MEDICATION GUIDE

Ticagrelor (TYE-ka-GREL-or)

Tablets

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

Ticagrelor tablets are used to lower your chance of having a heart attack or dying from a heart attack or stroke but ticagrelor tablets (and similar drugs) can cause bleeding that can be serious and sometimes lead to death. In cases of serious bleeding, such as internal bleeding, the bleeding may result in the need for blood transfusions or surgery. While you take ticagrelor tablets:

• you may bruise and bleed more easily
• you are more likely to have nose bleeds
• it will take longer than usual for any bleeding to stop

Call your doctor right away, if you have any of these signs or symptoms of bleeding while taking ticagrelor tablets:

• bleeding that is severe or that you cannot control
• pink, red or brown urine
• vomiting blood or your vomit looks like “coffee grounds”
• red or black stools (looks like tar)
• coughing up blood or blood clots

Do not stop taking ticagrelor tablets without talking to the doctor who prescribes it for you.

People who are treated with a stent, and stop taking ticagrelor tablets too soon, have a higher risk of getting a blood clot in the stent, having a heart attack, or dying. If you stop ticagrelor tablets because of bleeding, or for other reasons, your risk of a heart attack or stroke may increase. Your doctor may instruct you to stop taking ticagrelor tablets 5 days before surgery. This will help to decrease your risk of bleeding with your surgery or procedure. Your doctor should tell you when to start taking ticagrelor tablets again, as soon as possible after surgery.

Taking ticagrelor tablets with aspirin

Ticagrelor tablets are taken with aspirin. Talk to your doctor about the dose of aspirin that you should take with ticagrelor tablets. You should not take a dose of aspirin higher than 100 mg daily because it can affect how well ticagrelor tablets work. Do not take doses of aspirin higher than what your doctor tells you to take. Tell your doctor if you take other medicines that contain aspirin, and do not take new over-the-counter medicines with aspirin in them.

What are ticagrelor tablets?

Ticagrelor tablets are a prescription medicine used to treat people who:

• have had a heart attack or severe chest pain that happened because their heart was not getting enough oxygen.

Ticagrelor tablets are used with aspirin to lower your chance of having another serious problem with your heart or blood vessels, such as heart attack, stroke, or blood clots in your stent. These can be fatal.

Platelets are blood cells that help with normal blood clotting. Ticagrelor tablets help prevent platelets from sticking together and forming a clot that can block an artery. It is not known if ticagrelor tablets are safe and effective in children.

Who should not take ticagrelor tablets?

Do not take ticagrelor tablets if you:

• have a history of bleeding in the brain
• are bleeding now
• are allergic to ticagrelor or any of the ingredients in ticagrelor tablets. See the end of this Medication Guide for a complete list of ingredients in ticagrelor tablets.

What should I tell my doctor before taking ticagrelor tablets?

Before you take ticagrelor tablets, tell your doctor if you:

• have had bleeding problems in the past
• have had any recent serious injury or surgery
• plan to have surgery or a dental procedure
• have a history of stomach ulcers or colon polyps
• have lung problems, such as COPD or asthma
• have liver problems
• have a history of stroke
• are pregnant or plan to become pregnant. It is not known if ticagrelor tablets will harm your unborn baby. You and your doctor should decide if you will take ticagrelor tablets.
• are breastfeeding or plan to breastfeed. It is not known if ticagrelor passes into your breast milk. You and your doctor should decide if you will take ticagrelor tablets or breastfeed. You should not do both without talking with your doctor.

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

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Ticagrelor tablets may affect the way other medicines work, and other medicines may affect how ticagrelor tablets work.

Especially tell your doctor if you take:

• an HIV-AIDS medicine
• medicine for heart conditions or high blood pressure
• medicine for high blood cholesterol levels
• an anti-fungal medicine by mouth
• an anti-seizure medicine
• a blood thinner medicine
• rifampin (Rifater, Rifamate, Rimactane, Rifadin)

Ask your doctor or pharmacist if you are not sure if your medicine is listed above. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I take ticagrelor tablets?

• Take ticagrelor tablets exactly as prescribed by your doctor.
• Your doctor will tell you how many ticagrelor tablets to take and when to take them.
• Take ticagrelor tablets with a low dose (not more than 100 mg daily) of aspirin. You may take ticagrelor tablets with or without food.
• Take your doses of ticagrelor tablets around the same time every day.
• If you forget to take your scheduled dose of ticagrelor tablets, take your next dose at its scheduled time. Do not take 2 doses at the same time unless your doctor tells you to.
• If you take too much ticagrelor tablets or overdose, call your doctor or poison control center right away, or go to the nearest emergency room.

If you are unable to swallow the tablet(s) whole, you may crush the ticagrelor tablet(s) and mix it with water. Drink all the water right away. Refill the glass with water, stir, and drink all the water.

What are the possible side effects of ticagrelor tablets?

Ticagrelor tablets can cause serious side effects, including:

• See “What is the most important information I should know about ticagrelor tablets?”
• Shortness of breath. Call your doctor if you have new or unexpected shortness of breath when you are at rest, at night, or when you are doing any activity. Your doctor can decide what treatment is needed.

These are not all of the possible side effects of ticagrelor 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 ticagrelor tablets?

• Store ticagrelor tablets at room temperature between 68°F to 77°F (20°C to 25°C).

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

General information about ticagrelor tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ticagrelor tablets for a condition for which it was not prescribed. Do not give ticagrelor tablets to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or doctor for information about ticagrelor tablets that is written for health professionals.

What are the ingredients in ticagrelor tablets?

Active ingredient: ticagrelor.

60 mg or 90 mg tablets:

Inactive ingredients: mannitol, dibasic calcium phosphate, croscarmellose sodium, hydroxypropyl cellulose and magnesium stearate. The tablets are film-coated with a coating material containing hydroxypropyl methylcellulose, titanium dioxide, talc, polyethylene glycol 400, iron oxide yellow and iron oxide red.

Manufactured by:

MSN Laboratories Private Limited,

Mahabubnagar (Dt.),

Telangana - 509216 INDIA

M.L.No.: 5/MN/TS/2014/F/G

Manufactured for:

Sigmapharm Laboratories, LLC

Bensalem, PA 19020 USA

For more information call 215-352-6655 or go to www.sigmapharm.com.

OS039-07 REV.1119

Revised: 11/2019

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