Rivaroksaban Tzf

Leaflet accompanying the packaging: patient information

Rywaroksaban TZF, 15 mg, film-coated tablets

Rywaroksaban TZF, 20 mg, film-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 or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Rywaroksaban TZF and what is it used for
• 2. Important information before taking Rywaroksaban TZF
• 3. How to take Rywaroksaban TZF
• 4. Possible side effects
• 5. How to store Rywaroksaban TZF
• 6. Contents of the packaging and other information

1. What is Rywaroksaban TZF and what is it used for

Rywaroksaban TZF contains the active substance rivaroxaban and 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 form of irregular heart rhythm called atrial fibrillation not caused by a heart valve problem.
• 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.

Rywaroksaban TZF is used in children and adolescents under 18 years of age and with a body weight of 30 kg or more to:

• treat blood clots and prevent the recurrence of blood clots in the veins or blood vessels in the lungs, after at least 5 days of initial treatment with injectable medicines used to treat blood clots.

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

2. Important information before taking Rywaroksaban TZF

When not to take Rywaroksaban TZF:

• 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 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 changing anticoagulant treatment or when heparin is administered 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 Rywaroksaban TZF, and inform your doctorif you suspect that you have any of the above conditions.

Warnings and precautions

Before starting treatment with Rywaroksaban TZF, discuss it with your doctor or pharmacist.

When to be particularly careful when taking Rywaroksaban TZF

• if the patient has an increased risk of bleeding, such as:
• severe kidney disease in adults and moderate or severe kidney disease in children and adolescents, as kidney function may affect the amount of medicine acting in the patient's body;
• bleeding disorders;
• taking other medicines that prevent blood clotting (e.g., warfarin, dabigatran etexilate, apixaban, or heparin) when changing anticoagulant treatment or when heparin is administered to maintain the patency of a vein or artery catheter (see "Rywaroksaban TZF 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 genital or urinary system;
• disease of the blood vessels in the back of the eye (retinopathy);
• pulmonary disease in which the bronchi are dilated and filled with pus (bronchiectasis) or previous bleeding from the lungs;
• in patients with prosthetic 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 on possible changes to the treatment;
• if the patient has been diagnosed with 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 Rywaroksaban TZF. 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:

• they should carefully follow their doctor's instructions regarding the intake of Rywaroksaban TZF 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 Rywaroksaban TZF before and after the puncture or catheter removal, as instructed by the doctor;
• due to the need for special caution, the doctor should be informed immediately if numbness or weakness of the legs, bowel or bladder disorders occur after the anesthesia has ended.

Children and adolescents

Rywaroksaban TZF is not recommended for children with a body weight below 30 kg. There is a lack of sufficient data on the use of the medicine in children and adolescents for indications in adults.

Rywaroksaban TZF 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 the patient is taking:

certain medicines used to treat fungal infections (e.g., fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only topically on the skin;
ketoconazole 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 Rywaroksaban TZF, as the effect of Rywaroksaban TZF may be enhanced. The doctor will decide whether to use this medicine and whether the patient should be subject to particularly close monitoring.
If the doctor believes that the patient is at increased risk of developing stomach or duodenal ulcers, they may use a treatment to prevent stomach ulcers.

If the patient is 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 Rywaroksaban TZF, as the effect of Rywaroksaban TZF may be reduced when taken with the above medicines. The doctor will decide whether to use Rywaroksaban TZF and whether the patient should be subject to particularly close monitoring.

Pregnancy and breastfeeding

Rywaroksaban TZF should not be taken if the patient is pregnant or breastfeeding.
If there is a risk that the patient may become pregnant, they should use effective contraception while taking Rywaroksaban TZF. If the patient becomes pregnant while taking this medicine, they should inform their doctor immediately, who will decide on further treatment.

Driving and using machines

Rywaroksaban TZF may cause dizziness (frequent side effects) or fainting (uncommon side effects) (see section 4 "Possible side effects").
Patients who experience these side effects should not drive or operate machinery.

Rywaroksaban TZF 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, which means that the medicine is considered "sodium-free".

3. How to take Rywaroksaban TZF

This medicine should always be taken as directed by the doctor. If in doubt, consult the doctor or pharmacist.
The tablet(s) should be swallowed whole, preferably with water.
Rywaroksaban TZF should be taken with food.
If the patient has difficulty swallowing the whole tablet, they should discuss other ways of taking Rywaroksaban TZF with their doctor. The tablet can be crushed and mixed with water or soft food, such as apple sauce, immediately before administration. After taking this mixture, the patient should take a meal immediately. If necessary, the doctor may also administer the crushed tablet through a gastric tube.

