TICAGRELOR INTAS

Package leaflet: Information for the user

Ticagrelor Intas 60 mg film-coated tablets

ticagrelor
Generic medicine
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 you, because it may be harmful.
• If you experience any side effect, including any not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

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

What Ticagrelor Intas is used for
Ticagrelor Intas, 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 will die from heart disease or blood vessel-related conditions.

How Ticagrelor Intas works
Ticagrelor Intas acts on blood 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;
• 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 Intas helps prevent platelets from clumping together. This reduces the risk of forming a blood clot that could impair blood flow.

2. What you need to know before taking Ticagrelor Intas

Do not take Ticagrelor Intas 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 infection and AIDS).

Do not take Ticagrelor Intas if any of the situations listed above 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 Intas 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 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 Intas. This is because your risk of bleeding may be increased. 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 liver-related condition.
• 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 Intas and heparin:

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

Children and adolescents

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

Other medicines and Ticagrelor Intas

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

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 that 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 infection 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 Intas, 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 Intas is not recommended during pregnancy or if you suspect you are 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 Intas during this period.

If you are pregnant, suspect you may be pregnant, plan 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 Intas will affect your ability to drive or operate machinery. However, if you experience dizziness or confusion while taking this medicine, exercise caution when driving or operating machinery.

Ticagrelor Intas 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 Intas

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

How much Ticagrelor Intas to take

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

If you are taking Ticagrelor Intas with other medicines for blood clotting
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 per day).

How to take Ticagrelor Intas

• You may take the tablet with or without food.
• You can check when you took your last Ticagrelor Intas tablet by looking at the blister. There is a sun (for the morning) and a moon (for the evening) symbol. This will 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 do not miss any of the medicine, rinse the empty glass with half a glass of water and drink that as well.

If you are in hospital, the tablet may be given to you crushed and mixed with a small amount of water and administered through a tube inserted through the nose (nasogastric tube).

If you take more Ticagrelor Intas than you should
If you have taken more Ticagrelor Intas 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 Intas

• 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 missed dose.

If you stop taking Ticagrelor Intas
Do not stop taking Ticagrelor Intas without first talking to your doctor. Take this medicine regularly and for as long as your doctor prescribes it. If you stop taking Ticagrelor Intas, your risk of having another heart attack or stroke, or of dying from a heart- or blood vessel-related condition, 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 Intas 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). Serious bleeding is uncommon in frequency, but may be life-threatening.
Contact a doctor immediately 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 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 and severe headache without 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 (look like tar)
• coughing or vomiting blood clots.
  • Fainting (syncope)
• a temporary loss of consciousness due to a sudden reduction 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 may represent a side effect of Ticagrelor Intas. Shortness of breath related to Ticagrelor Intas is usually mild and characterized by a sudden, unexpected need for air, which generally occurs at rest and may appear during the first weeks of therapy; for many people, it may disappear over time. 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
• Feeling dizzy or as if the room is spinning
• Diarrhea or indigestion
• Feeling unwell (nausea)
• Constipation
• Rash
• Itching
• Severe pain and swelling in 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 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 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 experience 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 Intas

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is 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 no longer required. This will help protect the environment.

6. Package contents and other information

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

Description of the appearance of Ticagrelor Intas and contents of the pack
Ticagrelor Intas 60 mg are light pink, round (8 mm in diameter), biconvex, film-coated tablets,
imprinted with "KJ1" on one side.
Ticagrelor Intas 60 mg is available in blisters containing 14, 56, 60, 100, 168 or 180 film-coated tablets,
calendar blisters 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
Intas Third Party Sales 2005 S.L
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 Intas 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Ticagrelor Intas is and what it is used for
2. What you need to know before taking Ticagrelor Intas
3. How to take Ticagrelor Intas
4. Possible side effects
5. How to store Ticagrelor Intas
6. Package contents and other information

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

What is Ticagrelor Intas
Ticagrelor Intas contains an active substance called ticagrelor, which belongs to a group of medicines
known as platelet aggregation inhibitors (antiplatelet agents).
What Ticagrelor Intas is used for
Ticagrelor Intas, 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, or
• unstable angina (chest pain or angina that is not well controlled).

This medicine reduces the risk of having another heart attack or stroke, or of dying due to heart or blood vessel disease.
How Ticagrelor Intas works
Ticagrelor Intas 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 damaged or cut blood vessels.
However, platelets can also form clots inside the 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;
• 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 Intas helps prevent platelets from clumping together. This reduces the risk of forming a blood clot that could reduce blood flow.

2. What you need to know before taking Ticagrelor Intas

Do not take Ticagrelor Intas 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 infection and AIDS).

Do not take Ticagrelor Intas 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 Intas 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 any surgical procedure (including dental surgery) while taking Ticagrelor Intas. 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 regulating your heart rhythm (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 liver disease.
• 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), talk to your doctor or
pharmacist before taking this medicine.
If you are taking both Ticagrelor Intas and heparin:

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

Children and adolescents
Ticagrelor Intas is not recommended for children and adolescents under 18 years of age.
Other medicines and Ticagrelor Intas
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Ticagrelor Intas may affect how some medicines work, and some medicines may affect Ticagrelor Intas.
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
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 infection 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 Intas, 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 Intas is not recommended during pregnancy or if you suspect you might 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 treatment with Ticagrelor Intas during this period.
If you are pregnant, think you might be pregnant, plan 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 Intas will affect your ability to drive or operate machinery. However, if you experience dizziness or confusion while taking this medicine, exercise caution when driving or operating machinery.
Ticagrelor Intas 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 Intas

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

How much Ticagrelor Intas 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 Intas with other blood-thinning medicines
Your doctor will usually tell you to also take acetylsalicylic acid. This is a substance found in many medicines used to prevent blood clotting. Your doctor will advise you on the amount to take (generally between 75 and 150 mg daily).

How to take Ticagrelor Intas

• You may take the tablet with or without food.
• You can keep track of when you took the last Ticagrelor Intas tablet by looking at the blister pack. There is a sun symbol (for the morning) and a moon symbol (for the evening). This will 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.
• Mix and drink immediately.
• To ensure no medicine is left behind, rinse the empty glass with half a glass of water and drink it.

If you are in hospital, the tablet may be given mixed with some water and administered through a tube inserted through the nose (nasogastric tube).

If you take more Ticagrelor Intas than you should
If you have taken more Ticagrelor Intas 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 Intas

• 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 Intas
Do not stop taking Ticagrelor Intas without first talking to your doctor. Take this medicine regularly and for as long as your doctor prescribes it. Stopping Ticagrelor Intas may increase your risk of having another heart attack or stroke, or of dying from a disease related to heart or blood vessel problems.

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 Intas 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). Serious bleeding is uncommon in frequency but may be life-threatening.
Seek immediate medical attention if you experience any of the following symptoms – you may require 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, loss of balance, or lack of 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 longer than usual
• 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 reduction 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 be a side effect of Ticagrelor Intas. Shortness of breath associated with Ticagrelor Intas 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; in many cases, it resolves over time. 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 (as 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
• Diarrhea or indigestion
• Feeling unwell (nausea)
• Constipation
• Rash
• Itching
• Severe pain and swelling in 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 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 mental confusion

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, 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 Intas

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 Intas contains

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

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

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

Ticagrelor Intas 90 mg is available in blisters containing 14, 56, 60, 100, 168 or 180 film-coated tablets, calendar blisters 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
Intas Third Party Sales 2005 S.L
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