Ticagrelor Sandoz 60 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ticagrelor Sandoz 60 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 may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

What Ticagrelor Sandoz is

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

What Ticagrelor Sandoz is used for

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

• a myocardial infarction more than one year ago.

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

How Ticagrelor Sandoz 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 blood vessels that have been 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 Sandoz

Do not take Ticagrelor Sandoz

• if you are allergic to ticagrelor or to any of the other ingredients of this medicine (listed in section 6),
• if you currently have 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 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 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 bleeding from the stomach or intestines (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 want to stop treatment with this medicine 5 days before surgery,
• your heart rate is abnormally slow (normally less than 60 beats per minute) and you do not already have a device implanted to regulate your heart (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 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 they suspect a rare platelet disorder caused by heparin. 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 Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those available without a prescription. 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),
• 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, 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’, 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 and AIDS), cisapride (used to treat stomach acid), 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 you are given fibrinolytic agents, often called ‘clot busters’, such as streptokinase or alteplase.

Pregnancy and breastfeeding

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 using this medicine.

Driving and using machines

Ticagrelor is not expected to affect your ability to drive or operate machinery. However, if you feel dizzy or confused while taking this medicine, be cautious when driving or using machines.

Ticagrelor Sandoz contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take Ticagrelor Sandoz

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

How much to take

• 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).

Taking ticagrelor 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 you should take (usually between 75–150 mg daily).

How to take ticagrelor

• 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. This will indicate 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 Sandoz than you should

If you have taken more ticagrelor than you should, contact your doctor immediately or go to hospital immediately. Bring the medicine packaging 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, stating the medicine and the amount ingested.

If you forget to take ticagrelor

• 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 a missed dose.

If you stop taking ticagrelor

Do not stop taking ticagrelor without consulting your doctor. Take this medicine regularly and for as long as your doctor tells you to. If you stop taking ticagrelor, your risk of having another heart attack or stroke, or of dying from a heart or blood vessel-related condition, 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 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, which is very common. This 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 characterized by a sudden, unexpected need for air, typically occurring at rest. It may appear during the first weeks of treatment and, in many cases, may resolve on its own. If you think 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 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, which are signs of gout,
• dizziness or lightheadedness, or blurred vision, which are signs of low blood pressure,
• nosebleeds,
• heavier bleeding than usual after surgery or cuts (e.g., while shaving) and injuries,
• bleeding from the stomach lining (ulcer),
• bleeding from gums.

Uncommon (may affect up to 1 in 100 people)

• allergic reaction; a 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 effect, consult 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 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 Sandoz

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 CAD/EXP. The expiry date refers to 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 packaging to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ticagrelor Sandoz

• 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, maize starch, pregelatinized maize starch, talc (E553b), stearic fumarate and sodium.

Tablet coating: poly (vinyl alcohol) (E1203), talc (E553b), titanium dioxide (E171), glycerol monocaprylocaprate, sodium lauryl sulfate, iron oxide red (E172), iron oxide black (E172).

Nature of the product and pack contents

Film-coated tablets: the tablets are round, biconvex, pink in colour, marked with "60" on one side and smooth on the other, with a diameter of 8.6 mm ± 5%.

Ticagrelor Sandoz is available in:

• standard blisters (with or without sun/moon symbols) in packs of 10, 14, 20, 56, 60, 100 and 168 tablets,
• calendarized blisters (with or without sun/moon symbols) in packs of 14, 56 and 168 tablets,
• multiple packs containing 168 (3 packs of 56), 180 (3 packs of 60) and 200 (4 packs of 50) tablets in standard blisters (with or without sun/moon symbols),
• multiple packs containing 168 (3 packs of 56) in calendarized blisters (with or without sun/moon symbols).

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Parque Norte Business Centre

Roble Building

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceuticals d.d

Verovskova 57

1526 Ljubljana

Slovenia

or

PharOS MT Ltd.

HF62X, Hal Far Industrial Estate,

Birzebbugia BBG3000,

Malta

Date of the most recent review of this leaflet: December 2024

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