How many tablets to take

Adults

• To prevent the formation of blood clots in the brain (stroke) and other blood vessels in the body, the recommended dose is one 20 mg Rywaroksaban TZF tablet taken once a day. If the patient has kidney problems, the dose may be reduced to one 15 mg Rywaroksaban TZF tablet taken once a day.

If the patient requires a procedure to clear 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 Rywaroksaban TZF tablet taken once a day (or one 10 mg Rywaroksaban TZF tablet taken once a day in case of kidney function impairment) in combination with an antiplatelet agent such as clopidogrel.

• To treat 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 Rywaroksaban TZF tablet taken twice a day for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one 20 mg Rywaroksaban TZF tablet taken once a day. After at least 6 months of treatment for blood clots, the doctor may decide to continue treatment using one 10 mg tablet once a day or one 20 mg tablet once a day. If the patient has kidney problems and is taking one 20 mg Rywaroksaban TZF tablet once a day, the doctor may decide to reduce the dose after 3 weeks of treatment to one 15 mg Rywaroksaban TZF tablet taken once a day, if the risk of bleeding is greater than the risk of recurrent blood clots.

Children and adolescents

The dose of Rywaroksaban TZF depends on body weight and will be calculated by the doctor.

• The recommended dose for children and adolescents with a body weight of 30 kg to less than 50 kg is one 15 mg Rywaroksaban TZF tablet taken once a day.
• The recommended dose for children and adolescents with a body weight of 50 kg or more is one 20 mg Rywaroksaban TZF tablet taken once a day.

Each dose of Rywaroksaban TZF should be taken with a meal, with a drink (e.g., water or juice). The tablets should be taken daily at approximately the same time. It is a good idea to set an alarm to remind you.
For parents or caregivers: observe the child to ensure they have taken the entire dose.
The dose of Rywaroksaban TZF is dependent on body weight, so it is essential to attend scheduled doctor's appointments, as the dose may need to be adjusted due to weight changes.
Never adjust the dose yourself. If necessary, the doctor will adjust the dose.
Do not divide the tablet to obtain a partial dose. If a smaller dose is required, use a different form of rivaroxaban: an oral suspension. For children and adolescents who are unable to swallow whole tablets, use rivaroxaban in the form of an oral suspension.
If the oral suspension is not available, the Rywaroksaban TZF tablet can be crushed and mixed with water or apple sauce immediately before administration. After this mixture, the patient should take a meal. If necessary, the doctor may also administer the crushed tablet through a gastric tube.

If a dose is spat out or vomited

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

Consult the doctor if the patient spits out or vomits the dose or experiences repeated vomiting after taking Rywaroksaban TZF.

When to take Rywaroksaban TZF

Take one tablet every day until the doctor decides to stop the treatment.
It is best to take the tablet at the same time every day, as it will be easier to remember.
The doctor will decide how long to continue the treatment.
To prevent the formation of blood clots in the brain (stroke) and other blood vessels in the body:
If the patient's heart rhythm needs to be restored using a procedure called cardioversion, Rywaroksaban TZF should be taken as directed by the doctor.

Taking a higher dose of Rywaroksaban TZF than recommended

If the patient has taken a higher dose of Rywaroksaban TZF than recommended, they should contact their doctor immediately. Taking too much Rywaroksaban TZF increases the risk of bleeding.

Missing a dose of Rywaroksaban TZF

• Adults, children, adolescents: If the patient takes one 20 mg or one 15 mg tablet once a day and misses a dose, they should take it 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 next day, and then take one tablet once a day.
• Adults: If the patient takes one 15 mg tablet twice a day and misses a dose, they should take it as soon as possible. Do not take more than two 15 mg tablets in one day. If the patient misses a dose, they can take two 15 mg tablets at the same time to get a total of two tablets (30 mg) taken in one day. The next day, continue taking one 15 mg tablet twice a day.

Stopping treatment with Rywaroksaban TZF

Do not stop taking Rywaroksaban TZF without first consulting your doctor, as Rywaroksaban TZF treats and prevents a serious disease.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rywaroksaban TZF can cause side effects, although not everybody gets them.
Like other medicines with similar effects (anticoagulants), Rywaroksaban TZF 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.

