TICAGRELOR 60 mg Film-Coated Tablets

Зміст інструкції

1. Ticagrelor Mecial Valley 60 mg film-coated tablets
   1. What is Ticagrelor Medical Valley 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
2. Ticagrelor Medical Valley 90 mg film-coated tablets
   1. What is Ticagrelor Medical Valley 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

Ticagrelor Mecial Valley 60 mg film-coated tablets

Ticagrelor

Generic medicine

Read 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Ticagrelor Medical Valley and what it is used for

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

What is Ticagrelor Medical Valley used for
Ticagrelor Medical Valley in combination with acetylsalicylic acid (another antiplatelet
agent) must only be used in adult patients. This medicine has been prescribed for you because you have
had:
! a heart attack more than a year ago.
This medicine reduces the chances of you having another heart attack or stroke
or of dying from heart disease or related vascular disease.

How Ticagrelor Medical Valley works
Ticagrelor Medical Valley acts on cells called ‘platelets’ (also called thrombocytes). These are
very small cells in the blood that help stop bleeding by clumping together
to close small 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 can completely interrupt the blood supply; this can cause a
heart attack (myocardial infarction) or stroke, or
! the clot can partially block the blood vessels supplying the heart; this reduces the flow of
blood to the heart and can cause chest pain that comes and goes (called ‘unstable angina’).
Ticagrelor Medical Valley helps to block the clumping together of platelets. This reduces the
likelihood of a blood clot forming that can 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 any of the other ingredients of this medicine (listed in section 6).
• You have active bleeding.
• You have had a stroke caused by bleeding in the brain.
• You suffer from severe liver problems.
• You are taking any of the following medicines: ketoconazole (used for the treatment of fungal infections), clarithromycin (used for the treatment of 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 above situations apply to you. If you are unsure, ask 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 recent serious injury
• a recent surgical procedure (including dental surgery, ask your dentist)
• a disease that affects blood clotting
• recent bleeding from the stomach or intestines (e.g., due to a stomach ulcer or “polyps” in the colon)
• You are planning to have a surgical procedure (including dental surgery) at any time during your treatment with Ticagrelor Medical Valley. This is because there is an increased risk of bleeding. Your doctor may advise you to stop taking this medicine 5 days before the surgical procedure.
• Your heart rate is unusually low (typically less than 60 beats per minute) and you do not already have a device implanted that regulates your heart rhythm (pacemaker).
• You suffer from asthma or another lung problem or have difficulty breathing.
• You develop irregular breathing patterns such as acceleration, slowing down or brief pauses in breathing. The doctor will decide if further evaluation is necessary.
• You have already had problems with your liver or have previously had any condition that has affected your liver.
• You have already had blood tests showing a higher than normal amount of uric acid.

If any of the above situations apply to you (or if you are unsure), talk to your doctor or pharmacist before taking this medicine.
If you are taking both Ticagrelor Medical Valley and heparin:

• Your doctor may request a blood sample for diagnostic tests if they suspect a rare platelet disease caused by heparin. It is important to inform your doctor that you are taking both Ticagrelor Medical Valley and heparin, as Ticagrelor Medical Valley may affect the diagnostic test.

Children and adolescents
Ticagrelor Medical Valley is not recommended in 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 the way some medicines work, and some medicines can have an effect on Ticagrelor Medical Valley.
Tell your doctor or pharmacist if you are taking any of the following medicines:

• rosuvastatin (a medicine for the treatment of high cholesterol)
• more than 40 mg per day of simvastatin or lovastatin (medicines used to treat high cholesterol)
• rifampicin (an antibiotic)
• phenytoin, carbamazepine and phenobarbital (used to control seizures)
• digoxin (used to treat heart failure)
• cyclosporine (used to lower the body’s defenses)
• quinidine and diltiazem (used in the treatment of abnormal heart rhythm)
• beta-blockers and verapamil (used to treat high blood pressure)
• morphine and other opioids (used to treat severe pain)

In particular, tell 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 (abbreviated as NSAIDs), often used as painkillers, such as ibuprofen and naproxen.
• Selective Serotonin Reuptake Inhibitors (abbreviated as 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 for the treatment of migraine and headache).

Also, tell 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 during treatment with this medicine.
Talk to your doctor before taking this medicine if you are breastfeeding. The doctor will discuss with you the benefits and risks of treatment with Ticagrelor Medical Valley during this period.
If you are pregnant, suspect you are pregnant, or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
It is unlikely that Ticagrelor Medical Valley will affect your ability to drive or operate machinery. If you experience dizziness or confusion while taking Ticagrelor Medical Valley, be careful while driving or operating machinery.

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

3. How to take Ticagrelor Medical Valley

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

How much Ticagrelor Medical Valley to take

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

If you are taking Ticagrelor Medical Valley with other medicines for blood coagulation
Your doctor will generally tell 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 (usually between 75 and 150 mg per day).

How to take Ticagrelor Medical Valley
You can take the tablet during or away from meals.

If you have difficulty swallowing the tablet
If you have difficulty swallowing the tablet, you can 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 make sure you have not left any medicine, rinse the empty glass with half a glass of water and drink.

If you are in hospital, the tablet may be given to you mixed with a little water and
administered with a tube through your 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. Bring 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 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 Medical Valley
Do not stop taking Ticagrelor Medical Valley without first talking to your doctor. Take this
medicine regularly and until your doctor prescribes it. If you stop taking
Ticagrelor Medical Valley, this may increase your chances of having another heart attack or
a stroke, or of dying from a disease related to heart or blood vessel problems.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The following side effects may occur with this medicine: Ticagrelor Medical Valley affects blood
coagulation, therefore many side effects are related to bleeding. Bleeding can occur in any part of
the body. Some bleeding is common (such as bruising and nosebleeds). Severe bleeding is uncommon,
but can be life-threatening.

Contact a doctor immediately if you notice any of the following symptoms – you may need
urgent medical attention:

• Bleeding in the brain or inside the skull is an uncommon side effect and can cause signs of astroke, such as:
• sudden numbness or weakness of arms, legs or face, especially if only 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 severe headache of unknown cause
• Signs of bleeding such as:
• severe bleeding or that cannot be controlled
• unexpected bleeding or bleeding that lasts a long time
• pink, red or brown urine
• vomit that is red blood or looks like coffee grounds
• red or black stools (looks 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 problem called Thrombotic Thrombocytopenic Purpura (TTP) such as:
• fever and purplish 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:

• Feeling of shortness of breath- this event is very common. It may be due to your heart
  condition or another cause, or it may be a side effect of Ticagrelor Medical Valley. 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 can occur in the first weeks of therapy and may disappear for many.
  If your shortness of breath worsens or persists, tell your doctor. The doctor will decide whether
  treatment is necessary or further investigations are needed.

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

• High uric acid concentration in the blood (as shown by tests)
• Bleeding caused by blood diseases

Common (may affect up to 1 in 10 people)

• Bruising
• Headache
• Dizziness or feeling like the room is spinning
• Diarrhea or indigestion
• Feeling unwell (nausea)
• Constipation
• Skin rash
• Itching
• Severe pain and swelling of the joints - these are signs of gout
• Feeling dizzy or confused, or blurred vision - these are signs of low blood pressure
• Nosebleeds
• Bleeding following surgery or cuts (for example during shaving) and wounds, more than normal
• Bleeding from the stomach lining (ulcer)
• Gum bleeding

Uncommon (may affect up to 1 in 100 people)

• Allergic reaction - skin rash, itching, or swelling of the face or lips/tongue may be signs of an
  allergic reaction
• Confusion
• Vision problems caused by blood in the eyes
• Heavier vaginal bleeding or that occurs at times other than normal menstrual bleeding
• Bleeding in the joints and muscles that can cause painful swelling
• Blood in the ears
• Internal bleeding, this can cause dizziness or confusion

Not known (frequency cannot be estimated from available data)

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

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly through the . 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 the outer packaging after
the abbreviation EXP/Expiry. The expiry date refers to the last day of that month.
This medicine does not require special storage conditions.
Do not dispose of any medicine in waste water 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 ingredient is ticagrelor. Each film-coated tablet contains 60 mg of ticagrelor.
• The other ingredients 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)

Tablet 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 (diameter 8 mm), biconvex, pink tablets, with ‘I’ imprinted on one side, and smooth
on the other side.
Ticagrelor Medical Valley 60 mg film-coated tablets are packaged in

• Blisters made of transparent PVC/PVDC - aluminium containing 56 film-coated tablets

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 authorised in the Member States of the European Economic Area with the
following denominations
Netherlands: Ticagrelor Liconsa 60 mg film-coated tablets
Italy: Ticagrelor Medical Valley

Ticagrelor Medical Valley 90 mg film-coated tablets

Ticagrelor
Generic medicine

Read 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Ticagrelor Medical Valley and what it is used for

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

What is Ticagrelor Medical Valley used for
Ticagrelor Medical Valley in association with acetylsalicylic acid (another antiplatelet
agent) must only be used in adult patients. This medicine has been prescribed for you because you have
had:
! a heart attack, or

• unstable angina (angina or chest pain that is not well controlled)

This medicine reduces the chances of you having another heart attack or stroke
or of you dying from a heart or blood vessel related disease.

How Ticagrelor Medical Valley works
Ticagrelor Medical Valley acts on cells called ‘platelets’ (also called thrombocytes). These are
very small cells in the blood that help to stop bleeding by clumping together
to close small holes in cut or damaged blood vessels.
However, platelets can also form clots inside diseased blood vessels in the
heart and brain. This can be very dangerous, because:
! the clot can completely block the blood supply; this can cause a
heart attack (myocardial infarction) or stroke, or
! the clot can partially block the blood vessels supplying the heart; this reduces the flow of
blood to the heart and can cause chest pain that comes and goes (called ‘unstable angina’).
Ticagrelor Medical Valley helps to block platelets from clumping together. This reduces the
chance of a blood clot forming that can 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 any of the other ingredients of this medicine (listed in section 6).
• You have active bleeding.
• You have had a stroke caused by bleeding in the brain.
• You suffer from severe liver problems.
• You are taking any of the following medicines: ketoconazole (used for the treatment of fungal infections), clarithromycin (used for the treatment of bacterial infections), nefazodone (an antidepressant), ritonavir and atazanavir (used to treat HIV infection and AIDS). Do not take Ticagrelor Medical Valley if any of the above situations apply to you. If you are not sure, ask 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 recent serious injury
• a recent surgical procedure (including dental surgery, ask your dentist)
• a disease that affects blood clotting
• recent bleeding from the stomach or intestines (e.g., due to a stomach ulcer or “polyps” in the colon)
• You are planning to have a surgical procedure (including dental surgery) at any time during your treatment with Ticagrelor Medical Valley. This is because there is an increased risk of bleeding. Your doctor may advise you to stop taking this medicine 5 days before the surgery.
• Your heart rate is unusually low (typically less than 60 beats per minute) and you do not already have a device implanted that regulates your heart rhythm (pacemaker).
• You suffer from asthma or another lung problem or have difficulty breathing.
• You develop irregular breathing patterns such as acceleration, slowing down or brief pauses in breathing. Your doctor will decide if further evaluation is necessary.
• You have already had problems with your liver or have previously had any condition that has affected your liver.
• You have already had blood tests showing a higher than normal amount of uric acid.

If any of the above situations apply to you (or if you are not sure), talk to 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 tests if they suspect a rare platelet disease caused by heparin. It is important to inform your doctor that you are taking both Ticagrelor Medical Valley and heparin, as Ticagrelor Medical Valley may affect the diagnostic test.

Children and adolescents
Ticagrelor Medical Valley is not recommended in 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 the way some medicines work, and some medicines can have an effect on Ticagrelor Medical Valley.
Tell your doctor or pharmacist if you are taking any of the following medicines:

• rosuvastatin (a medicine for treating high cholesterol)
• more than 40 mg per day of simvastatin or lovastatin (medicines used to treat high cholesterol)
• rifampicin (an antibiotic)
• phenytoin, carbamazepine and phenobarbital (used to control seizures)
• digoxin (used to treat heart failure)
• cyclosporine (used to lower the body's defenses)
• quinidine and diltiazem (used in the treatment of abnormal heart rhythm)
• beta blockers and verapamil (used to treat high blood pressure)
• morphine and other opioids (used to treat severe pain)

In particular, tell 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’, which include warfarin.
• Non-Steroidal Anti-Inflammatory Drugs (abbreviated as NSAIDs), often used as painkillers, such as ibuprofen and naproxen.
• Selective Serotonin Reuptake Inhibitors (abbreviated as 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 for the treatment of migraine and headache).

Also, tell 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 during treatment with this medicine.
Talk to your doctor before taking this medicine if you are breastfeeding. The doctor will discuss with you the benefits and risks of treatment with Ticagrelor Medical Valley during this period.
If you are pregnant, suspect you are pregnant, or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
It is unlikely that Ticagrelor Medical Valley will affect your ability to drive or operate machinery. If you experience dizziness or confusion while taking Ticagrelor Medical Valley, be careful while driving or operating machinery.

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

3. How to take Ticagrelor Medical Valley

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

How much Ticagrelor Medical Valley to take

• The initial dose is two tablets at the same time (loading dose of 180 mg). This dose will usually be given to you in hospital.
• After this initial dose, the usual dose is one 90 mg tablet twice a day for a maximum of 12 months, unless your doctor tells you otherwise.
• Take this medicine at about the same time each day (for example, one tablet in the morning and one in the evening).

If you are taking Ticagrelor Medical Valley with other medicines for blood coagulation
Your doctor will generally tell 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 (usually between 75 and 150 mg per day).

How to take Ticagrelor Medical Valley
You can take the tablet during or away from meals.

If you have difficulty swallowing the tablet
If you have difficulty swallowing the tablet you can 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 make sure you have not left any medicine, rinse the empty glass with half a glass of water and drink.

If you are in hospital the tablet may be given to you mixed with a little water and
administered with a tube through your 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. Bring 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 as usual.
• Do not take a double dose (two doses at the same time) to make up for a missed 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 until your doctor prescribes it. If you stop taking
Ticagrelor Medical Valley, this may increase the chances of you having another heart attack or
a stroke, or that you may die from a condition related to heart or blood vessel problems.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The following side effects may occur with this medicine: Ticagrelor Medical Valley affects blood
coagulation, therefore many side effects are related to bleeding. Bleeding can occur in any part of
the body. Some bleeding is common (such as bruises and nosebleeds). Severe bleeding is uncommon,
but can be life-threatening.

Seek immediate medical attention if you notice any of the following symptoms – you may need
urgent medical care:

• Bleeding in the brain or inside the skull is an uncommon side effect and can cause signs of a stroke, such as:
• sudden numbness or weakness of arms, legs, or face, especially if on only one side of the body
• sudden confusion, difficulty speaking or understanding others
• sudden difficulty walking or loss of balance or coordination
• sudden dizziness or sudden and severe headache with no known cause
• Signs of bleeding such as:
• severe bleeding or that cannot be controlled
• unexpected bleeding or bleeding that lasts a long time
• pink, red, or brown urine
• vomiting blood or your vomit looks like coffee grounds
• red or black stools (appear tarry)
• 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 problem called Thrombotic Thrombocytopenic Purpura (TTP) such as:
• fever and purplish 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:

• Feeling short of breath- this event is very common. It may be due to your heart condition or
  another cause, or it may be a side effect of Ticagrelor Medical Valley. Shortness of breath due to
  Ticagrelor Medical Valley is

generally mild and characterized by a sudden, unexpected need for air that generally occurs at rest
and may occur in the first weeks of therapy and for many it may disappear. If your shortness of breath
worsens or persists over time, inform your doctor. The doctor will decide whether treatment is
necessary or to proceed with further investigations.

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

• High uric acid concentration in the blood (as shown by tests)
• Bleeding caused by blood diseases

Common (may affect up to 1 in 10 people)

• Bruising
• Headache
• Feeling dizzy or as if the room is spinning
• Diarrhea or indigestion
• Feeling unwell (nausea)
• Constipation
• Skin rash
• Itching
• Severe pain and swelling of the joints - these are signs of gout
• Feeling dizzy or confused, or blurred vision - these are signs of low blood pressure
• Nosebleeds
• Bleeding following surgery or cuts (for example while shaving) and wounds, more than normal
• Bleeding from the wall of the stomach (ulcer)
• Bleeding gums

Uncommon (may affect up to 1 in 100 people)

• Allergic reaction - skin rash, itching, or swelling of the face or lips/tongue may be signs of an
  allergic reaction
• Confusion
• Vision problems caused by blood in the eyes
• Heavier vaginal bleeding or that occurs at times other than your normal menstrual bleeding
• Bleeding into joints and muscles that can cause painful swelling
• Blood in the ears
• Internal bleeding, this can cause dizziness or confusion

Not known (frequency cannot be estimated from available data)

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can
also report side effects directly through the . 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 that is stated on the blister and the package after
the abbreviation EXP/Expiry. The expiry date refers to the last day of that month.
This medicine does not require special storage conditions.
Do not dispose of any medicine in 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 90 mg of ticagrelor.
• The other ingredients 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)

Tablet coating (90 mg): hypromellose (E464), titanium dioxide (E171), macrogol
(E1521), talc (E553b), yellow iron oxide (E172).

Description of the appearance of Ticagrelor Medical Valley and contents of the pack
Ticagrelor Medical Valley 90 mg film-coated tablets
Round (diameter 9 mm), biconvex, yellow tablets, with ‘T’ imprinted on one side, and smooth
on the other side.
Ticagrelor Medical Valley 90 mg film-coated tablets are packaged in

• Blisters made of transparent PVC/PVDC - aluminum containing 56 film-coated tablets

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 authorised in the Member States of the European Economic Area with the
following denominations
Netherlands: Ticagrelor Liconsa 90 mg film-coated tablets
Italy: Ticagrelor Medical Valley