Ticagrelor Mylan

Patient Information Leaflet

Ticagrelor Mylan 60 mg film-coated tablets, 90 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 further 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, talk to your doctor or pharmacist. See section 4.
Contents of this leaflet

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

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

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

What Ticagrelor Mylan is used for
Ticagrelor Mylan 60 mg film-coated tablets:
Ticagrelor Mylan, in combination with acetylsalicylic acid (another platelet aggregation inhibitor), is intended for use 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 or stroke, or of dying from heart or blood vessel disease.

Ticagrelor Mylan 90 mg film-coated tablets:
Ticagrelor Mylan, in combination with acetylsalicylic acid (another platelet aggregation inhibitor), is intended for use only in adult patients. You have been prescribed this medicine because you have had:

• a heart attack, or
• unstable angina (angina or chest pain that is not well controlled). This medicine reduces the risk of having another heart attack or stroke, or of dying from heart or blood vessel disease.

How Ticagrelor Mylan works
Ticagrelor Mylan 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 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 lead to 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 Mylan helps prevent platelets from clumping together. This reduces the risk of blood clot formation, which could otherwise reduce blood flow.

2. What you need to know before taking Ticagrelor Mylan

Do not take Ticagrelor Mylan 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). Do not take Ticagrelor Mylan 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 Mylan if:

• You have an increased risk of bleeding due to:
  • a serious recent injury
  • recent surgery (including dental surgery; consult your dentist)
  • a blood clotting disorder
  • recent gastrointestinal bleeding (e.g. due to gastric ulcer or colon "polyps").
• You are scheduled to undergo surgery (including dental surgery) at any time while taking Ticagrelor Mylan. 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 slow (typically less than 60 beats per minute) and you do not already have a device implanted to regulate your heart rhythm (pacemaker).
• You suffer from asthma or another lung condition or have breathing difficulties.
• You develop irregular breathing patterns such as acceleration, slowing, or brief pauses in breathing. Your doctor will decide whether further evaluation is needed.
• You have previously had liver problems or any illness affecting your liver.
• You have previously had blood tests showing higher than normal levels of uric acid. If any of the above situations apply to you (or if you are unsure), consult your doctor or pharmacist before taking this medicine.

If you are taking both Ticagrelor Mylan 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 Mylan and heparin, as Ticagrelor Mylan may affect the diagnostic test. Children and adolescents Ticagrelor Mylan is not recommended for children and adolescents under 18 years of age.

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

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

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

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

Additionally, inform your doctor that, since you are taking Ticagrelor Mylan, 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 Mylan is not recommended during pregnancy or if you suspect you are pregnant.
Women must use appropriate contraceptive methods to prevent pregnancy while taking this medicine.
Consult your doctor before taking this medicine if you are breastfeeding. Your doctor will discuss with you the benefits and risks of treatment with Ticagrelor Mylan during this period.
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
It is unlikely that Ticagrelor Mylan will affect your ability to drive or operate machinery. If you experience dizziness or confusion while taking this medicine, take care when driving or operating machinery.
Ticagrelor Mylan contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially "sodium-free".

3. How to take Ticagrelor Mylan

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
To open the bottle: unscrew the cap; the container will open only if the child-resistant cap is pressed down and turned in the direction of the arrow.

How much Ticagrelor Mylan to take
Ticagrelor Mylan 60 mg film-coated tablets

• The usual dose is one 60 mg tablet twice daily. Continue taking Ticagrelor Mylan 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).

Ticagrelor Mylan 90 mg film-coated tablets

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

If you take Ticagrelor Mylan with other blood-thinning medicines
Your doctor will usually tell you to also take acetylsalicylic acid. This is a substance found in many medicines used to prevent blood clotting. Your doctor will advise you on the amount to take (generally between 75 mg and 150 mg daily).

How to take Ticagrelor Mylan

• You may take the tablet with or without food.
• You can keep track of when you took your last dose of Ticagrelor Mylan by looking at the blister pack. There is a sun symbol (for morning) and a moon symbol (for evening). These will help you remember whether you have taken your dose.

If you have difficulty swallowing the tablet
If you have difficulty swallowing the tablet, you may crush it and mix it with water as follows:

• Crush the tablet into a fine powder.
• Pour the powder into half a glass of water.
• Mix and drink immediately.
• To ensure you do not leave any medicine behind, rinse the empty glass with half a glass of water and drink it. If you are in hospital, the tablet may be given mixed with some water and administered through a tube inserted through the nose (nasogastric tube).

If you take more Ticagrelor Mylan than you should
If you have taken more Ticagrelor Mylan than you should have, contact your doctor or go to hospital immediately. Take the medicine pack with you. You may be at increased risk of bleeding.

If you forget to take Ticagrelor Mylan

• 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 Mylan
Do not stop taking Ticagrelor Mylan without first talking to your doctor. Take this medicine regularly and for as long as your doctor prescribes it. Stopping Ticagrelor Mylan 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 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 of 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 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 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), unexplained extreme tiredness or confusion

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

• Shortness of breath – this is very common. This may be due to your heart condition or another cause, or it may be a side effect of Ticagrelor Mylan. Dyspnea (shortness of breath) due to ticagrelor is generally mild and characterized by a sudden, unexpected need for air, usually occurring at rest. It may appear during the first weeks of therapy and may resolve in many cases. If your shortness of breath worsens or persists over time, inform your doctor. Your doctor will decide whether treatment is needed or further investigations are required.

Other possible side effects

Very common (may affect more than 1 in 10 people)

• High level 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
• Diarrhea or indigestion
• Feeling unwell (nausea)
• Constipation
• Rash
• Itching
• Severe joint pain and swelling – these are signs of gout
• Dizziness, mental confusion, or blurred vision – these are signs of low blood pressure
• Nosebleed
• Bleeding after surgery or cuts (e.g. during shaving) and wounds, more than usual
• Bleeding from the stomach lining (ulcer)
• Bleeding gums

Uncommon (may affect up to 1 in 100 people)

• Allergic reaction – rash, itching, or swelling of the face or lips/tongue may be signs of an allergic reaction
• Confusion
• Vision problems caused by bleeding in the eyes
• Heavier vaginal bleeding or bleeding occurring at different times than normal menstrual bleeding
• Bleeding into joints and muscles, which may cause painful swelling
• Blood in the ears
• Internal bleeding, which may cause dizziness or mental confusion

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

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

Reporting of side effects

If you experience any side 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 Mylan

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, the bottle and the 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 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 Mylan contains

• The active substance is ticagrelor.
  Ticagrelor Mylan 60 mg film-coated tablets
  Each film-coated tablet contains 60 mg of ticagrelor.

Ticagrelor Mylan 90 mg film-coated tablets
Each film-coated tablet contains 90 mg of ticagrelor.

• The other components are:
  Tablet core: mannitol (E421), calcium hydrogen phosphate dihydrate, maize starch, pregelatinized starch (maize), talc (E553b), sodium stearoyl fumarate.

Ticagrelor Mylan 60 mg film-coated tablets:
Tablet coating: poly(vinyl alcohol) (E1203), talc (E553b), titanium dioxide (E171), glycerol monocaprylocaprate, sodium lauryl sulfate, iron oxide red (E172), iron oxide black (E172).
Ticagrelor Mylan 90 mg film-coated tablets
Tablet coating: poly(vinyl alcohol) (E1203), talc (E553b), titanium dioxide (E171), glycerol monocaprylocaprate, sodium lauryl sulfate, iron oxide yellow (E172).

Description of the appearance of Ticagrelor Mylan and the contents of the pack
Ticagrelor Mylan 60 mg film-coated tablets:
Film-coated tablet (tablet): The tablets are round, biconvex, pink, with “60” engraved on one side and smooth on the other, with a diameter of 8.6 mm ± 5%.
Ticagrelor Mylan 90 mg film-coated tablets:
Film-coated tablet (tablet): The tablets are round, biconvex, yellow, with “90” engraved on one side and smooth on the other, with a diameter of 9.6 mm ± 5%.

60 mg:
Ticagrelor Mylan is available in:

• Calendar blister packs (with sun/moon symbols) in cartons containing 14, 56 and 168 tablets
• Standard blister packs (with sun/moon symbols) in cartons containing 60 tablets
• Multiple pack containing 168 (3 packs of 56) tablets in calendar blister packs (with sun/moon symbols)
• Multiple pack containing 180 (3 packs of 60) tablets in standard blister packs (with sun/moon symbols)
• Unit-dose divisible blisters in cartons containing 14x1, 56x1 and 60x1 tablets
• Multiple pack containing 168x1 (3 packs of 56x1) tablets in unit-dose divisible blisters
• Bottles containing 30, 60 and 250 tablets

90 mg:
Ticagrelor Mylan is available in:

• Calendar blister packs (with sun/moon symbols) in cartons containing 14, 56 and 168 tablets
• Standard blister packs (with sun/moon symbols) in cartons containing 60 tablets
• Multiple pack containing 168 (3 packs of 56) tablets in calendar blister packs (with sun/moon symbols)
• Multiple pack containing 180 (3 packs of 60) tablets in standard blister packs (with sun/moon symbols)
• Unit-dose divisible blisters in cartons containing 14x1, 56x1, 60x1 and 100x1 tablets
• Multiple pack containing 168x1 (3 packs of 56x1) tablets in unit-dose divisible blisters
• Bottles containing 30, 60 and 250 tablets

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Mylan S.p.A., via Vittor Pisani 20, 20124 Milano, Italy

Responsible Person for Batch Release
PharOS MT Ltd
HF 62X, Hal Far Industrial Estate, Birzebbugia BBG 3000, Malta

This medicinal product is authorized in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names: