Rivaroxaban tzf

Package leaflet: Information for the patient

Rywaroksaban TZF, 10 mg, film-coated tablets
Rivaroxabanum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, 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 Rywaroksaban TZF is and what it is 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 Rywaroksaban TZF is and what it is used for

Rywaroksaban TZF contains the active substance rivaroxaban and is used in adults to:

• prevent the formation of blood clots in the veins following hip or knee replacement surgery. Your doctor has prescribed this medicine because your risk of developing blood clots 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 to prevent recurrence of blood clots in the blood vessels of the legs and/or lungs.

Rywaroksaban TZF belongs to a group of medicines called anticoagulants. It works by blocking a blood clotting factor (Factor Xa), thereby reducing the tendency to form blood clots.

2. Important 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 is experiencing excessive bleeding;
• if the patient has a disease or condition affecting an organ that leads to an increased risk of serious bleeding (e.g. stomach ulcer, trauma or bleeding in 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 switching anticoagulant therapy or when heparin is administered to maintain patency of a venous or arterial catheter;
• 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 your doctor if you suspect any of the above circumstances apply.

Warnings and precautions
Before starting treatment with Rywaroksaban TZF, discuss it with your doctor or
pharmacist.
Exercise particular caution when using Rywaroksaban TZF:

• if the patient has an increased risk of bleeding, such as in the following conditions:
  • moderate or severe kidney disease, as kidney function may affect the amount of medicine acting in the patient's body;
  • concomitant 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 patency of a venous or arterial catheter (see section "Rywaroksaban TZF and other medicines");
  • coagulation disorders;
  • very high blood pressure that does not decrease despite medication;
  • stomach or intestinal diseases 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, intestines, genital or urinary tract;
  • vascular disease of the posterior part of the eyeball (retinopathy);
  • lung disease in which bronchi are dilated and filled with pus (bronchiectasis) or previous pulmonary bleeding;
• in patients with prosthetic heart valves;
• if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing increased risk of clot formation), the patient should inform their doctor, who will decide whether treatment adjustment is necessary;
• if the patient has abnormal blood pressure or if surgery or another treatment to remove a pulmonary clot is planned. If the patient suspects any of the above conditions, they should inform their doctor before using Rywaroksaban TZF. 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 Rywaroksaban TZF before or after surgery;
• if catheterization or spinal puncture (e.g. for epidural or intrathecal anaesthesia or pain relief) is planned during surgery:
  • it is very important to take Rywaroksaban TZF exactly as directed by the doctor;
  • due to the need for special caution, immediately inform the doctor if numbness or weakness in the legs, or bowel or bladder dysfunction occurs after the anaesthesia ends.

Children and adolescents
Rywaroksaban TZF 10 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 you are currently taking, have recently taken, or plan to take, including those available without a prescription.
If the patient is taking
some antifungal medicines (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);
some antibacterial medicines (e.g. clarithromycin, erythromycin);
some 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);
anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid);
dronedarone, a medicine used to treat heart rhythm disorders;
some medicines used to treat depression (selective serotonin reuptake inhibitors (SSRI) or serotonin-noradrenaline reuptake inhibitors (SNRI)).
If the patient suspects any of the above conditions apply, they should inform their
doctor before using 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 the patient to be at increased risk of developing stomach or intestinal ulcers, they may prescribe preventive treatment.
If the patient is taking
some antiepileptic medicines (phenytoin, carbamazepine, phenobarbital);
St. John's wort (Hypericum perforatum) – an herbal remedy used for depression;
rifampicin, which belongs to the group of antibiotics.
If the patient suspects any of the above conditions apply, they should inform their
doctor before using Rywaroksaban TZF, as the effect of the medicine may be reduced. The doctor will decide whether to use Rywaroksaban TZF and whether the patient requires particularly close monitoring.
Pregnancy and breastfeeding
Do not use Rywaroksaban TZF 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, inform the doctor immediately, 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 contact their 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

• To prevent blood clots in the veins after hip or knee replacement surgery: The recommended dose is one tablet of Rywaroksaban TZF 10 mg taken once daily.
• For the treatment of blood clots in the legs, blood clots in the blood vessels of the lungs, and to prevent recurrence of blood clots: After at least 6 months of treatment for blood clots, the recommended dose is one tablet of 10 mg once daily or one tablet of 20 mg once daily. Your doctor has prescribed Rywaroksaban TZF 10 mg once daily for you.

Swallow the tablet whole, preferably with water.
Rywaroksaban TZF can be taken with or without food.
If you have difficulty swallowing the whole tablet, talk to your doctor about alternative ways of taking Rywaroksaban TZF. The tablet may be crushed and mixed with water or apple puree immediately before administration. If necessary, your doctor may administer crushed Rywaroksaban TZF tablets via a gastric tube.
When to take Rywaroksaban TZF
Take one tablet every day until your doctor decides to stop treatment.
It is best to take the tablet at the same time each day, as this makes it easier to remember.
Your doctor will decide how long treatment should continue.
To prevent blood clots in the legs after hip or knee replacement surgery:
Take the first tablet between 6 and 10 hours after surgery.
For patients undergoing major hip surgery, treatment usually lasts 5 weeks.
For patients undergoing major knee surgery, treatment usually lasts 2 weeks.
Taking more than the recommended dose of Rywaroksaban TZF
If you have taken more than the prescribed 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
If you forget to take a dose, take the tablet as soon as you remember. Take the next tablet the following day and then continue taking the tablets as usual, once daily. Do not take a double dose to make up for a missed dose.
Stopping Rywaroksaban TZF
Do not stop taking Rywaroksaban TZF without first consulting your doctor, as Rywaroksaban TZF prevents serious medical conditions.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicinal product may cause adverse reactions, although not everyone experiences them.
Like other medicines with a similar action (anticoagulants), Rywaroksaban TZF may cause bleeding, which potentially can 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 adverse reactions which may indicate bleeding:
Contact a doctor immediately if any of the following adverse reactions occur:

• bleeding into the brain or inside the skull (symptoms may include headache, one-sided paralysis, vomiting, seizures, decreased level of consciousness and neck stiffness. 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 pectoris, which may be signs of bleeding. The doctor may decide that close monitoring of the patient or a change in treatment is necessary.

Possible adverse reactions which may indicate skin reactions:
Contact a doctor immediately if the following skin reactions occur, such as:

• extensive, acute skin rash, blistering or mucosal lesions, e.g. in the mouth or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis). The frequency of these adverse reactions 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 adverse reactions is very rare (up to 1 in 10,000 patients).

Possible adverse reactions which may indicate a serious allergic reaction:
Contact a doctor immediately if the following adverse reactions occur:

• swelling of the face, lips, mouth, tongue or throat; urticaria 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 adverse reactions:
Common (may occur in up to 1 in 10 patients)

• decrease in red blood cells 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, bleeding from gums;
• bleeding into the eye (including bleeding from the white of the eye);
• bleeding into tissues or body cavities (hematoma, bruising);
• presence of blood in sputum (hemoptysis) during coughing;
• bleeding from the skin or subcutaneous bleeding;
• postoperative bleeding;
• oozing of blood or fluid from the 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 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 inside the skull;
• bleeding into a joint causing pain and swelling;
• thrombocytopenia (low platelet count, 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;
• dry mouth;
• urticaria.

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);
• local swelling;
• accumulation of blood (hematoma) in the groin as a complication of cardiac catheterization, when a catheter is inserted into an artery in the leg (pseudoaneurysm).

Very rare (may occur in up to 1 in 10,000 patients)

• accumulation of eosinophils, a type of granular white blood cells, causing lung inflammation (eosinophilic pneumonia).

Frequency unknown (frequency cannot be estimated from available data)

• kidney failure following severe bleeding;
• bleeding in the kidneys, sometimes with blood in urine, leading to impaired kidney function (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 adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of 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
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 Rywaroksaban TZF

Keep this medicine out of sight and reach of children.
No special storage conditions are required 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Rywaroksaban TZF contains

• The active substance is rivaroxaban. Each coated tablet contains 10 mg of rivaroxaban.
• Other components of the medicine 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 red (E172).

What Rywaroksaban TZF looks like and contents of the pack
Rywaroksaban TZF 10 mg are pink, round, biconvex coated tablets, embossed with the number "10" on one side and smooth on the other, with a diameter of approximately 9.1 mm.
The tablets are contained in PVC/Aluminum blisters, packed in a cardboard box.
The pack contains 10 coated tablets.

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

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