Rivaroksaban Tzf

Leaflet accompanying the packaging: patient information

Rywaroksaban TZF, 2.5 mg, film-coated tablets

Rivaroxaban

Read the contents of 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 as yours.
• 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

The patient has been given Rywaroksaban TZF because

• they have been diagnosed with acute coronary syndrome (a condition that includes heart attack and unstable angina, acute chest pain) and have elevated levels of cardiac biomarkers. Rywaroksaban TZF reduces the risk of another heart attack or reduces the risk of death due to heart or blood vessel disease in adults. Rywaroksaban TZF will not be given to the patient as the only medicine. The doctor will instruct the patient to also take:
• aspirin or
• aspirin and clopidogrel or ticlopidine.

Or

• they have been diagnosed with a high risk of blood clots due to coronary artery disease or peripheral artery disease, which causes symptoms. Rywaroksaban TZF reduces the risk of blood clots (atherothrombotic events) in adults. Rywaroksaban TZF will not be given to the patient as the only medicine. The doctor will instruct the patient to also take aspirin. In some cases, if the patient is taking Rywaroksaban TZF after a procedure to open up a narrowed or blocked artery in the leg to restore blood flow, the doctor may also prescribe clopidogrel for the patient to take for a short time in addition to aspirin.

Rywaroksaban TZF contains the active substance rivaroxaban and belongs to a group of medicines called anticoagulants. Its action is to block a blood clotting factor (factor Xa) and thereby reduce 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 brain or eye surgery);
• 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 given to maintain the patency of a vein or artery catheter;
• if the patient has been diagnosed with acute coronary syndrome and has had bleeding or a blood clot in the brain (stroke);
• if the patient has been diagnosed with coronary artery disease or peripheral artery disease and has had bleeding in the brain (stroke) or blockage of small arteries that supply blood to the brain tissues (cerebral sinus thrombosis), or if the patient has had a blood clot in the brain (ischemic stroke) in the last month);
• 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 also 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. Rywaroksaban TZF should not be taken with other blood clotting inhibitors, such as prasugrel or ticagrelor, except for aspirin, clopidogrel or ticlopidine.

Particular caution should be exercised when taking Rywaroksaban TZF:

• if the patient has an increased risk of bleeding, such as:
• severe kidney disease, as kidney function may affect the amount of medicine that works in the patient's 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 taking medicines;
• stomach or intestinal diseases that can cause bleeding, e.g. inflammation of the intestines and stomach or inflammation of the esophagus (throat and esophagus) e.g. due to gastroesophageal reflux disease (stomach acid flowing back 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 airways are dilated and filled with pus (bronchiectasis) or previous bleeding from the lungs;
• if the patient is over 75 years old;
• if the patient weighs 60 kg or less;
• coronary artery disease with severe symptomatic heart failure;
• in patients with artificial heart valves;
• if the patient has a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), the patient should inform their doctor, who will decide whether to change the treatment.

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 prescribe this medicine and whether the patient should be closely monitored.

If the patient needs to undergo surgery:

• they should carefully follow the 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 epidural or spinal anesthesia or pain relief):
• it is very important to take Rywaroksaban TZF before and after the puncture or catheter removal, according to the doctor's instructions;
• 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 anesthesia.

Children and adolescents

Rywaroksaban TZF 2.5 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

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those that are available without a prescription.

If the patient is 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 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, prasugrel and ticagrelor (see "Warnings and precautions"));
anti-inflammatory and pain-relieving medicines (e.g. naproxen or aspirin);
dronedarone, a medicine used to treat heart rhythm disorders;
certain medicines used to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and noradrenaline 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 prescribe this medicine and whether the patient should be closely monitored.
If the doctor believes that the patient is at increased risk of developing stomach or intestinal ulcers, they may use preventive treatment.

If the patient is 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 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. The doctor will decide whether to prescribe Rywaroksaban TZF and whether the patient should be closely monitored.

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 (common 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 some 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 according to the doctor's instructions. If you have any doubts, consult your doctor or pharmacist.

How many tablets to take

The recommended dose is one 2.5 mg tablet twice a day. Rywaroksaban TZF should be taken at approximately the same time every day (e.g. one tablet in the morning and one in the evening). The medicine can be taken with or without food.
If the patient has difficulty swallowing the whole tablet, they should talk to their 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, the doctor may administer the crushed tablet of Rywaroksaban TZF through a gastric tube.
Rywaroksaban TZF will not be given to the patient as the only medicine.
The doctor will instruct the patient to also take aspirin. If the patient is taking Rywaroksaban TZF after acute coronary syndrome, the doctor may also instruct them to take clopidogrel or ticlopidine.
If the patient is taking Rywaroksaban TZF after a procedure to open up a narrowed or blocked artery in the leg to restore blood flow, the doctor may also prescribe clopidogrel for the patient to take for a short time in addition to aspirin.
The doctor will tell the patient what dose of these medicines to take (usually 75-100 mg of aspirin per day or a daily dose of 75-100 mg of aspirin plus a daily dose of 75 mg of clopidogrel or a standard daily dose of ticlopidine).

When to start taking Rywaroksaban TZF

Treatment with Rywaroksaban TZF after acute coronary syndrome should be started as soon as possible after stabilization of the acute coronary syndrome, at the earliest 24 hours after hospital admission and when parenteral (by injection) anticoagulant treatment would normally be discontinued.
The doctor will tell the patient when to start treatment with Rywaroksaban TZF if they have been diagnosed with coronary artery disease or peripheral artery disease.
The doctor will decide how long to continue treatment.

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

Do not take a double dose to make up for a missed dose. If the patient misses a dose, they should take the next dose at the scheduled time.

Stopping treatment with Rywaroksaban TZF

Rywaroksaban TZF should be taken regularly and for the duration recommended by the doctor.
Do not stop taking Rywaroksaban TZF without first consulting your doctor.
If treatment with this medicine is stopped, the risk of another heart attack, stroke or death due to heart or blood vessel disease may increase.
If you have any further doubts about taking 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 may cause bleeding, which can be life-threatening. Excessive bleeding can lead to a sudden drop in blood pressure (shock). Not all of these will 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. A serious medical emergency. Seek medical help immediately!);
• prolonged or excessive bleeding;
• unusual weakness, fatigue, paleness, dizziness, headache, swelling of unknown cause, shortness of breath, chest pain or angina, which may be signs of bleeding. The doctor may decide to closely monitor the patient 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 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 paleness of the skin 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 the 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 the doctor);
• blood test results may show increased levels of bilirubin, 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 stagnation), hepatitis, including liver cell damage;
• jaundice (yellowing of the skin and eyes);
• local swelling;
• hematoma (collection of blood) 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 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 the medicine.

5. How to store Rywaroksaban TZF

Keep the medicine out of the sight and reach of children.
There are no special instructions 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 2.5 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, yellow iron oxide (E172).

What Rywaroksaban TZF looks like and what the packaging contains

Rywaroksaban TZF 2.5 mg are yellow, round, biconvex film-coated tablets, with "RVX" embossed on one side, smooth on the other, with a diameter of approximately 6.1 mm.
The tablets are in PVC/Aluminum blisters, packed in a cardboard box.
The packaging contains 56 film-coated tablets.

Marketing authorization holder

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

Manufacturer

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

Date of leaflet approval: