Ticagrelor Abdi

Package leaflet: Information for the user

Ticagrelor Abdi 60 mg film-coated tablets

ticagrelor
Generic medicine
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 adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

What Ticagrelor Abdi is
Ticagrelor Abdi contains an active substance called ticagrelor. This belongs to a group of
medicines known as antiplatelet agents.
What Ticagrelor Abdi is used for
Ticagrelor Abdi, in combination with acetylsalicylic acid (another antiplatelet agent), is intended for use in adult patients only. 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 a disease related to heart or blood vessel problems.

How Ticagrelor Abdi works
Ticagrelor Abdi 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 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 Abdi helps prevent platelets from sticking together. This reduces the risk of blood clot formation, which could otherwise reduce blood flow.

2. What you should know before taking Ticagrelor Abdi

Do not take Ticagrelor Abdi 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 suffer from severe liver disease.
• 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 infection)

Do not take Ticagrelor Abdi 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 Abdi 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 Abdi. 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 other lung conditions 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 that affected your liver.
• you have previously had blood tests showing elevated 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 Abdi and heparin:

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

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

Other medicines and Ticagrelor Abdi
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Ticagrelor Abdi may affect how certain medicines work, and some medicines may affect Ticagrelor Abdi. 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 infection), cisapride (used to treat heartburn), ergot alkaloids (used to treat migraine and headache).

Additionally, inform your doctor that, because you are taking Ticagrelor Abdi, 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 Abdi 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 Abdi 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 Abdi 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.

Sodium content
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially "sodium-free".

3. How to take Ticagrelor Abdi

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

• The usual dose is one 60 mg tablet twice daily. Continue taking Ticagrelor Abdi 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 Abdi 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 (generally between 75 and 150 mg daily).
How to take Ticagrelor Abdi

• You may take the tablet with or without food.
• You can keep track of when you took your last Ticagrelor Abdi tablet by looking at the blister pack. There is a sun symbol (for the morning) and a moon symbol (for the 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 do not leave 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 Abdi than you should
If you take more Ticagrelor 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 Abdi

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

If you stop taking Ticagrelor Abdi
Do not stop taking Ticagrelor Abdi without first talking to your doctor. Take this medicine regularly and for as long as your doctor prescribes it. Stopping Ticagrelor Abdi may increase your risk of having another heart attack or stroke, or of dying from a condition related to heart or blood vessel problems.
If you have any doubts 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 Abdi 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.
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 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 without 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
  • vomiting blood or vomit that 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 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 Abdi. Dyspnea (shortness of breath) due to Ticagrelor Abdi is generally mild and characterized by a sudden, unexpected need for air, which usually occurs at rest and may appear during the first weeks of therapy; for many people it may resolve spontaneously. 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 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
• Dizziness or sensation of spinning
• Diarrhoea or indigestion
• Feeling unwell (nausea)
• Constipation
• Rash
• Itching
• Severe joint pain and swelling – these are signs of gout
• Dizziness or mental confusion, or blurred vision – these are signs of low blood pressure
• Nosebleeds
• Bleeding after surgery or from cuts (e.g. during shaving) and wounds, greater 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
• Vision problems 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

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor. 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 Abdi

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 Abdi contains

• The active substance is ticagrelor. Each film-coated tablet contains 60 mg of ticagrelor.
• The other components are:
  Tablet core: mannitol (E421), calcium hydrogen phosphate dihydrate, croscarmellose sodium, hydroxypropylcellulose (E463), ethanol (96%), granulated mannitol, colloidal anhydrous silica, magnesium stearate (E470b)

Tablet coating: HPMC2910/hypromellose (E464), titanium dioxide (E171), iron oxide black/ferro-ferric oxide (E172), macrogol (PEG), yellow iron oxide (E172), red iron oxide (E172), talc.

Description of the appearance of Ticagrelor Abdi and contents of the pack
Film-coated tablet: The tablets are round, biconvex, light pink in colour, film-coated, with “ ” engraved on one side and smooth on the other.

Ticagrelor Abdi is available in:

• Blister packs in cartons containing 14, 56, 60 and 168 tablets

It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Abdi Farma GmbH
Donnersbergstraße 4
64646 Heppenheim
Germany

Manufacturers
Interpharma Services Ltd.
43A Cherni Vrach Blvd.
1407 Sofia
Bulgaria

Flavine Pharma France
3 Voie d'Allemagne
13127 Vitrolles
France

Pharmadox Healthcare Ltd.

1. KW20A Kordin Industrial Park, Paola PLA3000,
2. Warehouse No.1 and No.2, Hal Farrug Road, Luqa LQA9040,
   Malta

Package leaflet: information for the user

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

7. What Ticagrelor Abdi is and what it is used for

What Ticagrelor Abdi is
Ticagrelor Abdi contains an active substance called ticagrelor, which belongs to a group of medicines known as antiplatelet agents.
What Ticagrelor Abdi is used for
Ticagrelor Abdi, 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 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 a disease related to heart or blood vessel problems.

How Ticagrelor Abdi works
Ticagrelor Abdi 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 may 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 Abdi helps prevent platelets from sticking together. This reduces the chance of a blood clot forming, which could reduce blood flow.

8. What you need to know before taking Ticagrelor Abdi

Do not take Ticagrelor Abdi 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 infection)

Do not take Ticagrelor Abdi 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 Abdi 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 blood clotting disorder
  • recent stomach or intestinal bleeding (e.g., due to gastric ulcer or colon "polyps").
• you are scheduled to undergo surgery (including dental procedures) at any time while taking Ticagrelor Abdi. 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 (generally 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 other lung conditions 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 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 Abdi and heparin:

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

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

Other medicines and Ticagrelor Abdi
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Ticagrelor Abdi may affect how some medicines work, and some medicines may affect Ticagrelor Abdi. 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 and AIDS), cisapride (used to treat heartburn), ergot alkaloids (used to treat migraine and headache).

Additionally, inform your doctor that, because you are taking Ticagrelor Abdi, 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 Abdi 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 treatment with Ticagrelor Abdi 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 Abdi 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.

Sodium content
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially "sodium-free".

9. How to take Ticagrelor Abdi

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

How much Ticagrelor Abdi 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 take Ticagrelor Abdi 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 and 150 mg per day).

How to take Ticagrelor Abdi

• You may take the tablet with or without food.
• You can check when you took your last dose of Ticagrelor Abdi by looking at the blister pack. It shows a sun (for the morning) and a moon (for the evening), which 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 no medicine is left 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 water and administered through a tube inserted through the nose into the stomach (nasogastric tube).

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

If you forget to take Ticagrelor Abdi

• If you forget to take a dose, take the next dose at your 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 Abdi
Do not stop taking Ticagrelor Abdi without first talking to your doctor. Take this medicine regularly and for as long as your doctor prescribes it. Stopping Ticagrelor Abdi may increase your risk of having another heart attack or stroke, or of dying from a condition related to heart or blood vessel problems.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

10. 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 Abdi 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). 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 a 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 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
  • vomiting blood or vomit that looks like coffee grounds
  • red or black stools (appearing like 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 is a very common event. It may be due to your heart condition or another cause, or it could represent a side effect of Ticagrelor Abdi. Dyspnea (shortness of breath) due to Ticagrelor Abdi is generally mild and characterized by a sudden, unexpected need for air, which usually occurs at rest and may appear during the first weeks of treatment; 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 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 that the room is spinning
• Diarrhea or indigestion
• Feeling unwell (nausea)
• Constipation
• Rash
• Itching
• Severe joint pain and swelling – these are signs of gout
• Dizziness or confusion, or blurred vision – these are signs of low blood pressure
• Nosebleeds
• Bleeding after surgery or from 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 may be signs of an allergic reaction
• Confusion
• Vision problems 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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor. 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.

11. How to store Ticagrelor Abdi

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 requires no special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

12. Package contents and other information

What Ticagrelor Abdi contains

• The active substance is ticagrelor. Each film-coated tablet contains 90 mg of ticagrelor.
• The other components are: Tablet core: mannitol (E421), calcium hydrogen phosphate dihydrate, croscarmellose sodium, hydroxypropylcellulose (E463), ethanol (96%), granulated mannitol, colloidal anhydrous silica, magnesium stearate (E470b).

Tablet coating: HPMC2910/hypromellose (E464), titanium dioxide (E171), macrogol (PEG), yellow iron oxide (E172), talc.

Description of the appearance of Ticagrelor Abdi and package contents
Film-coated tablet: The tablets are round, biconvex, light yellow in colour, film-coated, with “ ” engraved on one side and smooth on the other.
Ticagrelor Abdi is available in:

• Blister packs in cartons containing 14, 56, 60, 100 and 168 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Abdi Farma GmbH
Donnersbergstraße 4
64646 Heppenheim
Germany

Manufacturers
Interpharma Services Ltd.
43A Cherni Vrach Blvd.
1407 Sofia
Bulgaria
Flavine Pharma France
3 Voie d'Allemagne
13127 Vitrolles
France
Pharmadox Healthcare Ltd.

1. KW20A Kordin Industrial Park, Paola PLA3000,
2. Warehouse No.1 and No.2, Hal Farrug Road, Luqa LQA9040, Malta