room right away if you have any of the following signs or symptoms of a severe allergic reaction:
  • hives
  • swelling of your face, lips, mouth, or tongue
  • trouble breathing or wheezing
  • dizziness
  • changes in your blood cell counts (thrombocytopenia or leukopenia).Your doctor should do blood

    tests to check your blood cell counts while you take cilostazol tablets.

The Most Common Side Effects Of Cilostazol Tablets Include: 

  • headache
  • abnormal stools
  • diarrhea

Tell your doctor if you have any side effect that bothers you or does not go away. These are not all the possible

side effects of cilostazol tablets. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How Should I Store Cilostazol Tablets? 

Store cilostazol tablets at 68 to 77 F (20 to 25 C).

Keep cilostazol tablets and all medicines out of the reach of children.

General information about the safe and effective use of cilostazol tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use cilostazol tablets for a condition for which they was not prescribed. Do not give cilostazol tablets to other people, even if they have the same symptoms that you have. They may harm them.

This Patient Information summarizes the most important information about cilostazol tablets. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about cilostazol tablets that is written for health professionals.

For more information, call 1-888-838-2872.

Active Ingredient: 

cilostazol, USP

What Are Cilostazol Tablets For? 

Cilostazol tablets 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 walking, resulting in these painful leg cramps.

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 cilostazol. ()
  • 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 reduce the blockage and improve blood flow.

How Do Cilostazol Tablets Work? 

  • The exact way that many drugs work is not well understood. Although how cilostazol tablets work is not completely 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.
  • Cilostazol tablets may reduce the leg pain that patients with intermittent claudication experience, allowing them to walk farther before their leg pain occurs.
  • Improvement in symptoms may occur as soon as 2 weeks, but could take up to 12 weeks. If you have not noticed any benefit from cilostazol tablets after 12 weeks you and your doctor may wish to discuss other forms of treatment.
  • Sometimes blood vessel disease of the legs causes pain at rest or breakdown of skin in the leg. Cilostazol tablets have not been shown to work in patients with these problems.

Who Should Not Take Cilostazol Tablets? 

  • Patients who have congestive heart failure (CHF) must not take cilostazol.The most common symptoms of CHF are shortness of breath and swelling of the legs. However, other conditions may also cause these symptoms. It is important that you discuss with your doctor whether you have CHF.
  • Over 1,300 patients took cilostazol tablets in studies that lasted for 3 to 6 months. The mortality rate in these patients was similar to placebo (less than 1%). These studies were too small to be sure there is not some increased risk of dying with longer use or in patients sicker than those in the studies.

How Should Cilostazol Tablets Be Taken? 

  • Follow your doctor s advice about how to take cilostazol tablets.
  • You should take cilostazol tablets twice a day, at least one half-hour before or two hours after breakfast and dinner. Take cilostazol tablets at about the same times each day.
  • Do not share cilostazol tablets with anyone else. It was prescribed only for you.
  • Keep cilostazol tablets and all drugs out of the reach of children.

Can Cilostazol Tablets Be Taken With Other Drugs? 

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

Drugs Interacting with Cilostazol
Generic Name (Brand Name)Type of Drug
erythromycin (such as E.E.S., Erythrocin)Antibiotic
ketoconazole (Nizoral), itraconazole (Sporanox)Antifungal
diltiazem (Cardizem)Antihypertensive
omeprazole (Prilosec)Gastric acid reducer

This list does not include every drug that may interact with cilostazol. 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 cilostazol.

What Are The Possible Side Effects Of Cilostazol Tablets? 

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

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

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

E.E.S.is a registered trademark of Abbott Laboratories Inc.

Erythrocinis a registered trademark of Hospira Inc.

Nizoraland Sporanoxare registered trademarks of Janssen Pharmaceutica Products, L.P.

Cardizemis a registered trademark of Biovail Labs INTL.

Prilosecis a registered trademark of the AstraZeneca group of companies.

Manufactured In India By: 

PIRAMAL HEALTHCARE LIMITED

Pithampur, Madhya Pradesh, India

Patient Information 

Rx only

Please read this leaflet before you start taking cilostazol tablets 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 cilostazol tablets when you start taking it and at regular check-ups. You should follow your doctor s advice about when to have check-ups.

Advise The Patient: 

  • to take cilostazol at least one-half hour before or two hours after food.
  • to discuss with their doctor before taking any CYP3A4 or CYP2C19 inhibitors (e.g., omeprazole).
  • that the beneficial effects of cilostazol on the symptoms of intermittent claudication may not be immediate. Although the patient may experience benefit in 2 to 4 weeks after initiation of therapy, treatment for up to 12 weeks may be required before a beneficial effect is experienced. Discontinue cilostazol if symptoms do not improve after 3 months.

Manufactured For: 

Teva Pharmaceuticals USA, Inc.

North Wales, PA 19454

Rev. O 5/2017

Cilostazol Can Cause Serious Side Effects: 

Cilostazol stops a protein called phosphodiesterase III from working. Other similar drugs which affect this protein may cause death if you already have heart problems, called class 3 to 4 (III-IV) heart failure.Do nottake cilostazol if you have heart failure of any kind.

What Is Cilostazol? 

Cilostazol is a prescription medicine used to reduce the symptoms of intermittent claudication and can increase your ability to walk further distances.

It is not known if cilostazol is safe and effective for use in children.

How Does Cilostazol Work? 

Improvement in symptoms may occur as soon as 2 weeks, but could take up to 12 weeks.

Do Not Take Cilostazol If You: 

have heart problems (heart failure)
are allergic to cilostazol or any of the ingredients in cilostazol.

Before You Take Cilostazol, Tell Your Doctor If You: 

drink grapefruit juice. Taking cilostazol and drinking grapefruit juice can increase the amount of cilostazol causing side effects.
have any other medical conditions
are pregnant or planning to become pregnant. It is not known if cilostazol will harm your unborn baby.
are breastfeeding or planning to breastfeed. It is not known if cilostazol passes into your breast milk. You and your doctor should decide if you will take cilostazol or breastfeed. You should not do both.

Tell your doctor about all the medicines you take,including prescription and over-the-counter medicines, vitamins and herbal supplements.

Ask your doctor for a list of these medicines if you are not sure. You can ask your pharmacist for a list of medicines that interact with cilostazol. Know the medicines you take. Keep a list of them to show to your doctor and pharmacist when you get a new medicine.

How Should I Take Cilostazol? 

Take cilostazol exactly as your doctor tells you to take it.
Your doctor will tell you how much cilostazol to take and when to take it.
Your doctor may change your dose if needed.
Take cilostazol30 minutes beforeyou eator 2 hours afteryou eat.

Cilostazol May Cause Serious Side Effects, Including: 

heart problems.Taking cilostazol may cause you to have heart problems, including a fast heartbeat, palpitations, irregular heartbeat, and low blood pressure.

Store cilostazol at room temperature between 20 C to 25 C (68 F to 77 F). [Store at USP Controlled Room Temperature.]

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

General information about the safe and effective use of cilostazol.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use cilostazol for a condition for which it was not prescribed. Do not give cilostazol to other people, even if they have the same symptoms that you have. It may harm them.

This Patient Information summarizes the most important information about cilostazol. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about cilostazol that is written for health professionals.

For more information, call 1-800-962-8364.

Inactive Ingredients: 

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate and microcrystalline cellulose.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Distr. by:West-Ward

Pharmaceuticals Corp.

Eatontown, NJ 07724

10003054/08

Revised April 2016



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