Ticagrelor STADA 60 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ticagrelor Stada 60 mg film-coated tablets EFG

Ticagrelor Stada 90 mg 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 others, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

What Ticagrelor Stada is

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

What Ticagrelor Stada is used for

Ticagrelor Stada 60 mg film-coated tablets:

Ticagrelor, in combination with acetylsalicylic acid (another antiplatelet agent), is intended for use in adults only. You have been prescribed this medicine because you have had:

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

Ticagrelor Stada 90 mg film-coated tablets:

Ticagrelor, in combination with acetylsalicylic acid (another antiplatelet agent), is intended for use in adults only. You have been prescribed this medicine because you have had:

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

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

How Ticagrelor Stada works

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

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 forming a blood clot that could restrict blood flow.

2. What you need to know before taking Ticagrelor Stada

DO NOT take Ticagrelor Stada 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 and AIDS)

Do not take ticagrelor if any of the above apply to you. 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 an increased risk of bleeding due to:

  • a recent serious injury
  • recent surgery (including dental procedures; consult 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 your risk of bleeding may increase. 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 rhythm (a pacemaker).

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

• you develop irregular breathing patterns, such as periods of faster, slower, or brief pauses in breathing. Your doctor will decide whether further evaluation is needed.

• you have had liver problems or a previous illness 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 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 need to take a blood sample for diagnostic testing if heparin-induced thrombocytopenia (a rare platelet disorder caused by heparin) is suspected. 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 Stada

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

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

• rosuvastatin or 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 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, inform 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’, such as 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
• cisapride (used to treat stomach acid), ergot alkaloids (used to treat migraines and headaches)
• 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). These must not be taken with Ticagrelor Stada (see also section 2 “DO NOT take Ticagrelor Stada if”)

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

Pregnancy and breastfeeding

The use of ticagrelor is not recommended if you are pregnant or may 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 operate machinery. However, if you feel dizzy or confused while taking this medicine, take care when driving or using machines.

3. How to take Ticagrelor Stada

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

How much to take

Ticagrelor Stada 60 mg film-coated tablets:

• The usual dose is one 60 mg tablet twice daily. Continue taking ticagrelor until your doctor tells you otherwise.

Ticagrelor Stada 90 mg film-coated tablets:

• The initial dose is two 90 mg tablets 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 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 in the evening).

Taking Ticagrelor Stada with other blood-thinning medicines

Your doctor will usually also prescribe acetylsalicylic acid. This is a substance present 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 Stada

• You may take this medicine with or without food.

If you have difficulty swallowing the tablet

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

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

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

If you take more Ticagrelor Stada 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: 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you forget to take Ticagrelor Stada

• 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 once) to make up for forgotten doses.

If you stop taking Ticagrelor Stada

Do not stop taking 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 may cause adverse effects, although not everyone experiences them.

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

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 (bright red) 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 and in the mouth, with or without yellowing of the skin or eyes (jaundice), unexplained extreme fatigue or confusion.

Consult your doctor if you notice any of the following:

• Feeling short of breath – this is very common. It may be due to heart disease or another cause, or it may be a side effect of ticagrelor. Shortness of breath related to ticagrelor is usually mild and is typically characterized by a sudden, unexpected need for air that usually occurs at rest and may appear during the first weeks of treatment; in many cases, it may resolve spontaneously. 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 blood (as seen in blood tests)
• bleeding due to blood disorders

Common (may affect up to 1 in 10 people)

• bruising
• headache
• feeling dizzy or as if everything is spinning
• diarrhoea or indigestion
• feeling unwell (nausea)
• constipation
• rash
• itching
• severe pain and inflammation in joints – these are signs of gout
• feeling dizzy or lightheaded, or blurred vision – these are signs of low blood pressure
• nosebleeds
• heavier bleeding than usual 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 – a skin rash, itching, or 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 (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 possible adverse effects 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 Stada

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and outer packaging following EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Ticagrelor Stada

The active substance is ticagrelor.

Ticagrelor Stada 60 mg: Each film-coated tablet contains 60 mg of ticagrelor.

Ticagrelor Stada 90 mg: Each film-coated tablet contains 90 mg of ticagrelor.

The other components are:

Tablet core: mannitol, calcium hydrogen phosphate dihydrate, hydroxypropylcellulose, calcium carmellose, magnesium stearate.

Film coating of the tablets:

Ticagrelor Stada 60 mg: hypromellose (E464), titanium dioxide (E171), iron oxide red (E172), macrogol (E1521).

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

Appearance of the product and contents of the container

Ticagrelor Stada 60 mg: The tablets are round, biconvex, pink in colour, film-coated, with an approximate diameter of 8 mm.

Ticagrelor Stada 90 mg: The tablets are round, biconvex, yellow in colour, film-coated, with an approximate diameter of 9 mm.

Ticagrelor Stada is available in blisters and unit dose blisters in pack sizes of 14, 56, 60, 100 and 168 tablets.

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer:

STADA Arzneimittel AG

Stadastrasse 2 - 18

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36

1190 Wien

Austria

or

Centrafarm Services B.V.

Van de Reijtstraat 31-E

4814 NE Breda

The Netherlands

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Date of last review of this leaflet: January 2023

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