Rivaroxaban tzf

Patient Information Leaflet

Rywaroksaban TZF, 2.5 mg, coated tablets
Rivaroxabanum
Please read this leaflet carefully before taking this medicine, as 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, tell your doctor or pharmacist. See section 4.

Table of contents

1. What Rywaroksaban TZF is and what it is used for
2. What you need to know 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 Rywaroksaban TZF is and what it is used for

You have been prescribed Rywaroksaban TZF because:

• You have been diagnosed with acute coronary syndrome (a condition including heart attack and unstable angina, causing acute chest pain) and elevated levels of cardiac biomarkers have been detected. Rywaroksaban TZF reduces, in adults, the risk of further heart attack or reduces the risk of death due to heart or blood vessel disease. Rywaroksaban TZF will not be given to you as the only treatment. Your doctor will also prescribe you:
  • acetylsalicylic acid, or
  • acetylsalicylic acid and clopidogrel or ticlopidine.

Or

• You have been diagnosed with a high risk of blood clots due to coronary artery disease or peripheral artery disease causing symptoms. Rywaroksaban TZF reduces, in adults, the risk of blood clots (atherothrombotic events). Rywaroksaban TZF will not be given to you as the only treatment. Your doctor will also prescribe you acetylsalicylic acid. In some cases, if you are receiving Rywaroksaban TZF after a procedure to unblock or widen a narrowed or blocked artery in the lower limb to restore blood flow, your doctor may also prescribe clopidogrel to be taken in addition to acetylsalicylic acid for a short period.

Rywaroksaban TZF contains the active substance rivaroxaban and 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. Information before using Rywaroksaban TZF

When not to use 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 active 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 catheter patency in a vein or artery;
• if the patient has been diagnosed with acute coronary syndrome and previously experienced bleeding or blood clot in the brain (stroke);
• if the patient has been diagnosed with coronary artery disease or peripheral arterial disease and previously had bleeding in the brain (hemorrhagic stroke), or blockage of small arteries supplying blood to tissues in deep brain structures (lacunar stroke), or if the patient had an ischemic (non-lacunar) stroke within the last month;
• 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 Rywaroksaban TZF, and inform the doctor if the patient suspects any of the above-mentioned circumstances.

Warnings and precautions
Before starting treatment with Rywaroksaban TZF, discuss it with a doctor or pharmacist. Rywaroksaban TZF should not be used in combination with other anticoagulant medicines besides acetylsalicylic acid, clopidogrel or ticlopidine, such as prasugrel or ticagrelor.
Exercise special caution when using Rywaroksaban TZF:

• if the patient has an increased risk of bleeding, such as in the following conditions:
  • severe kidney disease, as kidney function may affect the amount of drug acting in the patient's body;
  • use of other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin) when switching anticoagulant therapy or when heparin is administered to maintain catheter patency in a vein or artery (see section "Rywaroksaban TZF and other medicines");
  • coagulation disorders;
  • very high blood pressure that does not decrease despite treatment;
  • stomach or intestinal diseases that may cause bleeding, e.g. inflammation of the intestines and stomach or esophagus (throat and esophagus), e.g. due to gastroesophageal reflux disease (backflow of stomach acid into the esophagus), or tumors located in the stomach, intestines, genital or urinary system;
  • blood vessel disease of the posterior part of the eyeball (retinopathy);
  • lung disease with bronchiectasis and filled with pus (bronchiectasis) or previous lung bleeding;
  • if the patient is over 75 years of age;
  • if the patient weighs 60 kg or less;
  • coronary artery disease with severe symptomatic heart failure;
• in patients with heart valve prostheses;
• if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing increased risk of blood clots), the patient should inform the doctor, who will decide whether treatment adjustment is needed. If the patient suspects any of the above-mentioned conditions, they should inform the doctor before taking Rywaroksaban TZF. The doctor will decide whether to use this medicine and whether the patient requires particularly close monitoring.

If the patient needs surgery:

• strictly follow the doctor's instructions regarding the timing of taking Rywaroksaban TZF before or after surgery;
• if during surgery spinal catheterization or spinal puncture is planned (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 directed by the doctor;
  • due to the need for special caution, immediately inform the doctor if, after anesthesia ends, numbness or weakness in the legs, or bowel or bladder dysfunction occurs.

Children and adolescents
Rywaroksaban TZF 2.5 mg is not recommended for patients under 18 years of age. There is insufficient data on the use of this medicine in children and adolescents.

Rywaroksaban TZF and other medicines
Tell your doctor or pharmacist about all medicines currently used, recently used, or planned for use, including those available without a prescription.

If the patient is taking:

• certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless 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, prasugrel and ticagrelor (see section "Warnings and precautions"));
• anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid);
• dronedarone, a medicine used to treat heart rhythm disorders;
• certain antidepressants (selective serotonin reuptake inhibitors (SSRI) or serotonin-norepinephrine reuptake inhibitors (SNRI)).

If the patient suspects any of the above conditions, they should inform the doctor before 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 requires particularly close monitoring.

If the doctor considers that the patient has an increased risk of developing stomach or intestinal ulcers, they may prescribe preventive treatment.

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 any of the above conditions, they should inform the doctor before taking Rywaroksaban TZF, as the effect of Rywaroksaban TZF may be reduced. The doctor will decide whether to use Rywaroksaban TZF and whether the patient requires particularly close monitoring.

Pregnancy and breastfeeding
Rywaroksaban TZF must not be used 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 Rywaroksaban TZF. If the patient becomes pregnant while taking this medicine, she should immediately inform the doctor, who will decide on further treatment.

Driving and operating machinery
Rywaroksaban TZF may cause dizziness (common side effects) or fainting (uncommon side effects) (see section 4 "Possible side effects"). Patients experiencing 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 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 Rywaroksaban TZF

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

How many tablets to take
The recommended dose is one 2.5 mg tablet twice daily. Rywaroksaban TZF should be taken at approximately the same time each day (for example, one tablet in the morning and one in the evening). This medicine may be taken with or without food.

If a patient has difficulty swallowing the whole tablet, discuss alternative ways of taking Rywaroksaban TZF with the doctor. The tablet may be crushed and mixed with water or apple puree immediately before administration. If necessary, the doctor may administer crushed Rywaroksaban TZF tablets via a gastric tube.

Rywaroksaban TZF will not be given to the patient as the only medication.
Your doctor will prescribe acetylsalicylic acid for you to take. If you are receiving Rywaroksaban TZF after an acute coronary syndrome, your doctor may also prescribe clopidogrel or ticlopidine.

If you are receiving Rywaroksaban TZF after a procedure to restore blood flow in a blocked or narrowed artery of the lower limb, your doctor may also prescribe clopidogrel to be taken in addition to acetylsalicylic acid for a short period.

Your doctor will inform you of the doses of these medications to take (usually 75–100 mg of acetylsalicylic acid daily, or a daily dose of 75–100 mg acetylsalicylic acid plus a daily dose of 75 mg clopidogrel, or the standard daily dose of ticlopidine).

When to start taking Rywaroksaban TZF
Treatment with Rywaroksaban TZF after an acute coronary syndrome should be initiated as soon as possible after stabilization of the acute coronary syndrome, no earlier than 24 hours after hospital admission and at the point when parenteral (injected) anticoagulant therapy would normally be discontinued.

Your doctor will advise you when to start treatment with Rywaroksaban TZF if you have been diagnosed with coronary artery disease or peripheral artery disease.
Your doctor will decide how long treatment should continue.

Taking more than the recommended dose of Rywaroksaban TZF
If you have taken more than the recommended dose of Rywaroksaban TZF, contact your doctor immediately. Taking too high a dose of 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 you miss a dose, take the next dose at the scheduled time.

Stopping Rywaroksaban TZF
Rywaroksaban TZF must be taken regularly and for the duration prescribed by your doctor. Do not stop taking Rywaroksaban TZF without first consulting your doctor. Stopping this medicine may increase the risk of another heart attack, stroke, or death due to heart or blood vessel disease.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Like other medicines with a similar action (anticoagulants), Rywaroksaban TZF may cause bleeding, which could potentially be life-threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). Signs of bleeding are not always obvious or visible.

Possible side effects which may be signs of bleeding:
Contact your doctor immediately if any of the following side effects occur:

• 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 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, which may be signs of bleeding. Your doctor may decide that close monitoring or a change in treatment is necessary.

Possible side effects which may be signs of skin reactions:
Contact your doctor immediately if any of the following skin reactions occur:

• Widespread, acute skin rash, blistering or mucosal changes, 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);
• Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), causing rash, fever, internal organ inflammation, hematological disorders and systemic involvement. The frequency of these side effects is very rare (up to 1 in 10,000 patients).

Possible side effects which may be signs of a serious allergic reaction:
Contact your doctor immediately if any of the following side effects occur:

• Swelling of the face, lips, mouth, tongue or throat; hives and breathing difficulties; sudden drop in blood pressure. The frequency of these reactions 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 occur in up to 1 in 10 patients)

• Decrease in red blood cell count, which may cause paleness of the skin and lead to weakness or shortness of breath;
• Bleeding from the stomach or intestines, 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 white part of the eye);
• Bleeding into tissues or body cavities (hematoma, bruising);
• Presence of blood in sputum (hemoptysis) when coughing;
• Bleeding from the skin or under the skin;
• Bleeding after surgery;
• Oozing of blood or fluid from a surgical wound;
• Swelling of limbs;
• Limb pain;
• Kidney function disorders (may be observed in tests performed by the doctor);
• Fever;
• Stomach pain, indigestion, feeling of nausea or vomiting, constipation, diarrhoea;
• Low blood pressure (symptoms may include dizziness or fainting upon standing);
• General decrease in 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 up to 1 in 100 patients)

• Bleeding into the brain or within the skull;
• 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 the 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 up to 1 in 1,000 patients)

• Bleeding into muscles;
• Cholestasis (bile stasis), hepatitis including liver cell damage;
• Yellowing of the skin and eyes (jaundice);
• Localized swelling;
• Collection of blood (hematoma) in the groin as a complication of cardiac catheterization, 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 granular white 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 (anticoagulant-related nephropathy);
• Increased pressure in the muscles of arms and legs following bleeding, which may lead to pain, swelling, altered sensation, numbness or paralysis (compartment syndrome following bleeding).

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects 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
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.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Rywaroksaban TZF

Keep this medicine out of sight and reach of children.
There are no special storage instructions for this 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 indicated.
Medicines must 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 package and other information

What Rywaroksaban TZF contains

• The active substance is rivaroxaban. Each coated tablet contains 2.5 mg of rivaroxaban.
• The other ingredients are: tablet core: hypromellose, microcrystalline cellulose, sodium lauryl sulfate, lactose monohydrate, sodium croscarmellose, magnesium stearate.
  tablet coating: hypromellose type 2910, titanium dioxide (E171), macrogol 3350, iron oxide yellow (E172).

What Rywaroksaban TZF looks like and contents of the pack
Rywaroksaban TZF 2.5 mg are yellow, round, biconvex coated tablets, embossed with "RVX" on one side and smooth on the other, with a diameter of approximately 6.1 mm.
The tablets are contained in PVC/Aluminium blisters, packed in a cardboard box.
The pack contains 56 coated tablets.

Marketing Authorisation Holder
Tarchomin Pharmaceutical Works "Polfa" Joint Stock Company
A. Fleminga Street 2
03-176 Warsaw
Phone number: 22 811-18-14

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