Teva-Ticagrelor: Uses, Side Effects and Dosage

What is Teva-Ticagrelor used for?

Teva-Ticagrelor is used in combination with low dose acetylsalicylic acid (aspirin) in adults to help prevent blood clots and reduce the risk of having or dying from conditions caused by blood clots. This includes:

• stroke
• heart attack
• heart or blood vessel problems.

Teva-Ticagreloris given to patients who:

• have had a heart attack or angina (chest pain)
• have had a heart attack over a year ago and are at high risk of having a heart attack or stroke
• have coronary artery disease (buildup of plaque in the arteries), type 2 diabetes, no history of a heart attack or stroke, and have previously had a procedure to open a blocked or narrowed heart blood vessel (percutaneous coronary intervention or PCI). This may have included placement of a small tube (stent) to keep the blocked or narrowed blood vessel open. These patients also have a high risk of having a heart attack or stroke.

How does Teva-Ticagrelor work?

Teva-Ticagrelor belongs to a group of medicines called antiplatelet agents.

Platelets are very small fragments in the blood that clump together during blood clotting.

Teva-Ticagrelor helps prevent this clumping and reduces the risk of blood clots forming.

What are the ingredients in Teva-Ticagrelor?

Medicinal ingredient: Ticagrelor

Non-medicinal ingredients: Mannitol, anhydrous dibasic calcium phosphate, povidone, sodium starch glycolate, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, talc, iron oxide yellow (90 mg), iron oxide red.

Teva-Ticagrelor comes in the following dosage forms:

Film-coated tablets, 60 mg and 90 mg.

Do not use Teva-Ticagrelor if:

• you are allergic to ticagrelor or any of the ingredients in Teva-Ticagrelor.
• you are actively bleeding due to a medical condition, such as bleeding in your stomach or gut from an ulcer or bleeding in your skull or brain.
• you have a history of bleeding inside your skull or brain.
• you have liver problems.

• you are taking the following medicines:

  • ketoconazole, a medicine used to treat fungal infections,
  • clarithromycin, a medicine used to treat bacterial infections,
  • nefazodone, a medicine used to treat depression,
  • ritonavir or atazanavir, medicines used to treat HIV/AIDS.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Teva-Ticagrelor. Talk about any health conditions or problems you may have, including if you:

• have an increased risk of bleeding because of:

  • a recent serious injury
  • your daily activities put you at high risk of having a serious injury
  • recent surgery (including dental procedures)
  • recent bleeding from your stomach or gut (such as a stomach ulcer or colon ‘polyps’)
  • a bleeding disorder

• have an increased risk of bleeding because you take any of the following:

  • blood thinners such as warfarin
  • medicines that help dissolve blood clots such as streptokinase and alteplase
  • non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, celecoxib and naproxen
  • high dose acetylsalicylic acid (aspirin)
• are having surgery (including dental procedures) at any time while taking Teva-Ticagrelor
• had a stroke in the past.
• have a history of slow heartbeat, are taking medicines that slow down your heartbeat or have a condition that puts you at risk of having slow heartbeat episodes.
• have a history of asthma or other breathing problems.
• have a history of gout.
• have been told by a healthcare professional that you have high levels of uric acid in your blood.
• have kidney problems.

Other warnings you should know about:

Do not stop taking Teva-Ticagrelor without first talking to your healthcare professional. If you stop taking Teva-Ticagrelor, blood clots may form and cause a stroke, heart attack, or other serious complications. This can lead to severe disability or even death.

Teva-Ticagrelor may cause serious side effects, including:

• Increased levels of uric acid in the blood: This can lead to a disease called gout that causes painful joints. Tell your healthcare professional right away if you experience red, swollen, hot or painful joints.
• Bradyarrhythmia (slower than normal heart rate related to problems with the control of the heart rhythm): This may happen shortly after taking Teva-Ticagrelor. Your healthcare professional will closely monitor your heart rate during the first few weeks of treatment. Tell your healthcare professional right away if you experience a slow heart rate.

• Thrombotic Thrombocytopenic Purpura (TTP) (a rare disorder that causes blood clots to form in small blood vessels throughout the body): Rare cases of TTP were reported in patients taking Teva-Ticagrelor. This condition can cause serious complications or even death. Tell your healthcare professional right away if you experience some or all of the following symptoms:

  • fever
  • purplish spots on the skin or in the mouth (purpura)
  • yellowing of the skin or eyes (jaundice)
  • unexplained extreme tiredness or confusion
• Dyspnea (shortness of breath): This includes shortness of breath when you are at rest, active and during sleep. It usually stops as you continue taking Teva-Ticagrelor. Tell your healthcare professional right away if you experience shortness of breath, especially if it gets worse or does not seem to go away.

See the Serious side effects and what to do about them table, below, for more information on these and other serious side effects.

Irregular breathing: The following side effects were reported in a small number of patients while taking Teva-Ticagrelor (frequency cannot be estimated from the available data):

• Central sleep apnea (disorder in which your breathing repeatedly stops and starts during sleep,

and may occur in patients with heart disease, stroke or other causes)

• Cheyne-Stokes respiration (a rare abnormal breathing pattern that involves a period of fast, shallow breathing followed by slow heavier breathing and moments without any breath at all)

Tell your healthcare professional if you develop any of the irregular breathing side effects above. Your healthcare professional will decide if you need further evaluation.

Surgery:

• If you should see another healthcare professional or a dentist, you should inform them that you are taking Teva-Ticagrelor.
• Tell your healthcare professional if you are going to have any surgeries, including dental procedures, while taking Teva-Ticagrelor. There is an increased risk of bleeding if you take Teva-Ticagrelor during these procedures. It can be life threatening.
• Your healthcare professional may ask you to stop taking Teva-Ticagrelor before the surgery, and to resume taking Teva-Ticagrelor after the procedure. It is important that you take Teva-Ticagrelor before and after the procedure exactly at the times the healthcare professional has instructed.

Driving and using machines: Teva-Ticagrelor can cause dizziness, confusion, vertigo and fainting. You should not drive or use machines until you know how Teva-Ticagrelor affects you.

Pregnancy:

• It is not known if Teva-Ticagrelor can cause harm to your baby during pregnancy. Therefore, Teva-Ticagrelor should not be used while you are pregnant.
• Your healthcare professional may recommend that you use a highly effective birth control method while taking Teva-Ticagrelor.
• Talk to your healthcare professional right away if you discover that you are pregnant while taking Teva-Ticagrelor.

Breastfeeding: It is not known if Teva-Ticagrelor can pass into breast milk. Therefore, Teva-Ticagrelor should not be used during breastfeeding. Talk to your healthcare professional about ways to feed your baby if you were planning to breastfeed while taking

Teva-Ticagrelor.

Check-ups and testing: If you have coronary artery disease and type 2 diabetes, your healthcare professional will regularly monitor you to make sure Teva-Ticagrelor is right for you. Your healthcare professional will discuss any risks and ways to prevent possible side effects while you are taking Teva-Ticagrelor.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may also interact with Teva-Ticagrelor:

• blood thinners such as warfarin
• medicines that help dissolve blood clots such as streptokinase and alteplase
• non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, celecoxib and naproxen
• high dose (greater than 150 mg daily) acetylsalicylic acid (aspirin)
• rifampin, a medicine used to treat bacterial infections
• medicines used to prevent epilepsy or seizures such as carbamazepine, phenytoin, or phenobarbital
• dexamethasone, a medicine used to relieve inflammation and treat other conditions
• cyclosporine, a medicine used to suppress your immune system
• rosuvastatin, simvastatin, or lovastatin, medicines used to treat high blood cholesterol
• digoxin, a medicine used to treat various heart conditions
• morphine, a medicine used to relieve pain

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

While you are on Teva-Ticagrelor it is important that you do not take any medicine other than that prescribed by your healthcare professional.

How to take Teva-Ticagrelor:

• Take Teva-Ticagrelor with or without food.

• Take Teva-Ticagrelor exactly as your healthcare professional tells you.
• Swallow the Teva-Ticagrelor tablet whole with some water.
• Take one in the morning and one in the evening at around the same time every day.
• Your healthcare professional will also tell you to take low dose acetylsalicylic acid (aspirin) (between 75 mg and 150 mg) once a day.
• Your healthcare professional will tell you how long you should take Teva-Ticagrelor. Do not stop taking Teva-Ticagrelor without first talking to your healthcare professional.

If you have trouble swallowing the tablet(s), follow the steps below to crush the Teva-Ticagrelor

tablet(s). This will help make sure that all of the crushed tablet(s) will be transferred to the drinking glass.

• use a mortar and pestle or a similar device to crush the tablet(s)
• add a small amount of water (100 mL) to the mortar and pestle/device and stir for 1 minute
• transfer the water and crushed tablet mixture to a drinking glass
• add more water (100 mL) to the mortar and pestle/device and stir for 30 seconds
• transfer the water and crushed tablet mixture to the same drinking glass
• stir the contents of the drinking glass and drink it right away

How to use the blister (6x10 tablets) pack:

Teva-Ticagrelor comes in a blister pack with the time of day printed on the back of the blister (to help you keep track of your doses).

There are 10 tablets in each blister: 10 are labelled with the time of day (AM or PM). All 10 tablets are exactly the same. Use the following dosing instructions:

First dose for each blister pack:

• Start with the tablet that is labelled “AM” or “PM”,

Second dose (one tablet) from the blister pack:

• Take your second tablet (about 12 hours later) that matches the time of day (AM or PM),

Next doses from the blister pack:

• Continue to take one tablet alternating morning (AM) and evening (PM), until they are all finished.

Usual dose:

Adults - 90 mg

If you had a recent heart attack or angina (chest pain), a healthcare professional will give you 180 mg (two 90 mg tablets) of Teva-Ticagrelor for your first dose. After this first dose, the usual dose is one 90 mg tablet twice a day.

After one year your healthcare professional may continue your treatment with a lower dose of

Teva-Ticagrelor

Adults - 60 mg

The usual dose is one 60 mg tablet twice a day if you:

• had a heart attack over a year ago, or
• have coronary heart disease, type 2 diabetes, no previous history of a heart attack or stroke, and have had a procedure to open a blocked or narrowed heart blood vessel (PCI).

Overdose:

Symptoms of an overdose include:

• Excessive bleeding
• Shortness of breath
• Pauses in heartbeat

Missed Dose:

If you forget or miss a dose of Teva-Ticagrelor, skip the missed dose and take the next dose as scheduled. Do not double the dose to make up for the missed dose.

What are possible side effects from using Teva-Ticagrelor?

These are not all the possible side effects you may have when taking Teva-Ticagrelor. If you experience any side effects not listed here, tell your healthcare professional.

The most common side effects of Teva-Ticagrelor are:

• Headache
• Feeling dizzy or like the room is spinning
• Abdominal pain, constipation, diarrhea or indigestion (heartburn)
• Nausea or vomiting
• Itching
• A tingling feeling
• Inflamed stomach lining
• Fatigue, muscle weakness
• Anxiety
• Sore throat or runny nose
• Cough
• Feeling dizzy or lightheaded, or having blurred vision (signs of low blood pressure)
• Bleeding gums

Teva-Ticagrelor affects blood clotting, so most side effects are related to bleeding. Bleeding may occur in any part of the body. Some bleeding is common (like bruising and nose bleeds). Severe bleeding is uncommon, but can be life threatening (see Serious side effects and what to do about them table below).

Teva-Ticagrelor can cause abnormal blood test results. Your healthcare professional will decide when to perform blood tests and will interpret the results.

Serious side effects and what to do about them

Serious side effects and what to do about them

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

• Store Teva-Ticagrelor tablets at room temperature (15°C - 30°C).
• Keep Teva-Ticagrelor and all medicines out of the reach and sight of children.
• The expiry date of this medicine is printed on the package label. Do not use the medicine after this date.

If you want more information about Teva-Ticagrelor:

• Talk to your healthcare professional
• Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website http://www.tevacanada.com; or by calling 1-800-268-4127 ext. 3; or email druginfo@tevacanada.com.

Last revised: NOV 08, 2024