Ticagrelor Pensa

Patient Information Leaflet: Information for the User

Ticagrelor Pensa 60 mg film-coated tablets

Ticagrelor
Generic 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What TICAGRELOR PENSA is and what it is used for

TICAGRELOR PENSA contains an active substance called ticagrelor, which belongs to a group
of medicines known as antiplatelet agents.
What TICAGRELOR PENSA is used for
TICAGRELOR PENSA, in combination with acetylsalicylic acid (another antiplatelet agent), should be used only in adult patients. You have been prescribed this medicine because you have had:

• a heart attack more than one year ago. This medicine reduces the risk of having another heart attack, stroke, or dying due to heart or blood vessel disease.

How TICAGRELOR PENSA works
TICAGRELOR PENSA acts on blood cells called “platelets” (also known as thrombocytes).
These very small blood cells help stop bleeding by clumping together to seal 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 may completely block the blood flow; 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 intermittent chest pain (called “unstable angina”).

TICAGRELOR PENSA helps prevent platelets from clumping together. This reduces the risk of forming a blood clot that could reduce blood flow.

2. What you should know before taking TICAGRELOR PENSA

Do not take TICAGRELOR PENSA if:

• you are allergic to ticagrelor or to any of the other ingredients of this medicine (listed in section 6).
• you have active bleeding.
• you have had a stroke caused by cerebral haemorrhage.
• 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)

Do not take TICAGRELOR PENSA if any of the above conditions 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 PENSA if:

• you have an increased risk of bleeding due to:
  • a recent serious injury
  • a recent surgical procedure (including dental surgery; consult your dentist)
  • a condition affecting blood clotting
  • recent bleeding from the stomach or intestines (such as a gastric ulcer or colon "polyps")
• you are scheduled to undergo any surgical procedure (including dental procedures) while taking TICAGRELOR PENSA. This is due to the increased risk of bleeding. Your doctor may ask you to stop taking this medicine 5 days before surgery.
• your heart rate is unusually slow (generally less than 60 beats per minute) and you do not already have a device regulating your heart rhythm (pacemaker).
• you have asthma or other lung problems or breathing difficulties.
• you develop irregular breathing patterns such as acceleration, slowing, or brief pauses in breathing. Your doctor will decide whether further evaluation is needed.
• you have had liver problems or any previous condition that may have affected your liver.
• you have had a blood test showing higher than normal levels of uric acid. If any of the above conditions apply to you (or if you are unsure), talk to your doctor or pharmacist before taking this medicine.

If you are taking both TICAGRELOR PENSA 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 PENSA and heparin, as TICAGRELOR PENSA may affect the diagnostic test.

Children and adolescents
TICAGRELOR PENSA is not recommended for children and adolescents under 18 years of age.

Other medicines and TICAGRELOR PENSA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because TICAGRELOR PENSA may affect how some medicines work, and some medicines may affect TICAGRELOR PENSA. 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 (medicines used to control epileptic seizures).
• digoxin (a medicine used to treat heart failure).
• ciclosporin (a medicine used to suppress the immune system).
• quinidine and diltiazem (medicines used to treat abnormal heart rhythm).
• beta-blockers and verapamil (medicines used to treat high blood pressure).
• morphine and other opioids (medicines used to treat severe pain).

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

• oral anticoagulants, often referred to as "blood thinners", including warfarin.
• Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), often used as painkillers, such as ibuprofen and naproxen.
• Selective Serotonin Reuptake Inhibitors (SSRIs) taken as antidepressants, such as paroxetine, sertraline, and citalopram.
• other medicines such as ketoconazole (used to treat fungal infections), clarithromycin (used to treat bacterial infections), nefazodone (an antidepressant), ritonavir and atazanavir (used to treat HIV and AIDS), cisapride (used to treat heartburn), ergot alkaloids (used to treat migraine and headache).

Fibrinolytic agents, often called "thrombolytics", such as streptokinase or alteplase, may increase the risk of bleeding if taken together with TICAGRELOR PENSA. Inform your doctor that you are being treated with TICAGRELOR PENSA if these medicines are prescribed.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not use TICAGRELOR PENSA if you are pregnant or suspect you are pregnant. Women of childbearing potential must use adequate contraceptive methods to avoid pregnancy while taking this medicine.
Talk to your doctor before taking this medicine if you are breastfeeding. Your doctor will discuss with you the benefits and risks of taking TICAGRELOR PENSA during this period.
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
It is unlikely that TICAGRELOR PENSA will affect your ability to drive or use machines. However, if you experience dizziness or confusion while taking this medicine, take care when driving or using machines.

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

3. How to take TICAGRELOR PENSA

Always take this medicine exactly as instructed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
How much TICAGRELOR PENSA to take

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

If you are taking TICAGRELOR PENSA with other blood-thinning medicines
Your doctor will usually also instruct you to take acetylsalicylic acid. This is a substance
found in many medicines used to prevent blood clotting. Your doctor will advise you on the amount to take (usually between 75 and 150 mg daily).
How to take TICAGRELOR PENSA
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 you do not leave any medicine behind, rinse the empty glass with another half glass of water and drink it. If you are in hospital, the tablet may be given to you mixed with some water and administered through a tube inserted through the nose (nasogastric tube).

If you take more TICAGRELOR PENSA than you should
If you take more TICAGRELOR PENSA than you should, contact your doctor or go immediately
to the nearest emergency department. Take the medicine packaging with you. You may be at increased risk of bleeding.
If you forget to take TICAGRELOR PENSA

• If you forget to take a dose, take the next dose at the scheduled 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 PENSA
Do not stop taking TICAGRELOR PENSA without first talking to your doctor. Take this medicine regularly and for the full duration prescribed by your doctor. If you stop taking this medicine, you may have an increased 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, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. The following adverse effects may occur with this medicine:
TICAGRELOR PENSA affects blood clotting, therefore most adverse effects are related to bleeding. Bleeding can occur anywhere in the body.
Some bleeding events (such as bruising and nosebleeds) are common. Severe bleeding is uncommon in frequency but can be life-threatening.
Seek immediate medical advice if you experience any of the following symptoms, as you may require 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 (resembling tar).
• coughing up or vomiting blood clots.
  • Fainting (syncope)
• a temporary loss of consciousness due to a sudden reduction 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), extreme fatigue, or unexplained confusion.

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

• Shortness of breath: this event is very common. It may be due to heart disease or another cause, or it may be an adverse effect of TICAGRELOR PENSA. Dyspnea associated with TICAGRELOR PENSA is generally mild and characterized by a sudden and unexpected need for air, which usually occurs at rest and may appear during the first weeks of treatment; for many people, it may resolve spontaneously. If shortness of breath worsens or persists, inform your doctor. Your doctor will decide whether treatment is needed or further investigations are required.

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

• high concentration of uric acid in the blood (as detected by laboratory tests)
• bleeding caused by blood disorders

Common: (may affect up to 1 in 10 people)

• bruising
• headache
• dizziness or sensation of spinning
• diarrhoea or indigestion
• feeling unwell (nausea)
• constipation
• rash
• itching
• severe joint pain and swelling – these are signs of gout
• dizziness or mental confusion, or blurred vision – these are signs of low blood pressure
• nosebleeds
• heavier than normal bleeding following surgery or cuts (e.g. during shaving) and wounds
• bleeding from the stomach lining (ulcer)
• bleeding gums

Uncommon: (may affect up to 1 in 100 people)

• allergic reaction: rash, itching, or swelling of the face or lips/tongue may be signs of an allergic reaction
• confusion
• visual disturbances caused by bleeding in the eyes
• heavier vaginal bleeding or bleeding occurring at different times compared to normal menstrual bleeding
• bleeding into joints and muscles causing painful swelling
• blood in the ears
• internal haemorrhage, which may cause dizziness or mental confusion

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

• unusually slow heart rate (generally less than 60 beats per minute)

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. How to store TICAGRELOR PENSA

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 carton and blister after
the word “Exp.”.
The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Ticagrelor Pensa contains

• The active substance is ticagrelor. Each film-coated tablet contains 60 mg of ticagrelor.
• The other components are:
  Tablet core: mannitol (E421), calcium hydrogen phosphate dihydrate (E341), sodium starch glycolate, hypromellose, magnesium stearate (E470b).
  Tablet coating: hypromellose, titanium dioxide (E171), macrogol, red iron oxide (E172), black iron oxide (E172).

Description of the appearance of Ticagrelor Pensa and package contents
Film-coated tablet (tablet): the tablets are round, biconvex, pink in colour, with '60' printed on one side and a diameter of 8 mm.
Carton box containing transparent PVC-PVDC/Al blisters of 10 and 14 film-coated tablets.
Pack sizes of 56 or 60 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Towa Pharmaceutical S.p.A.
Via Enrico Tazzoli, 6
20154 Milan
Italy

Manufacturers:
S.C. Labormed-Pharma S.A.
44B Bd. Theodor Pallady
3rd District, 032266 Bucharest
Romania
Farmaceutsko – Hemijska Industrija (FHI) Zdravlje AD
Vlajkova 199, 16 000 Leskovac,
Serbia
KeVaRo GROUP Ltd.
9, Tsaritsa Eleonora Str., office 23,
Sofia 1618,
Bulgaria
Adalvo Ltd.
Malta Life Sciences Park Building1, Level 4
Sir Temi Zammit Buildings San
Gwann SGN 3000
Malta

This medicinal product is authorised in the European Economic Area Member States under the following names:
Italy: Ticagrelor Pensa
Spain: Ticagrelor pensa 90 mg comprimidos recubiertos con película EFG
Estonia: Thibaqy

Package leaflet: Information for the user

TICAGRELOR PENSA 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 further 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 any adverse reaction occurs, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What TICAGRELOR PENSA is and what it is used for

TICAGRELOR PENSA contains an active substance called ticagrelor, which belongs to a group
of medicines known as antiplatelet agents.
What TICAGRELOR PENSA is used for
TICAGRELOR PENSA, in combination with acetylsalicylic acid (another antiplatelet agent), is intended for use in adult patients only. You have been prescribed this medicine because you have had:

• a heart attack, or
• unstable angina (angina or chest pain that is not well controlled).

This medicine reduces the risk of having another heart attack, stroke, or dying from a heart- or blood vessel-related disease.

How TICAGRELOR PENSA works
TICAGRELOR PENSA acts on blood cells called "platelets" (also known as thrombocytes). These very small blood cells help stop bleeding by clumping together to seal small openings in damaged or ruptured 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 blood flow; 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 intermittent chest pain (called "unstable angina").

TICAGRELOR PENSA helps prevent platelet aggregation. This reduces the likelihood of forming a blood clot that could restrict blood flow.

2. What you need to know before taking TICAGRELOR PENSA

Do not take TICAGRELOR PENSA if:

• you are allergic to ticagrelor or to 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 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 PENSA if any of the above conditions 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 PENSA if:

• you have an increased risk of bleeding due to:
  • a recent serious injury
  • a recent surgery (including dental surgery; please consult your dentist)
  • a condition affecting blood clotting
  • recent bleeding from the stomach or intestines (such as a stomach ulcer or colon "polyps")
• you are scheduled to undergo surgery (including dental procedures) at any time while taking TICAGRELOR PENSA. This is because of the increased risk of bleeding. Your doctor may ask you to stop taking this medicine 5 days before surgery.
• your heart rate is unusually slow (generally less than 60 beats per minute) and you do not already have a device regulating your heart rhythm (pacemaker).
• you suffer from asthma or other lung problems or breathing difficulties.
• you develop irregular breathing patterns such as acceleration, slowing, or brief pauses in breathing. Your doctor will decide whether further evaluation is needed.
• you have had liver problems or previously had any condition that may have affected your liver.
• you have had a blood test showing higher than normal levels of uric acid.

If any of the above conditions apply to you (or if you are unsure), consult your doctor or pharmacist before taking this medicine.

If you are taking both TICAGRELOR PENSA 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 PENSA and heparin, as TICAGRELOR PENSA may affect the diagnostic test.

Children and adolescents
TICAGRELOR PENSA is not recommended for children and adolescents under 18 years of age.

Other medicines and TICAGRELOR PENSA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because TICAGRELOR PENSA may affect how some medicines work, and some medicines may affect TICAGRELOR PENSA. 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 (medicines used to control epileptic seizures).
• digoxin (a medicine used to treat heart failure).
• cyclosporine (a medicine used to suppress the immune system).
• quinidine and diltiazem (medicines used to treat abnormal heart rhythm).
• beta-blockers and verapamil (used to treat high blood pressure).
• morphine and other opioids (medicines used to treat severe pain).

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

• oral anticoagulants, often referred to as "blood thinners", including warfarin.
• Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), often taken as painkillers, such as ibuprofen and naproxen.
• Selective Serotonin Reuptake Inhibitors (SSRIs), taken as antidepressants, such as paroxetine, sertraline, and citalopram.
• other medicines such as ketoconazole (used to treat fungal infections), clarithromycin (used to treat bacterial infections), nefazodone (an antidepressant), ritonavir and atazanavir (used to treat HIV and AIDS infection), cisapride (used to treat heartburn), ergot alkaloids (used to treat migraine and headache).

Fibrinolytic agents, often called "thrombolytics", such as streptokinase or alteplase, may increase the risk of bleeding when taken together with TICAGRELOR PENSA. Inform your doctor that you are being treated with TICAGRELOR PENSA if he prescribes these medicines.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not use TICAGRELOR PENSA if you are pregnant or suspect you are pregnant. Women should use adequate 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 taking TICAGRELOR PENSA during this period.
If you are pregnant, think you may be pregnant, planning 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 PENSA will affect your ability to drive or use machines. If you experience dizziness or confusion while taking this medicine, exercise caution when driving or operating machinery.

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

3. How to take TICAGRELOR PENSA

Always take this medicine exactly as your doctor has instructed. If you have any doubts,
consult your doctor or pharmacist.
How much TICAGRELOR PENSA to take

• The initial dose is two tablets taken at once (loading dose of 180 mg). This dose is normally administered in hospital.
• After this initial dose, the usual dose is one 90 mg tablet twice daily for up to 12 months, unless your doctor tells you otherwise.
• Take this medicine every day at the same time (for example, one tablet in the morning and one in the evening).

If you take TICAGRELOR PENSA with other blood-thinning medicines
Your doctor will usually also instruct you to take acetylsalicylic acid. This is a substance
found in many medicines used to prevent blood clotting. Your doctor will tell you how much to take (usually between 75 and 150 mg per day).
How to take TICAGRELOR PENSA
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, then drink immediately.
• To ensure you do not leave any medicine behind, rinse the empty glass with another half glass of water and drink that too. If you are in hospital, this 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 PENSA than you should
If you take more TICAGRELOR PENSA than prescribed, contact your doctor or go immediately
to the nearest emergency department. Take the medicine pack with you. You may be at increased
risk of bleeding.
If you forget to take TICAGRELOR PENSA

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

If you stop taking TICAGRELOR PENSA
Do not stop taking TICAGRELOR PENSA without first talking to your doctor. Take this
medicine regularly and for as long as your doctor prescribes it. If you stop taking this medicine,
you may have an increased 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 using this medicine, consult 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 PENSA affects blood clotting; therefore, most side effects are related to bleeding. Bleeding can occur anywhere in the body.
Some bleeding (such as bruising and nosebleeds) is common. Severe bleeding is rare but can be life-threatening.
Seek immediate medical attention if you experience any of the following symptoms; you may require urgent medical treatment:

• Bleeding in the brain or within the skull is an uncommon side effect and may cause signs of stroke, such as:
  • sudden numbness or weakness in the arms, legs, or face, especially on one side of the body.
  • sudden confusion, difficulty speaking or understanding others.
  • sudden difficulty walking, loss of balance, or lack of 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.
  • vomiting blood or vomit that 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), extreme fatigue, or unexplained confusion.

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

• Shortness of breath: This is a very common event. It may be due to heart disease or another cause, or it may be a side effect of TICAGRELOR PENSA. Dyspnea related to TICAGRELOR PENSA is generally mild and characterized by a sudden and unexpected need for air, usually occurring at rest. It may appear during the first weeks of treatment and may resolve over time. If 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 (detected by laboratory tests)
• bleeding due to blood disorders

Common: (may affect up to 1 in 10 people)

• bruising
• headache
• dizziness or sensation of spinning
• diarrhoea or indigestion
• feeling unwell (nausea)
• constipation
• rash
• itching
• severe pain and swelling in the joints – these are signs of gout
• dizziness, mental confusion, or blurred vision – these are signs of low blood pressure
• nosebleeds
• heavier than normal bleeding following surgery or cuts (e.g. during shaving) and wounds
• bleeding from the stomach lining (ulcer)
• bleeding gums

Uncommon: (may affect up to 1 in 100 people)

• allergic reaction: skin rash, itching, or swelling of the face or lips/tongue may be signs of an allergic reaction
• confusion
• vision problems caused by bleeding in the eyes
• heavier vaginal bleeding or bleeding occurring at different times compared to normal menstrual bleeding
• bleeding into joints and muscles causing painful swelling
• blood in the ears
• internal bleeding, which may cause dizziness or mental confusion

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

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store TICAGRELOR PENSA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after the word "Exp.".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ticagrelor Pensa contains

• The active substance is ticagrelor. Each film-coated tablet contains 90 mg of ticagrelor.
• Other components are:
  Tablet core: mannitol (E421), calcium hydrogen phosphate dihydrate (E341), sodium starch glycolate, hypromellose, magnesium stearate (E470b).
  Tablet coating: hypromellose, titanium dioxide (E171), macrogol, yellow iron oxide (E172), talc (E553b).

Description of the appearance of Ticagrelor Pensa and package contents
Film-coated tablet: the tablets are round, biconvex, yellow in colour, with '90' engraved on one side and a diameter of 9 mm.
Carton box containing transparent PVC-PVDC/Al blisters of 10 and 14 film-coated tablets.
Pack size of 56 or 60 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Towa Pharmaceutical S.p.A.
Via Enrico Tazzoli, 6
20154 Milan
Italy

Manufacturers:
S.C. Labormed-Pharma S.A.
44B Bd. Theodor Pallady
3rd District, 032266 Bucharest
Romania

Farmaceutsko – Hemijska Industrija (FHI) Zdravlje AD
Vlajkova 199, 16 000 Leskovac,
Serbia

KeVaRo GROUP Ltd.
9, Tsaritsa Eleonora Str., office 23,
Sofia 1618,
Bulgaria

Adalvo Ltd.
Malta Life Sciences Park Building1, Level 4
Sir Temi Zammit Buildings San
Gwann SGN 3000
Malta

This medicinal product is authorised in the European Economic Area Member States under the following names:
Italy: Ticagrelor Pensa
Spain: Ticagrelor pensa 90 mg comprimidos recubiertos con película EFG
Estonia: Thibaqy