Kogavant

Package leaflet: Information for the user

KOGAVANT, 90 mg, coated tablets
Ticagrelor
Read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

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

1. What Kogavant is and what it is used for

What Kogavant is
Kogavant contains the active substance called ticagrelor. It belongs to a group of medicines known as antiplatelet agents.

What Kogavant is used for
Kogavant, in combination with acetylsalicylic acid (another antiplatelet medicine), is used only in adults who have had:

• a heart attack (myocardial infarction), or
• unstable angina (acute coronary syndrome – a type of severe chest pain caused by blocked blood flow to part of the heart).

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

How Kogavant works
Kogavant affects blood cells called platelets (also known as thrombocytes). Platelets are very small blood cells that help stop bleeding by clumping together and sealing small holes at the site of a cut or blood vessel injury.

However, platelets can also form blood clots inside diseased blood vessels in the heart and brain. This can be very dangerous because:

• a clot may completely block blood flow – this may lead to a heart attack (myocardial infarction) or stroke, or
• a clot may partially block blood vessels leading to the heart – reducing blood flow to the heart and causing chest pain that varies in intensity (called unstable angina).

Kogavant helps prevent platelets from clumping together, thereby reducing the risk of clot formation that could impair blood flow.

2. Important information before taking Kogavant

When not to use Kogavant

• If the patient is allergic to ticagrelor or any of the other ingredients of this medicine (listed in section 6);
• If the patient is currently bleeding;
• If the patient has had a stroke caused by bleeding into the brain;
• If the patient has severe liver disease;
• If the patient is 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 infections).
    Kogavant must not be used if any of the above situations apply. If in doubt, consult a doctor or pharmacist before starting treatment with this medicine.

Warnings and precautions
Before taking Kogavant, consult a doctor or pharmacist:

• If the patient has an increased risk of bleeding due to:
  • recent serious injury;
  • recent surgical procedures (including dental procedures – advice should be sought from a dentist);
  • the patient's condition affecting blood clotting;
  • recent gastrointestinal bleeding (such as stomach ulcer or intestinal polyps);
• If the patient will undergo any surgical procedure (including dental) while taking Kogavant. This is due to an increased risk of bleeding. The doctor may advise stopping the medicine 5 days before the planned procedure;
• If the patient has a slow heart rate (usually less than 60 beats per minute) and does not have a pacemaker implanted;
• If the patient has asthma or other lung diseases or breathing difficulties;
• If the patient develops breathing problems such as rapid breathing, slow breathing, or apnoea. The doctor will decide whether further evaluation is needed;
• If the patient has any liver disorders or has previously had a condition that could have damaged the liver;
• If blood tests have shown high levels of uric acid. Talk to a doctor or pharmacist before taking the medicine if any of the above situations apply (or if in doubt).

If the patient is taking both Kogavant and heparin:

• The doctor may take a blood sample for diagnostic testing if heparin-induced thrombocytopenia (a rare platelet disorder) is suspected. It is important to inform the doctor about taking both Kogavant and heparin, as Kogavant may affect the diagnostic test result.

Children and adolescents
Kogavant is not recommended for use in children and adolescents under 18 years of age.
Other medicines and Kogavant
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. This is necessary because Kogavant may affect the action of other medicines, and other medicines may affect Kogavant.
Inform your doctor or pharmacist if you are taking any of the following medicines:

• rosuvastatin (a medicine used to reduce cholesterol levels);
• simvastatin or lovastatin in doses greater than 40 mg per day (medicines used to reduce cholesterol levels);
• rifampicin (an antibiotic);
• phenytoin, carbamazepine, and phenobarbital (used to control epileptic seizures);
• digoxin (used to treat heart failure);
• cyclosporine (used to suppress the immune system);
• quinidine and diltiazem (used to treat heart rhythm disorders);
• beta-blockers and verapamil (used to treat high blood pressure);
• morphine and other opioids (used to treat severe pain)

Especially inform your doctor or pharmacist if you are taking any of the following medicines, which increase the risk of bleeding:

• oral anticoagulants, often called blood-thinning medicines, including warfarin;
• non-steroidal anti-inflammatory drugs (NSAIDs), commonly used as painkillers, such as ibuprofen and naproxen;
• selective serotonin reuptake inhibitors (SSRIs), used 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 infections), cimetidine (used to treat heartburn), ergot alkaloids (used to treat migraines and headaches).

Also inform your doctor about taking Kogavant and the increased risk of bleeding if your doctor prescribes fibrinolytic medicines, often called clot-dissolving medicines, such as streptokinase or alteplase.
Pregnancy and breastfeeding
Kogavant is not recommended during pregnancy or if there is a possibility of becoming pregnant.
Women should use appropriate contraceptive methods while taking this medicine to avoid becoming pregnant.
Before taking this medicine, inform your doctor if you are breastfeeding. Your doctor will discuss the benefits and risks of using Kogavant while breastfeeding.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before taking this medicine.
Driving and operating machinery
It is unlikely that Kogavant will impair the ability to drive or operate machinery. However, if dizziness or confusion occurs while taking this medicine, caution should be exercised when driving or operating machinery.
Sodium content
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to take Kogavant

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, please
contact your doctor or pharmacist.
What dose to take
Heart attack (myocardial infarction)

• The usual dose is 60 mg twice daily. You should continue taking Kogavant for as long as your doctor recommends. For maintenance treatment, the 60 mg tablets available on the market should be used, since the 90 mg tablets cannot be divided into equal parts.

Unstable angina (acute coronary syndrome)

• The initial dose is 180 mg once daily as a single dose (loading dose). This dose is usually administered in hospital.
• After the initial dose, the usual dose is one 90 mg tablet taken twice daily for up to 12 months, unless otherwise directed by your doctor.
• It is recommended to take this medicine at the same time each day (e.g. one tablet in the morning and one in the evening).

Taking Kogavant with other blood-thinning medicines
Your doctor will usually recommend taking acetylsalicylic acid at the same time. This is a substance
present in many medicines that prevent blood clotting. Your doctor will advise you on the dose to take (usually 75 to 150 mg daily).
How to take Kogavant

• Tablets may be taken with or without food.
• You can check when you last took a Kogavant tablet by looking at the blister pack. The blister contains printed symbols showing a sun (for morning doses) and a moon (for evening doses). These symbols help patients remember when they last took a dose.

What to do if you have difficulty swallowing the tablet
If you have difficulty swallowing the tablet, it may be crushed and mixed with water as follows:

• Crush the tablet into a fine powder;
• Pour the powder into half a glass of water;
• Mix and drink immediately;
• To ensure the entire dose is taken, add another half glass of water, swirl and drink. If the patient is being treated in hospital, the crushed tablet may be administered through a nasogastric tube after dissolving in water.

Taking more Kogavant than prescribed
If you take more Kogavant than prescribed, contact your doctor immediately or go to hospital.
Bring the medicine packaging with you. There may be an increased risk of bleeding.
If you miss a dose of Kogavant

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

Stopping Kogavant
Do not stop taking Kogavant without talking to your doctor. You should take this medicine regularly and for as long as your doctor recommends. Stopping Kogavant may increase the risk of another heart attack or stroke, or death due to heart or blood vessel disease.
If you have any further questions about using this medicine, please consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions may occur during treatment with this medicine:
Kogavant affects blood clotting; therefore, most adverse reactions are related to bleeding. Bleeding may occur at any site in the body. Some bleeding events are common (e.g. bruising and nosebleeds). Severe bleeding is uncommon but may be life-threatening.
Contact your doctor immediately if any of the following symptoms occur – urgent medical attention may be required:

• Intracranial bleeding (bleeding into the brain) is an uncommon adverse reaction and may cause stroke-like symptoms such as:
  • sudden numbness or weakness of the arms, legs, or face, especially if affecting only one side of the body;
  • sudden confusion, difficulty speaking or understanding others;
  • sudden difficulty walking, loss of balance or coordination;
  • sudden dizziness or sudden severe headache with no known cause;
• Signs of bleeding such as:
  • heavy or difficult-to-stop bleeding;
  • unexpected bleeding or bleeding lasting a long time;
  • urine discolored pink, red or brown;
  • vomiting blood or material that looks like coffee grounds;
  • stool discolored red or black (resembling tar);
  • coughing or vomiting blood clots;
• Fainting
  • temporary loss of consciousness caused by a sudden reduction in blood flow to the brain (common).
• Symptoms related to 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 disorientation.

Discuss with your doctor if the patient experiences:

• Shortness of breath – very common. It may be caused by heart disease or another condition, or may be an adverse reaction to Kogavant. Shortness of breath associated with Kogavant is usually mild and characterized by sudden, unexpected breathlessness, typically occurring at rest. It may appear during the first few weeks of treatment and then not recur for several weeks. If shortness of breath worsens or persists for a long time, contact your doctor. The doctor will decide whether treatment or additional tests are needed.

Other possible adverse reactions
Very common (may affect more than 1 in 10 people)

• Increased blood uric acid levels (detected in laboratory tests)
• Bleeding due to blood disorders

Common (may affect up to 1 in 10 people)

• Bruising
• Headache
• Dizziness or spinning sensation
• Diarrhea or indigestion
• Nausea
• Constipation
• Rash
• Itching
• Intense joint pain and swelling – symptoms of gout
• Dizziness, lightheadedness, or blurred vision – symptoms of low blood pressure
• Nosebleeds
• Bleeding after surgery or from minor cuts (e.g. during shaving) and wounds that are more severe than usual
• Bleeding from the gastric mucosa (ulcer)
• Bleeding gums

Uncommon (may affect up to 1 in 100 people)

• Allergic reaction – rash, itching, swelling of the face or lips/tongue may be signs of an allergic reaction
• Disorientation (confusion)
• Visual disturbances caused by blood in the eye
• Vaginal bleeding that is heavier than usual or occurs at a different time than regular menstrual bleeding
• Bleeding into joints and muscles, causing painful swelling
• Blood in the ear
• Internal bleeding, which may cause dizziness or lightheadedness

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

• Abnormally low heart rate (usually less than 60 beats per minute)

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C,
02-222 Warsaw,
Tel.: + 48 22 49 21 301,
Fax: + 48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Kogavant

Keep this medicine out of sight and reach of children.
No special storage conditions are required for this medicine.
Do not use this medicine after the expiry date stated on the carton and blister after:
"EXP". The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer in use. Proper disposal helps protect
the environment.

6. Contents of the packaging and other information

What the medicine Kogavant contains

• The active substance is ticagrelor. Each tablet contains 90 mg of ticagrelor.
• Other components are:
  Tablet core
  Mannitol
  Microcrystalline cellulose type 102
  Povidone K-25
  Sodium croscarmellose
  Magnesium stearate

Coating
Hypromellose 6 mPas (E464)
Titanium dioxide (E 171)
Macrogol 400 (E 1521)
Iron oxide yellow (E 172)
Talc

What Kogavant looks like and contents of the pack
Round, biconvex, yellow tablets with a diameter of approximately 9.5 mm, embossed with "D5" on one side and smooth on the other.
Kogavant is available in:

• PVC/PVDC/Aluminium blister packs (symbols: sun/moon) containing 10 tablets; cardboard boxes containing 60 tablets (6 blisters) or 120 tablets (12 blisters).
• Calendar-type PVC/PVDC/Aluminium blister packs (symbols: sun/moon) containing 14 tablets; cardboard boxes containing 56 tablets (4 blisters), 112 tablets (8 blisters), or 168 tablets (12 blisters).

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Gedeon Richter Polska Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki

This medicine is authorised for marketing in the European Economic Area countries under the following names:
Bulgaria: KOGAVANT 90 mg film-coated tablets
Czech Republic: KOGAVANT
Estonia: KOGAVANT
Hungary: KOGAVANT 90 mg filmtabletta
Lithuania: KOGAVANT 90 mg plėvele dengtos tabletės
Poland: KOGAVANT
Romania: KOGAVANT 90 mg comprimate filmate
Slovakia: KOGAVANT 90 mg filmom obalené tablety

For further information about this medicine, please contact:
Gedeon Richter Polska Sp. z o.o.
Medical Department
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
tel.: +48 (22) 755 96 48
[email protected]