Possible side effects that may be a sign of bleeding:

Tell your doctor immediatelyif you experience any of the following side effects:

• 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. This is a serious medical emergency. Seek medical help immediately!);
• prolonged or excessive bleeding;
• unusual weakness, fatigue, pallor, dizziness, headache, unexplained swelling, shortness of breath, chest pain, or angina, which may be signs of bleeding. The doctor may decide to monitor the patient closely or change the treatment.

Possible side effects that may be a sign of skin reactions:

Tell your doctor immediatelyif you experience any of the following skin reactions, such as:

• widespread, severe skin rash, blistering, or changes to the mucous membranes, e.g., in the mouth or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis). The frequency of these side effects is very rare (up to 1 in 10,000 patients);
• a drug reaction that causes a 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 patients).

Possible side effects that may be a sign of a severe allergic reaction

Tell your doctor immediatelyif you experience any of the following side effects:

• swelling of the face, lips, mouth, tongue, or throat; hives and difficulty breathing; a sudden drop in blood pressure. The frequency of these side effects is very rare (anaphylactic reactions, including anaphylactic shock, may occur in up to 1 in 10,000 patients) and uncommon (angioedema and allergic edema may occur in 1 in 100 patients).

General list of possible side effects:

Frequent(may affect up to 1 in 10 people)

• reduction 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 tract (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 when 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 (which can be observed in tests performed by the doctor);
• fever;
• stomach pain, nausea, feeling of 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;
• increased activity of certain 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;
• 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 (which can be observed in tests performed by the doctor);
• blood test results may show increased bilirubin levels, activity of certain 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;
• accumulation of blood (hematoma) in the groin as a complication of heart catheterization, when the 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;
• bleeding in the kidneys, sometimes with blood in the urine, leading to kidney failure (nephropathy associated with anticoagulant therapy);
• increased pressure in the muscles of the legs and arms after bleeding, which can lead to pain, swelling, changes in sensation, numbness, or paralysis (compartment syndrome after bleeding).

Side effects in children and adolescents

Generally, the side effects observed in children and adolescents treated with Rywaroksaban TZF were similar in type to those observed in adults and were mainly mild to moderate.
Side effects observed more frequently in children and adolescents:
Very common(may affect more than 1 in 10 people)

• headache
• fever
• nasal bleeding, vomiting Frequent(may affect up to 1 in 10 people)
• rapid heartbeat
• blood test results may show increased bilirubin levels (bile pigment)
• thrombocytopenia (low platelet count, cells involved in blood clotting)
• excessive menstrual bleeding Uncommon(may affect up to 1 in 100 people)
• blood test results may show increased levels of a bilirubin subtype (direct bilirubin, bile pigment).

Reporting side effects

If side effects occur, including any side effects 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Rywaroksaban TZF

Keep the medicine out of the sight and reach of children.
There are no special precautions for storing the medicine.
Do not use this medicine after the expiry date (EXP) stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Rywaroksaban TZF contains

• The active substance of the medicine is rivaroxaban. Each film-coated tablet contains 15 mg or 20 mg of rivaroxaban.
• Other ingredients of the medicine are: tablet core: hypromellose, microcrystalline cellulose, sodium lauryl sulfate, lactose monohydrate, croscarmellose sodium, magnesium stearate. tablet coating: hypromellose type 2910, titanium dioxide (E171), macrogol 3350, iron oxide red (E172).

What Rywaroksaban TZF looks like and contents of the pack

Rywaroksaban TZF, 15 mg are red, round, biconvex film-coated tablets, with the number "15" embossed on one side, smooth on the other, with a diameter of approximately 6.1 mm.
Rywaroksaban TZF, 20 mg are brown-red, round, biconvex film-coated tablets, with the number "20" embossed on one side, smooth on the other
Rywaroksaban TZF, 15 mg
Tablets are available in PVC/Aluminum blisters, packaged in a cardboard box. The packaging contains 14 or 28 film-coated tablets.
Rywaroksaban TZF, 20 mg
Tablets are available in PVC/Aluminum blisters, packaged in a cardboard box. The packaging contains 14 or 28 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Tarchomińskie Zakłady Farmaceutyczne "Polfa" S.A.
ul. A. Fleminga 2
03-176 Warsaw
Phone: 22 811-18-14

Manufacturer

ELPEN Pharmaceutical Co., Inc.
Marathonos Ave. 95
19009 Pikermi Attiki
Greece

Date of leaflet approval: