Ticagrelor Combix 90 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ticagrelor Combix 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, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

2. What you need to know before taking Ticagrelor Combix

3. How to take Ticagrelor Combix

4. Possible side effects

5. Storage of Ticagrelor Combix

6. Contents of the pack and other information

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

What Ticagrelor Combix is

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

What Ticagrelor Combix is used for

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 of dying from a heart- or blood vessel-related disease.

How Ticagrelor Combix 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 damaged 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 sticking together. This reduces the likelihood of a blood clot forming, which could reduce blood flow.

2. What you need to know before taking Ticagrelor Combix

Do not take Ticagrelor Combix

• if you are allergic to ticagrelor or to any of the other ingredients of this medicine (listed in section 6),
• if you are currently experiencing bleeding,
• if you have had a stroke caused by bleeding in the brain,
• if you have severe liver disease,
• if 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 any of the above 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 this medicine:

• if you have an increased risk of bleeding due to:
  • a recent serious injury,
  • a recent surgical procedure (including dental procedures; consult your dentist),
  • a disorder affecting blood clotting,
  • recent bleeding from the stomach or intestine (such as stomach ulcer or colon 'polyps'),
• if you are scheduled for 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,
• if 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 (pacemaker),
• if you have asthma or other lung problems or difficulty breathing,
• if you develop irregular breathing patterns, such as periods of rapid breathing, slow breathing, or brief pauses in breathing. Your doctor will decide whether further evaluation is needed,
• if you have had liver problems or a previous illness that may have affected your liver,
• if you have had a blood test showing elevated 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 require 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 and heparin, as ticagrelor may affect the diagnostic test.

Children and adolescents

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

Other medicines and Ticagrelor Combix

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

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 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 referred to as 'blood thinners', such as 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 infection and AIDS), cisapride (used to treat stomach acid reflux), and ergot alkaloids (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 fibrinolytic agents (often called 'clot busters'), such as streptokinase or alteplase, are administered.

Pregnancy and breastfeeding

The use of this medicine is not recommended if you are pregnant or could become pregnant. Women of childbearing potential 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 this medicine 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

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

Ticagrelor Combix contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, it is essentially "sodium-free".

3. How to take Ticagrelor Combix

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

How much to take

• The initial dose is two tablets at once (a loading dose of 180 mg). This dose is normally given to you 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 Combix with other blood-thinning medicines

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

How to take Ticagrelor Combix

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 via the nose (nasogastric tube).

If you take more Ticagrelor Combix 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 have an increased risk of bleeding.

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

If you forget to take Ticagrelor Combix

• 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 Combix

Do not stop taking this medicine without consulting your doctor. Take this medicine regularly and for as long as your doctor tells you to. If you stop taking this medicine, 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 anywhere in the body. Some degree of bleeding is common (such as bruising and nosebleeds). Serious bleeding is rare but can potentially be life-threatening.

Contact 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 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.

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 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 pain and swelling in the joints – these are signs of gout

• Dizziness or lightheadedness, or blurred vision – these are 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 – 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

• 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 effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ticagrelor Combix

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

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

PVC/PVDC-Aluminum blisters: store below 30°C. Keep in the original packaging to protect from light.

PVC/PE/PVDC-Aluminum blisters: this medicine does not require any special storage temperature. Keep in the original packaging to protect from light.

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

6. Contents of the pack and other information

Composition of Ticagrelor Combix

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

Tablet core: hypromellose, mannitol (E421), microcrystalline cellulose, sodium carboxymethyl starch (type A) and magnesium stearate.

Tablet coating: hypromellose, titanium dioxide (E171), macrogol, talc and yellow iron oxide (E172).

Appearance of the product and contents of the pack

Round, biconvex, yellow, film-coated tablets with a diameter of approximately 9.1 mm, marked with "90" on one side and plain on the other.

Ticagrelor Combix 90 mg is available in PVC/PVDC-aluminum or PVC/PE/PVDC-aluminum blisters, in packs of 56 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Genepharm S.A.

18th km, Marathonos Avenue,

Pallini Attikis, 15351

Greece

Date of the most recent revision of the package leaflet: July 2024

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/