Rivaroksaban Tzf

Package Leaflet: Information for the Patient

Rywaroksaban TZF, 10 mg, Film-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 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 pack 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 veins after hip or knee replacement surgery. Your 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 veins of the legs and/or lungs.

Rywaroksaban TZF 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 Rywaroksaban TZF

When not to take Rywaroksaban TZF:

• if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6);
• if you have excessive bleeding;
• if you have 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 you are taking other medicines that prevent blood clotting (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 you have liver disease that leads to an increased risk of bleeding;
• if you are pregnant or breastfeeding. You must not take Rywaroksaban TZF and you must inform your doctorif you suspect that you have become pregnant or are planning to become pregnant.

Warnings and precautions

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

Be careful when taking Rywaroksaban TZF:

• if you have an increased risk of bleeding, such as:
• mild or moderate kidney disease, as kidney function may affect the amount of medicine that works in your body;
• taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin) when changing anticoagulant treatment or when heparin is given to maintain the patency of a vein or artery catheter (see "Rywaroksaban TZF and other medicines");
• bleeding disorders;
• very high blood pressure that does not decrease despite treatment;
• stomach or intestinal diseases that may cause bleeding, e.g. inflammation of the stomach and intestines 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 artificial heart valves;
• if you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clot formation), you should inform your doctor, who will decide whether to change the treatment;
• if you have been diagnosed with abnormal blood pressure or if surgery is planned to remove a blood clot from the lungs.

If you suspect that you have any of the above conditions, you must inform

your doctorbefore taking Rywaroksaban TZF. Your doctor will decide whether to prescribe this medicine and whether you need to be closely monitored.

If you need to have surgery:

• you must carefully follow your doctor's instructions regarding the intake of Rywaroksaban TZF at a strictly specified time before or after surgery;
• if catheterization or spinal puncture is planned during surgery (e.g. for spinal anesthesia or pain relief):
• it is very important to take Rywaroksaban TZF according to your doctor's instructions;
• due to the need for special caution, you should immediately inform your doctor if you experience numbness or weakness in your legs, bowel or bladder disorders after anesthesia.

Children and adolescents

Rywaroksaban TZF 10 mg is not recommended for people under 18 years of age. There is a lack of sufficient data on the use of the medicine in children and adolescents.

Rywaroksaban TZF and other medicines

Tell your doctor or pharmacist about all the 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 for fungal infections (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only locally on the skin;

ketoconazole in tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol);

certain medicines for bacterial infections (e.g. clarithromycin, erythromycin);

certain antiviral medicines for HIV infection or AIDS treatment (e.g. ritonavir);

other medicines that 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 for depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs)).

If you suspect that you have any of the above conditions, you must inform

your doctorbefore taking Rywaroksaban TZF, as the effect of Rywaroksaban TZF may be enhanced. Your doctor will decide whether to prescribe this medicine and whether you need to be closely monitored.

If you are taking

certain medicines for epilepsy (phenytoin, carbamazepine, phenobarbital);

St. John's wort (Hypericum perforatum), a herbal medicine used for depression;

rifampicin, which belongs to a group of antibiotics.

If you suspect that you have any of the above conditions, you must inform

your doctorbefore taking Rywaroksaban TZF, as the effect of the medicine may be reduced. Your doctor will decide whether to prescribe Rywaroksaban TZF and whether you need to be closely monitored.

Pregnancy and breastfeeding

You must not take Rywaroksaban TZF if you are pregnant or breastfeeding.

If there is a risk that you may become pregnant, you should use effective contraception while taking Rywaroksaban TZF. If you become pregnant while taking this medicine, you should immediately inform your doctor, 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 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 Rywaroksaban TZF

This medicine should always be taken exactly as your doctor has instructed. If you are unsure, ask 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 Rywaroksaban TZF tablet taken once a day.
• For 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 Rywaroksaban TZF 10 mg once a day for you.

Swallow the tablet, preferably with water.

Rywaroksaban TZF 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 Rywaroksaban TZF. The tablet can be crushed and mixed with water or apple sauce, just before taking it. If necessary, your doctor may administer the crushed Rywaroksaban TZF tablet through a gastric tube.

When to take Rywaroksaban TZF

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 will be easier to remember.

Your doctor will decide how long you should 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 than the recommended dose of Rywaroksaban TZF

If you have taken more than the recommended dose of Rywaroksaban TZF, you should immediately contact your doctor. Taking too much Rywaroksaban TZF increases the risk of bleeding.

Missing a dose of Rywaroksaban TZF

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 dose.

Stopping treatment with Rywaroksaban TZF

You must not stop taking Rywaroksaban TZF without first consulting your doctor, as Rywaroksaban TZF prevents a serious disease.

If you have any further questions about the use of this medicine, ask 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 may 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:

You must immediately inform your doctorif 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. You must immediately seek medical help!);
• 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. Your doctor may decide to closely monitor you or change the treatment.

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

You must immediately inform your doctorif you experience the following skin reactions, such as:

• widespread, acute skin rash, blistering, or changes in 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 (maximum 1 in 10,000 patients);
• 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 (maximum 1 in 10,000 patients).

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

You must immediately inform your doctorif you experience the following side effects:

• swelling of the face, lips, mouth, tongue, or throat; hives and difficulty breathing; 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 up to 1 in 100 patients).

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 (nausea) or vomiting, constipation, diarrhea;
• low blood pressure (symptoms may include dizziness or fainting when standing up);
• 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;
• 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 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 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;
• bleeding in the kidneys, 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, you should 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

Tel.: +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 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 month stated.

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 pack and other information

What Rywaroksaban TZF contains

• The active substance of the medicine is rivaroxaban. Each film-coated tablet contains 10 mg of rivaroxaban.
• The 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, 10 mg is a pink, round, biconvex film-coated tablet, with the number "10" embossed on one side, smooth on the other, with a diameter of about 9.1 mm.

The tablets are in a PVC/Aluminum blister pack, packed in a cardboard box.

The pack contains 10 film-coated tablets.

Marketing authorization holder

Tarchomińskie Zakłady Farmaceutyczne "Polfa" Spółka Akcyjna

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 approval of the leaflet: