TICAGRELOR STADA 60 mg FILM-COATED TABLETS

2. What you need to know before you take Ticagrelor Stada

Do not take Ticagrelor Stada if:

• you are allergic to ticagrelor or any of the other ingredients of this medicine (listed in section 6).
• you have any current 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 you are in any of the above situations. If you are unsure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Consult your doctor or pharmacist before taking ticagrelor if:

• you have a higher risk of bleeding due to:

• a recent severe injury
• a recent surgery (including dental surgery, ask your dentist about this)
• you have a disorder that affects blood clotting
• a recent stomach or intestine bleeding (such as stomach ulcer or colon ‘polyps’)

• you need to have surgery (including dental surgery) at any time while taking ticagrelor. This is because it increases the risk of bleeding. Your doctor may want to stop your 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 have a device that regulates your heart (pacemaker).
• you have asthma or other lung problems or breathing difficulties.
• you develop irregular breathing patterns, such as rapid, slow, or brief pauses in breathing. Your doctor will decide if you need any further evaluation.
• you have had any liver problems or have had a disease that may have affected your liver.
• you have had a blood test that shows high levels of uric acid.

If any of the above applies 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 tests if they suspect the presence of a rare platelet disorder caused by heparin. It is essential that you inform your doctor that you are taking ticagrelor and heparin, as ticagrelor may affect the diagnostic test.

Children and adolescents

Ticagrelor should not be given to children and adolescents under 18 years of age.

Other medicines and Ticagrelor Stada

Tell your doctor or pharmacist if you are using, have recently used, or might 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 or 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 epilepsy)
• digoxin (used to treat heart failure)
• cyclosporin (used to suppress the body's immune system)
• quinidine and diltiazem (used to treat irregular 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 referred to as ‘blood thinners’, including warfarin.
• Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) frequently 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 acidity), 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 notbe taken with Ticagrelor Stada (see also section 2 “Do not take Ticagrelor Stada if”)

Tell your doctor if, because you are taking ticagrelor, you may have a higher risk of bleeding if your doctor gives you fibrinolytics, often referred to as ‘clot dissolvers’, such as streptokinase or alteplase.

Pregnancy and breastfeeding

Ticagrelor should not be used 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 use machines. If you feel dizzy or confused while taking this medicine, be careful while driving or using machines.

3. How to take Ticagrelor Stada

Follow exactly the instructions of your doctor. If you are unsure, consult your doctor or pharmacist.

How much to take

Ticagrelor Stada 60 mg film-coated tablets:

• The usual dose is one 60 mg tablet twice a day. Continue taking ticagrelor as long as your doctor tells you.

Ticagrelor Stada 90 mg film-coated tablets:

• The initial dose is two 90 mg tablets at the same time (a loading dose of 180 mg). This dose will usually be given to you in the hospital.
• After this initial dose, the usual dose is one 90 mg tablet twice a day for 12 months, unless your doctor tells you otherwise.

• Take this medicine at the same time every day (for example, one tablet in the morning and one in the evening).

Taking Ticagrelor Stada with other medicines for blood clotting

Your doctor will also usually 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 (usually between 75-150 mg daily).

How to take Ticagrelor Stada

• You can take this medicine with or without food.

If you have difficulty swallowing the tablet

If you have difficulty swallowing the tablet, you can crush it and mix 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 make sure you have taken all the medicine, rinse the empty glass with another half a glass of water and drink

If you are in the hospital, this tablet may be given to you mixed with a little water through a tube in your 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 the hospital immediately. Bring the medicine pack with you. You may have a higher risk of bleeding.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the medicine pack and leaflet to the healthcare professional.

If you forget to take Ticagrelor Stada

• If you forget to take a dose, just 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 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, you may increase the risk of having another heart attack or stroke, or dying from a heart or blood vessel-related disease.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Ticagrelor affects blood clotting, so most side effects are related to bleeding. Bleeding can occur anywhere in the body. Some level of bleeding is common (such as bruising and nosebleeds). Severe bleeding is rare but can 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 inside the skull is an uncommon side effect, and can cause signs of a stroke such as:
• • sudden numbness or weakness of the arms, legs, or face, especially if it affects only one side of the body
  • sudden confusion, difficulty speaking or understanding others
  • sudden difficulty walking or loss of balance or coordination
  • sudden feeling of dizziness or severe headache of unknown cause

• Signs of bleeding such as:
• • severe or uncontrolled bleeding
  • unexpected or prolonged bleeding
  • urine that is pink, red, or brown
  • vomiting blood or vomit that looks like “coffee grounds”
  • black or red stools (like tar)
  • coughing or vomiting blood

• Fainting (syncope)
• • temporary loss of consciousness due to a sudden drop in blood flow to the brain (frequent)

• Signs of a blood clotting problem 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), extreme tiredness, or confusion.

Tell your doctor if you notice any of the following:

• Difficulty breathing - this is very common. It may be due to heart disease or another cause, or it may be a side effect of ticagrelor. The breathing difficulty related to ticagrelor is usually mild and is characterized by a sudden, unexpected need for air that usually occurs at rest and may disappear in many cases. If you think your breathing difficulty has worsened or lasts a long time, tell your doctor. They will decide if you need treatment or further investigation.

Other possible side effects

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

• high levels 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
• feeling dizzy or like everything is spinning
• diarrhea or indigestion
• feeling sick (nausea)
• constipation
• rash
• itching
• severe pain and swelling in the joints - these are signs of gout
• feeling dizzy or faint, or blurred vision - these are signs of low blood pressure
• nosebleeds
• bleeding more than usual after surgery or cuts (for example, when shaving) and wounds
• bleeding from the stomach walls (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 or irregular vaginal bleeding, or bleeding between periods
• bleeding in the joints and muscles that causes painful swelling
• bleeding in the ear
• internal bleeding, which can cause dizziness or fainting

Frequency not known(cannot be estimated from the available data)

• abnormally low heart rate (normally below 60 beats per minute)

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side 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 which is stated on the blister and on the carton after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container Content and Additional Information

Composition of Ticagrelor Stada

The active ingredient 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:

Core of the tablet:mannitol, calcium hydrogen phosphate dihydrate, hydroxypropylcellulose, calcium carmellose, magnesium stearate.

Coating of the tablets:

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

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

Appearance of the Product and Container Content

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

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

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratory 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

Netherlands

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

Date of the Last Revision of this Leaflet:January 2023

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