Ticagrelor Kern Pharma 60 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ticagrelor Kern Pharma 60mg film-coated tablets EFG

Ticagrelor Kern Pharma 90mg film-coated tablets EFG

Read the entire leaflet carefully before you start 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 pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Ticagrelor Kern Pharma is and what it is used for

What is Ticagrelor Kern Pharma

This medicine contains an active substance called ticagrelor. It belongs to a group of medicines known as antiplatelet agents.

What Ticagrelor Kern Pharma is used for

Ticagrelor Kern Pharma 60 mg film-coated tablets:

Ticagrelor, in combination with acetylsalicylic acid (another antiplatelet agent), should only be used in adults. Your doctor has prescribed this medicine because you have had:

• a myocardial infarction (heart attack) more than one year ago.

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

Ticagrelor Kern Pharma 90 mg film-coated tablets:

Ticagrelor, in combination with acetylsalicylic acid (another antiplatelet agent), should only be used in adults. Your doctor has prescribed this medicine because you have had:

• a myocardial infarction (heart attack), or
• unstable angina (unstable chest pain or chest discomfort not adequately controlled).

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

How Ticagrelor Kern Pharma works

Ticagrelor acts on cells called 'platelets' (also known as thrombocytes). These very small blood cells help stop bleeding by clumping together to plug small holes in damaged or injured blood vessels.

However, platelets can also form clots inside damaged blood vessels in 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 leading to the heart; this reduces blood flow to the heart and may cause intermittent chest pain (known as 'unstable angina').

Ticagrelor helps prevent platelets from clumping together. This reduces the likelihood of a blood clot forming, which could reduce blood flow.

2. What you need to know before starting to take Ticagrelor Kern Pharma

Do not take Ticagrelor Kern Pharma if:

• You are allergic to ticagrelor or to any of the other ingredients of this medicine (listed in section 6).

• You are currently experiencing bleeding.

• You have had a stroke caused by bleeding in the brain.

• You have severe liver disease.

• You are taking any of the following medicines:

• ketoconazole (used to treat fungal infections)

• clarithromycin (used to treat bacterial infections)

• nefazodone (an antidepressant)

• ritonavir and atazanavir (used to treat HIV infection and AIDS)

Do not take ticagrelor if you are in any of the above situations. If you have any doubts, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking ticagrelor if:

• You have a higher risk of bleeding due to:

• a recent serious injury

• a recent surgery (including dental procedures; ask your dentist about this)

• a disorder affecting blood clotting

• recent stomach or intestinal bleeding (such as stomach ulcer or colon 'polyps')

• You need to undergo surgery (including dental procedures) at any time while taking ticagrelor. This is because the risk of bleeding increases. Your doctor may decide to stop treatment with this medicine 5 days before surgery.

• Your heart rate is abnormally slow (usually less than 60 beats per minute) and you do not already have a device implanted to regulate your heart (pacemaker).

• You have asthma or other lung problems or difficulty breathing.

• You develop irregular breathing patterns, such as periods of rapid breathing, slow breathing, or brief pauses in breathing. Your doctor will decide whether you need further evaluation.

• You have had liver problems or previously had a condition that may have affected your liver.

• You have had a blood test showing that your uric acid level is higher than normal.

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

If you are taking ticagrelor and heparin:

• Your doctor may require a blood sample for diagnostic testing if he or she suspects a rare platelet disorder caused by heparin. It is important that you inform your doctor that you are taking both ticagrelor and heparin, as ticagrelor may affect the diagnostic test.

Children and adolescents

Ticagrelor is not recommended for use in children and adolescents under 18 years of age.

Other medicines and Ticagrelor Kern Pharma

Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines. This is because ticagrelor may affect how some medicines work, and some medicines may affect ticagrelor.

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 levels)
• rifampicin (an antibiotic)
• phenytoin, carbamazepine, and phenobarbital (used to control epileptic seizures)
• digoxin (used to treat heart failure)
• ciclosporin (used to suppress the body's immune system)
• quinidine and diltiazem (used to treat abnormal heart rhythms)
• beta-blockers and verapamil (used to treat high blood pressure)
• morphine and other opioids (used to treat acute 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 called 'blood thinners', including warfarin.
• Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), commonly 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 infection and AIDS), cisapride (used to treat stomach acid), ergot derivatives (used to treat migraines and headaches).

Also inform your doctor that, because you are taking ticagrelor, you may have an increased risk of bleeding if your doctor administers fibrinolytic agents, often called 'clot busters', such as streptokinase or alteplase.

Pregnancy and breastfeeding

The use of ticagrelor is not recommended if you are pregnant or could become pregnant. Women should 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 explain the benefits and risks of taking ticagrelor during this period.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Ticagrelor is unlikely to affect your ability to drive or use machines. However, if you feel dizzy or confused while taking this medicine, take care when driving or operating machinery.

Sodium content

This medicine contains less than 1 mmol of sodium (23 mg) per dose, which is essentially "sodium-free".

3. How to take Ticagrelor Kern Pharma

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

How much to take

Ticagrelor Kern Pharma 60 mg film-coated tablets:

• The usual dose is one 60 mg tablet twice daily. Continue taking ticagrelor until your doctor tells you otherwise.
• Take this medicine at the same time each day (for example, one tablet in the morning and one at night).

Ticagrelor Kern Pharma 90 mg film-coated tablets:

• The initial dose is two tablets taken together (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 12 months, unless your doctor tells you otherwise.
• Take this medicine at the same time each day (for example, one tablet in the morning and one at night).

Taking Ticagrelor Kern Pharma with other blood-thinning medicines

Your doctor will usually also prescribe acetylsalicylic acid. This is a substance found in many medicines used to prevent blood clotting. Your doctor will tell you how much to take (normally between 75–150 mg daily).

How to take Ticagrelor Kern Pharma

• You may take this medicine with or without food.
• You can check when you took your last ticagrelor tablet by looking at the blister pack. A sun (for morning) and a moon (for night) are shown, which will help you determine 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
• Stir and drink immediately
• To ensure no medicine is left behind, rinse the empty glass with another half glass of water and drink it

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

If you take more Ticagrelor Kern Pharma than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Ticagrelor Kern Pharma

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

If you stop taking Ticagrelor Kern Pharma

Do not stop treatment with ticagrelor without consulting your doctor. Take this medicine regularly and for as long as your doctor tells you. If you stop taking ticagrelor, your risk of having another heart attack or stroke, or of dying from a heart or blood vessel-related disease, may increase.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. The following adverse effects may occur with this medicine:

Ticagrelor affects blood clotting, so most adverse effects are related to bleeding. Bleeding may occur in any part of the body. Some degree of bleeding is common (such as bruising and nosebleeds). Serious bleeding is rare, but can potentially be life-threatening.

Tell your doctor immediately if you notice any of the following – you may need urgent medical treatment:

• Bleeding in the brain or within the skull is an uncommon adverse effect, and may cause signs of stroke such as:

• sudden numbness or weakness in the arms, legs, or face, especially if affecting 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 severe headache of unknown 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"

• black or red stools (resembling tar)

• coughing up blood or vomiting blood

• 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:

• Shortness of breath – this is very common. It may be due to heart disease or another cause, or may be a side effect of ticagrelor. Shortness of breath related to ticagrelor is usually mild and is characterized by a sudden, unexpected need for air, typically occurring at rest. It may appear during the first weeks of treatment and may resolve in many cases. If you feel your shortness of breath has worsened or persists, inform your doctor. Your doctor will decide whether you need treatment or further investigations.

Other possible adverse effects

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

• High level of uric acid in the blood (as seen in blood tests)
• Bleeding due to 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 – signs of gout
• Dizziness, lightheadedness, or blurred vision – signs of low blood pressure
• Nosebleeds
• Heavier than normal bleeding after surgery or cuts (e.g., while 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, swelling of the face, or swelling of the lips/tongue may be signs of an allergic reaction
• Confusion
• Vision problems caused by bleeding in the eye
• Heavier vaginal bleeding, or bleeding occurring at different times than your usual menstrual period
• Bleeding into joints and muscles causing painful swelling
• Blood in the ear
• Internal bleeding, which may cause dizziness or lightheadedness

Frequency not known (cannot be estimated from available data)

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

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ticagrelor Kern Pharma

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and packaging after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Ticagrelor Kern Pharma

Ticagrelor Kern Pharma 60 mg film-coated tablets:

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

• The other components are:

Tablet core: mannitol (E-421), calcium hydrogen phosphate dihydrate, sodium carboxymethyl starch (type A) (from potato), hypromellose, magnesium stearate.

Film coating of the tablets: hypromellose, titanium dioxide (E-171), macrogol, black iron oxide (E-172), red iron oxide (E-172).

Ticagrelor Kern Pharma 90 mg film-coated tablets:

• The active substance is ticagrelor. Each film-coated tablet contains 90 mg of ticagrelor.

• The other components are:

Tablet core: mannitol (E-421), calcium hydrogen phosphate dihydrate, sodium carboxymethyl starch (type A) (from potato), hypromellose, magnesium stearate.

Film coating of the tablets: hypromellose, titanium dioxide (E-171), macrogol, yellow iron oxide (E-172), talc.

Appearance of the product and contents of the pack

Ticagrelor Kern Pharma 60 mg film-coated tablets:

The film-coated tablets are round, biconvex, pink in colour, marked with a “60” on one side, and approximately 8 mm in diameter.

This medicine is available in PVC/PVDC-Aluminum blisters, in packs containing 60 tablets.

Ticagrelor Kern Pharma 90 mg film-coated tablets:

The film-coated tablets are round, biconvex, yellow in colour, marked with a “90” on one side, and approximately 9 mm in diameter.

This medicine is available in PVC/PVDC-Aluminum blisters, in packs containing 56 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Manufacturer:

Adalvo Ltd.

Malta Life Sciences Park

Building 1, Level 4

Sir Temi Zammit Buildings

San Gwann SGN 3000, Malta

or

KeVaRo GROUP Ltd.

9, Tsaritsa Eleonora Str.,

office 23, Sofia 1618,

Bulgaria

or

PGF Pharma International d.o.o.

Ulica Roberta Frangesa-Mihanovica 9,

Zagreb, 10110,

Croatia

Date of the most recent revision of this package leaflet: October 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.