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BRILINTA- ticagrelor tablet


  1. Patient Information
  2. Advise Patients That They:
  3. Call Your Doctor Right Away, If You Have Any Of These Signs Or Symptoms Of Bleeding While Taking Brilinta:
  4. Brilinta Is A Prescription Medicine Used To Treat People Who:
  5. Do Not Take Brilinta If You:
  6. Before You Take Brilinta, Tell Your Doctor If You:
  7. Especially Tell Your Doctor If You Take:
  8. How Should I Take Brilinta?
  9. Brilinta Can Cause Serious Side Effects, Including:
  10. Active Ingredient:
  11. 60 Mg Tablets:inactive Ingredients:

Patient Information 

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

Advise patients daily doses of aspirin should not exceed 100 mg and to avoid taking any other medications that contain aspirin.

Advise Patients That They: 

Will bleed and bruise 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.

Advise patients to contact their doctor if they experience unexpected shortness of breath, especially if severe.

Advise patients to inform physicians and dentists that they are taking BRILINTA before any surgery or dental procedure.

Advise women that breastfeeding is not recommended during treatment with BRILINTA[

BRILINTA is used to lower your chance of having a heart attack or dying from a heart attack or strokebut BRILINTA (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 BRILINTA:

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 Brilinta: 

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 BRILINTA without talking to the doctor who prescribes it for you.People who are treated with a stent, and stop taking BRILINTA too soon, have a higher risk of getting a blood clot in the stent, having a heart attack, or dying. If you stop BRILINTA 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 BRILINTA 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 BRILINTA again, as soon as possible after surgery.

Taking BRILINTA with aspirin

BRILINTA is taken with aspirin. Talk to your doctor about the dose of aspirin that you should take with BRILINTA. You should not take a dose of aspirin higher than 100 mg daily because it can affect how well BRILINTA works. 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.

Brilinta Is 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.

BRILINTA is 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. BRILINTA helps prevent platelets from sticking together and forming a clot that can block an artery.

It is not known if BRILINTA is safe and effective in children.

Do Not Take Brilinta If You: 

have a history of bleeding in the brain
are bleeding now
are allergic to ticagrelor or any of the ingredients in BRILINTA.

Before You Take Brilinta, 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 BRILINTA will harm your unborn baby. You and your doctor should decide if you will take BRILINTA.
are breastfeeding or plan to breastfeed. It is not known if BRILINTA passes into your breast milk. You and your doctor should decide if you will take BRILINTA or breastfeed. You should not do both without talking with your doctor.

Tell all of your doctors and dentists that you are taking BRILINTA. They should talk to the doctor who prescribed BRILINTA 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.BRILINTA may affect the way othermedicines work, and other medicines may affect how BRILINTA works.

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 Brilinta? 

Take BRILINTA exactly as prescribed by your doctor.
Your doctor will tell you how many BRILINTA tablets to take and when to take them.
Take BRILINTA with a low dose (not more than 100 mg daily) of aspirin. You may take BRILINTA with or without food.
Take your doses of BRILINTA around the same time every day.
If you forget to take your scheduled dose of BRILINTA, 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 BRILINTA 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 BRILINTA tablet(s) and mix it with water. Drink all the water right away. Refill the glass with water, stir, and drink all the water.

Brilinta Can Cause Serious Side Effects, Including: 

Store BRILINTA at room temperature between 68 F to 77 F (20 C to 25 C).

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

General information about BRILINTA

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use BRILINTA for a condition for which it was not prescribed. Do not give BRILINTA 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 BRILINTA that is written for health professionals.

Active Ingredient: 

ticagrelor.

90 mg tablets:
Inactive ingredients: mannitol, dibasic calcium phosphate, sodium starch glycolate, hydroxypropyl cellulose, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide, talc, polyethylene glycol 400, and ferric oxide yellow.

60 Mg Tablets:inactive Ingredients: 

mannitol, dibasic calcium phosphate, sodium starch glycolate, hydroxypropyl cellulose, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide, polyethylene glycol 400, ferric oxide black and ferric oxide red.

Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850

For more information call 1-800-236-9933 or go towww.Brilinta.com.

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 04/2019



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