Ticagrelor Sun

PACKAGE LEAFLET

Package leaflet: Information for the user

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

Ticagrelor
Generic medicine
Please read this entire 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

What Ticagrelor SUN is
Ticagrelor SUN contains an active substance called ticagrelor. It belongs to a group of medicines
called antiplatelet drugs.
What Ticagrelor SUN is used for
[60 mg]
Ticagrelor SUN in combination with acetylsalicylic acid (another antiplatelet agent) should only be used in adults. You have been given this medicine
because you have had:

• a heart attack, more than one year ago. It reduces the likelihood of having another heart attack, stroke, or dying due to a disease related to the heart or blood vessels.

[90 mg]
Ticagrelor SUN in combination with acetylsalicylic acid (another antiplatelet agent) should only be used in adults. You have been given this medicine
because you have had:

• a heart attack, or
• unstable angina (angina or chest pain that is not well controlled). It reduces the likelihood of having another heart attack, stroke, or dying due to a disease related to the heart or blood vessels.

How Ticagrelor SUN works
Ticagrelor SUN affects cells called "platelets" (also known as thrombocytes). These very small
blood cells help stop bleeding by clumping together to plug small holes in blood vessels that have been cut or damaged.
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 flow; this can cause a heart attack (myocardial infarction) or a stroke, or
• the clot may partially block the blood vessels of the heart; this reduces blood flow to the heart and may cause chest pain that comes and goes (called "unstable angina"). Ticagrelor SUN helps prevent platelets from clumping together. This reduces the chance of forming a blood clot that could reduce blood flow.

2. What you need to know before taking Ticagrelor SUN

Do not take Ticagrelor SUN:

• If you are allergic to ticagrelor or to any of the other ingredients of this medicine (listed in section 6).
• If you are currently experiencing active bleeding.
• If you have had a stroke caused by bleeding in the brain.
• If you have severe liver disease.
• If 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 SUN if any of the above conditions apply to you. If you have any doubts, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking Ticagrelor SUN if:

• You have an increased risk of bleeding due to:
  • a serious recent injury
  • a recent surgical procedure (including dental procedures; consult your dentist)
  • a disease affecting blood clotting
  • recent bleeding from the stomach or intestines (e.g., due to gastric ulcer or colon "polyps")
• You are scheduled to undergo surgery (including dental surgery) at any time while taking Ticagrelor SUN. This is because of the increased risk of bleeding. Your doctor may ask you to stop taking this medicine 5 days before surgery.
• Your heart rate is unusually low (typically less than 60 beats per minute) and you do not already have a device implanted to stimulate the heart (pacemaker).
• You have asthma or other lung problems or breathing difficulties.
• You develop irregular breathing patterns such as acceleration, slowing, or brief pauses in breathing. Your doctor will decide whether further evaluation is needed.
• You have had liver problems or previously had a disease that may have affected your liver.
• You have had a blood test showing higher than normal levels of uric acid. If any of the above conditions apply to you (or if you are unsure), consult your doctor or pharmacist before taking this medicine.

If you are taking both Ticagrelor SUN and heparin:

• Your doctor may request a blood sample for diagnostic testing if they suspect a rare platelet disorder caused by heparin. It is important to inform your doctor that you are taking both Ticagrelor SUN and heparin, as Ticagrelor SUN may affect the diagnostic test.

Children and adolescents
Ticagrelor SUN is not recommended for children and adolescents under 18 years of age.

Other medicines and Ticagrelor SUN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Ticagrelor SUN can affect how some medicines work, and some medicines can affect Ticagrelor SUN.
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 per day 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 rhythms)
• 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), often taken 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), ergot alkaloids (used to treat migraine and headache)

Also inform your doctor that, because you are taking Ticagrelor SUN, you may have an increased risk of bleeding if fibrinolytic agents (often called "clot busters," such as streptokinase or alteplase) are administered.

Pregnancy and breastfeeding
The use of Ticagrelor SUN is not recommended if you are pregnant or suspect you may be pregnant. Women should use appropriate contraceptive methods to avoid 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 taking Ticagrelor SUN during this period.
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
It is unlikely that Ticagrelor SUN will affect your ability to drive or use machines. However, if you experience dizziness or confusion while taking this medicine, exercise caution when driving or operating machinery.

Ticagrelor SUN contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, which means it is essentially "sodium-free."

If you have informed your doctor that you have an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Ticagrelor SUN

Always take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
How much to take
[60 mg]

• The usual dose is one 60 mg tablet twice daily. Continue taking Ticagrelor SUN 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).

[90 mg]

• The initial dose is two tablets taken at once (a loading dose of 180 mg). This dose is normally administered in hospital.
• After this initial dose, the usual dose is one 90 mg tablet twice daily for up to 12 months, unless your doctor tells you otherwise.
• 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 SUN with other blood-thinning medicines
Your doctor will usually also instruct you to 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 75–150 mg daily).
How to take Ticagrelor SUN

• You may take the tablet with or without food.

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 no medicine is left behind, rinse the empty glass with another half glass of water and drink this too. If you are in hospital, this tablet may be administered mixed with a small amount of water through a nasogastric tube (a tube inserted through the nose).

If you take more Ticagrelor SUN than you should
If you take more Ticagrelor SUN than prescribed, contact your doctor or go to hospital immediately. Take the medicine packaging with you. You may be at increased risk of bleeding.

If you forget to take Ticagrelor SUN

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

If you stop taking Ticagrelor SUN
Do not stop taking Ticagrelor SUN without first talking to your doctor. Take this medicine regularly for as long as your doctor prescribes it. If you stop taking Ticagrelor SUN, your risk of having another heart attack or stroke, or of dying from a heart or blood vessel-related disease, may increase.
If you have any questions about how to use this medicine, ask 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 SUN affects blood clotting, so most side effects are related to bleeding. Bleeding can occur in any part of the body. Some bleeding events are common (such as bruising and nosebleeds). Serious bleeding is uncommon in frequency but can be life-threatening.
Seek immediate medical advice if you notice 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 of the arms, legs, or face, especially on one side of the body
  • sudden confusion, difficulty speaking or understanding others
  • sudden difficulty walking, 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 in colour or looks like "coffee grounds"
  • red or black stools (resembling tar)
  • coughing up or vomiting blood clots
• Fainting (syncope):
  • a 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 is very common. It may be due to your heart condition or another cause, or it may be a side effect of Ticagrelor SUN. Dyspnea due to Ticagrelor SUN is usually mild and characterized by sudden, unexpected breathlessness, typically occurring at rest, and often appearing within the first weeks of treatment. For many people, it resolves spontaneously. If your shortness of breath worsens or persists, 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
• Diarrhoea or indigestion
• Feeling unwell (nausea)
• Constipation
• Rash
• Itching
• Severe joint pain and swelling – signs of gout
• Dizziness, lightheadedness, or blurred vision – signs of low blood pressure
• Nosebleeds
• Bleeding after surgery or minor cuts (e.g. during shaving) and wounds bleeding more than usual
• Bleeding from the stomach lining (ulcer)
• Bleeding gums

Uncommon (may affect up to 1 in 100 people)

• Allergic reaction – rash, itching, or swelling of the face or lips/tongue may be signs of an allergic reaction
• Confusion
• Vision problems caused by bleeding in the eyes
• Vaginal bleeding that is heavier than normal or occurs at different times compared to the normal menstrual cycle
• Bleeding into joints and muscles causing painful swelling
• Blood in the ear
• Internal bleeding, which may cause dizziness or lightheadedness

Frequency not known (cannot be estimated from the available data)

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

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ticagrelor SUN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton 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 SUN contains

• The active substance is ticagrelor. Each film-coated tablet contains 60 mg of ticagrelor. Each film-coated tablet contains 90 mg of ticagrelor.
• The other components are: Tablet core: lactose monohydrate, microcrystalline cellulose (E460), hydroxypropyl cellulose, sodium croscarmellose (E468), magnesium stearate (E470b).

[60 mg]
Film coating of tablets: hypromellose (E464), titanium dioxide (E171), macrogol,
iron oxide black (E172), iron oxide red (E172).
[90 mg]
Film coating of tablets: hypromellose (E464), titanium dioxide (E171), talc (E553b), macrogol, iron oxide yellow (E172).

Description of the appearance of Ticagrelor SUN and package contents
[60 mg]
Film-coated tablet (tablet): The tablets are round, biconvex, film-coated, pink in colour, marked with "60" over "T" on one side and smooth on the other.
[90 mg]
Film-coated tablets (tablets): The tablets are round, biconvex, film-coated, yellow in colour, marked with "90" over "T" on one side and smooth on the other.

[60 mg]
Ticagrelor SUN 60 mg film-coated tablets are packaged in transparent PVC/PVDC/Al blisters, in cartons containing 20, 56, 60, 168, 200 film-coated tablets.
[90 mg]
Ticagrelor SUN 90 mg film-coated tablets are packaged in transparent PVC/PVDC/Al blisters, in cartons containing 20, 56, 60, 100, 168, 200 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132JH Hoofddorp
The Netherlands

Local Representative
Sun Pharma Italia Srl
Via Giulio Richard 3
20143 Milano
Italy

Manufacturers
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132JH Hoofddorp
The Netherlands
Terapia SA
124 Fabricii Street,
400632, Cluj-Napoca,
Romania

This medicinal product is authorized in the Member States of the European Economic Area under the following names: