Kardatuxan

Package Leaflet: Information for the User

KARDATUXAN, 15 mg, coated tablets

KARDATUXAN, 20 mg, coated tablets

Rivaroxaban

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Kardatuxan and what is it 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 is Kardatuxan and what is it used for

Kardatuxan contains the active substance rivaroxaban.
Kardatuxan is used in adults to:

• prevent the formation of blood clots in the brain (stroke) and other blood vessels in the patient's body, if the patient has a type of irregular heartbeat called atrial fibrillation not caused by heart valve problems.
• treat blood clots in the veins of the legs (deep vein thrombosis) and blood vessels in the lungs (pulmonary embolism) and prevent the recurrence of blood clots in the blood vessels of the legs and/or lungs.

Kardatuxan belongs to a group of medicines called anticoagulants. Its action is based on
blocking the blood clotting factor (factor Xa) and thus reducing the tendency to form
blood clots.

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 the body that leads to an increased risk of serious bleeding (e.g. stomach ulcer, injury or bleeding into the brain, recent brain or eye surgery),
• if the patient is taking other medicines that prevent the formation of blood clots (e.g. warfarin, dabigatran, apixaban or heparin), except when changing anticoagulant treatment or when heparin is given to maintain the patency of a vein or artery catheter,
• if the patient has liver disease that leads to an increased risk of bleeding,
• if the patient is pregnant or breastfeeding.

Do not take Kardatuxan, and also inform your doctorif you suspect that you have any of the above conditions.

Warnings and precautions

Before starting to take Kardatuxan, consult your doctor or pharmacist.

When to be particularly careful when taking Kardatuxan

• if the patient has an increased risk of bleeding, in such conditions as:
• severe kidney disease in adults, as kidney function may affect the amount of medicine acting in the patient's body,
• bleeding disorders,
• taking other medicines that prevent the formation of blood clots (e.g. warfarin, dabigatran etexilate, apixaban or heparin) when changing anticoagulant treatment or when heparin is given to maintain the patency of a vein or artery catheter (see "Kardatuxan and other medicines"),
• very high blood pressure that does not decrease despite taking medicines,
• stomach or intestinal diseases that may cause bleeding, e.g. inflammation of the intestines and stomach or inflammation of the esophagus (throat and esophagus) e.g. due to reflux disease of the esophagus (backflow of stomach acid into the esophagus) or tumors located in the stomach or intestines, or the genital or urinary system,
• disease of the blood vessels in the back of the eyeballs (retinopathy),
• pulmonary disease in which the bronchi are dilated and filled with pus (bronchiectasis) or previous bleeding from the lungs,
• in patients with artificial heart valves,
• if the patient has a disorder called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), the patient should inform the doctor, who will decide on possible changes in treatment,
• if the patient has been diagnosed with abnormal blood pressure or a surgical procedure or other treatment is planned to remove a blood clot from the lungs.

If the patient suspects that they have any of the above conditions, they should inform

their doctorbefore taking Kardatuxan .The doctor will decide whether to use this medicine and whether the patient should be subject to particularly close monitoring.

If the patient needs to undergo surgery:

• it is very important to follow the doctor's instructions regarding the intake of Kardatuxan at a precisely specified time before or after surgery,
• if catheterization or spinal puncture is planned during surgery (e.g. for epidural or spinal anesthesia or pain relief):
• it is very important to take Kardatuxan before and after the puncture or catheter removal, in accordance with the doctor's instructions,
• due to the need for special caution, it is necessary to immediately inform the doctor if numbness or weakness of the legs, bowel or bladder disorders occur after the end of anesthesia.

Children and adolescents

Kardatuxan is not recommended for children and adolescents under 18 years of age.There are
insufficient data on the use of Kardatuxan in children and adolescents for the indications in adults.

Kardatuxan and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take, including those that are available without a prescription.

• If you are taking:
• certain medicines used to treat fungal infections (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only locally on the skin,
• ketokonazole in tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol),
• certain medicines used to treat bacterial infections (e.g. clarithromycin, erythromycin),
• certain antiviral medicines used to treat HIV or AIDS (e.g. ritonavir),
• other medicines used to reduce blood clotting (e.g. enoxaparin, clopidogrel or vitamin K antagonists, such as warfarin and acenocoumarol),
• 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 (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs)).

If the patient suspects that they have any of the above conditions, they should inform

their doctorbefore taking Kardatuxan ,as the action of Kardatuxan may be enhanced if taken with the above medicines. The doctor will decide whether to use this medicine and whether the patient should be subject to particularly close monitoring.
If the doctor considers that the patient is at increased risk of developing stomach or duodenal ulcers, they may use treatment to prevent ulcers.

