TICAGRELOR MEDICAL VALLEY

Package leaflet: Information for the patient/user

Ticagrelor Mecial Valley 60 mg film-coated tablets

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

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

Contents of this leaflet:

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

1. What Ticagrelor Medical Valley is and what it is used for

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

What Ticagrelor Medical Valley is used for
Ticagrelor Medical Valley, in combination with acetylsalicylic acid (another antiplatelet agent), should only be used in adult patients. You have been prescribed this medicine because you have had:
! a heart attack more than one year ago.

This medicine reduces the likelihood that you will suffer another heart attack or stroke, or that you might die from heart or blood vessel disease.

How Ticagrelor Medical Valley works
Ticagrelor Medical Valley acts on cells called 'platelets' (also known as thrombocytes). These are very small blood cells that help stop bleeding by clumping together to seal tiny holes in damaged or cut blood vessels.

However, platelets can also form clots inside 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 Medical Valley helps prevent platelets from sticking together. This reduces the chance of a blood clot forming, which could otherwise reduce blood flow.

2. What you need to know before taking Ticagrelor Medical Valley

Do not take Ticagrelor Medical Valley 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 Medical Valley 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 Medical Valley if:

• You have an increased risk of bleeding due to:
  • a serious recent injury
  • a recent surgical procedure (including dental surgery; please 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 Medical Valley. This is because there is an increased risk of bleeding. Your doctor may instruct you to stop taking this medicine 5 days before the surgical procedure.
• Your heart rate is unusually low (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 another lung disease or have breathing difficulties.
• You experience irregular breathing patterns such as short 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 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 Medical Valley and heparin:

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

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

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

Inform your doctor or pharmacist if you are taking any of the following medicines:

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

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

• oral anticoagulants, often referred to as "blood thinners", including warfarin
• Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), commonly used as painkillers, such as ibuprofen and naproxen
• Selective Serotonin Reuptake Inhibitors (SSRIs), taken as antidepressants, such as paroxetine, sertraline, and citalopram
• other medicines such as ketoconazole (used to treat fungal infections), clarithromycin (used to treat bacterial infections), nefazodone (an antidepressant), ritonavir and atazanavir (used to treat HIV and AIDS 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 Medical Valley, you may have an increased risk of bleeding if he or she prescribes fibrinolytic agents, often called "thrombolytics", such as streptokinase or alteplase.

Pregnancy and breastfeeding
The use of Ticagrelor Medical Valley is not recommended during pregnancy or if you suspect you may be pregnant. Women of childbearing potential 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 Medical Valley 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 Medical Valley will affect your ability to drive or operate machinery. However, if you experience dizziness or confusion while taking Ticagrelor Medical Valley, exercise caution when driving or using 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 Medical Valley

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

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

If you take Ticagrelor Medical Valley with other blood-thinning medicines
Your doctor will usually instruct you to also take acetylsalicylic acid. This is a substance found in many medicines used to prevent blood clotting. Your doctor will tell you how much to take (usually between 75 and 150 mg per day).
How to take Ticagrelor Medical Valley
You may take the tablet with or without food.
If you have difficulty swallowing the tablet
If you have difficulty swallowing the tablet, you may crush it and mix it with water as follows:

• Crush the tablet into a fine powder.
• Pour the powder into half a glass of water.
• Stir and drink immediately.
• To ensure no medicine is left behind, rinse the empty glass with half a glass of water and drink that as well.

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

• 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 forgotten dose.

If you stop taking Ticagrelor Medical Valley
Do not stop taking Ticagrelor Medical Valley without first talking to your doctor. Take this medicine regularly and for as long as your doctor prescribes it. Stopping Ticagrelor Medical Valley 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 everyone gets them. The following side effects may occur with this medicine:
Ticagrelor Medical Valley 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 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 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 a long time
  • pink, red, or brown urine
  • vomit that is red or looks like coffee grounds
  • red or black stools (resembling tar)
  • coughing up or vomiting blood clots
• Fainting (syncope)
  • temporary loss of consciousness due to a sudden drop in blood flow to the brain (common)
• Signs of a blood clotting disorder called Thrombotic Thrombocytopenic Purpura (TTP) such as:
  • fever and purple spots (called purpura) on the skin or in the mouth, with or without yellowing of the skin or eyes (jaundice), unexplained extreme 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 be a side effect of Ticagrelor Medical Valley. Dyspnea (shortness of breath) due to Ticagrelor Medical Valley is generally mild and characterized by a sudden, unexpected need for air, usually occurring at rest and typically appearing within the first weeks of treatment; for many people, it may resolve 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 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, 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
• 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 determined from available data)

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

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the
adverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ticagrelor Medical Valley

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.
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. Contents of the pack and other information

What Ticagrelor Medical Valley contains

• The active substance is ticagrelor. Each film-coated tablet contains 60 mg of ticagrelor.
• The other components are:
  Tablet core: microcrystalline cellulose (E460), mannitol (E421), crospovidone (E1202), povidone K30 (E1201), sodium starch glycolate (type A), anhydrous colloidal silica (E551), magnesium stearate (E470b)

Film coating (60 mg): hypromellose (E464), titanium dioxide (E171), macrogol (E1521), red iron oxide (E172), black iron oxide (E172).

Description of the appearance of Ticagrelor Medical Valley and contents of the pack
Ticagrelor Medical Valley 60 mg film-coated tablets
Round, biconvex, pink tablets (8 mm in diameter), imprinted with 'I' on one side and smooth on the other side.

Ticagrelor Medical Valley 60 mg film-coated tablets are packaged in

• Blister packs made of transparent PVC/PVDC - aluminium, containing 56 film-coated tablets.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Medical Valley Invest AB
Brädgårdsvägen 28
236 32 Höllviken
Sweden

Manufacturer:
Laboratorios Liconsa, S.A.
Avda. Miralcampo, Nº7,
Pol. Ind. Miralcampo,
19200 Azuqueca de Henares,
Guadalajara,
Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Netherlands: Ticagrelor Liconsa 60 mg filmomhulde tabletten
Italy: Ticagrelor Medical Valley

Patient/Consumer Information Leaflet

Ticagrelor Medical Valley 90 mg film-coated tablets

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

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

Contents of this leaflet:

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

1. What Ticagrelor Medical Valley is and what it is used for

What Ticagrelor Medical Valley is
Ticagrelor Medical Valley contains an active substance called ticagrelor, which belongs to a
group of medicines known as antiplatelet agents.
What Ticagrelor Medical Valley is used for
Ticagrelor Medical Valley, 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 risk that you will suffer another heart attack or stroke, or die from heart disease or blood vessel-related conditions.
How Ticagrelor Medical Valley works
Ticagrelor Medical Valley 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 may cause chest pain that comes and goes (called 'unstable angina').
Ticagrelor Medical Valley helps prevent platelets from clumping together. This reduces the risk of blood clot formation, which could reduce blood flow.

2. What you need to know before taking Ticagrelor Medical Valley

Do not take Ticagrelor Medical Valley 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 or atazanavir (used to treat HIV and AIDS infection).

Do not take Ticagrelor Medical Valley 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 Medical Valley if:

• You have an increased risk of bleeding due to:
  • a serious recent injury
  • a recent surgical procedure (including dental surgery; please 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 Medical Valley. 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 implanted to regulate your heart rhythm (pacemaker).
• You suffer from asthma or another lung condition or have breathing difficulties.
• You experience irregular breathing patterns such as short 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 condition that affected 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 Medical Valley and heparin:

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

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

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

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)
• cyclosporine (used to suppress the immune system)
• quinidine and diltiazem (used to treat abnormal heart rhythm)
• beta-blockers and verapamil (used to treat high blood pressure)
• morphine and other opioids (used to treat severe pain)

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

• "oral anticoagulants", often referred to as "blood thinners", including warfarin.
• Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), commonly used as painkillers, such as ibuprofen and naproxen.
• Selective Serotonin Reuptake Inhibitors (SSRIs), taken as antidepressants, such as paroxetine, sertraline, and citalopram.
• other medicines such as ketoconazole (used to treat fungal infections), clarithromycin (used to treat bacterial infections), nefazodone (an antidepressant), ritonavir and atazanavir (used to treat HIV and AIDS 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 Medical Valley, 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 Medical Valley is not recommended if you are pregnant or suspect you may be pregnant. Women must 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 Medical Valley 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 Medical Valley will affect your ability to drive or operate machinery. However, if you experience dizziness or confusion while taking Ticagrelor Medical Valley, exercise caution when driving or using 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 Medical Valley

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

How much Ticagrelor Medical Valley to take

• The initial dose is two tablets taken together (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 Medical Valley 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 per day).

How to take Ticagrelor Medical Valley
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.
• Stir and drink immediately.
• To ensure no medicine is left behind, rinse the empty glass with half a glass of water and drink that too.

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

If you take more Ticagrelor Medical Valley than you should
If you have taken more Ticagrelor Medical Valley than you should, 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 Medical Valley

• 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 forgotten dose.

If you stop taking Ticagrelor Medical Valley
Do not stop taking Ticagrelor Medical Valley without first talking to your doctor. Take this medicine regularly and for as long as prescribed by your doctor. Stopping Ticagrelor Medical Valley may increase your risk of having another heart attack or stroke, or of dying from a heart- or blood vessel-related condition.

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 everyone gets them. The following side effects may occur with this medicine:
Ticagrelor Medical Valley 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 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 speech
  • sudden difficulty walking or loss of balance or coordination
  • sudden dizziness or sudden, severe headache with no known cause
• Signs of bleeding such as:
  • severe or uncontrollable bleeding
  • unexpected bleeding or bleeding that lasts a long time
  • pink, red, or brown urine
  • vomit that is red in color or looks like coffee grounds
  • red or black stools (resembling tar)
  • coughing up or vomiting blood clots
• Fainting (syncope)
  • temporary loss of consciousness due to a sudden drop in blood flow to the brain (common)
• Signs of a blood clotting disorder called Thrombotic Thrombocytopenic Purpura (TTP) such as:
  • fever and purple spots (called purpura) on the skin or in the mouth, with or without yellowing of the skin or eyes (jaundice), unexplained extreme fatigue or confusion

Contact your doctor if you notice any of the following symptoms:

• Shortness of breath – this event is very common. It may be due to your heart condition or another cause, or it may represent a side effect of Ticagrelor Medical Valley. Dyspnea (shortness of breath) due to Ticagrelor Medical Valley is
  generally mild and characterized by a sudden, unexpected need for air that usually occurs at rest and may appear within the first weeks of treatment; for many people, it may resolve over time. If your shortness of breath worsens or persists, inform your doctor. Your doctor will decide whether treatment is needed or further investigations are required.

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

• High levels of uric acid in the blood (shown by laboratory tests)
• Bleeding caused by blood disorders

Common (may affect up to 1 in 10 people)

• Bruising
• Headache
• Dizziness or sensation of spinning (vertigo)
• 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
• 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 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

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

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

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national adverse reaction reporting system. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ticagrelor Medical Valley

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.
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 Medical Valley contains

• The active substance is ticagrelor. Each film-coated tablet contains 90 mg of ticagrelor.
• The other components are:
  Tablet core: microcrystalline cellulose (E460), mannitol (E421), crospovidone (E1202), povidone K30 (E1201), sodium starch glycolate (type A), colloidal anhydrous silica (E551), magnesium stearate (E470b)

Coating of the tablet (90 mg): hypromellose (E464), titanium dioxide (E171), macrogol (E1521), talc (E553b), yellow iron oxide (E172).

Description of the appearance of Ticagrelor Medical Valley and pack contents

Ticagrelor Medical Valley 90 mg film-coated tablets
Yellow, round (9 mm diameter), biconvex film-coated tablets, marked with 'T' on one side and smooth on the other.

Ticagrelor Medical Valley 90 mg film-coated tablets are supplied in

• Blister packs made of transparent PVC/PVDC - aluminium containing 56 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:
Medical Valley Invest AB
Brädgårdsvägen 28
236 32 Höllviken
Sweden

Manufacturer:
Laboratorios Liconsa, S.A.
Avda. Miralcampo, Nº7,
Pol. Ind. Miralcampo,
19200 Azuqueca de Henares,
Guadalajara, Spain

This medicinal product is authorized in the European Economic Area countries under the following names:

Netherlands: Ticagrelor Liconsa 90 mg filmomhulde tabletten
Italy: Ticagrelor Medical Valley