TICAGRELOR ACCORD

Patient Information Leaflet: Information for the User

Ticagrelor Accord 60 mg Film-coated Tablets

ticagrelor
Generic medicine
Read this entire leaflet carefully before you start taking this medicine, as 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 may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

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

What Ticagrelor Accord is
Ticagrelor Accord contains an active substance called ticagrelor, which belongs to a group of
medicines known as antiplatelet agents.
What Ticagrelor Accord is used for
Ticagrelor Accord, 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:

• a heart attack more than one year ago.

This medicine reduces the likelihood that you will suffer another heart attack or stroke, or that you may die due to heart disease or blood vessel-related conditions.
How Ticagrelor Accord works
Ticagrelor Accord 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 Accord helps prevent platelets from clumping together. This reduces the risk of blood clot formation, which could otherwise reduce blood flow.

2. What you need to know before taking Ticagrelor Accord

Do not take Ticagrelor Accord if:

• You are allergic to ticagrelor or to any of the other ingredients of this medicine (listed in
  section 6).
• You are currently experiencing 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 Accord 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 Accord if:

• You have an increased risk of bleeding due to:
  • a serious recent injury
  • a recent surgical procedure (including dental surgery; 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 to undergo surgery (including dental surgery) at any time while taking Ticagrelor Accord. 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 (typically less than 60 beats per minute) and you do not already have a device implanted to regulate your heart rhythm (pacemaker).
• You suffer from asthma or another lung disorder or have 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 previously had liver problems or any condition affecting your 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 Accord 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 Accord and heparin, as Ticagrelor Accord may affect the diagnostic test.

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

• ‘oral anticoagulants’, often referred to as ‘blood thinners’, including warfarin;
• non-steroidal anti-inflammatory drugs (NSAIDs), often 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 Accord, 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 Accord is not recommended if you are pregnant or 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 Accord during this period.
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, seek
advice from your doctor or pharmacist before taking this medicine.
Driving and using machines
It is unlikely that Ticagrelor Accord will affect your ability to drive or operate machinery. If you experience dizziness or confusion while taking Ticagrelor Accord, exercise caution when driving or operating machinery.
Ticagrelor Accord contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. How to take Ticagrelor Accord

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
How much Ticagrelor Accord to take

• The usual dose is one 60 mg tablet twice daily. Continue taking Ticagrelor Accord for the entire duration indicated 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 take Ticagrelor Accord 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
(generally between 75 and 150 mg daily).
How to take Ticagrelor Accord

• 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 half a glass of water and drink that too.

If you are in hospital, the tablet may be given to you mixed with a small amount of water and administered via a tube inserted through the nose (nasogastric tube).
If you take more Ticagrelor Accord than you should
If you have taken more Ticagrelor Accord than prescribed, contact your doctor or go to hospital
immediately. Take the medicine pack with you. You may be at increased risk of bleeding.
If you forget to take Ticagrelor Accord

• If you miss a dose, take your 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 Accord
Do not stop taking Ticagrelor Accord without first talking to your doctor. Take this medicine
regularly and for as long as your doctor prescribes it. Stopping Ticagrelor Accord may increase
your risk of having another heart attack or stroke, or of dying from a condition related to heart or blood vessel disease.
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 will get them. The following side effects may occur with this medicine:
Ticagrelor Accord affects blood clotting, therefore many side effects are related to bleeding. Bleeding can occur in any part of the body. Some bleeding is common (such as bruising and nosebleeds). Serious bleeding is uncommon in frequency, but may 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 in the 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 or uncontrollable bleeding
  • 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)
• 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 tiredness 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 could represent a side effect of Ticagrelor Accord. Shortness of breath related to Ticagrelor Accord is generally mild and characterized by a sudden, unexpected need for air, usually occurring at rest, and may appear within the first weeks of treatment and resolve for many. 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
• Feeling dizzy or as if the room is spinning
• Diarrhoea or indigestion
• Feeling unwell (nausea)
• Constipation
• Rash
• Itching
• Severe pain and swelling in the joints – these are signs of gout
• Feeling dizzy or confused, or blurred vision – these are 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 from the gums

Uncommon (may affect up to 1 in 100 people)

• Allergic reaction – rash, itching, or swelling of the face or lips/tongue, which may be signs of an allergic reaction
• Confusion
• Visual disturbances caused by bleeding in the eyes
• Heavier vaginal bleeding or bleeding occurring at different times than normal menstrual bleeding
• Bleeding into joints and muscles which may cause painful swelling
• Blood in the ears
• Internal bleeding, which may cause dizziness or confusion

Not known (frequency cannot be estimated from the available data)

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

Reporting of side effects
If you get any side effects, 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Ticagrelor Accord

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

• The active substance is ticagrelor. Each film-coated tablet contains 60 mg of ticagrelor.
• The other components are: Tablet core: microcrystalline cellulose (E460), sodium croscarmellose (E468), povidone, sodium stearyl fumarate.

Film coating: hypromellose (E464), titanium dioxide (E171), macrogol (E1521), talc (E553b), iron oxide red (E172), iron oxide black (E172).

Description of the appearance of Ticagrelor Accord and package contents
Ticagrelor Accord 60 mg are light pink, round (8 mm in diameter), biconvex, film-coated tablets, marked with “KJ1” on one side.
Ticagrelor Accord 60 mg is available in blisters containing 14, 56, 60, 100, 168 or 180 film-coated tablets, calendar blister packs containing 14, 56 or 168 film-coated tablets, or unit-dose perforated blister packs containing 14 x 1, 56 x 1, 60 x 1, 100 x 1, 168 x 1 or 180 x 1 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer
Accord Healthcare Polska Sp. z.o.o.
Ul. Lutomierska 50, 95-200, Pabianice,
Poland
Accord Healthcare B.V. Winthontlaan 200,
3526 KV Utrecht,
The Netherlands
Laboratori Fundació Dau C/ C, 12-14 Pol. Ind. Zona Franca,
Barcelona, 08040,
Spain
Pharmadox Healthcare Limited, KW20A Kordin Industrial Park,
Paola, PLA 3000, Malta

Package leaflet: Information for the user

Ticagrelor Accord 90 mg film-coated tablets

ticagrelor
Generic medicine
Please read this leaflet carefully before 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 their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

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

What Ticagrelor Accord is
Ticagrelor Accord contains an active substance called ticagrelor, which belongs to a group of
medicines known as platelet aggregation inhibitors.
What Ticagrelor Accord is used for
Ticagrelor Accord, in combination with acetylsalicylic acid (another platelet aggregation inhibitor),
should be used only in adult patients. You have been prescribed this medicine because you have had:

• a heart attack more than one year ago, or
• unstable angina (angina or chest pain that is not well controlled).

This medicine reduces the likelihood that you will suffer another heart attack or stroke, or that you will die from heart or blood vessel-related disease.
How Ticagrelor Accord works
Ticagrelor Accord 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 Accord helps prevent platelets from clumping together. This reduces the risk of blood clots forming, which could reduce blood flow.

2. What you need to know before taking Ticagrelor Accord

Do not take Ticagrelor Accord if:

• You are allergic to ticagrelor or to any of the other ingredients of this medicine (listed in section 6).
• You are currently experiencing 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 Accord 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 Accord if:

• You have an increased risk of bleeding due to:
  • a serious recent injury
  • recent surgery (including dental surgery; 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 surgery) at any time while taking Ticagrelor Accord. 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 low (typically less than 60 beats per minute) and you do not already have a device implanted to regulate your heart rhythm (pacemaker).
• You suffer from asthma or another lung condition or have 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 previously had liver problems or any condition affecting your 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 Accord 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 Accord and heparin, as Ticagrelor Accord may interfere with the diagnostic test.

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

Other medicines and Ticagrelor Accord
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Ticagrelor Accord may affect how some medicines work, and some medicines may affect Ticagrelor Accord.

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)
• cyclosporine (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 Accord, 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 Accord is not recommended if you are pregnant or 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 Accord 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 Accord will affect your ability to drive or operate machinery. However, if you experience dizziness or confusion while taking Ticagrelor Accord, exercise caution when driving or operating machinery.

Ticagrelor Accord contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially "sodium-free".

3. How to take Ticagrelor Accord

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

• 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 Accord with other blood-thinning medicines
Your doctor will usually tell you to take acetylsalicylic acid as well. This is a substance found in many medicines used to prevent blood clotting. Your doctor will advise you on the dose to take (usually between 75 and 150 mg per day).
How to take Ticagrelor Accord

• 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 you have not left any medicine behind, rinse the empty glass with half a glass of water and drink that too.

If you are in hospital, the tablet may be given to you mixed with a small amount of water and administered through a tube passed through the nose (nasogastric tube).
If you take more Ticagrelor Accord than you should
If you have taken more Ticagrelor Accord than you should have, contact your doctor or go to hospital immediately. Take the medicine pack with you. You may be at increased risk of bleeding.
If you forget to take Ticagrelor Accord

• 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 the forgotten dose.

If you stop taking Ticagrelor Accord
Do not stop taking Ticagrelor Accord without first talking to your doctor. Take this medicine regularly and for as long as your doctor prescribes it. If you stop taking Ticagrelor Accord, 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 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 everyone gets them. The following side effects may occur with this medicine:
Ticagrelor Accord affects blood clotting, therefore many 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). Severe bleeding is uncommon in frequency but may be life-threatening.

Seek immediate medical attention 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 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 or uncontrollable bleeding
  • 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 could represent a side effect of Ticagrelor Accord. Shortness of breath related to Ticagrelor Accord is usually mild and characterized by a sudden, unexpected need for air, typically occurring at rest, and may appear during the first weeks of treatment and resolve for many. 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
• Feeling dizzy or as if the room is spinning
• Diarrhoea or indigestion
• Feeling sick (nausea)
• Constipation
• Rash
• Itching
• Severe pain and swelling in the joints – these are signs of gout
• Feeling dizzy or confused, or blurred vision – these are signs of low blood pressure
• Nosebleeds
• Bleeding after surgery or cuts (e.g. during shaving) and wounds, more than usual
• Bleeding from the stomach lining (ulcer)
• Bleeding from the gums

Uncommon (may affect up to 1 in 100 people)

• Allergic reaction – rash, itching, or swelling of the face or lips/tongue, which may be signs of an allergic reaction
• Confusion
• Visual disturbances caused by bleeding in the eyes
• Heavier vaginal bleeding or bleeding occurring at different times 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 the available data)

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

Reporting of side effects
If you get any side effects, 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 https://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 Accord

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

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

Tablet coating: hypromellose (E464), titanium dioxide (E171), macrogol (E1521), talc (E553b), yellow iron oxide (E172)

Description of the appearance of Ticagrelor Accord and package contents
Ticagrelor Accord 90 mg are light yellow, round (9 mm in diameter), biconvex, film-coated tablets, marked with "KJ2" on one side.

Ticagrelor Accord 90 mg is available in blisters containing 14, 56, 60, 100, 168 or 180 film-coated tablets, calendar blister packs containing 14, 56 or 168 film-coated tablets, or unit-dose perforated blisters containing 14 x 1, 56 x 1, 60 x 1, 100 x 1, 168 x 1 or 180 x 1 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer
Accord Healthcare Polska Sp. z.o.o.
Ul. Lutomierska 50, 95-200, Pabianice,
Poland
Accord Healthcare B.V. Winthontlaan 200,
3526 KV Utrecht, The Netherlands
Laboratori Fundació Dau C/ C, 12-14 Pol. Ind. Zona Franca,
Barcelona, 08040, Spain
Pharmadox Healthcare Limited, KW20A Kordin Industrial Park,
Paola, PLA 3000, Malta