PRASUGREL- prasugrel tablet, film coated 
Panacea Biotec Limited

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MEDICATION GUIDE

Prasugrel tablets

(Pra-soo-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?

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

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.

What is Prasugrel tablet?

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

Prasugrel tablet 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 tablets 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 tablets?

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

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?

What are the possible side effects of Prasugrel tablets?

Prasugrel tablets can cause serious side effects, including:

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 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, call Apotex Corp. at 1-800-706-5575

What are the ingredients in Prasugrel tablets?

Active Ingredient: prasugrel hydrochloride, USP

Inactive Ingredients: microcrystalline cellulose, mannitol, low-substituted hydroxypropyl cellulose, hypromellose, stearic acid, and glyceryl behenate. The color coatings contain lactose monohydrate, hypromellose, titanium dioxide, triacetin, iron oxide yellow, and iron oxide red (only in Prasugrel 10 mg tablet).

Revised: September, 2020

Manufactured by:

Panacea Biotec Pharma Limited

Malpur, Baddi, District Solan (H.P.) - 173 205, India.

Mfg. Lic. No.: MNB/05/202

Manufactured for:

Apotex Corp.

Weston, Florida 33326

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

* The brands listed are trademarks of their respective owners.

Item Code: PPIP053A

Revised: 12/2020
Panacea Biotec Limited