Kogavant

Patient Information Leaflet

KOGAVANT, 60 mg, film-coated tablets
Ticagrelor
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet Contents

1. What Kogavant is and what it is used for
2. What you need to know 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 an 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).
  Kogavant reduces the likelihood of having another heart attack or stroke, or of dying due to heart or blood vessel 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 openings when a blood vessel is cut or damaged.

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

• a clot may completely block blood flow – leading 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 (known as 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 to the patient. 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 from a dentist should be sought);
  • conditions affecting blood clotting;
  • recent gastrointestinal bleeding (such as stomach ulcer or intestinal polyps);
• If the patient will undergo any surgical procedure (including dental procedures) during treatment with 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 disease that could have damaged the liver;
• If blood tests have shown high levels of uric acid. Talk to a doctor or pharmacist before taking Kogavant 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, have recently taken, or 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 at doses higher than 40 mg per day (medicines used to reduce cholesterol levels);
• rifampicin (an antibiotic);
• phenytoin, carbamazepine, and phenobarbital (used to control 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).

You should 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 of childbearing potential should use appropriate contraceptive methods while taking this medicine to avoid becoming pregnant.
Inform your doctor if you are breastfeeding. Your doctor will discuss the benefits and risks of using Kogavant during breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.
Driving and operating machinery
It is unlikely that Kogavant will impair the ability to drive or operate machinery. However, if dizziness or disorientation occurs during treatment, 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 as directed by your doctor. If you have any doubts, you should
contact your doctor or pharmacist.
What dose to take
Heart attack (myocardial infarction)

• The usual dose is one 60 mg tablet taken twice daily. You should continue taking Kogavant for as long as your doctor recommends.

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 maintenance dose is one 90 mg tablet taken twice daily for up to 12 months, unless your doctor advises otherwise. Since the 60 mg tablets cannot be divided into equal halves, they should not be used for ongoing treatment of acute coronary syndrome, and Kogavant medicine of appropriate strength should be used instead. 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 used to prevent blood clotting. Your doctor will advise you on the dose to
take (usually between 75 and 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 took their last 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 the glass, and drink. If you are being treated in hospital, the crushed tablet may be administered through a nasogastric tube (nasogastric feeding tube).

Taking more Kogavant than recommended
If you take more Kogavant than prescribed, contact your doctor immediately or go to hospital.
Take 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 the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, 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 anywhere in the body. Some bleeding events are common (e.g., bruising and nosebleeds). Severe bleeding occurs less frequently but may be life-threatening.
Contact a doctor immediately if any of the following symptoms occur – urgent medical care may be required:

• Intracranial or cerebral haemorrhage is an uncommon adverse reaction and may cause stroke-like symptoms 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, loss of balance or coordination;
  • sudden dizziness or sudden severe headache without known cause;
• Signs of bleeding such as:
  • heavy bleeding or bleeding difficult to stop;
  • unexpected bleeding or bleeding lasting a long time;
  • urine coloured pink, red, or brown;
  • vomiting blood or vomit that looks like coffee grounds;
  • stools coloured red or black (resembling tar);
  • coughing up 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 purplish 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 the doctor if the patient experiences:

• Shortness of breath – very common. It may be caused by heart disease or another condition, or it may be an adverse reaction to Kogavant. Shortness of breath associated with Kogavant treatment is usually mild and characterized by sudden, unexpected breathlessness, usually at rest. It may occur during the first few weeks of treatment and then not reappear for many weeks. If shortness of breath worsens or persists for a long time, contact the 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 vertigo
• Diarrhoea or indigestion
• Nausea
• Constipation
• Rash
• Itching
• Severe joint pain and swelling – symptoms of gout
• Dizziness, lightheadedness, or blurred vision – symptoms of low blood pressure
• Nosebleeds
• Bleeding after surgery or from 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 not listed in this leaflet, inform a 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 provide more information on the safety of this medicine.

5. How to store Kogavant

Keep this medicine out of the sight and reach of children.
No special storage instructions apply to this medicine.
Do not use this medicine after the expiry date stated on the carton and blister pack following:
"EXP". The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Kogavant contains

• The active substance is ticagrelor. Each tablet contains 60 mg of ticagrelor.
• The other ingredients are:
  Tablet core
  Mannitol
  Microcrystalline cellulose type 102
  Povidone K-25
  Sodium croscarmellose
  Magnesium stearate

Coating
Hypromellose 6 mPa·s (E464)
Titanium dioxide (E 171)
Macrogol 400 (E 1521)
Red iron oxide (E 172)
Black iron oxide (E 172)

What Kogavant looks like and contents of the pack
Round, biconvex, pink tablets with a diameter of approximately 8 mm, marked with an embossed "D4" on one side and smooth on the other.

Kogavant is available in:

• PVC/PVDC/Aluminium blister packs (symbols: sun/moon) containing 10 tablets; in 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; in 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 medicinal product is authorised in the European Economic Area countries under the following names:
Bulgaria: KOGAVANT 60 mg philmirani tabletki
Czech Republic: KOGAVANT
Estonia: KOGAVANT
Hungary: KOGAVANT 60 mg filmtabletta
Lithuania: KOGAVANT 60 mg plėvele dengtos tabletės
Poland: KOGAVANT
Romania: KOGAVANT 60 mg comprimate filmate
Slovakia: KOGAVANT 60 mg filmom obalené tablety

For further information about this medicinal product, 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]