Kardatuxan

Package leaflet: Information for the user

KARDATUXAN, 2.5 mg, coated tablets
Rivaroxabanum
Please read 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 a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

1. What Kardatuxan is and what it is used for
2. What you need to know 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 prescribed Kardatuxan because

• you have been diagnosed with acute coronary syndrome (a condition including heart attack and unstable angina, i.e. acute chest pain) and elevated levels of cardiac biomarkers have been detected. Kardatuxan reduces the risk of subsequent heart attack or the risk of death due to heart- or blood vessel-related disease in adults. Kardatuxan will not be given to you as a single treatment. Your doctor will also prescribe you:
• acetylsalicylic acid or
• acetylsalicylic acid 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 causing symptoms. Kardatuxan reduces the risk of blood clots (atherosclerotic thrombotic events) in adults. Kardatuxan will not be given to you as a single treatment. Your doctor will also prescribe you acetylsalicylic acid. In certain cases, if you are receiving Kardatuxan after a procedure to unblock a narrowed or blocked artery in the lower limb to restore blood flow, your doctor may also prescribe clopidogrel for you to take in addition to acetylsalicylic acid for a short period.

Kardatuxan contains the active substance rivaroxaban and belongs to a group of medicines called anticoagulants. It works by blocking a blood clotting factor (Factor Xa), thereby reducing the tendency for blood clots to form.

2. Important information before taking Kardatuxan

When not to take Kardatuxan

• if the patient is allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6),
• if the patient has excessive bleeding,
• if the patient has a disease or condition of an organ that leads to an increased risk of serious bleeding (e.g. stomach ulcer, trauma or bleeding into the brain, recent surgical procedure on the brain or eyes),
• if the patient is taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant therapy or if heparin is administered to maintain the patency of a venous or arterial catheter,
• if the patient has been diagnosed with acute coronary syndrome and has previously experienced bleeding or blood clot in the brain (stroke),
• if the patient has been diagnosed with coronary artery disease or peripheral arterial disease and has previously had bleeding in the brain (hemorrhagic stroke) or occlusion of small arteries supplying blood to tissues in deep brain structures (lacunar stroke), or if the patient has had a blood clot in the brain (ischemic, non-lacunar stroke) within the last month,
• if the patient has liver disease that leads to an increased risk of bleeding,
• if the patient is pregnant or breastfeeding. Do not use Kardatuxan and inform your doctor if you suspect any of the above circumstances apply.

Warnings and precautions
Before starting to take Kardatuxan, consult a doctor or pharmacist.
Kardatuxan should not be used in combination with other anticoagulant medicines besides acetylsalicylic acid, clopidogrel or ticlopidine, such as prasugrel or ticagrelor.
When to exercise special caution when taking Kardatuxan

• if the patient has an increased risk of bleeding, in conditions such as:
• severe kidney disease, as kidney function may affect the amount of medicine acting in the patient's body,
• taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin) when switching anticoagulant therapy or when heparin is administered to maintain the patency of a venous or arterial catheter (see section "Kardatuxan with other medicines"),
• coagulation disorders,
• very high blood pressure that does not decrease despite treatment with medication,
• diseases of the stomach or intestines that may cause bleeding, e.g. inflammation of the intestines and stomach or esophagitis (throat and esophagus), e.g. due to gastroesophageal reflux disease (backflow of stomach acid into the esophagus), or tumors located in the stomach, intestines, genital or urinary system,
• vascular disease of the posterior part of the eyeball (retinopathy),
• lung disease with bronchiectasis (dilated bronchi filled with pus) or previous pulmonary hemorrhage,
• if the patient is over 75 years of age,
• if the patient has a body weight less than 60 kg,
• coronary artery disease with severe symptomatic heart failure,
• in patients with prosthetic heart valves,
• if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing increased risk of clot formation), the patient should inform the doctor, who will decide whether treatment adjustment is necessary. If the patient suspects any of the above conditions apply, they should inform their doctor before taking Kardatuxan. The doctor will decide whether to use this medicine and whether the patient requires particularly close monitoring.

If the patient needs to undergo surgery:

• strictly follow the doctor's instructions regarding the timing of Kardatuxan administration before or after surgery,
• if spinal catheterization or puncture (e.g. for epidural or spinal anesthesia or pain relief) is planned during surgery,
• it is very important to take Kardatuxan before and after the puncture or catheter removal, as directed by the doctor,
• due to the need for special caution, immediately inform the doctor if numbness or weakness in the legs, bowel or bladder dysfunction occurs after anesthesia wears off.

Children and adolescents
Kardatuxan 2.5 mg tablets are not recommended for patients under 18 years of age. There is insufficient data on the use of this medicine in children and adolescents.
Kardatuxan with other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take, including those available without a prescription.

• If the patient is taking
• certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only topically on the skin,
• ketoconazole tablets (used in the treatment of Cushing's syndrome, in which the body produces excessive cortisol),
• certain antibiotics (e.g. clarithromycin, erythromycin),
• certain antiviral medicines used in HIV infection or AIDS treatment (e.g. ritonavir),
• other medicines used to reduce blood clotting (e.g. enoxaparin, clopidogrel or vitamin K antagonists such as warfarin or acenocoumarol, prasugrel and ticagrelor (see section "Warnings and precautions")),
• anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid),
• dronedarone, a medicine used to treat heart rhythm disorders,
• certain medicines used to treat depression (selective serotonin reuptake inhibitors (SSRI) or serotonin-norepinephrine reuptake inhibitors (SNRI)). If the patient suspects any of the above conditions apply, they should inform their doctor before taking Kardatuxan, as the effect of Kardatuxan may be enhanced. The doctor will decide whether to use this medicine and whether the patient requires particularly close monitoring. If the doctor considers the patient to be at increased risk of developing stomach or intestinal ulcers, they may prescribe preventive treatment to prevent ulcer formation.
• If the patient is taking
• certain medicines used to treat epilepsy (phenytoin, carbamazepine, phenobarbital),
• St. John's wort ( Hypericum perforatum ), an herbal medicine used for depression,
• rifampicin, an antibiotic. If the patient suspects any of the above conditions apply, they should inform their doctor before taking Kardatuxan, as the effect of Kardatuxan may be reduced when taken together with the above-mentioned medicines. The doctor will decide whether to use Kardatuxan and whether the patient requires particularly close monitoring.

Pregnancy and breastfeeding
Kardatuxan must not be used if the patient is pregnant or breastfeeding. If there is a risk that the patient may become pregnant, an effective method of contraception should be used during treatment with Kardatuxan. If the patient becomes pregnant while taking this medicine, she must immediately inform her doctor, who will decide on further management.

Driving and operating machinery
Kardatuxan may cause dizziness (common side effects) and fainting (uncommon side effects) (see section 4, "Possible side effects"). Patients experiencing these side effects should not drive, ride a bicycle, or operate tools or machinery.

Kardatuxan contains lactose and sodium.
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
The medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning the medicine is considered "sodium-free".

3. How to take Kardatuxan

This medicine should always be taken as prescribed by your doctor. If you have any doubts, you should contact your doctor or pharmacist.

How many tablets to take
The recommended dose is one 2.5 mg tablet twice daily. Kardatuxan should be taken at approximately the same time each day (for example, one tablet in the morning and one in the evening). This medicine may be taken with or without food.

If a patient has difficulty swallowing the whole tablet, they should discuss alternative ways of taking Kardatuxan with their doctor. The tablet may be crushed and mixed with water or soft food such as apple puree immediately before administration.

If necessary, the doctor may administer crushed Kardatuxan tablets via a gastric tube.

Kardatuxan will not be given to the patient as the only medication.

Your doctor will prescribe acetylsalicylic acid for the patient to take.

If the patient is receiving Kardatuxan after an acute coronary syndrome, the doctor may also prescribe clopidogrel or ticlopidine.

If the patient is receiving Kardatuxan after a procedure to restore blood flow in a narrowed or blocked artery of the lower limb, the doctor may also prescribe clopidogrel to be taken for a short period in addition to acetylsalicylic acid.

Your doctor will inform you of the doses of these medicines to take (usually 75–100 mg of acetylsalicylic acid per day, or a daily dose of 75–100 mg acetylsalicylic acid plus a daily dose of 75 mg clopidogrel, or the standard daily dose of ticlopidine).

When to take Kardatuxan
Treatment with Kardatuxan after acute coronary syndrome should be initiated as soon as possible after stabilization of the acute coronary syndrome, no earlier than 24 hours after hospital admission and at the time when parenteral (by injection) anticoagulant treatment would normally be discontinued.

Your doctor will inform 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 treatment should continue.

Taking more Kardatuxan than prescribed
If a patient has taken more than the prescribed dose of Kardatuxan, they should contact their doctor immediately. Taking too high a dose of Kardatuxan increases the risk of bleeding.

Missing a dose of Kardatuxan
Do not take a double dose to make up for a missed dose. If a patient misses a dose, they should take the next dose at the scheduled time.

Stopping Kardatuxan
Kardatuxan should be taken regularly and for the duration prescribed by the doctor.
Do not stop taking Kardatuxan without first consulting your doctor. Stopping treatment with this medicine may increase the risk of another heart attack, stroke, or death due to heart- or blood vessel-related disease.

If you have any further questions about the use of this medicine, please consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Kardatuxan may cause side effects, although not everyone will experience them.
Like other medicines with a similar mechanism of action that reduce blood clot formation, Kardatuxan may cause bleeding, which could potentially be life-threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). Signs of bleeding are not always obvious or visible.
You should contact your doctor immediately if any of the following side effects occur:

Signs of bleeding:

• Bleeding into the brain or inside the skull (symptoms may include headache, one-sided paralysis, vomiting, seizures, decreased level of consciousness, and neck stiffness. This is a serious medical emergency. Seek immediate medical help!),
• Prolonged or excessive bleeding,
• Unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain, or angina. Your doctor may decide that close monitoring or a change in treatment is necessary.

Signs of severe skin reactions:

• Widespread, acute skin rash, blistering, or mucosal lesions (e.g., in the mouth or eyes) (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Drug reaction with eosinophilia and systemic symptoms (DRESS), characterized by rash, fever, internal organ inflammation, hematological disorders, and systemic involvement. The frequency of these adverse reactions is very rare (up to 1 in 10,000 people).

Signs of severe allergic reactions:

• Swelling of the face, lips, mouth, tongue, or throat; urticaria and breathing difficulties; 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).

General list of possible side effects:
Common (may occur in 1 out of 10 people)

• Decrease in red blood cells, which may cause paleness of the skin and lead to weakness or shortness of breath,
• Bleeding from the stomach or intestines, bleeding from the urinary or genital tract (including blood in urine and heavy menstrual bleeding), nosebleeds, gum bleeding,
• Bleeding into the eye (including bleeding from the conjunctiva),
• Bleeding into tissues or body cavities (hematoma, bruising),
• Presence of blood in sputum (hemoptysis) during coughing,
• Bleeding from the skin or subcutaneous bleeding,
• Bleeding after surgery,
• Oozing of blood or fluid from a surgical wound,
• Swelling of the limbs,
• Limb pain,
• Kidney function disorders (may be observed in tests performed by a doctor),
• Fever,
• Stomach pain, indigestion, nausea, vomiting, constipation, diarrhea,
• Low blood pressure (symptoms may include dizziness or fainting upon standing),
• General decrease in strength and energy (weakness, fatigue), headache, dizziness,
• Rash, itching of the skin,
• Increased activity of certain liver enzymes, which may be evident in blood test results.

Uncommon (may occur in 1 out of 100 people)

• Bleeding into the brain or inside the skull (see signs of bleeding above),
• Bleeding into a joint causing pain and swelling,
• Thrombocytopenia (low platelet count, blood cells involved in clotting),
• Allergic reactions, including allergic skin reactions,
• Liver function disorders (may be observed in tests performed by a doctor),
• Blood tests may show increased levels of bilirubin, increased activity of certain pancreatic or liver enzymes, or increased platelet count,
• Fainting,
• Malaise,
• Rapid heartbeat,
• Dry mouth,
• Urticaria.

Rare (may occur in 1 out of 1,000 people)

• Bleeding into muscles,
• Cholestasis (bile stasis), hepatitis including liver cell damage,
• Yellowing of the skin and eyes (jaundice),
• Localized swelling,
• Blood collection (hematoma) in the groin as a complication of cardiac catheterization when the catheter is inserted into an artery in the leg (pseudoaneurysm).

Very rare (may occur in 1 out of 10,000 people)

• Accumulation of eosinophils, a type of white granulocytic blood cells, causing lung inflammation (eosinophilic pneumonia).

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

• Kidney failure following severe bleeding,
• Increased pressure within the muscles of arms or legs after bleeding, which may lead to pain, swelling, altered sensation, numbness, or paralysis (compartment syndrome following bleeding).

Reporting of side effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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 effects can also be reported to the marketing authorization holder.
Reporting of adverse effects helps to provide more information on the safety of the medicine.

5. How to store the medicine

Keep the medicine out of the sight and reach of children.
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 specified month.
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 must 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 Kardatuxan contains

• The active substance is rivaroxaban. Each tablet contains 2.5 mg of rivaroxaban.
• 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 film-coated tablets are yellow, round, biconvex (approximately 5.5 mm in diameter), with "D0" embossed on one side.
The tablets are contained:

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

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 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

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]