Ticagrelor Olpha

Package leaflet: Information for the user

Ticagrelor Olpha 90 mg film-coated tablets

Ticagrelor
Equivalent medicine
Please read all of this leaflet carefully before you start taking this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

What Ticagrelor Olpha is
Ticagrelor Olpha contains an active substance called ticagrelor, which belongs to a group of
medicines known as antiplatelet agents.
What Ticagrelor Olpha is used for
Ticagrelor Olpha, 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 of having another heart attack or stroke, or of dying from heart or blood vessel disease.

How Ticagrelor Olpha works
Ticagrelor Olpha 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 intermittent chest pain (known as 'unstable angina').

Ticagrelor Olpha helps prevent platelet aggregation. This reduces the risk of forming a blood clot that could impair blood flow.

2. What you need to know before taking Ticagrelor Olpha

Do not take Ticagrelor Olpha if:

• You are allergic to ticagrelor or to any of the other ingredients of this medicine (listed
  in section 6).
• You are currently experiencing bleeding.
• You have had a stroke caused by bleeding in the brain.
• You have severe liver problems.
• You are taking any of the following medicines:
  • ketoconazole (used to treat fungal infections)
  • clarithromycin (used to treat bacterial infections)
  • nefazodone (an antidepressant)
  • ritonavir and atazanavir (used to treat HIV and AIDS infection)

Do not take Ticagrelor Olpha 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 Olpha if:

• You have an increased risk of bleeding due to:
  • a serious recent injury
  • a recent surgical procedure (including dental surgery; consult your dentist)
  • a blood clotting disorder
  • recent bleeding from the stomach or intestines (e.g., due to gastric ulcer or colon "polyps")
• You are scheduled to undergo surgery (including dental surgery) at any time while taking Ticagrelor Olpha. This is because there is an increased risk of bleeding. Your doctor may instruct you to stop taking this medicine 5 days before surgery.
• Your heart rate is unusually low (typically less than 60 beats per minute) and you do not already have a device implanted to regulate your heart rhythm (pacemaker).
• You suffer from asthma or another lung condition or have breathing difficulties.
• You develop irregular breathing patterns such as acceleration, slowing, or brief pauses in breathing. Your doctor will decide whether further evaluation is needed.
• You have previously had liver problems or any 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 Olpha 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 Olpha and heparin, as Ticagrelor Olpha may interfere with the diagnostic test.

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

Other medicines and Ticagrelor Olpha
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Ticagrelor Olpha can affect how some medicines work, and some medicines can affect Ticagrelor Olpha. Inform your doctor or pharmacist if you are taking any of the following medicines:

• rosuvastatin (a medicine used to treat high cholesterol)
• more than 40 mg daily of simvastatin or lovastatin (medicines used to treat high cholesterol)
• rifampicin (an antibiotic)
• phenytoin, carbamazepine, and phenobarbital (used to control epileptic seizures)
• digoxin (used to treat heart failure)
• ciclosporin (used to suppress the immune system)
• quinidine and diltiazem (used to treat abnormal heart rhythm)
• beta-blockers and verapamil (used to treat high blood pressure)
• morphine and other opioids (used to treat severe pain)

In particular, inform your doctor or pharmacist if you are taking any of the following medicines that increase the risk of bleeding:

• 'oral anticoagulants', often referred to as 'blood thinners', including warfarin.
• Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), 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), or ergot alkaloids (used to treat migraine and headache).

Additionally, inform your doctor that, because you are taking Ticagrelor Olpha, 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 Olpha 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 Olpha during this period.
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

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

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

3. How to take Ticagrelor Olpha

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

How much Ticagrelor Olpha to take

• The initial dose is two tablets taken together (a loading dose of 180 mg). This dose is usually 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 Olpha 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 how much to take (usually between 75 and 150 mg per day).

How to take Ticagrelor Olpha
You may take the tablet during or apart from meals.

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 that too.

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

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

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

If you stop taking Ticagrelor Olpha
Do not stop taking Ticagrelor Olpha without first talking to your doctor. Take this medicine regularly and for as long as your doctor prescribes it. Stopping Ticagrelor Olpha 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, 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 Olpha 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). 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 a stroke, such as:
  • sudden numbness or weakness in the arms, legs, or face, especially on one side of the body
  • sudden confusion, difficulty speaking or understanding others
• sudden difficulty walking or loss of balance or coordination
• sudden dizziness or sudden, severe headache with no known cause
  • Signs of bleeding such as:
• severe or uncontrollable bleeding
• unexpected bleeding or bleeding that lasts 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 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 may represent a side effect of Ticagrelor Olpha. Dyspnea (shortness of breath) due to Ticagrelor Olpha is generally mild and characterized by a sudden, unexpected need for air, usually occurring at rest. It may appear during the first weeks of treatment and may resolve for many patients. If your shortness of breath worsens or persists over time, inform your doctor. Your doctor will decide whether treatment is needed or further investigations are required.

Other possible side effects
Very common (may affect more than 1 in 10 people)

• High levels of uric acid in the blood (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
• Diarrhea or indigestion
• Feeling unwell (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
• Nosebleed
• 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 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 may 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 Olpha

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, following the abbreviation EXP/Scad. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions. Store in the original packaging to protect the medicine from light. Do not dispose of any medicine 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 Olpha contains

• The active substance is ticagrelor. Each film-coated tablet contains 90 mg of ticagrelor.
• The other components are: Tablet core: hypromellose 2910, mannitol, microcrystalline cellulose, sodium starch glycolate, magnesium stearate. Tablet coating: hypromellose 2910, titanium dioxide (E171), macrogol 400, talc, yellow iron oxide (E172).

Description of the appearance of Ticagrelor Olpha and contents of the pack
Film-coated tablet (tablet): the tablets are round, biconvex, yellow in colour, film-coated, marked with '90' on one side and smooth on the other.
Ticagrelor Olpha is available in:
Blister packs containing 10, 14 or 15 film-coated tablets. Carton packs containing 56 tablets (4 blisters), 60 tablets (4 blisters), 100 tablets (10 blisters), 100 x 1 tablet (10 perforated blisters), 168 tablets (12 blisters) and 196 tablets (14 blisters).
It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Olpha AS,
Rupnicu iela 5,
Olaine, Olaines novads, LV-2114,
Latvia

Manufacturer:
Olpha AS,
Rupnicu iela 5,
Olaine, Olaines novads, LV-2114,
Latvia
Genepharm S.A,
18 km Marathonos Avenue,
15351 Pallini Attiki,
Greece

Package leaflet: information for the user

Ticagrelor Olpha 60 mg film-coated tablets

Ticagrelor
Generic medicine
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if 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, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

What Ticagrelor Olpha is
Ticagrelor Olpha contains an active substance called ticagrelor, which belongs to a group of
medicines known as platelet aggregation inhibitors.

What Ticagrelor Olpha is used for
Ticagrelor Olpha, 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 likelihood that you will suffer another heart attack or stroke, or that you may die from heart or blood vessel disease.

How Ticagrelor Olpha works
Ticagrelor Olpha 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 Olpha 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 Olpha

Do not take Ticagrelor Olpha 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 infection and AIDS)

Do not take Ticagrelor Olpha 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 Olpha if:

• You have an increased risk of bleeding due to:
  • a recent severe injury
  • recent surgery (including dental procedures; consult your dentist)
  • a blood clotting disorder
  • recent gastrointestinal bleeding (e.g., due to gastric ulcer or colon "polyps")
• You are scheduled for surgery (including dental procedures) at any time while taking Ticagrelor Olpha. 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 heart rhythm-regulating device implanted (pacemaker).
• You suffer from asthma or another lung condition or have breathing difficulties.
• You develop irregular breathing patterns such as periods of 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-related illness.
• 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 Olpha 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 Olpha and heparin, as Ticagrelor Olpha may interfere with the diagnostic test.

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

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

Additionally, inform your doctor that, since you are taking Ticagrelor Olpha, 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 Olpha is not recommended if you are pregnant or suspect you may be pregnant.
Women must use appropriate contraceptive methods to prevent 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 Olpha 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 Olpha will affect your ability to drive or operate machinery. However, if you experience dizziness or confusion while taking Ticagrelor Olpha, exercise caution when driving or operating machinery.

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

3. How to take Ticagrelor Olpha

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

• The usual dose is one 60 mg tablet twice daily. Continue taking Ticagrelor Olpha for the entire duration indicated by your doctor.
• Take this medicine at approximately the same time each day (for example, one tablet in the morning and one in the evening).

If you are taking Ticagrelor Olpha with other blood-thinning medicines
Your doctor will usually instruct you to also take acetylsalicylic acid. This is a substance
present 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 Olpha
You may take the tablet with or without food.
If you have difficulty swallowing the tablet
If you have difficulty swallowing the tablet, you may crush it and mix it with water as follows:

• Crush the tablet into a fine powder
• Pour the powder into half a glass of water
• Stir and drink immediately
• To ensure no medicine is left behind, rinse the empty glass with another half glass of water and drink it. If you are in hospital, the tablet may be given mixed with a small amount of water and administered via a nasogastric tube (a tube passed through the nose into the stomach).

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

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

If you stop taking Ticagrelor Olpha
Do not stop taking Ticagrelor Olpha without first talking to your doctor. Take this
medicine regularly and for as long as your doctor prescribes it. Stopping Ticagrelor Olpha
may increase your risk of having another heart attack or stroke, or of dying from a condition related to heart or blood vessel disease.
If you have any 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 everybody gets them.
The following side effects may occur with this medicine:
Ticagrelor Olpha 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 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 adverse 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, severe headache with no known cause
• Signs of bleeding such as:
  • severe bleeding or bleeding that cannot be controlled
  • unexpected bleeding or bleeding that lasts a long time
  • pink, red or brown urine
  • vomit that is red in colour or looks like coffee grounds
  • red or black stools (which look 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 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 Olpha. Dyspnoea (shortness of breath) due to Ticagrelor Olpha is generally mild and characterised 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 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 blood uric acid levels (as 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
• 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 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 different times from normal menstrual bleeding
• Bleeding into joints and muscles, which may cause painful swelling
• Blood in the ears
• Internal bleeding, which may cause dizziness or mental confusion

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

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

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
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 Olpha

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 blister and carton after the abbreviation EXP/Scad. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Store in the original packaging to protect the medicine from light.
Do not dispose of any medicine 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 Olpha contains

• The active substance is ticagrelor. Each film-coated tablet contains 60 mg of ticagrelor.
• The other components are: Tablet core: hypromellose 2910, mannitol, microcrystalline cellulose, sodium starch glycolate, magnesium stearate. Tablet coating: hypromellose 2910, titanium dioxide (E171), macrogol 400, talc, and iron oxide red (E172).

Description of the appearance of Ticagrelor Olpha and package contents
Film-coated tablet (tablet): The tablets are round, biconvex, pink in colour, film-coated, with '60' engraved on one side and smooth on the other side.
Ticagrelor Olpha is available in:
Blister packs of 14 or 15 film-coated tablets. Carton packs containing 56 tablets (4 blisters), 60 tablets (4 blisters), 168 tablets (12 blisters), and 196 tablets (14 blisters).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Olpha AS,
Rupnicu iela 5,
Olaine, Olaines novads, LV-2114,
Latvia

Manufacturer:
Olpha AS,
Rupnicu iela 5,
Olaine, Olaines novads, LV-2114,
Latvia
Genepharm S.A,
18 km Marathonos Avenue,
15351 Pallini Attiki,
Greece