KOGAVANT 90 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. KOGAVANT, 90 mg, film-coated tablets
   1. Read all of this leaflet carefully before taking this medicine because it contains important information for you.
   2. Contents of the pack and other information
3. What Kogavant is and what it is used for
   1. What Kogavant is
   2. What Kogavant is used for
   3. How Kogavant works
4. What you need to know before you take Kogavant
   1. Do not take Kogavant
   2. Warnings and precautions
   3. Children and adolescents
   4. Other medicines and Kogavant
   5. Pregnancy and breast-feeding
   6. Driving and using machines
   7. Sodium content
5. How to take Kogavant
   1. How much to take
   2. Taking Kogavant with other anti-clotting medicines
   3. How to take Kogavant
   4. What to do if you have difficulty swallowing the tablet
   5. What to do if you take more Kogavant than you should
   6. What to do if you forget to take Kogavant
   7. What to do if you stop taking Kogavant
6. Possible side effects
   1. Stop taking Kogavant and seek medical help immediately if you notice any of the following serious side effects
   2. Tell your doctor if you notice any of the following side effects
   3. Other possible side effects
   4. Very common (may affect more than 1 in 10 people)
   5. Common (may affect up to 1 in 10 people)
   6. Frequency not known (cannot be estimated from the available data)
   7. Reporting of side effects
7. How to store Kogavant
8. Contents of the pack and other information
   1. What Kogavant contains
   2. What Kogavant looks like and contents of the pack
   3. Marketing Authorisation Holder and Manufacturer
   4. This medicine is authorised in the Member States of the European Economic Area under the following names:
   5. Date of last revision of the leaflet:

Package Leaflet: Information for the User

KOGAVANT, 90 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. What you need to know 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, which belongs to a group of medicines called antiplatelet medicines.

What Kogavant is used for

Kogavant is used in adults to prevent a heart attack or stroke in people who have had a heart attack or have a condition known as acute coronary syndrome (which includes conditions such as unstable angina or certain types of heart attack). Kogavant is used in combination with acetylsalicylic acid (another antiplatelet medicine) to reduce the rate of heart attacks and strokes.

How Kogavant works

Kogavant works by preventing the formation of blood clots. It does this by blocking a chemical that is involved in the formation of blood clots.

2. What you need to know 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 have active 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)

Warnings and precautions

Before taking Kogavant, tell your doctor or pharmacist if:

• You have an increased risk of bleeding due to:
• recent severe injury
• recent surgery (including dental surgery - consult your dentist)
• a condition that affects blood clotting
• recent bleeding from the stomach or intestines (such as stomach ulcers or intestinal polyps)
• You will be having surgery (including dental surgery) while taking Kogavant. Your doctor may tell you to stop taking Kogavant for 5 days before surgery.
• You have a slow heart rate (usually less than 60 beats per minute) and do not have a pacemaker.
• You have asthma or other lung diseases or breathing difficulties.
• You develop breathing difficulties such as rapid breathing, slow breathing, or pauses in breathing. Your doctor will decide if further evaluation is needed.
• You have any liver problems or have had a liver disease in the past.
• Your blood tests show high levels of uric acid. Tell your doctor or pharmacist if any of these apply to you.

If you are taking Kogavant and heparin:

• Your doctor may take a blood sample to check for a rare blood clotting disorder caused by heparin. It is important to tell your doctor that you are taking Kogavant and heparin, as Kogavant may affect the results of this test.

Children and adolescents

Kogavant is not recommended for children and adolescents under 18 years of age.

Other medicines and Kogavant

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

• 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 suppress 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)

Particularly 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), such as 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)

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

Do not take Kogavant if you are pregnant or think you may be pregnant. Women of childbearing potential should use appropriate contraceptive methods to prevent pregnancy while taking Kogavant. If you are breast-feeding, tell your doctor before taking Kogavant. Your doctor will discuss the benefits and risks of taking Kogavant while breast-feeding.

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 Kogavant, 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 not sure, check with your doctor or pharmacist.

How much to take

Heart attack (myocardial infarction)

• The usual dose is 60 mg twice a day. Continue taking Kogavant for as long as your doctor recommends. For long-term treatment, use the 60 mg tablets available on the market, as the 90 mg tablets cannot be divided into equal parts.

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.
• 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 anti-clotting medicines

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

How to take Kogavant

• You can take the tablets 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 help you remember when you took your last dose.

What to do if you have difficulty swallowing the tablet

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

• crush the tablet into a fine powder
• add the powder to half a glass of water
• mix and drink immediately
• to make sure you take all of the medicine, add another half glass of water, swirl, and drink

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 first. You should take Kogavant regularly and for as long as your doctor recommends. Stopping Kogavant may increase your risk of having another heart attack or stroke.

4. Possible side effects

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

Stop taking Kogavant and seek medical help immediately if you notice any of the following serious side effects

• Bleeding in 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
• Bleeding symptoms, such as:
• heavy or prolonged bleeding
• unexpected bleeding or bleeding that lasts a long time
• 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 caused by a sudden decrease 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 severe tiredness or confusion

Tell your doctor if you notice any of the following side effects

• Shortness of breath - very common.This may be caused by heart disease or another cause, or it may be a side effect of Kogavant. Shortness of breath associated with Kogavant is usually mild and characterized by sudden, unexpected shortness of breath at rest, which may occur during the first few weeks of treatment and then resolve for many weeks. If shortness of breath worsens or persists, contact your doctor. Your doctor will decide if treatment or further evaluation is 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 caused by blood disorders

Common (may affect up to 1 in 10 people)

• Bruising
• Headache
• Dizziness or feeling dizzy or lightheaded
• Diarrhea or indigestion
• Nausea (feeling sick)
• Constipation
• Rash
• Itching
• Increased pain and swelling of the joints - symptoms of gout
• Dizziness or lightheadedness or blurred vision - symptoms of low blood pressure
• Nosebleeds
• Bleeding after surgery or from cuts and wounds that is more than usual
• Bleeding from the stomach (stomach ulcers)
• Bleeding gums

Uncommon (may affect up to 1 in 100 people)

• Allergic reactions - rash, itching, swelling of the face or lips/tongue, which may be signs of an allergic reaction
• Disorientation (confusion)
• Vision disturbances caused by bleeding in the eye
• Vaginal bleeding that is heavier or occurs at a different time than your regular menstrual period
• Bleeding into the 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 the available data)

• 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.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. 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 90 mg of ticagrelor.
• The other ingredients are:

Core: mannitol, microcrystalline cellulose, povidone K-25, sodium croscarmellose, magnesium stearate

Coating: hypromellose 6 mPas (E464), titanium dioxide (E 171), macrogol 400 (E 1521), yellow iron oxide (E 172), talc

What Kogavant looks like and contents of the pack

Yellow, round, biconvex film-coated tablets, approximately 9.5 mm in diameter, with "D5" engraved on one side and a smooth surface on the other.

Kogavant is available in:

• PVC/PVDC/Aluminium blister packs (sun/moon symbols) containing 10 tablets; in cardboard boxes containing 60 tablets (6 blisters) or 120 tablets (12 blisters)
• Calendar PVC/PVDC/Aluminium blister packs (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 90 mg филмирани таблетки

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 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: