Kardatuxan

Package leaflet: Information for the user

KARDATUXAN, 10 mg, film-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, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. 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 any not listed in this leaflet, please tell your doctor. 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

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

• prevent blood clots in the veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because your risk of developing blood clots 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 to prevent further development of blood clots in the blood vessels of the legs and/or lungs.

Kardatuxan 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 surgery 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 an intravenous or arterial catheter,
• if the patient has a liver disease that leads to an increased risk of bleeding,
• if the patient is pregnant or breastfeeding. Do not use Kardatuxan, and also inform the doctor if the patient suspects that any of the above circumstances apply.

Warnings and precautions
Before starting to take Kardatuxan, consult a doctor or pharmacist.
When to exercise special caution when taking Kardatuxan

• if the patient has an increased risk of bleeding, such as in the following conditions:
• moderate or severe kidney disease, as kidney function may affect the amount of medicine acting 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 if heparin is administered to maintain the patency of an intravenous or arterial catheter (see section "Kardatuxan with other medicines"),
• coagulation disorders,
• very high blood pressure that does not decrease despite medication,
• diseases of the stomach or intestines that may cause bleeding, e.g. inflammation of the intestines and stomach or oesophagitis (throat and oesophagus), e.g. due to gastro-oesophageal reflux disease (backflow of stomach acid into the oesophagus) or tumours located in the stomach or intestines, or in the reproductive or urinary system,
• blood vessel disease in the back of the eye (retinopathy),
• lung disease with bronchiectasis (dilated bronchi filled with pus) or previous lung bleeding,
• in patients with prosthetic heart valves,
• if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing an increased risk of blood clots), the patient should inform the doctor, who will decide whether a change in treatment is necessary,
• if the patient has abnormal blood pressure or if surgery or other treatment to remove a pulmonary embolism is planned.

If the patient suspects that any of the above conditions apply, they should inform the doctor
before taking Kardatuxan. The doctor will decide whether to use this medicine and whether the
patient should be placed under particularly close observation.
If the patient needs to undergo surgery:

• it is essential to strictly follow the doctor's instructions regarding the timing of taking Kardatuxan before or after surgery,
• if during the surgical procedure a lumbar puncture or placement of a catheter into the spine is planned (e.g. for epidural or spinal anaesthesia or for pain relief):
• it is essential to strictly follow the doctor's instructions regarding the timing of taking Kardatuxan,
• the patient should immediately inform the doctor if, after the anaesthesia ends, symptoms such as numbness, weakness of the lower limbs, or disturbances in bowel or bladder function occur, as immediate treatment will be necessary in such cases.

Children and adolescents
Kardatuxan 10 mg tablets are not recommended for patients under 18 years of age. There is
insufficient data on the use of the medicine in children and adolescents.
Kardatuxan with other medicines
Tell 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 too much 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),
• 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-noradrenaline reuptake inhibitors (SNRI)). If the patient suspects that any of the above conditions apply, they should inform the 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 should be placed under particularly close observation. If the doctor considers that the patient has an increased risk of developing gastric or duodenal ulcer, they may prescribe treatment to prevent peptic ulcer disease.
• If the patient is taking
• certain medicines used to treat epilepsy (phenytoin, carbamazepine, phenobarbital),
• St. John's wort ( Hypericum perforatum ), a herbal remedy used for depression,
• rifampicin, which belongs to the group of antibiotics. If the patient suspects that any of the above conditions apply, they should inform the doctor before taking Kardatuxan, as the effect of Kardatuxan may be reduced. The doctor will decide whether to use Kardatuxan and whether the patient should be placed under particularly close observation.

Pregnancy and breastfeeding
Do not use Kardatuxan 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, they should immediately inform the doctor, who will decide on further treatment.
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 contact 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 the doctor. If in doubt, consult your doctor or pharmacist.

How many tablets to take

• To prevent blood clots in veins after hip or knee replacement surgery: The recommended dose is one Kardatuxan 10 mg tablet taken once daily.
• For the treatment of blood clots in the leg veins, blood clots in the blood vessels of the lungs, and to prevent recurrence of blood clots: After at least 6 months of treatment for blood clots, the recommended dose is one 10 mg tablet once daily or one 20 mg tablet once daily. Your doctor has prescribed Kardatuxan 10 mg once daily.

The tablet should be swallowed whole, preferably with water.
Kardatuxan may be taken with or without food.
If you have difficulty swallowing the whole tablet, discuss alternative ways of taking Kardatuxan with your doctor. The tablet may be crushed and mixed with water or soft food such as apple puree immediately before administration.
If necessary, your doctor may administer crushed Kardatuxan tablets through a gastric tube.

When to take Kardatuxan
Take one tablet every day until your doctor decides to stop treatment.
It is best to take the tablet at the same time each day, as this makes it easier to remember.
Your doctor will decide how long treatment should continue.

To prevent blood clots in the leg veins after hip or knee replacement surgery:
The first tablet should be taken between 6 and 10 hours after surgery.
For patients undergoing major hip surgery, treatment usually lasts 5 weeks.
For patients undergoing major knee surgery, treatment usually lasts 2 weeks.

Taking more Kardatuxan than recommended
If you have taken more Kardatuxan than prescribed, contact your doctor immediately. Taking too high a dose of Kardatuxan increases the risk of bleeding.

If you forget to take Kardatuxan
If you forget to take a dose, take it as soon as you remember. Take the next tablet the following day, and then continue taking the tablets as usual, once daily.
Do not take a double dose to make up for a missed tablet.

Stopping Kardatuxan
Do not stop taking Kardatuxan without first talking to your doctor, as Kardatuxan helps prevent a serious condition.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Like other medicines with a similar mechanism of action that reduce blood clot formation, Kardatuxan
may cause bleeding, which potentially could 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 adverse reactions 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, acute medical emergency. Immediate medical assistance must be sought!),
• prolonged or excessive bleeding,
• unusual weakness, fatigue, pallor, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina. Your doctor may decide that close monitoring of the patient 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 syndrome), characterized by rash, fever, internal organ inflammation, hematological and systemic disorders. The frequency of these adverse reactions is very rare (occurring in up to 1 in 10,000 people).
• Signs of severe allergic reactions:
• swelling of the face, lips, oral cavity, tongue or throat; difficulty swallowing; urticaria and breathing difficulties; sudden drop in blood pressure. The frequency of severe hypersensitivity 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 adverse reactions:
Common (may occur in up to 1 in 10 people)

• reduced number of red blood cells, which may cause skin pallor and lead to weakness or shortness of breath,
• gastrointestinal or intestinal bleeding, 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 sclera),
• bleeding into tissues or body cavities (hematoma, bruising),
• presence of blood in sputum (hemoptysis) during coughing,
• bleeding from the skin or subcutaneous bleeding,
• postoperative bleeding,
• oozing of blood or fluid from a surgical wound,
• limb swelling,
• limb pain,
• kidney function disorders (may be observed in tests performed by a doctor),
• fever,
• stomach pain, indigestion, nausea or vomiting, constipation, diarrhea,
• low arterial blood pressure (symptoms may include dizziness or fainting upon standing),
• general loss of 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 up to 1 in 100 people)

• bleeding into the brain or within the skull (see signs of bleeding above),
• bleeding into a joint causing pain and swelling,
• thrombocytopenia (low platelet count, the blood cells involved in blood 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 up to 1 in 1,000 people)

• bleeding into muscles,
• cholestasis (bile stasis), hepatitis including liver cell damage (liver inflammation, including liver injury),
• yellowing of the skin and eyes (jaundice),
• localized swelling,
• accumulation of blood (hematoma) in the groin as a complication of cardiac catheterization procedure, when the catheter is inserted into an artery in the leg (pseudoaneurysm).

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

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

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

• kidney failure following severe bleeding,
• increased pressure in the muscles of arms and legs following bleeding, which may lead to pain, swelling, sensory changes, numbness or paralysis (compartment syndrome following bleeding).

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed
in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can
be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the 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 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 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 10 mg of rivaroxaban.
• The other ingredients are:
  Tablet core: microcrystalline cellulose (type 101), sodium croscarmellose, monohydrate lactose, hypromellose 6cP, sodium lauryl sulphate, magnesium stearate. See section 2 "Kardatuxan contains lactose and sodium".
  Tablet coating: macrogol PEG 4000 (E 1521), hypromellose 6cP, titanium dioxide (E 171), monohydrate lactose, iron oxide red (E 172), triacetin.

What Kardatuxan looks like and contents of the pack
Kardatuxan 10 mg film-coated tablets are light pink, round, biconvex (approximately 5.5 mm in diameter) with "D1" embossed on one side.
The tablets are contained:

• in blisters packed in cardboard boxes containing 5, 10, 14, 28, 30, 56, 90, 98, or 100 film-coated tablets, or
• in unit-dose blisters packed in cardboard boxes containing 10 x 1, 30 x 1, 90 x 1, or 100 x 1 tablet. The blisters contain 5, 10, or 14 film-coated tablets each.

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 European Economic Area countries 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

For further information about this medicinal product, 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]