Kardatuxan

Package Leaflet: Information for the User

KARDATUXAN, 2.5 mg, coated tablets

Rivaroxaban

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

1. What Kardatuxan is and what it is used for

You have been given Kardatuxan because

• you have been diagnosed with acute coronary syndrome (a condition where the blood flow to your heart is suddenly blocked) and have elevated levels of cardiac biomarkers. Kardatuxan reduces the risk of having another heart attack or reduces the risk of death from a heart or blood vessel condition in adults. Kardatuxan will not be given to you as the only medicine. Your doctor will also ask you to take:
• aspirin or
• aspirin and clopidogrel or ticlopidine.

or

• you have been diagnosed with a high risk of blood clots due to coronary artery disease or peripheral arterial disease, which causes symptoms. Kardatuxan reduces the risk of blood clots (atherothrombotic events) in adults. Kardatuxan will not be given to you as the only medicine. Your doctor will also ask you to take aspirin. In some cases, if you are given Kardatuxan after a procedure to open up a narrowed or blocked artery in your leg to restore blood flow, your doctor may also prescribe clopidogrel for you to take for a short time in addition to aspirin.

Kardatuxan contains the active substance rivaroxaban and belongs to a group of medicines called anticoagulants. Its action is to block the blood clotting factor (factor Xa) and thereby reduce the tendency to form blood clots.

2. Important information before taking Kardatuxan

When not to take Kardatuxan

• if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6),
• if you have excessive bleeding,
• if you have a disease or condition of the body that increases the risk of serious bleeding (e.g. stomach ulcer, injury or bleeding in the brain, recent brain or eye surgery),
• if you are taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant therapy or when heparin is given to maintain patency of a venous or arterial catheter,
• if you have had acute coronary syndrome and have had bleeding or a blood clot in the brain (stroke),
• if you have coronary artery disease or peripheral arterial disease and have had bleeding in the brain (stroke) or blockage of small arteries supplying blood to the tissues in the deep structures of the brain (sinus thrombosis) or if you have had a blood clot in the brain (ischemic stroke) in the last month),
• if you have liver disease that increases the risk of bleeding,
• if you are pregnant or breastfeeding. Do not take Kardatuxan and inform your doctorif you think you may have any of the above conditions.

Warnings and precautions

Before taking Kardatuxan, tell your doctor or pharmacist. Kardatuxan should not be taken with other blood clotting inhibitors, such as prasugrel or ticagrelor, except for aspirin, clopidogrel or ticlopidine.

When to be extra careful while taking Kardatuxan

• if you have an increased risk of bleeding, such as:
• severe kidney disease, as kidney function may affect the amount of medicine that works in your body,
• taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin) when switching anticoagulant therapy or when heparin is given to maintain patency of a venous or arterial catheter (see "Kardatuxan and other medicines"),
• bleeding disorders,
• very high blood pressure that does not decrease despite treatment,
• stomach or intestinal diseases that may cause bleeding, such as inflammation of the stomach and intestines or esophagitis (e.g. due to reflux disease), or tumors in the stomach, intestines, genital or urinary tract,
• disease of the blood vessels in the back of the eye (retinopathy),
• lung disease where the airways are enlarged and filled with pus (bronchiectasis) or previous bleeding from the lungs,
• if you are over 75 years old,
• if you weigh less than 60 kg,
• coronary artery disease with severe symptomatic heart failure,
• in patients with prosthetic heart valves,
• if you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), you should inform your doctor, who will decide whether to change your treatment.

If you think you may have any of the above conditions, tell your doctor

before taking Kardatuxan. Your doctor will decide whether to give you this medicine and whether you need to be closely monitored.

If you need to have surgery:

• you must follow your doctor's instructions exactly regarding when to take Kardatuxan before or after surgery,
• if catheterization or spinal puncture is planned (e.g. for epidural or spinal anesthesia or pain relief)
• it is very important to take Kardatuxan before and after the puncture or removal of the catheter, as instructed by your doctor
• due to the need for extra caution, you should immediately inform your doctor if you experience numbness or weakness in your legs, bowel or bladder problems after anesthesia.

Children and adolescents

Kardatuxan 2.5 mg tablets are not recommended for people under 18 years of age. There is not enough data on the use of this medicine in children and adolescents.

Kardatuxan and other medicines

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

• If you are taking
• certain medicines for fungal infections (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only locally on the skin,
• ketokonazole tablets (used to treat Cushing's syndrome, a condition where the body produces too much cortisol),
• certain medicines for bacterial infections (e.g. clarithromycin, erythromycin),
• certain antiviral medicines for HIV or AIDS (e.g. ritonavir),
• other medicines that reduce blood clotting (e.g. enoxaparin, clopidogrel or vitamin K antagonists, such as warfarin or acenocoumarol, prasugrel and ticagrelor (see "Warnings and precautions")),
• anti-inflammatory and pain-relieving medicines (e.g. naproxen or aspirin),
• dronedarone, a medicine for irregular heart rhythm,
• certain medicines for depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and noradrenaline reuptake inhibitors (SNRIs)).

If you think you may have any of the above conditions, tell your doctor

before taking Kardatuxan, as the effect of Kardatuxan may be increased. Your doctor will decide whether to give you this medicine and whether you need to be closely monitored.
If your doctor thinks you are at increased risk of stomach or intestinal ulcers, they may give you a medicine to prevent ulcers.

• If you are taking
• certain medicines for epilepsy (phenytoin, carbamazepine, phenobarbital),
• St. John's Wort (Hypericum perforatum), a herbal medicine used for depression,
• rifampicin, an antibiotic.

If you think you may have any of the above conditions, tell your doctor

before taking Kardatuxan, as the effect of Kardatuxan may be reduced if taken with these medicines. Your doctor will decide whether to give you Kardatuxan and whether you need to be closely monitored.

Pregnancy and breastfeeding

Do not take Kardatuxan if you are pregnant or breastfeeding. If there is a risk that you may become pregnant, you should use effective contraception while taking Kardatuxan. If you become pregnant while taking this medicine, tell your doctor immediately, who will decide on further treatment.

Driving and using machines

Kardatuxan may cause dizziness (a common side effect) and fainting (an uncommon side effect) (see section 4, "Possible side effects"). Patients who experience these side effects should not drive, ride a bicycle or operate machinery.

Kardatuxan contains lactose and sodium

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.
The medicine contains less than 1 mmol sodium (23 mg) per tablet, which means it is essentially "sodium-free".

3. How to take Kardatuxan

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

How much to take

The recommended dose is one 2.5 mg tablet twice a day. Kardatuxan should be taken at the same time every day (e.g. one tablet in the morning and one in the evening). This medicine can be taken with or without food.
If you have difficulty swallowing the whole tablet, talk to your doctor about other ways to take Kardatuxan. The tablet can be crushed and mixed with water or a soft food, such as apple puree, just before taking it.
If necessary, your doctor may give you a crushed Kardatuxan tablet through a gastric tube.
Kardatuxan will not be given to you as the only medicine.
Your doctor will ask you to take aspirin.
If you are given Kardatuxan after acute coronary syndrome, your doctor may also ask you to take clopidogrel or ticlopidine.
If you are given Kardatuxan after a procedure to open up a narrowed or blocked artery in your leg to restore blood flow, your doctor may prescribe clopidogrel for you to take for a short time in addition to aspirin.
Your doctor will tell you how much of these medicines to take (usually 75-100 mg of aspirin per day or a daily dose of 75-100 mg of aspirin plus a daily dose of 75 mg of clopidogrel or a standard daily dose of ticlopidine).

When to take Kardatuxan

Treatment with Kardatuxan after acute coronary syndrome should be started as soon as possible after stabilization of acute coronary syndrome, at the latest 24 hours after hospitalization and when parenteral (injected) anticoagulant therapy would normally be discontinued.
Your doctor will tell you when to start treatment with Kardatuxan if you have been diagnosed with coronary artery disease or peripheral arterial disease.
Your doctor will decide how long to continue treatment.

If you take more Kardatuxan than you should

If you take more Kardatuxan than you should, contact your doctor immediately. Taking too much Kardatuxan increases the risk of bleeding.

If you forget to take Kardatuxan

Do not take a double dose to make up for a forgotten dose. If you miss a dose, take the next dose at the scheduled time.

If you stop taking Kardatuxan

Kardatuxan should be taken regularly and for the duration recommended by your doctor.
Do not stop taking Kardatuxan without first talking to your doctor. If you stop taking this medicine, you may increase your risk of having another heart attack, stroke or death from a heart or blood vessel condition.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Kardatuxan can cause side effects, although not everybody gets them.
Like other medicines that reduce blood clotting, Kardatuxan may cause bleeding, which can be life-threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). Not all of these signs of bleeding will be obvious or visible.

Signs of bleeding:

• bleeding into the brain or inside the skull (symptoms may include headache, one-sided weakness, vomiting, seizures, decreased level of consciousness and stiffness of the neck. A serious medical emergency. Seek medical attention immediately!),
• prolonged or excessive bleeding,
• unusual weakness, tiredness, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina. Your doctor may decide to monitor you closely or change your treatment.

Signs of severe skin reactions:

• widespread, severe skin rash, blistering or peeling of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• a drug reaction that causes a rash, fever, inflammation of internal organs, blood disorders and systemic disorders (DRESS syndrome). The frequency of these side effects is very rare (up to 1 in 10,000 people).

Signs of severe allergic reactions

• swelling of the face, lips, mouth, tongue or throat; hives and difficulty breathing; a sudden drop in blood pressure. The frequency of severe allergic reactions is very rare (anaphylactic reactions, including anaphylactic shock, may occur in up to 1 in 10,000 people) and uncommon (angioedema and allergic edema may occur in 1 in 100 people).

