Ticagrelor Zentiva
Italy
Table of Contents
Package leaflet: Information for the user
Ticagrelor Zentiva 60 mg film-coated tablets
ticagrelor
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
- If you experience any side effect, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
What this leaflet contains:
- What Ticagrelor Zentiva is and what it is used for
- What you need to know before taking Ticagrelor Zentiva
- How to take Ticagrelor Zentiva
- Possible side effects
- How to store Ticagrelor Zentiva
- Contents of the pack and other information
1. What Ticagrelor Zentiva is and what it is used for
What Ticagrelor Zentiva is
Ticagrelor Zentiva contains an active substance called ticagrelor, which belongs to a group of medicines known as platelet aggregation inhibitors.
What Ticagrelor Zentiva is used for
Ticagrelor Zentiva, in combination with acetylsalicylic acid (another platelet aggregation inhibitor), 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 risk that you will suffer another heart attack or stroke, or that you may die from heart disease or blood vessel-related conditions.
How Ticagrelor Zentiva works
This medicine 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 Zentiva helps prevent platelet aggregation. This reduces the likelihood of forming a blood clot that could reduce blood flow.
2. What you should know before taking Ticagrelor Zentiva
Do not take Ticagrelor Zentiva 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 Zentiva 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 Zentiva 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 any surgical procedure (including dental surgery) while taking Ticagrelor Zentiva. 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 (generally less than 60 beats per minute) and you do not already have a device regulating your heart rhythm (pacemaker) implanted.
- 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 illness 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 Zentiva 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 Zentiva and heparin, as Ticagrelor Zentiva may interfere with the diagnostic test.
Children and adolescents
Ticagrelor Zentiva is not recommended for children and adolescents under 18 years of age.
Other medicines and Ticagrelor Zentiva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Ticagrelor Zentiva may affect how some medicines work, and some medicines may affect Ticagrelor Zentiva. 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), 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).
Fibrinolytic agents, often called "thrombolytics", such as streptokinase or alteplase, may increase the risk of bleeding if taken together with Ticagrelor Zentiva. Inform your doctor that you are being treated with Ticagrelor Zentiva.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not use Ticagrelor Zentiva if you are pregnant or 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 Zentiva during this period.
Driving and using machines
It is unlikely that Ticagrelor Zentiva will affect your ability to drive or operate machinery. However, if you experience dizziness or confusion while taking Ticagrelor Zentiva, exercise caution when driving or operating machinery.
Ticagrelor Zentiva 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 Zentiva
Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
How much Ticagrelor Zentiva to take
- The usual dose is one 60 mg tablet twice daily. Continue taking Ticagrelor Zentiva 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 take Ticagrelor Zentiva 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 daily).
How to take Ticagrelor Zentiva
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.
- 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 to you mixed with a small amount of water and administered through a nasogastric tube (a tube passed through the nose into the stomach).
If you take more Ticagrelor Zentiva than you should
If you have taken more Ticagrelor Zentiva than prescribed, contact your doctor or go to the hospital immediately. Take the medicine package with you. You may be at increased risk of bleeding.
If you forget to take Ticagrelor Zentiva
- 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 Zentiva
Do not stop taking Ticagrelor Zentiva without first talking to your doctor. Take this medicine regularly for as long as your doctor prescribes it. Stopping Ticagrelor Zentiva 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 questions about how to use this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur with this medicine:
Ticagrelor Zentiva 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 can be life-threatening.
Seek immediate medical advice if you notice any of the following symptoms – you may need urgent medical treatment:
- Bleeding in the brain or within the skull is an uncommon side effect and may cause signs of stroke, such as:
- sudden numbness or weakness 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 bleeding or bleeding that cannot be controlled
- unexpected bleeding or bleeding that lasts a long time
- pink, red or brown urine
- vomit that is bright 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 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 this medicine. Shortness of breath caused by Ticagrelor Zentiva 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 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
- dizziness or sensation of spinning (vertigo)
- diarrhoea or indigestion
- nausea
- constipation
- rash
- itching
- severe pain and swelling of joints – these are signs of gout
- dizziness or mental confusion, 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 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 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 Zentiva
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 Zentiva 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 (E341), sodium carboxymethyl starch, hypromellose, magnesium stearate (E470b).
Tablet coating: hypromellose, titanium dioxide (E171), macrogol, red iron oxide (E172), black iron oxide (E172).
Description of the appearance of Ticagrelor Zentiva and package contents
Film-coated tablet (tablet): the tablets are round, biconvex, pink in colour, with '60' engraved on one side and a diameter of 8 mm.
Carton box containing transparent PVC-PVDC/Al blisters of 10 and 14 film-coated tablets.
Pack sizes of 14, 30, 56, 60, 100 or 168 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Zentiva Italia S.r.l.
Via P. Paleocapa, 7
20121 Milano
Italy
Manufacturers:
Labormed-Pharma S.A.
44B Bd. Theodor Pallady
3rd District, 032266 Bucharest
Romania
and
Adalvo Ltd.
Malta Life Sciences Park
Building 1, Level 4
Sir Temi Zammit Buildings
San Gwann SGN 3000, Malta
This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names
| Member State | Medicinal product name |
| Italy, Portugal, Norway | Ticagrelor Zentiva |
| Denmark | Ticagrelor Zentiva 60 mg Ticagrelor Zentiva 90 mg |
| Germany | Ticagrelor Zentiva 60 mg Film-coated tablets Ticagrelor Zentiva 90 mg Film-coated tablets |
| France | TICAGRELOR ZENTIVA 90 mg, film-coated tablet |
| Lithuania | Ticagrelor Zentiva 90 mg film-coated tablets |
| Latvia | Ticagrelor Zentiva 90 mg film-coated tablets |
| Sweden | Ticagrelor Zentiva 60 mg Ticagrelor Zentiva 90 mg |
Package leaflet: information for the user
Ticagrelor Zentiva 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 they have the same symptoms as you, because it could be harmful.
- If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Ticagrelor Zentiva is and what it is used for
- What you need to know before taking Ticagrelor Zentiva
- How to take Ticagrelor Zentiva
- Possible side effects
- How to store Ticagrelor Zentiva
- Contents of the pack and other information
1. What Ticagrelor Zentiva is and what it is used for
What Ticagrelor Zentiva is
Ticagrelor Zentiva contains an active substance called ticagrelor, which belongs to a group of medicines
called platelet aggregation inhibitors.
What Ticagrelor Zentiva is used for
Ticagrelor Zentiva, in combination with acetylsalicylic acid (another platelet aggregation inhibitor), 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 risk of having another heart attack or stroke, or of dying from heart or blood vessel disease.
How Ticagrelor Zentiva works
This medicine 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, or
- the clot may partially block the blood vessels supplying the heart; this reduces blood flow to the heart and can cause chest pain that comes and goes (called 'unstable angina').
Ticagrelor Zentiva helps prevent platelets from clumping together. This reduces the likelihood of forming a blood clot that could reduce blood flow.
2. What you should know before taking Ticagrelor Zentiva
Do not take Ticagrelor Zentiva 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 Zentiva 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 Zentiva 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 any surgical procedure (including dental surgery) while taking Ticagrelor Zentiva. 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 slow (typically less than 60 beats per minute) and you do not already have a device regulating your heart rhythm (pacemaker) implanted.
- you suffer from asthma or another lung condition or have breathing difficulties.
- you develop irregular breathing patterns such as periods of faster, slower, or brief pauses in breathing. Your doctor will decide whether further evaluation is needed.
- you have previously had liver problems or any other 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 Zentiva 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 Zentiva and heparin, as Ticagrelor Zentiva may interfere with the diagnostic test.
Children and adolescents
Ticagrelor Zentiva is not recommended for children and adolescents under 18 years of age.
Other medicines and Ticagrelor Zentiva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Ticagrelor Zentiva may affect how some medicines work, and some medicines may affect Ticagrelor Zentiva.
Tell 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 infection and AIDS), cisapride (used to treat heartburn), or ergot alkaloids (used to treat migraine and headache).
Fibrinolytic agents, often called "thrombolytics", such as streptokinase or alteplase, may increase the risk of bleeding if taken together with Ticagrelor Zentiva. Inform your doctor that you are being treated with Ticagrelor Zentiva.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not use Ticagrelor Zentiva if you are pregnant or suspect you are pregnant. Women of childbearing potential should use appropriate contraceptive methods to avoid pregnancy during treatment with 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 Zentiva during this period.
Driving and using machines
It is unlikely that Ticagrelor Zentiva will affect your ability to drive or operate machinery. However, if you experience dizziness or confusion while taking Ticagrelor Zentiva, exercise caution when driving or operating machinery.
Ticagrelor Zentiva 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 Zentiva
Take this medicine exactly as your doctor has told you. If you are in doubt, consult your doctor or pharmacist.
How much Ticagrelor Zentiva to take
- The initial dose is two tablets 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 Zentiva with other medicines for blood clotting
Your doctor will generally also tell you to take acetylsalicylic acid. This is a substance found in many medicines used to prevent blood clotting. Your doctor will advise you on how much to take (usually between 75 and 150 mg per day).
How to take Ticagrelor Zentiva
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 it. If you are in hospital, the tablet may be given to you mixed with a small amount of water and administered via a tube through the nose (nasogastric tube).
If you take more Ticagrelor Zentiva than you should
If you have taken more Ticagrelor Zentiva 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 Zentiva
- 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 Zentiva
Do not stop taking Ticagrelor Zentiva without first talking to your doctor. Take this medicine regularly and for as long as your doctor prescribes it. Stopping Ticagrelor Zentiva 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 questions about using 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 Zentiva 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 can 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 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 bleeding or bleeding that cannot be controlled
- unexpected bleeding or bleeding that lasts a long time
- pink, red, or brown urine
- vomit that is red in color or looks like coffee grounds
- red or black stools (appearing like tar)
- coughing up or vomiting blood clots
- Fainting (syncope)
- a temporary loss of consciousness due to a sudden drop in blood flow to the brain (common)
- Signs of a blood clotting disorder called Thrombotic Thrombocytopenic Purpura (TTP) such as:
- fever and purple spots (called purpura) on the skin or in the mouth, with or without yellowing of the skin or eyes (jaundice), unexplained extreme fatigue or confusion
Contact your doctor if you notice any of the following symptoms:
- Shortness of breath – this event is very common. It may be due to your heart condition or another cause, or it could represent a side effect of this medicine. Shortness of breath caused by Ticagrelor Zentiva 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 should be carried out.
Other possible side effects
Very common: may affect more than 1 in 10 people
- high concentration 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 (vertigo)
- diarrhoea or indigestion
- nausea
- constipation
- rash
- itching
- severe joint pain and swelling – these are signs of gout
- dizziness, mental confusion, or blurred vision – these are signs of low blood pressure
- nosebleeds
- bleeding after surgery or 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 – rash, itching, or swelling of the face or lips/tongue may be signs of an allergic reaction
- confusion
- visual problems 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
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 Zentiva
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 Zentiva 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 (E341), sodium carboxymethyl starch, hypromellose, magnesium stearate (E470b).
Tablet coating: hypromellose, titanium dioxide (E171), macrogol, yellow iron oxide (E172), talc (E553b).
Description of the appearance of Ticagrelor Zentiva and pack sizes
Film-coated tablet: The tablets are round, biconvex, yellow in colour, with '90' engraved on one side and a diameter of 9 mm.
Carton pack containing transparent PVC-PVDC/Al blisters of 10 and 14 film-coated tablets.
Pack sizes of 14, 30, 56, 60, 100 or 168 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Zentiva Italia S.r.l.
Via P. Paleocapa, 7
20121 Milano, Italy
Manufacturers:
Labormed-Pharma S.A.
44B Bd. Theodor Pallady
3rd District, 032266 Bucharest
Romania
and
Adalvo Ltd.
Malta Life Sciences Park
Building 1, Level 4
Sir Temi Zammit Buildings
San Gwann SGN 3000, Malta
This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names
| Member State | Medicinal Product Name |
| Italy, Portugal, Norway | Ticagrelor Zentiva |
| Denmark | Ticagrelor Zentiva 60 mg Ticagrelor Zentiva 90 mg |
| Germany | Ticagrelor Zentiva 60 mg Filmtabletten Ticagrelor Zentiva 90 mg Filmtabletten |
| France | TICAGRELOR ZENTIVA 90 mg, comprimé pelliculé |
| Lithuania | Ticagrelor Zentiva 90 mg plėvele dengtos tabletės |
| Latvia | Ticagrelor Zentiva 90 mg apvalkotās tabletes |
| Sweden | Ticagrelor Zentiva 60 mg Ticagrelor Zentiva 90 mg |