Kardatuxan

Package leaflet: Information for the user

KARDATUXAN, 15 mg, film-coated tablets
KARDATUXAN, 20 mg, film-coated tablets
Rivaroxabanum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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 package and other information

1. What Kardatuxan is and what it is 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 body in patients who have a type of irregular heartbeat called non-valvular atrial fibrillation.
• treat blood clots in the veins of the legs (deep vein thrombosis) and blood vessels of the lungs (pulmonary embolism), and to 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. It works by
inhibiting a blood clotting factor (Factor Xa), thereby 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 an organ leading 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 clots (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant therapy or if heparin is administered to maintain the patency of a catheter in a vein or artery,
• 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 inform your doctor if you suspect that any of the above conditions apply to you.
Warnings and precautions
Before starting to take Kardatuxan, consult your doctor or pharmacist.
When to exercise special caution when using Kardatuxan

• if the patient has an increased risk of bleeding, such as in the following conditions:
• severe kidney disease in adults, as kidney function may affect the amount of medicine acting in the patient's body,
• blood clotting disorders,
• taking other medicines that prevent blood clots (e.g. warfarin, etexilate of dabigatran, apixaban or heparin) when switching anticoagulant therapy or when heparin is administered to maintain the patency of a catheter in a vein or artery (see section "Kardatuxan with other medicines"),
• 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 genital or urinary system,
• blood vessel disease of the back of the eyeball (retinopathy),
• lung disease in which the bronchi are dilated and filled with pus (bronchiectasis) 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 treatment needs to be changed,
• if the patient has been diagnosed with abnormal blood pressure or if surgery or another treatment to remove a blood clot from the lungs is planned.

If you suspect that any of the above conditions apply to you, inform your 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 taking Kardatuxan before or after surgery,
• if spinal catheterization or spinal puncture (e.g. for epidural or spinal anaesthesia or pain relief) is planned during surgery:
• it is very important to take Kardatuxan before and after the puncture or removal of the catheter, as directed by the doctor,
• due to the need for special caution, immediately inform the doctor if numbness or weakness in the legs, or disturbances in bowel or bladder function occur after the anaesthesia wears off.

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 adult indications.
Kardatuxan with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take, including those available without a prescription.

• If the patient is taking:
• certain medicines used for fungal infections (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 used for bacterial infections (e.g. clarithromycin, erythromycin),
• certain antiviral medicines used for 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 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 (SSRI) or serotonin-noradrenaline reuptake inhibitors (SNRI)).

If you suspect that any of the above conditions apply to you, inform your doctor before taking Kardatuxan, as the effect of Kardatuxan may be enhanced when taken simultaneously with the above medicines. The doctor will decide whether to use this medicine and whether the patient requires particularly close monitoring.
If the doctor considers that the patient has an increased risk of developing stomach or duodenal ulcers, preventive treatment for peptic ulcer disease may be prescribed.

• 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 you suspect that any of the above conditions apply to you, inform your doctor before taking Kardatuxan, as the effect of Kardatuxan may be reduced. The doctor will decide whether to use Kardatuxan and whether the patient requires particularly close monitoring.
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, inform the doctor immediately, 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, the patient should consult a 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 directed by the physician. If in doubt, consult a doctor or pharmacist.
Kardatuxan should be taken with food.
The tablet(s) should be swallowed, preferably with water.
If a patient has difficulty swallowing the whole tablet, discuss alternative methods of taking Kardatuxan with the doctor. The tablet can be crushed and mixed with water or apple puree immediately before administration. The meal should then be consumed immediately.
If necessary, the doctor may administer crushed Kardatuxan tablet via a gastric tube.

How many tablets to take

• Adults
• For prevention of blood clots in the brain (stroke) and other blood vessels in the body: The recommended dose is one Kardatuxan 20 mg tablet once daily. If the patient has renal impairment, the dose may be reduced to one Kardatuxan 15 mg tablet once daily.

If a procedure to open blood vessels in the heart is required (called percutaneous coronary intervention – PCI with stent placement), there is limited evidence supporting dose reduction to one Kardatuxan 15 mg tablet once daily (or one Kardatuxan 10 mg tablet once daily in case of renal impairment), in combination with an antiplatelet medicine such as clopidogrel.

• For treatment of blood clots in the veins of the legs, blood clots in the blood vessels of the lungs, and prevention of recurrence of blood clots: The recommended dose is one Kardatuxan 15 mg tablet twice daily for the first 3 weeks. For treatment beyond 3 weeks, the recommended dose is one Kardatuxan 20 mg tablet once daily. After at least 6 months of treatment for blood clots, the doctor may decide to continue treatment with either one 10 mg tablet once daily or one 20 mg tablet once daily. If the patient has renal impairment and is taking one Kardatuxan 20 mg tablet once daily, the doctor may decide to reduce the dose after 3 weeks of treatment to one Kardatuxan 15 mg tablet once daily, if the risk of bleeding is greater than the risk of further blood clots.

Do not split the tablet to achieve a partial dose. If a lower dose is required, an alternative formulation of rivaroxaban (oral suspension granules) should be used.
Patients unable to swallow whole tablets should use oral suspension granules.
If the oral suspension is not available, the Kardatuxan tablet may be crushed and mixed with water or apple puree immediately before administration. The meal should be taken after this mixture. If necessary, the doctor may also administer the crushed tablet via a gastric tube.

If a dose is vomited or spat out

• within 30 minutes of taking Kardatuxan, take a new dose.
• more than 30 minutes after taking Kardatuxan, do not take a new dose. In this case, take the next dose of Kardatuxan at the usual time.

Contact the doctor if there are repeated episodes of vomiting or spitting out the dose after taking Kardatuxan.

When to take Kardatuxan
Take the tablet(s) every day until the doctor decides to stop treatment.
It is best to take the tablet(s) at the same time each day, as this makes it easier to remember.
The doctor will decide how long the patient should continue treatment.
For prevention of blood clots in the brain (stroke) and other blood vessels in the body:
If a procedure (cardioversion) is required to restore normal heart rhythm, Kardatuxan should be taken as directed by the doctor.

Missed dose of Kardatuxan

• If the patient takes one 20 mg tablet or one 15 mg tablet once daily and a dose is missed, take the tablet as soon as possible. Do not take more than one tablet in one day to make up for the missed dose. Take the next tablet the following day, then continue taking one tablet once daily.
• If the patient takes one 15 mg tablet twice daily and a dose is missed, take the tablet as soon as possible. Do not take more than two 15 mg tablets in one day. If the patient forgets to take a dose, they may take two 15 mg tablets at the same time to achieve a total of two tablets (30 mg) taken within one day. The next day, resume taking one 15 mg tablet twice daily.

Taking more Kardatuxan than recommended
If a patient has taken too many Kardatuxan tablets, contact a doctor immediately.
Taking too high a dose of Kardatuxan increases the risk of bleeding.

Stopping Kardatuxan
Do not stop taking Kardatuxan without first consulting the doctor, as Kardatuxan treats and prevents serious medical conditions.
If there are any further questions about the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, Kardatuxan may cause adverse reactions, although not everyone experiences them.
As with other medicines that have a similar effect of reducing 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). The signs of bleeding are not always obvious or visible.
You should immediately contact your doctor 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 weakness, vomiting, seizures, decreased level of consciousness and neck stiffness. This is a serious, sudden 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 of the patient is necessary or that the treatment method should be changed.

• Signs of severe skin reactions
• widespread, acute skin rash, blistering or mucosal changes, e.g. in the mouth or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• drug reaction causing rash, fever, internal organ inflammation, hematological disorders and systemic symptoms (DRESS syndrome). 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, mouth, tongue or throat; hives 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 adverse reactions
Common (may occur in 1 out of 10 people)

• decreased number of red blood cells, which may cause paleness of the skin and lead to weakness or shortness of breath,
• bleeding from the stomach or intestine, bleeding from the urinary or genital system (including blood in urine and severe 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 under the skin,
• bleeding after surgery,
• 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 blood pressure (symptoms may include dizziness or fainting upon standing),
• general lack of strength and energy (weakness, fatigue), headache, dizziness,
• rash, itching of the skin,
• increased activity of certain liver enzymes, which may be seen 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 number of platelets, 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,
• dryness of the mouth,
• hives.

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 area as a complication of cardiac catheterization procedure when a 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,
• bleeding in the kidneys, sometimes with blood in the urine, leading to kidneys being unable to function properly (drug-induced anticoagulant-related nephropathy),
• increased pressure within the muscles of the legs and arms occurring after bleeding, which may lead to pain, swelling, altered sensation, numbness or paralysis (compartment syndrome following bleeding).

Reporting of adverse reactions
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
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 sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister marked with:
"EXP". The expiry date refers to the last day of the stated month.
No special storage conditions are required 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 15 mg or 20 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”.
  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 film-coated tablets are pink, round, biconvex (approximately 6 mm in diameter) with "D2" engraved on one side.
The tablets are contained:

• in blisters packed in cardboard boxes containing 10, 14, 28, 30, 42, 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, 100 x 1 tablets. The blisters contain 10 or 14 film-coated tablets.

Kardatuxan 20 mg film-coated tablets are brownish-red, round, biconvex (approximately 7 mm in diameter) with "D3" engraved on one side.
The tablets are contained:

• in blisters packed in cardboard boxes containing 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, 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 for sale in 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

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]