Ticagrelor Teva

Package leaflet: Information for the user

Ticagrelor Teva 60 mg film-coated tablets, 90 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Ticagrelor Teva is and what it is used for
2. What you need to know before taking Ticagrelor Teva
3. How to take Ticagrelor Teva
4. Possible side effects
5. How to store Ticagrelor Teva
6. Contents of the pack and other information

1. What Ticagrelor Teva is and what it is used for

What Ticagrelor Teva is
Ticagrelor Teva contains an active substance called ticagrelor, which belongs to a group of
medicines known as antiplatelet agents.
What Ticagrelor Teva is used for
Ticagrelor Teva, in combination with acetylsalicylic acid (another antiplatelet agent),
should only be used in adult patients. You have been prescribed this medicine because you have had:
Ticagrelor Teva 60 mg tablets

• a heart attack more than one year ago. Ticagrelor Teva 90 mg tablets
• a heart attack or
• unstable angina (angina or chest pain that is not well controlled). This medicine reduces the likelihood of having another heart attack or stroke, or of dying from heart or blood vessel-related disease.

How Ticagrelor Teva works
Ticagrelor Teva acts on cells called 'platelets' (also known as thrombocytes). These are very small blood cells that help stop bleeding by clumping together to seal tiny holes in cut or damaged blood vessels.
However, platelets can also form clots inside diseased blood vessels of the heart and brain. This can be very dangerous because:

• the clot may completely block the blood supply; this can cause a heart attack (myocardial infarction) or a stroke, or
• the clot may partially block the blood vessels supplying the heart; this reduces blood flow to the heart and may cause chest pain that comes and goes (called 'unstable angina').

Ticagrelor Teva helps prevent platelets from clumping together. This reduces the likelihood of forming a blood clot that could reduce blood flow.

2. What you should know before taking Ticagrelor Teva

Do not take Ticagrelor Teva if:

• you are allergic to ticagrelor or to any of the other ingredients of this medicine (listed in section 6),
• you have active bleeding,
• you have had a stroke caused by bleeding in the brain,
• you have severe liver problems,
• you are taking any of the following medicines:
  • ketoconazole (used to treat fungal infections)
  • clarithromycin (used to treat bacterial infections)
  • nefazodone (an antidepressant)
  • ritonavir and atazanavir (used to treat HIV and AIDS).

Do not take Ticagrelor Teva if any of the above situations apply to you. If you are unsure, consult your
doctor or pharmacist before taking this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Ticagrelor Teva if:

• you have an increased risk of bleeding due to:
  • a serious recent injury
  • a recent surgery (including dental procedures; consult your dentist)
  • a blood clotting disorder
  • recent bleeding from the stomach or intestines (e.g., due to gastric ulcer or colon “polyps”)
• you are scheduled for surgery (including dental procedures) at any time while taking Ticagrelor Teva. This is because there is an increased risk of bleeding. Your doctor may instruct you to stop taking this medicine 5 days before surgery
• your heart rate is unusually slow (usually less than 60 beats per minute) and you do not already have a heart rhythm-regulating device implanted (pacemaker)
• you suffer from asthma or another lung condition or have breathing difficulties
• you develop irregular breathing patterns such as rapid breathing, slow breathing, or brief pauses in breathing. Your doctor will decide whether further evaluation is needed
• you have previously had liver problems or any condition affecting the liver
• you have previously had blood tests showing higher than normal levels of uric acid.

If any of the above situations apply to you (or if you are unsure), consult your doctor or pharmacist
before taking this medicine.
If you are taking both Ticagrelor Teva and heparin:

• your doctor may request a blood sample for diagnostic testing if heparin-induced thrombocytopenia (a rare platelet disorder caused by heparin) is suspected. It is important to inform your doctor that you are taking both Ticagrelor Teva and heparin, as Ticagrelor Teva may affect the diagnostic test.

Children and adolescents
Ticagrelor Teva is not recommended for children and adolescents under 18 years of age.
Other medicines and Ticagrelor Teva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines. This is because Ticagrelor Teva may affect how certain medicines work, and some
medicines may affect Ticagrelor Teva.
Inform your doctor or pharmacist if you are taking any of the following medicines:

• rosuvastatin (a medicine used to treat high cholesterol)
• more than 40 mg daily of simvastatin or lovastatin (medicines used to treat high cholesterol)
• rifampicin (an antibiotic)
• phenytoin, carbamazepine, and phenobarbital (used to control epileptic seizures)
• digoxin (used to treat heart failure)
• ciclosporin (used to suppress the immune system)
• quinidine and diltiazem (used to treat abnormal heart rhythm)
• beta-blockers and verapamil (used to treat high blood pressure)
• morphine and other opioids (used to treat severe pain).

In particular, inform your doctor or pharmacist if you are taking any of the following medicines
which increase the risk of bleeding:

• ‘oral anticoagulants’, often referred to as ‘blood thinners’, including warfarin
• non-steroidal anti-inflammatory drugs (NSAIDs), commonly used as painkillers, such as ibuprofen and naproxen
• selective serotonin reuptake inhibitors (SSRIs), taken as antidepressants, such as paroxetine, sertraline, and citalopram
• other medicines such as ketoconazole (used to treat fungal infections), clarithromycin (used to treat bacterial infections), nefazodone (an antidepressant), ritonavir and atazanavir (used to treat HIV and AIDS), cisapride (used to treat heartburn), or ergot alkaloids (used to treat migraine and headache).

Additionally, inform your doctor that, because you are taking Ticagrelor Teva, you may have an
increased risk of bleeding if your doctor prescribes fibrinolytic agents, often called ‘thrombolytics’,
such as streptokinase or alteplase.
Pregnancy and breastfeeding
The use of Ticagrelor Teva is not recommended during pregnancy or if you suspect you may be
pregnant.
Women must use appropriate contraceptive methods to prevent pregnancy while taking this
medicine.
Consult your doctor before taking this medicine if you are breastfeeding. Your doctor will discuss
with you the benefits and risks of treatment with Ticagrelor Teva during this period.
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
It is unlikely that Ticagrelor Teva will affect your ability to drive or operate machinery. However, if
you experience dizziness or confusion while taking Ticagrelor Teva, exercise caution when driving or
operating machinery.
Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially “sodium-free”.

3. How to take Ticagrelor Teva

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
How much Ticagrelor Teva to take
Ticagrelor Teva 60 mg tablets

• The usual dose is one 60 mg tablet twice daily. Continue taking Ticagrelor Teva for the entire duration prescribed by your doctor.

• Take this medicine at approximately the same time each day (for example, one tablet in the morning and one in the evening).
  Ticagrelor Teva 90 mg tablets

• The initial dose is two tablets taken at the same time (a loading dose of 180 mg). This dose is usually administered in a hospital setting.

• After this initial dose, the usual dose is 90 mg twice daily for up to 12 months, unless otherwise instructed by your doctor.

• Take this medicine at approximately the same time each day (for example, one tablet in the morning and one in the evening).

If you are taking Ticagrelor Teva with other blood-thinning medicines
Your doctor will usually instruct you to also take acetylsalicylic acid. This is a substance found in many medicines used to prevent blood clotting. Your doctor will tell you how much to take (usually between 75 and 150 mg daily).
How to take Ticagrelor Teva

• You may take the tablet with or without food.
• You can keep track of when you last took a Ticagrelor Teva tablet by looking at the blister pack. There is a sun symbol (for morning) and a moon symbol (for evening) to help you remember whether you have taken your dose.

If you have difficulty swallowing the tablet
If you have difficulty swallowing the tablet, you may crush it and mix it with water as follows:

• Crush the tablet into a fine powder.
• Pour the powder into half a glass of water.
• Stir and drink immediately.
• To ensure you have not left any medicine behind, rinse the empty glass with another half glass of water and drink it. If you are in hospital, the tablet may be given to you mixed with a small amount of water and administered through a tube inserted through the nose (nasogastric tube).

If you take more Ticagrelor Teva than you should
If you have taken more Ticagrelor Teva than prescribed, contact your doctor or go to hospital immediately. Bring the medicine pack with you. You may be at increased risk of bleeding.
If you forget to take Ticagrelor Teva

• If you forget to take a dose, take the next dose at the usual time.
• Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

If you stop taking Ticagrelor Teva
Do not stop taking Ticagrelor Teva without first talking to your doctor. Take this medicine regularly and for as long as your doctor prescribes it. Stopping Ticagrelor Teva may increase your risk of having another heart attack or stroke, or of dying from a heart- or blood vessel-related condition.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur with this medicine.
Ticagrelor Teva affects blood clotting, therefore many side effects are related to bleeding. Bleeding can occur anywhere in the body. Some bleeding events are common (such as bruising and nosebleeds). Severe bleeding is uncommon in frequency, but may be life-threatening.
Contact a doctor immediately if you experience any of the following symptoms – you may need urgent medical treatment:

• Bleeding in the brain or within the skull is an uncommon side effect and may cause signs of stroke, such as:
  • sudden numbness or weakness in arms, legs, or face, especially on one side of the body
  • sudden confusion, difficulty speaking or understanding others
  • sudden difficulty walking or loss of balance or coordination
  • sudden dizziness or sudden, severe headache with no known cause.
• Signs of bleeding such as:
  • severe bleeding or bleeding that cannot be controlled
  • unexpected bleeding or bleeding that lasts a long time
  • pink, red, or brown urine
  • vomit that is red or looks like coffee grounds
  • red or black stools (resembling tar)
  • coughing up or vomiting blood clots.
• Fainting (syncope)
  • temporary loss of consciousness due to a sudden drop in blood flow to the brain (common).
• Signs of a blood clotting disorder called thrombotic thrombocytopenic purpura (TTP), such as:
  • fever and purple spots (called purpura) on the skin or in the mouth, with or without yellowing of the skin or eyes (jaundice), unexplained extreme fatigue or confusion.

Contact your doctor if you notice any of the following symptoms:

• Shortness of breath – this event is very common. It may be due to your heart condition or another cause, or it may represent a side effect of Ticagrelor Teva. Dyspnea (shortness of breath) due to Ticagrelor Teva is generally mild and characterized by a sudden, unexpected need for air, usually occurring at rest, and may appear during the first weeks of treatment and resolve in many cases. If your shortness of breath worsens or persists over time, inform your doctor. Your doctor will decide whether treatment is needed or further investigations are required.

Other possible side effects
Very common (may affect more than 1 in 10 people)

• high levels of uric acid in the blood (shown by laboratory tests)
• bleeding caused by blood disorders.

Common (may affect up to 1 in 10 people)

• bruising
• headache
• dizziness or sensation of spinning (vertigo)
• diarrhoea or indigestion
• feeling unwell (nausea)
• constipation
• rash
• itching
• severe joint pain and swelling – signs of gout
• dizziness, mental confusion, or blurred vision – signs of low blood pressure
• nosebleeds
• bleeding after surgery or cuts (e.g. during shaving) and wounds, more than normal
• bleeding from the stomach lining (ulcer)
• bleeding gums.

Uncommon (may affect up to 1 in 100 people)

• allergic reaction – skin rash, itching, or swelling of the face or lips/tongue may be signs of an allergic reaction
• confusion
• visual disturbances caused by bleeding in the eyes
• heavier vaginal bleeding or bleeding occurring at times different from normal menstrual bleeding
• bleeding into joints and muscles, which may cause painful swelling
• blood in the ears
• internal bleeding, which may cause dizziness or mental confusion.

Not known (frequency cannot be estimated from available data)

• abnormally slow heart rate (usually less than 60 beats per minute).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ticagrelor Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, bottle, and blister after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ticagrelor Teva contains
The active substance is ticagrelor.
Each film-coated tablet of Ticagrelor Teva 60 mg contains 60 mg of ticagrelor.
Each film-coated tablet of Ticagrelor Teva 90 mg contains 90 mg of ticagrelor.
The other components are:
Tablet core: mannitol (E421), calcium hydrogen phosphate, povidone, sodium starch glycolate
type A, magnesium stearate (E470b).
Tablet coating:
Ticagrelor Teva 60 mg: hypromellose (E464), titanium dioxide (E171), macrogol (E1521), talc (E553b)
and red iron oxide (E172).
Ticagrelor Teva 90 mg: hypromellose (E464), titanium dioxide (E171), talc (E553b), macrogol
(E1521), yellow iron oxide (E172) and red iron oxide (E172).

Description of the appearance of Ticagrelor Teva and contents of the pack
Ticagrelor Teva 60 mg: film-coated tablet: round, light pink to pink tablets, marked ‘137’ on one side and ‘A’ on the other, approximately 8 mm in diameter.
Ticagrelor Teva 90 mg: film-coated tablet: round, light yellow to yellow tablets, marked ‘A91’ on one side and smooth on the other, approximately 9 mm in diameter.

The following pack sizes are available:
Blister packs in OPA/Al/PVC-Al and PVC/PVDC-Al with sun/moon symbols
Packs: 10, 30, 60, 100, 120 and 180 tablets
Calendar blister packs in OPA/Al/PVC-Al and PVC/PVDC-Al with sun/moon symbols
Packs: 14, 56, 168 and 196 tablets
Unit-dose divisible blister packs in OPA/Al/PVC-Al and PVC/PVDC-Al with sun/moon symbols
Packs: 10x1, 30x1, 60x1, 90x1 and 180x1 tablets
Calendar unit-dose divisible blister packs in OPA/Al/PVC-Al and PVC/PVDC-Al with sun/moon symbols
Packs: 14x1, 56x1, 168x1 and 196x1 tablets
HDPE bottle with child-resistant cap and desiccant
Packs: 60, 100 and 180 tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Teva B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands

Manufacturer
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)
Prilaz baruna Filipovića 25
10000 Zagreb
Croatia