Kogavant

Package Leaflet: Information for the User

KOGAVANT, 60 mg, film-coated tablets

Ticagrelor

Read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

• 1. What Kogavant is and what it is used for
• 2. Before you take 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 ticagrelor. It belongs to a group of medicines called antiplatelet medicines.

What Kogavant is used for

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

• a heart attack (myocardial infarction) or
• unstable angina (acute coronary syndrome - a type of severe chest pain caused by blockage of blood flow to the heart). The medicine reduces the risk of having another heart attack or stroke, or dying from a heart or blood vessel-related problem.

How Kogavant works

Kogavant works by affecting platelets (also called thrombocytes) in the blood. Platelets are very small blood cells that help stop bleeding by clumping together and blocking the damaged area of the blood vessel.

• A blockage (clot) can completely block the flow of blood - this can cause a heart attack (myocardial infarction) or stroke, or
• A blockage (clot) can cause a partial blockage of the blood vessels leading to the heart - this reduces blood flow to the heart and can cause chest pain (unstable angina).

Kogavant helps prevent platelets from clumping together and forming a blood clot that can cause a heart attack or stroke.

2. Before you take Kogavant

Do not take Kogavant:

• If you are allergic to ticagrelor or any of the other ingredients of this medicine (listed in section 6);
• If you are currently 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:
• ketokonazole (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 Kogavant if any of the above applies to you. If you are in doubt, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Before taking Kogavant, tell your doctor or pharmacist:

• If you have an increased risk of bleeding due to:
• a recent serious injury;
• recent surgery (including dental surgery - you should consult your dentist);
• a condition that affects blood clotting;
• recent bleeding from the stomach or intestines (such as stomach ulcers or intestinal polyps);
• If you are going to have surgery (including dental surgery) while taking Kogavant. This is because of the increased risk of bleeding. Your doctor may tell you to stop taking Kogavant 5 days before the planned surgery;
• If you have a slow heart rate (usually less than 60 beats per minute) and do not have a pacemaker;
• If you have asthma or other lung disease or breathing difficulties;
• If you develop breathing difficulties such as rapid breathing, slow breathing, or pauses in breathing. Your doctor will decide if further evaluation is needed;
• If you have any liver problems or have had a disease in the past that may have damaged your liver;
• If your blood test results show high levels of uric acid. You should tell your doctor or pharmacist if any of the above applies to you (or if you are unsure).

If you are taking Kogavant and heparin:

• Your doctor may take a blood sample to do diagnostic tests if they suspect a rare platelet disorder caused by heparin. It is important to tell your doctor that you are taking both Kogavant and heparin, as Kogavant may affect the results of the diagnostic test.

Children and adolescents

Kogavant should not be used in children and adolescents under 18 years of age.

Other medicines and Kogavant

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and any you plan to take. This is because Kogavant may affect the way other medicines work, and other medicines may affect Kogavant.

• rosuvastatin (used to lower cholesterol levels);
• simvastatin or lovastatin in doses greater than 40 mg per day (used to lower cholesterol levels);
• rifampicin (an antibiotic);
• phenytoin, carbamazepine, and phenobarbital (used to control seizures);
• digoxin (used to treat heart failure);
• cyclosporin (used to weaken the immune system);
• quinidine and diltiazem (used to treat irregular heartbeat);
• beta-blockers and verapamil (used to treat high blood pressure);
• morphine and other opioids (used to treat severe 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 called blood thinners, including warfarin;
• non-steroidal anti-inflammatory drugs (NSAIDs), often 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 ketokonazole (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 heartburn), and ergot alkaloids (used to treat migraines and headaches).

You should also tell your doctor if you are taking Kogavant and have an increased risk of bleeding if your doctor prescribes you fibrinolytic medicines, also known as clot-dissolving medicines, such as streptokinase or alteplase.

Pregnancy and breast-feeding

Kogavant should not be used during pregnancy or if you are planning to become pregnant. Women should use appropriate contraceptive methods to avoid becoming pregnant while taking this medicine. If you are breast-feeding, consult your doctor before taking this medicine. Your doctor will discuss the benefits and risks of taking Kogavant while breast-feeding. If you are pregnant, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

It is unlikely that Kogavant will affect your ability to drive or use machines. However, if you experience dizziness or confusion while taking this medicine, be careful when driving or using machines.

Sodium content

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which is essentially sodium-free.

3. How to take Kogavant

Always take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

How much to take

Heart attack (myocardial infarction)

• The usual dose is one 60 mg tablet twice a day. Continue taking Kogavant for as long as your doctor recommends.

Unstable angina (acute coronary syndrome)

• The initial dose is 180 mg once a day as a single dose (loading dose). This dose is usually given in a hospital.
• After the initial dose, the usual dose is one 90 mg tablet twice a day for up to 12 months, unless your doctor tells you otherwise. Since the 60 mg tablet cannot be divided into equal halves, it should not be used for further treatment of acute coronary syndrome, and Kogavant of the appropriate strength should be used instead. It is recommended to take this medicine at the same time every day (e.g., one tablet in the morning and one in the evening).

Taking Kogavant with other medicines that prevent blood clotting

Your doctor will usually prescribe acetylsalicylic acid to be taken with Kogavant. This is a substance found in many medicines that prevent blood clotting. Your doctor will tell you what dose to take (usually between 75 and 150 mg per day).

How to take Kogavant

• Tablets can be taken with or without food.
• You can check when you last took a tablet by looking at the blister pack. The blister pack has a sun symbol (for morning doses) and a moon symbol (for evening doses). These symbols show you when you took your last dose.

What to do if you have trouble swallowing the tablet

If you have trouble swallowing the tablet, you can crush it and mix it with water as follows:

• crush the tablet into a fine powder;
• put the powder into half a glass of water;
• mix and drink immediately;
• to make sure you take all the medicine, refill the glass with half a glass of water, rinse, and drink. If you are in the hospital, the tablet can be mixed with water and given through a nasogastric tube.

What to do if you take more Kogavant than you should

If you take more Kogavant than you should, contact your doctor or go to the hospital immediately. Take the medicine pack with you. You may be at risk of bleeding.

What to do if you forget to take Kogavant

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

What to do if you stop taking 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 having another heart attack or stroke, or dying from a heart or blood vessel-related problem. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:

Kogavant affects blood clotting, and most side effects are related to bleeding. Bleeding can occur anywhere in the body. Some bleeding is common (e.g., bruising and nosebleeds). Severe bleeding is uncommon but can be life-threatening.

Seek medical help immediately if you have any of the following symptoms - you may need urgent medical attention:

• Bleeding into the brain or inside the skull is an uncommon side effect and may cause stroke-like symptoms, such as:
• sudden numbness or weakness of the arms, legs, or face, especially if it occurs on one side of the body;
• sudden confusion, trouble speaking or understanding;
• sudden trouble walking, loss of balance or coordination;
• sudden dizziness or severe headache with no known cause;
• Signs of bleeding, such as:
• heavy or prolonged bleeding;
• unexpected or prolonged bleeding;
• urine that is pink, red, or brown;
• vomiting blood or material that looks like coffee grounds;
• stool that is red or black (like tar);
• coughing or vomiting blood clots;
• Fainting
• temporary loss of consciousness due to a sudden decrease 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 or in the mouth, with or without jaundice, unexplained extreme tiredness or confusion.

Tell your doctor if you have:

• Shortness of breath - this is very common.It may be caused by heart disease or another cause, or it may be a side effect of Kogavant. Shortness of breath related to Kogavant is usually mild and characterized by sudden, unexpected shortness of breath, usually at rest, which may occur during the first few weeks of treatment and then not occur for many weeks. If shortness of breath worsens or persists, consult your doctor. Your doctor will decide if treatment or further tests are needed.

Other possible side effects

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

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

Common (may affect up to 1 in 10 people)

• Formation of bruises
• Headache
• Feeling dizzy or lightheaded
• Diarrhea or indigestion
• Nausea (feeling sick)
• Constipation
• Rash
• Itching
• Increased pain and swelling of the joints - these are symptoms of gout
• Feeling dizzy or faint, or blurred vision - these are symptoms of low blood pressure
• Nosebleeds
• Bleeding after surgery or from cuts and wounds that is more than usual
• Bleeding from the stomach lining (stomach ulcers)
• 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)
• Vision problems due to blood in the eye
• Vaginal bleeding that is heavier or occurs at a different time than usual menstrual bleeding
• Bleeding into the joints and muscles, causing painful swelling
• Blood in the ear
• Internal bleeding, which can cause dizziness or fainting.

Rare (may affect up to 1 in 1,000 people)

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

Reporting of side effects

If you get 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 national reporting system listed in the website. By reporting side effects, you can help 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. There are no special storage instructions for this medicine. Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month. 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. Contents of the pack and other information

What Kogavant contains

• The active substance is ticagrelor. Each tablet contains 60 mg of ticagrelor.
• The other ingredients are: CoreMannitol 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 red (E 172)
Iron oxide black (E 172)

What Kogavant looks like and contents of the pack

Round, biconvex, pink tablets with a diameter of about 8 mm, with "D4" engraved on one side and a smooth surface on the other.

Kogavant is available in:

• PVC/PVDC/Aluminum blisters (sun/moon symbols) containing 10 tablets; in cardboard boxes containing 60 tablets (6 blisters) or 120 tablets (12 blisters).
• Calendar PVC/PVDC/Aluminum blisters (sun/moon symbols) 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 medicine is authorised in the Member States of the European Economic Area under the following names:

Bulgaria:
KOGAVANT 60 mg филмирани таблетки
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 more information on this medicine, 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]

Date of last revision of the leaflet: