Kardatuxan

Leaflet attached to the packaging: information for the user

KARDATUXAN, 10 mg, coated tablets

Rivaroxaban

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor. 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 and is used in adults to

• prevent the formation of blood clots in the veins after hip or knee replacement surgery. The doctor has prescribed this medicine because the risk of blood clot formation is increased after surgery.
• treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of 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 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 blood clotting (e.g., warfarin, dabigatran, apixaban, or heparin), except when switching anticoagulant therapy or when heparin is used to maintain catheter patency in a vein or artery,
• 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 these circumstances have occurred.

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, such as:
• moderate or severe kidney disease, as kidney function may affect the amount of medicine that works in the patient's body,
• if the patient is taking other medicines that prevent blood clotting (e.g., warfarin, dabigatran, apixaban, or heparin), except when switching anticoagulant therapy or when heparin is used to maintain catheter patency in a vein or artery (see "Kardatuxan and other medicines"),
• bleeding disorders,
• 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 (stomach acid flowing back into the esophagus) or tumors located in the stomach or intestines, or the genital or urinary system,
• vascular disease of the back of the eye (retinopathy),
• lung disease in which the airways 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 clot formation), the patient should inform their doctor, who will decide whether to change the treatment,
• if the patient has abnormal blood pressure or is scheduled for surgery or other treatment 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 monitored particularly closely.

If the patient needs to have surgery:

• they must follow the doctor's instructions regarding the intake of Kardatuxan at a strictly specified time before or after surgery,
• if spinal puncture or catheter insertion into the spine is planned during surgery (e.g., for epidural or spinal anesthesia or to reduce pain):
• they must follow the doctor's instructions regarding the intake of Kardatuxan at a strictly specified time,
• they should immediately inform their doctor if they experience symptoms such as numbness, weakness of the lower limbs, disorders of bowel or bladder function, or difficulty urinating, as immediate treatment may be necessary.

Children and adolescents

Kardatuxan 10 mg tablets are not recommended for people under 18 years of age. There is insufficient 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 currently taking or have recently taken, as well as any medicines you plan to take, including those 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 or 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 effect of Kardatuxan may be enhanced. The doctor will decide whether to use this medicine and whether the patient should be monitored particularly closely.
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 effect of Kardatuxan may be reduced. The doctor will decide whether to use Kardatuxan and whether the patient should be monitored particularly closely.

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 (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 bike, or operate tools or machines.

Kardatuxan contains lactose and sodium

If you have previously 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 it is considered "sodium-free".

3. How to take Kardatuxan

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

How many tablets to take

• To prevent blood clots in the veins after hip or knee replacement surgery, the recommended dose is one 10 mg Kardatuxan tablet taken once a day.
• 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, after at least 6 months of treatment for blood clots, the recommended dose is one 10 mg tablet once a day or one 20 mg tablet once a day. Your doctor has prescribed Kardatuxan 10 mg once a day for you.

Swallow the tablet whole, preferably with water.
Kardatuxan can be taken with or without food.
If you have difficulty swallowing the whole tablet, you should talk to your doctor about other ways to take Kardatuxan. The tablet can be crushed and mixed with water or soft food, such as apple sauce, immediately before taking it.
If necessary, your doctor may administer the crushed Kardatuxan tablet through a gastric tube.

When to take Kardatuxan

Take one tablet every day until your doctor decides to stop the treatment.
It is best to take the tablet at the same time every day, as it is easier to remember.
Your doctor will decide how long to continue the treatment.
To prevent blood clots in the veins of the legs after hip or knee replacement surgery:
The first tablet should be taken 6 to 10 hours after surgery.
In patients after major hip surgery, treatment usually lasts 5 weeks.
In patients after major knee surgery, treatment usually lasts 2 weeks.

Taking more Kardatuxan than prescribed

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

Missing a dose of Kardatuxan

If you have forgotten to take a dose, you should take the tablet as soon as you remember. Take the next tablet the next day, and then take the tablets as usual, once a day.
Do not take a double dose to make up for the missed tablet.

Stopping Kardatuxan treatment

You should not stop taking Kardatuxan without first talking to your doctor, as Kardatuxan prevents the occurrence of a serious disease.
If you have any further doubts about taking this medicine, you should consult 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 effect of reducing blood clot formation, Kardatuxan can cause bleeding, which can potentially be life-threatening. Excessive bleeding can lead to a sudden drop in blood pressure (shock). These may not always be obvious or visible signs of bleeding.
You should immediately inform your doctorif 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. You should immediately seek medical help!),
• prolonged or excessive bleeding,
• unusual weakness, fatigue, pallor, 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., in the mouth or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• drug reaction causing rash, fever, inflammation of internal organs, hematological 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; difficulty swallowing; 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)

• decrease in red blood cell count, which may cause pallor and be the cause of weakness or shortness of breath,
• bleeding from the stomach or intestine, bleeding from the urinary or genital system (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 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 your doctor)
• fever,
• stomach pain, nausea, feeling of nausea (nausea) or vomiting, constipation, diarrhea,
• low blood pressure (symptoms may include dizziness or fainting when standing up),
• general decrease in strength and 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 a 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 your 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 muscles,
• cholestasis (bile stagnation), hepatitis, including liver cell damage (inflammation of the liver, including liver damage),
• jaundice (yellowing of the skin and eyes),
• local swelling,
• accumulation of blood (hematoma) in the groin as a complication of cardiac 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 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 after bleeding).

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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 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 month.
There are no special precautions for storing 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. You should ask your pharmacist how to dispose of medicines that are no longer needed. 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 10 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, iron oxide red (E 172), triacetin.

What Kardatuxan looks like and what the pack contains

Kardatuxan 10 mg coated tablets are light pink, round, biconvex (diameter approximately 5.5 mm) with "D1" embossed on one side.
The tablets are:

• in blisters packed in cardboard boxes containing 5, 10, 14, 28, 30, 56, 90, 98, 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. The blisters contain 5, 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 10 mg филмирани таблетки
Czech Republic:
KARDATUXAN
Estonia:
KARDATUXAN
Hungary:
KARDATUXAN 10 mg filmtabletta
Latvia: KARDATUXAN 10 mg apvalkotās tabletes
Lithuania:
KARDATUXAN 10 mg plėvele dengtos tabletės
Poland: KARDATUXAN
Romania:
KARDATUXAN 10 mg comprimate filmate
Slovakia:
KARDATUXAN 10 mg filmom obalené tablety
To obtain more detailed information on this medicine, you should 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: June 2023