Prasugrel (Page 6 of 7)

16 HOW SUPPLIED/STORAGE AND HANDLING

Product: 50090-5169

NDC: 50090-5169-0 30 TABLET, FILM COATED in a BOTTLE

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling ( Medication Guide).

Administration

  • Advise patients not to break prasugrel tablets.
  • Remind patients not to discontinue prasugrel tablets without first discussing it with the physician who prescribed prasugrel tablets [see Warnings and Precautions (5.3)] .
  • Inform patients to keep prasugrel tablets in the container in which it comes, and keep the container closed tightly with the gray cylinder (desiccant) inside.

Bleeding

Inform patients that they:

  • will bruise and bleed more easily.
  • will take longer than usual to stop bleeding.
  • should report any unanticipated, prolonged, or excessive bleeding, or blood in their stool or urine [see Warnings and Precautions (5.1)] .

Thrombotic Thrombocytopenic Purpura

  • Inform patients that TTP is a rare but serious condition that has been reported with prasugrel tablets.
  • Instruct patients to get prompt medical attention if they experience symptoms of TTP that cannot otherwise be explained [see Warnings and Precautions (5.4)] .

Hypersensitivity

Inform patients that they may have hypersensitivity reactions and to seek immediate medical attention if any signs and symptoms of a hypersensitivity reaction occur. Patients who have had hypersensitivity reactions to other thienopyridines may have hypersensitivity reactions to prasugrel tablets.

Invasive Procedures

Instruct patients to:

  • inform physicians and dentists that they are taking prasugrel tablets before any invasive procedure is scheduled [see Warnings and Precautions (5.1)] .
  • tell the doctor performing the invasive procedure to talk to the prescribing health care professional before stopping prasugrel tablets.

Concomitant Medications

Ask patients to list all prescription medications, over-the-counter medications, or dietary supplements they are taking or plan to take so the physician knows about other treatments that may affect bleeding risk (e.g., warfarin and NSAIDs) [see Drug Interactions ( 7.1, 7.2)]. .

Manufactured For:
Accord Healthcare, Inc.,
1009 Slater Road,
Suite 210-B,
Durham, NC 27703,
USA

Manufactured by:
Intas Pharmaceuticals Limited,
Plot No. : 457, 458,
Village – Matoda,
Bavla Road, Ta.- Sanand,
Dist.- Ahmedabad – 382 210.
India.

10 2907 1 697807

Issued May 2019

MEDICATION GUIDE
Prasugrel Tablets
(PRA-soo-grel)

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 tablets are used to lower your chance of having a heart attack or other serious problems with your heart or blood vessels. But, prasugrel tablets can cause bleeding, which can be serious, and sometimes lead to death. You should not start to take prasugrel tablets 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 tablets and then have heart bypass surgery.
  • Do not take prasugrel tablets 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 tablets. See the end of this Medication Guide for a list of ingredients in prasugrel tablets.
  • 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 tablets. Follow your doctor’s instructions about stopping prasugrel tablets. Do not stop taking prasugrel tablets unless your doctor tells you to.
  • Before having any surgery, you should talk to your doctor about stopping prasugrel tablets. If possible, prasugrel tablets should be stopped at least 1 week (7 days) before any surgery, as instructed by the doctor who prescribed prasugrel tablets 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 tablets increases your risk of bleeding because it lessens the ability of your blood to clot. While you take prasugrel tablets:
    • 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 tablets without talking to the doctor who prescribes it for you. People who are treated with angioplasty and have a stent, and stop taking prasugrel tablets too soon, have a higher risk of a blood clot in the stent, having a heart attack, or dying. If you must stop prasugrel tablets because of bleeding, your risk of a heart attack may be higher. See “ What are the possible side effects of prasugrel tablets?” for more information about side effects.

What are prasugrel tablets?

Prasugrel tablets are 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 tablets are 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 tablets help prevent platelets from sticking together and forming a clot that can block an artery or a stent.

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

What should I tell my doctor before taking prasugrel tablets?

Prasugrel tablets 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 tablets?”
  • pregnant, or are planning to get pregnant. It is not known if prasugrel tablets 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 tablets 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 tablets. They should talk to the doctor who prescribed prasugrel tablets 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 tablets?”

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 tablets?

  • Take prasugrel tablets exactly as prescribed by your doctor.
  • Take prasugrel tablets one time each day.
  • You can take prasugrel tablets with or without food.
  • Do not split prasugrel tablets.
  • Take prasugrel tablets with aspirin as instructed by your doctor.
  • Your doctor will decide how long you should take prasugrel tablets. Do not stop taking prasugrel tablets without first talking to the doctor who prescribed it for you. See “ What is the most important information I should know about prasugrel tablets?”
  • If you miss a dose, take prasugrel tablets 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 tablets, 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 tablets?

Prasugrel tablets can cause serious side effects, including:

  • See “ What is the most important information I should know about prasugrel tablets?”
  • A blood clotting problem called Thrombotic Thrombocytopenic Purpura (TTP). TTP can happen with prasugrel tablets, 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 tablets, 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 tablets.
    • 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 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 prasugrel tablets?

  • Keep prasugrel tablets at room temperature between 59°F to 86°F (15°C to 30°C).
  • Keep and dispense only in original container.
  • Keep the container closed tightly with the gray cylinder inside.
  • Protect prasugrel tablets from moisture.

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

General Information about prasugrel tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use prasugrel tablets for a condition for which it was not prescribed. Do not give your prasugrel tablets 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 tablets. If you would like more information about prasugrel tablets, talk with your doctor or pharmacist.

For more information, go to www.accordhealthcare.us or call Accord Healthcare at 1-866-941-7875.

What are the ingredients in prasugrel tablets?

Active Ingredient: prasugrel

Inactive Ingredients: microcrystalline cellulose, hypromellose, low substituted hydroxyl propyl cellulose and sucrose stearate. The color coatings contain lactose monohydrate, hypromellose, titanium dioxide, triacetin, iron oxide yellow, and iron oxide red (only in 10-mg tablet).

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

*The brands listed are trademarks of their respective owners.

Manufactured For:
Accord Healthcare, Inc.,
1009 Slater Road,
Suite 210-B,
Durham, NC 27703,
USA

Manufactured By:
Intas Pharmaceuticals Limited,
Plot No. : 457, 458,
Village – Matoda,
Bavla Road, Ta.- Sanand,
Dist.- Ahmedabad – 382 210. India.

10 2907 1 697807

Issued May 2019

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