• If you are taking
• certain medicines used to treat epilepsy (phenytoin, carbamazepine, phenobarbital),
• St. John's wort ( Hypericum perforatum), a herbal medicine used to treat depression,
• rifampicin, which belongs to a group of antibiotics.

If the patient suspects that they have any of the above conditions, they should inform

their doctorbefore taking Kardatuxan ,as the action of Kardatuxan may be reduced. The doctor will decide whether to use Kardatuxan and whether the patient should be subject to particularly close monitoring.

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, you should immediately inform your doctor, who will decide on further treatment.

Driving and using machines

Kardatuxan may cause dizziness (common side effects) and fainting (uncommon side effects) (see section 4 "Possible side effects"). Patients who experience these side effects should not drive vehicles, ride bicycles, or operate tools or machines.

Kardatuxan contains lactose and sodium.

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.
The medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means that the medicine is considered "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.
Kardatuxan should be taken with food.
Swallow the tablet(s) whole, preferably with water.
If you have difficulty swallowing whole tablets, you should talk to your doctor about other ways of taking Kardatuxan. The tablet can be crushed and mixed with water or apple sauce, just before taking it. Then you should eat a meal immediately.
If necessary, your doctor may give you a crushed Kardatuxan tablet through a gastric tube.

How many tablets to take

• Adults
• In the prevention of blood clots in the brain (stroke) and other blood vessels in the body. The recommended dose is one 20 mg Kardatuxan tablet once a day. If you have kidney problems, the dose may be reduced to one 15 mg Kardatuxan tablet once a day.

If you need a procedure to open up the blood vessels in the heart (called percutaneous coronary intervention - PCI with stent placement), there is limited evidence to support a dose reduction to one 15 mg Kardatuxan tablet once a day (or one 10 mg Kardatuxan tablet once a day in case of kidney problems) in combination with an antiplatelet agent such as clopidogrel.

• In the treatment of blood clots in the veins of the legs, blood clots in the blood vessels of the lungs, and to prevent the recurrence of blood clots. The recommended dose is one 15 mg Kardatuxan tablet twice a day for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one 20 mg Kardatuxan tablet once a day. After at least 6 months of treatment for blood clots, your doctor may decide to continue treatment with one 10 mg tablet once a day or one 20 mg tablet once a day. If you have kidney problems and are taking one 20 mg Kardatuxan tablet once a day, your doctor may decide to reduce the dose after 3 weeks of treatment to one 15 mg Kardatuxan tablet once a day, if the risk of bleeding is greater than the risk of further blood clots.

Do not divide the tablet to get a partial dose. If a smaller dose is needed, an alternative form of rivaroxaban (granules for oral suspension) should be used.
Patients who are unable to swallow whole tablets should use the granules for oral suspension.
If the oral suspension is not available, the Kardatuxan tablet can be crushed and mixed with water or apple sauce, just before taking it. After this mixture, you should eat a meal. If necessary, your doctor may also give you a crushed tablet through a gastric tube.

If you spit out the dose or vomit

• less than 30 minutes after taking Kardatuxan, you should take a new dose.
• more than 30 minutes after taking Kardatuxan, do nottake a new dose. In this case, the next dose of Kardatuxan should be taken at the usual time.

You should contact your doctor if you spit out the dose or vomit repeatedly after taking Kardatuxan.

When to take Kardatuxan

Take the tablet(s) every day until your doctor decides to stop treatment.
It is best to take the tablet(s) at the same time every day, as it is easier to remember.
Your doctor will decide how long you should continue treatment.
Prevention of blood clots in the brain (stroke) and other blood vessels in the body:
If your heart needs to be restored to a normal rhythm using a procedure called cardioversion, Kardatuxan should be taken as directed by your doctor.

Missed dose of Kardatuxan

• If you take one 20 mg or one 15 mg tablet oncea day and you miss a dose, you should take it as soon as possible. Do not take more than one tablet in a 24-hour period to make up for a missed dose. Take the next tablet at the usual time the next day, and then take one tablet once a day.
• If you take one 15 mg tablet twicea day and you miss a dose, you should take it as soon as possible. Do not take more than two 15 mg tablets in a 24-hour period. If you miss a dose, you can take two 15 mg tablets at the same time to get a total of two tablets (30 mg) in a 24-hour period. The next day, continue taking one 15 mg tablet twice a day.

Take more Kardatuxan than prescribed

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

Stop taking Kardatuxan

Do not stop taking Kardatuxan without first talking to your doctor, as Kardatuxan treats and prevents serious diseases.
If you have any further questions about the use of this medicine, 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 with a similar action that reduces blood clotting, Kardatuxan can cause bleeding, which can potentially be life-threatening. Excessive bleeding can lead to a sudden drop in blood pressure (shock). Not all of these will be obvious or visible signs of bleeding.

Immediately inform your doctor if you experience any of the following side effects:

• 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. Medical help should be sought immediately!),
• prolonged or excessive bleeding,
• unusual weakness, fatigue, 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, acute skin rash, blistering or changes to the mucous membranes, e.g. tongue or eyes (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; 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 affect up to 1 in 10 people)

• reduced red blood cell count, which may cause paleness and be the cause of weakness or shortness of breath,
• bleeding from the stomach or intestine, bleeding from the urinary tract (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding gums,
• bleeding into the eye (including bleeding from the conjunctiva),
• bleeding into tissues or body cavities (hematoma, bruising),
• blood in the sputum when coughing (hemoptysis),
• bleeding from the skin or subcutaneous bleeding,
• bleeding after surgery,
• oozing of blood or fluid from the wound after surgery,
• swelling of the limbs,
• limb pain,
• kidney function disorders (can be observed in tests performed by the doctor),
• fever,
• stomach pain, nausea (nausea) or vomiting, constipation, diarrhea,
• low blood pressure (symptoms may include dizziness or fainting when standing),
• general weakness and lack of energy (weakness, fatigue), headache, dizziness,
• rash, itching of the skin,
• increased activity of some 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 the joint, causing pain and swelling,
• thrombocytopenia (low platelet count, cells involved in blood clotting),
• allergic reactions, including allergic skin reactions,
• liver function disorders (can be observed in tests performed by the doctor),
• blood test results may show increased bilirubin levels, activity of some pancreatic or liver 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 stasis), 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 (pseudoaneurysm).

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

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

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

• kidney failure after severe bleeding,
• kidney bleeding, sometimes with blood in the urine, leading to kidney failure (nephropathy associated with anticoagulant drugs),
• increased pressure in the muscles of the legs and arms, occurring after bleeding, which can lead to pain, swelling, changes in sensation, numbness, or paralysis (compartment syndrome after bleeding).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 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 precautions for storage of the medicinal product.
Crushed tablets
Crushed tablets are stable in water or apple sauce 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 of Kardatuxan is rivaroxaban. Each tablet contains 15 mg or 20 mg of rivaroxaban.
• The other ingredients are: Tablet core: microcrystalline cellulose (type 101), sodium carmellose, lactose monohydrate, hypromellose 6cP, sodium lauryl sulfate, magnesium stearate. See section 2 "Kardatuxan contains lactose and sodium". Coating for 15 mg tablet: macrogol PEG 4000 (E 1521), hypromellose 6cP, titanium dioxide (E 171), lactose monohydrate, yellow iron oxide (E 172), red iron oxide (E 172), triacetin. Coating for 20 mg tablet: macrogol PEG 4000 (E 1521), hypromellose 6cP, titanium dioxide (E
• 171), lactose monohydrate, yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172), triacetin.

What Kardatuxan looks like and contents of the pack

Kardatuxan, 15 mg, coated tablets, are pink, round, biconvex (diameter approximately 6 mm) with "D2" embossed on one side.
Tablets are available:

• in blisters packed in cardboard boxes containing 10, 14, 28, 30, 42, 56, 90, 98 or 100 coated tablets or
• in single-dose blisters packed in cardboard boxes containing 10 x 1, 30 x 1, 90 x 1, 100 x 1 tablet.

Kardatuxan, 20 mg, coated tablets, are brown-red, round, biconvex (diameter approximately 7 mm) with "D3" embossed on one side.
Tablets are available:

• in blisters packed in cardboard boxes containing 10, 14, 28, 30, 56, 90, 98 or 100 coated tablets or
• in single-dose blisters packed in cardboard boxes containing 10 x 1, 30 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.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki

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

Bulgaria:
КАРДАТУКСАН 15 mg, 20 mg филмирани таблетки
Czech Republic:
KARDATUXAN
Estonia:
KARDATUXAN
Hungary:
KARDATUXAN 15 mg, 20 mg filmtabletta
Latvia: KARDATUXAN 15 mg, 20 mg apvalkotās tabletes
Lithuania:
KARDATUXAN 15 mg, 20 mg plėvele dengtos tabletės
Poland: KARDATUXAN
Romania:
KARDATUXAN 15 mg, 20 mg comprimate filmate
Slovakia:
KARDATUXAN 15 mg, 20 mg filmom obalené tablety
To obtain more detailed information on this medicine, please contact:
Gedeon Richter Polska Sp. z o.o.
Medical Department
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
phone: +48 (22) 755 96 48
[email protected]

Date of last revision of the leaflet: May 2024