Full list of possible side effects:

Common(may affect up to 1 in 10 people)

• reduced number of red blood cells, which can cause paleness and be the reason for weakness or shortness of breath,
• bleeding from the stomach or intestines, bleeding from the urinary or genital tract (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding from the gums,
• bleeding into the eye (including bleeding from the conjunctiva),
• bleeding into tissues or body cavities (hematoma, bruising),
• appearance of blood in sputum (hemoptysis) while coughing,
• bleeding from the skin or bleeding under the skin,
• bleeding after surgery,
• oozing of blood or fluid from the wound after surgery,
• swelling of the limbs,
• limb pain,
• kidney problems (which can be seen in tests performed by your doctor),
• fever,
• stomach pain, nausea (nausea) or vomiting, constipation, diarrhea,
• low blood pressure (symptoms may include dizziness or fainting when standing up),
• general weakness and lack of energy (weakness, fatigue), headache, dizziness,
• rash, itching of the skin,
• increased activity of certain liver enzymes, which can be seen in blood test results.

Uncommon(may affect up to 1 in 100 people)

• bleeding into the brain or inside the skull (see above signs of bleeding),
• bleeding into a joint, causing pain and swelling,
• thrombocytopenia (low platelet count, cells involved in blood clotting),
• allergic reactions, including allergic skin reactions,
• liver problems (which can be seen in tests performed by your doctor),
• blood test results may show increased levels of bilirubin, certain liver or pancreatic enzymes, or platelet count,
• fainting,
• malaise,
• rapid heartbeat,
• dry mouth,
• hives.

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

• bleeding into the muscles,
• cholestasis (bile stagnation), hepatitis, including liver cell damage,
• jaundice (yellowing of the skin and eyes),
• local swelling,
• blood accumulation (hematoma) in the groin as a complication of heart catheterization, when a catheter is inserted into an artery in the leg.

Very rare(may affect up to 1 in 10,000 people)

• accumulation of eosinophils, a type of white granular blood cells that cause inflammation in the lungs (eosinophilic pneumonia).

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

• kidney failure after severe bleeding,
• increased pressure in the muscles of the legs and arms, which can cause pain, swelling, changes in sensation, numbness or paralysis (compartment syndrome due to bleeding).

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Jerozolimskie Avenue 181C,
02-222 Warsaw,
Phone: +48 22 49 21 301,
Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Kardatuxan

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 carton and blister after "EXP". The expiry date refers to the last day of that month.
There are no special storage instructions for this medicinal product.
Crushed tablets
Crushed tablets are stable in water or apple puree for up to 4 hours.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Kardatuxan contains

• The active substance is rivaroxaban. Each tablet contains 2.5 mg of rivaroxaban.
• The other ingredients are: Tablet core: microcrystalline cellulose (type 101), sodium croscarmellose, lactose monohydrate, hypromellose 6cP, sodium lauryl sulfate, magnesium stearate. See section 2 "Kardatuxan contains lactose and sodium". Tablet coating: macrogol PEG 4000 (E 1521), hypromellose 6cP, titanium dioxide (E 171), lactose monohydrate, yellow iron oxide (E 172), triacetin.

What Kardatuxan looks like and contents of the pack

Kardatuxan 2.5 mg coated tablets are yellow, round, biconvex (diameter approximately 5.5 mm) with "D0" embossed on one side.
Tablets are available:

• in blisters packed in cardboard boxes containing 14, 20, 28, 30, 56, 60, 90, 98, 100, 168 or 196 coated tablets or
• in single-dose blisters packed in cardboard boxes containing 20 x 1, 30 x 1, 60 x 1, 90 x 1, 100 x 1 tablet. Blisters contain 10 or 14 coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Gedeon Richter Polska Sp. z o.o.
Poniatowskiego 5 Street
05-825 Grodzisk Mazowiecki

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

Bulgaria:

КАРДАТУКСАН 2,5 mg филмирани таблетки

Czech Republic:

KARDATUXAN

Estonia:

KARDATUXAN

Hungary:

KARDATUXAN 2,5 mg filmtabletta

Latvia:

KARDATUXAN 2,5 mg apvalkotās tabletes

Lithuania:

KARDATUXAN 2,5 mg plėvele dengtos tabletės

Poland:

KARDATUXAN

Romania:

KARDATUXAN 2,5 mg comprimate filmate

Slovakia:

KARDATUXAN 2,5 mg filmom obalené tablety

To obtain more detailed information on this medicine, please contact:
Gedeon Richter Polska Sp. z o.o.
Medical Department
Poniatowskiego 5 Street
05-825 Grodzisk Mazowiecki
Phone: +48 (22) 755 96 48
[email protected]

Date of last revision of the leaflet: June 2023