MEDICATION GUIDE

Prasugrel (praˊsoo grel)

tablets

Read this Medication Guide before you start taking prasugrel tablets and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment.

What is the most important information I should know about prasugrel tablets?

• Prasugrel is used to lower your chance of having a heart attack or other serious problems with your heart or blood vessels. But, prasugrel can cause bleeding, which can be serious, and sometimes lead to death. You should not start to take prasugrel if it is likely that you will have heart bypass surgery (coronary artery bypass graft surgery or CABG) right away. You have a higher risk of bleeding if you take prasugrel and then have heart bypass surgery.
• Do not take prasugrel tablet if you:
  • currently have abnormal bleeding, such as stomach or intestinal bleeding, or bleeding in your head
  • have had a stroke or “mini-stroke” (also known as transient ischemic attack or TIA)
  • are allergic to prasugrel or any of the ingredients in prasugrel tablet. See the end of this Medication Guide for a list of ingredients in prasugrel tablet.
• Get medical help right away if you think you may be having a stroke or TIA. Symptoms that you may be having a stroke or TIA include:
  • sudden slurring of speech,
  • sudden weakness or numbness in one part of your body,
  • sudden blurry vision, or sudden severe headache.
• If you have a stroke or TIA while taking prasugrel tablets, your doctor will probably stop your prasugrel. Follow your doctor's instructions about stopping prasugrel tablet. Do not stop taking prasugrel tablet unless your doctor tells you to.
• Before having any surgery you should talk to your doctor about stopping prasugrel tablet. If possible, prasugrel tablet should be stopped at least 1 week (7 days) before any surgery, as instructed by the doctor who prescribed prasugrel tablet for you.

Your risk of bleeding while taking prasugrel tablets may be higher if you also:

• have had trauma, such as an accident or surgery
• have stomach or intestine bleeding that is recent or keeps coming back, or you have a stomach ulcer
• have severe liver problems
• have moderate to severe kidney problems
• weigh less than 132 pounds
• take other medicines that increase your risk of bleeding, including:
  • warfarin sodium (Coumadin*, Jantoven*)
  • a medicine that contains heparin
  • other medicines to prevent or treat blood clots
  • regular daily use of non-steroidal anti-inflammatory drugs (NSAIDs)

Tell your doctor if you take any of these medicines. Ask your doctor if you are not sure if your medicine is one listed above.

• Prasugrel increases your risk of bleeding because it lessens the ability of your blood to clot. While you take prasugrel:
  • you will bruise and bleed more easily
  • you are more likely to have nose bleeds
  • it will take longer for any bleeding to stop
• Call your doctor right away if you have any of these signs or symptoms of bleeding:
  • unexpected bleeding or bleeding that lasts a long time
  • bleeding that is severe or you cannot control
  • pink or brown urine
  • red or black stool (looks like tar)
  • bruises that happen without a known cause or get larger
  • cough up blood or blood clots
  • vomit blood or your vomit looks like “coffee grounds”
• Do not stop taking prasugrel without talking to the doctor who prescribes it for you. People who are treated with angioplasty and have a stent, and stop taking prasugrel too soon, have a higher risk of a blood clot in the stent, having a heart attack, or dying. If you must stop prasugrel because of bleeding, your risk of a heart attack may be higher. See “ What are the possible side effects of prasugrel tablet?” for more information about side effects.

What is prasugrel tablet?

Prasugrel tablet is a prescription medicine used to treat people who:

• have had a heart attack or severe chest pain that happens when your heart does not get enough oxygen, and
• have been treated with a procedure called “angioplasty” (also called balloon angioplasty).

Prasugrel is used to lower your chance of having another serious problem with your heart or blood vessels, such as another heart attack, a stroke, blood clots in your stent, or death.

Platelets are blood cells that help with normal blood clotting. Prasugrel helps prevent platelets from sticking together and forming a clot that can block an artery or a stent.

It is not known if prasugrel tablet is safe and works in children.

What should I tell my doctor before taking prasugrel tablet?

Prasugrel tablet may not be right for you. Tell your doctor about all of your medical conditions, including if you:

• have any bleeding problems
• have had a stroke or “mini-stroke” (also known as transient ischemic attack or TIA)
• are allergic to any medicines, including clopidogrel (Plavix*) or ticlopidine hydrochloride (Ticlid*)
• have a history of stomach ulcers, colon polyps, diverticulosis
• have liver problems
• have kidney problems
• have had any recent severe injury or surgery
• plan to have surgery or a dental procedure. See “ What is the most important information I should know about prasugrel tablet?”
• pregnant, or are planning to get pregnant. It is not known if prasugrel will harm your baby.
• if you are breast-feeding. It is not known if prasugrel passes into your breast-milk. You and your doctor should decide if you will take prasugrel or breast-feed. You should not do both without talking with your doctor.

Tell all of your doctors and dentists that you are taking prasugrel tablet. They should talk to the doctor who prescribed prasugrel tablet for you, before you have any surgery or invasive procedure.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Certain medicines may increase your risk of bleeding. See “ What is the most important information I should know about prasugrel tablet?”

Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.

How should I take prasugrel tablet?

• Take prasugrel tablet exactly as prescribed by your doctor.
• Take prasugrel tablet one time each day.
• You can take prasugrel tablet with or without food.
• Take prasugrel tablet with aspirin as instructed by your doctor.
• Your doctor will decide how long you should take prasugrel tablet. Do not stop taking prasugrel tablet without first talking to the doctor who prescribed it for you. See “ What is the most important information I should know about prasugrel tablet?”
• If you miss a dose, take prasugrel tablet as soon as you remember. If it is almost time for your next dose, skip the missed dose. Just take the next dose at your regular time. Do not take two doses at the same time unless your doctor tells you to.
• If you take too much prasugrel tablet, call your local emergency room or poison control center right away.
• Call your doctor or healthcare provider right away if you fall or injure yourself, especially if you hit your head. Your doctor or healthcare provider may need to check you.

What are the possible side effects of prasugrel tablet?

Prasugrel tablet can cause serious side effects, including:

• See “ What is the most important information I should know about prasugrel tablet?”
• A blood clotting problem called Thrombotic Thrombocytopenic Purpura (TTP). TTP can happen with prasugrel tablet, sometimes after a short time (less than 2 weeks). TTP is a blood clotting problem where blood clots form in blood vessels and can happen all over the body. TTP needs to be treated in a hospital right away, because you may die. Get medical help right away if you have any of these symptoms and they cannot be explained by another medical condition:
  • purplish spots called purpura on the skin or mucous membranes (such as on the mouth) due to bleeding under the skin
  • paleness or jaundice (a yellowish color of the skin or eyes)
  • feeling tired or weak
  • fever
  • fast heart rate or feeling short of breath
  • headache, speech changes, confusion, coma, stroke, or seizure
  • low amount of urine or urine that is pink-tinged or has blood in it
  • stomach area (abdominal) pain, nausea, vomiting, or diarrhea
  • visual changes
• Serious allergic reactions. Serious allergic reactions can happen with prasugrel, or if you have had a serious allergic reaction to the medicine clopidogrel (Plavix*) or ticlopidine (Ticlid*). Get medical help right away if you get any of these symptoms of a severe allergic reaction while taking prasugrel tablet.
  • swelling or hives of your face, lips, in or around your mouth, or throat
  • trouble breathing or swallowing
  • chest pain or pressure
  • dizziness or fainting

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of prasugrel tablet. 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 prasugrel tablet?

• Keep prasugrel tablet at room temperature between 59°F to 86°F (15°C to 30°C).
• Keep prasugrel tablet in the container it comes in.
• Keep the container closed tightly with the gray cylinder inside.
• Protect prasugrel tablet from moisture.

Keep prasugrel tablet and all medicines out of the reach of children.

General Information about prasugrel tablet

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use prasugrel tablet for a condition for which it was not prescribed. Do not give your prasugrel tablet to other people, even if they have the same symptoms you have. It may harm them.

This Medication Guide summarizes the most important information about prasugrel tablet. If you would like more information about prasugrel tablet, talk with your doctor or pharmacist. For more information, contact HEC Pharm USA Inc. at 1-267-348-3664.

What are the ingredients in prasugrel tablet?

Active Ingredient: prasugrel

Inactive Ingredients: mannitol, hypromellose, low-substituted hydroxypropyl cellulose, microcrystalline cellulose, sucrose stearate, and glyceryl behenate. The color coatings contain lactose, hypromellose, titanium dioxide, triacetin, and iron oxide red.

Revised: December 25, 2018

Manufactured by:

Sunshine Lake Pharma Co., Ltd.

Guang Dong Province 523808

P.R. China

Manufactured for:

HEC Pharm USA Inc.

13200 Townsend Road

Philadelphia, PA 19154

This Medication Guide has been approved by the U.S. Food and Drug Administration.

*The brands listed are trademarks of their respective owners and are not trademarks of HEC Pharm USA Inc.