Razarxo

Package leaflet: Information for the patient

Razarxo, 10 mg, coated tablets
Rivaroxabanum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

1. What Razarxo is and what it is used for
2. What you need to know before taking Razarxo
3. How to take Razarxo
4. Possible side effects
5. How to store Razarxo
6. Contents of the pack and other information

1. What Razarxo is and what it is used for

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

• prevent blood clots in the veins after 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.

Razarxo 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. Important information before using Razarxo

When not to use Razarxo

• 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 in 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 the patency of a catheter in a vein or artery,
• 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 Razarxo and inform your doctor if the patient suspects that any of the above-mentioned circumstances apply.
Warnings and precautions
Before starting to take Razarxo, consult a doctor or pharmacist.
When to exercise special caution when using Razarxo

• 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,
  • if the patient is taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin) when switching anticoagulant therapy or when heparin is administered to maintain the patency of a catheter in a vein or artery (see section "Razarxo with other medicines"),
  • disorders of blood coagulation,
  • very high blood pressure that does not decrease despite medication,
  • diseases of the stomach or intestines that may cause bleeding, e.g. inflammation of the intestines and stomach or inflammation of the oesophagus (throat and oesophagus), e.g. due to gastro-oesophageal reflux disease (backflow of stomach acid into the oesophagus) or tumours located in the stomach or intestines or in the genital or urinary system,
  • blood vessel disease in the back of the eye (retinopathy),
  • lung 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 causing an increased risk of blood clots), the patient should inform the doctor, who will decide whether a change in treatment is necessary,
• if the patient has abnormal blood pressure or is scheduled for surgery or other treatment aimed at removing a pulmonary embolism.

If the patient suspects that any of the above-mentioned conditions apply, inform the doctor
before using Razarxo. The doctor will decide whether to use this medicine and whether the
patient should be subjected to particularly close monitoring.
If the patient needs to undergo surgery

• strictly follow the doctor's instructions regarding the timing of taking Razarxo before or after surgery,
• if during the surgical procedure a lumbar puncture or placement of a catheter into the spine is planned (e.g. for epidural or spinal anaesthesia, or for pain relief):
  • strictly follow the doctor's instructions regarding the timing of taking Razarxo,
  • immediately inform the doctor if, after the anaesthesia ends, the patient experiences symptoms such as: numbness or weakness of the lower limbs, disturbances in bowel or bladder function, as immediate treatment will be necessary in such a case.

Children and adolescents
Razarxo 10 mg tablets are not recommended for patients under 18 years of age. There is
insufficient data on the use of the medicine in children and adolescents.
Razarxo with 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 for fungal infections (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),
  • 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),
  • 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 (SSRI) or serotonin-noradrenaline reuptake inhibitors (SNRI)).

If the patient suspects that any of the above-mentioned conditions apply, inform the doctor
before using Razarxo, as the effect of Razarxo may be enhanced. The doctor will decide whether
to use this medicine and whether the patient should be subjected to particularly close monitoring.
If the doctor considers that the patient has an increased risk of developing stomach or intestinal
ulcers, they may prescribe treatment to prevent peptic disease.

• If the patient is taking
  • certain medicines used to treat epilepsy (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 that any of the above-mentioned conditions apply, inform the doctor
before using Razarxo, as the effect of Razarxo may be reduced. The doctor will decide whether
to use Razarxo and whether the patient should be subjected to particularly close monitoring.
Pregnancy, breastfeeding and fertility
Do not use Razarxo 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
Razarxo. If the patient becomes pregnant while taking this medicine, inform the doctor immediately,
who will decide on further treatment.
Driving and operating machinery
Razarxo may cause dizziness (common side effects) and fainting (uncommon side effects) (see
section 4 "Possible side effects"). Patients experiencing these side effects should not drive, ride
a bicycle or operate tools or machinery.
Razarxo contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning that the medicine is considered "sodium-free".

3. How to take Razarxo

This medicine should always be taken as prescribed by the doctor. In case of doubt, consult your
doctor or pharmacist.
How many tablets to take

• To prevent the formation of blood clots in veins after hip or knee replacement surgery, the recommended dose is one 10 mg Razarxo tablet taken once daily.
• For the treatment of blood clots in the leg veins, 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 10 mg tablet once daily or one 20 mg tablet once daily. The doctor has prescribed the patient Razarxo 10 mg once daily.

The tablet should be swallowed whole, preferably with water.
Razarxo may be taken during or independently of meals.
If the patient has difficulty swallowing the whole tablet, the patient should discuss alternative
methods of taking Razarxo with the doctor. The tablet may be crushed and mixed with water or soft
food, such as apple puree, immediately before administration.
If necessary, the doctor may administer crushed Razarxo tablets via a gastric tube.
When to take Razarxo
The tablet should be taken every day until the 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.
The doctor will decide how long treatment should continue.
To prevent blood clots in leg veins after hip or knee replacement surgery:
The first tablet should be taken between 6 and 10 hours after surgery.
In patients undergoing major hip surgery, treatment usually lasts 5 weeks.
In patients undergoing major knee surgery, treatment usually lasts 2 weeks.
Taking more than the recommended dose of Razarxo
If the patient has taken more than the recommended dose of Razarxo, contact the doctor immediately.
Taking too high a dose of Razarxo increases the risk of bleeding.
Missed dose of Razarxo
If the patient forgets to take a dose, take the tablet as soon as remembered. The next tablet should be taken the following day, and then continue taking tablets as usual, once daily.
Do not take a double dose to make up for a missed tablet.
Stopping treatment with Razarxo
Do not stop taking Razarxo without first discussing it with the doctor, as Razarxo prevents the occurrence of a serious condition.
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 medicine can cause adverse reactions, although not everyone will experience them.
As with other medicines with a similar action reducing blood clot formation, Razarxo may cause bleeding, which potentially could be life-threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). Signs of bleeding are not always obvious or visible.
You should contact your doctor immediately if any of the following adverse reactions occur:

Signs of bleeding

• Bleeding into the brain or inside the skull (symptoms may include headache, one-sided paralysis, vomiting, seizures, decreased level of consciousness, and neck stiffness. This is a serious, acute medical emergency. Seek immediate medical help!),
• Prolonged or excessive bleeding,
• Unusual weakness, fatigue, paleness, dizziness, headache, appearance of unexplained swelling, shortness of breath, chest pain, or angina. Your doctor may decide that close monitoring or a change in treatment is necessary.

Signs of severe skin reactions

• Widespread, acute skin rash, blistering, or lesions on mucous membranes, e.g., in the mouth or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Drug reaction causing rash, fever, internal organ inflammation, hematological disorders, and systemic symptoms (DRESS syndrome). The frequency of these adverse reactions is very rare (occurring in up to 1 in 10,000 patients).

Signs of severe allergic reactions

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

General list of possible adverse reactions
Common (may occur in up to 1 in 10 people)

• Decrease in red blood cells, which may cause pale 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 severe menstrual bleeding), nosebleeds, bleeding gums,
• Bleeding into the eye (including bleeding from the sclera),
• Bleeding into tissues or body cavities (hematoma, bruising),
• Appearance of blood in sputum (hemoptysis) during 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 a doctor),
• Fever,
• Stomach pain, indigestion, nausea, or vomiting, constipation, diarrhea,
• Low blood pressure (symptoms may include dizziness or fainting upon standing),
• Generalized weakness and 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 people)

• Bleeding into the brain or inside the skull (see signs of bleeding above),
• 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,
• Dryness of the mouth,
• Hives.

Rare (may occur in up to 1 in 1,000 people)

• Bleeding into muscles,
• Cholestasis (bile stasis), hepatitis, including liver cell damage,
• Yellowing of the skin and eyes (jaundice),
• Localized swelling,
• Blood collection (hematoma) in the groin area 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 white granular 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 urine, leading to impaired kidney function (drug-induced anticoagulant nephropathy),
• Increased pressure in the muscles of arms and legs following bleeding, which may cause pain, swelling, altered sensation, numbness, or paralysis (compartment syndrome following bleeding).

Reporting of adverse reactions
If any adverse symptoms occur, including any possible adverse effects not listed in this leaflet, you should inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
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 Razarxo

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after the word "EXP". The expiry date refers to the last day of the stated month.
No special storage conditions apply for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Razarxo contains

• The active substance is rivaroxaban. Each coated tablet contains 10 mg of rivaroxaban.
• The other ingredients are: mannitol, microcrystalline cellulose, polyethylene glycol 8000, poloxamer 188, sodium lauryl sulfate, sodium croscarmellose, colloidal anhydrous silica, and sodium stearyl fumarate in the tablet core; and hypromellose 2910 - 15 cP, polyethylene glycol 4000, titanium dioxide (E 171), and iron oxide red (E 172) in the tablet coating. See section 2 "Razarxo contains sodium".

What Razarxo looks like and contents of the pack
Brownish-red, round, slightly biconvex coated tablets with the imprint “10” on one side.
Dimensions: approximately 6.5 mm in diameter.
Razarxo is available in packs containing:

• 10, 15, 30, 60, 90, and 100 coated tablets in non-perforated blisters.
• 10 x 1, 30 x 1, 60 x 1, 90 x 1, and 100 x 1 coated tablets in single-dose perforated blisters.
• calendar packs: 14, 28, 42, 56, 98 coated tablets in non-perforated blisters.

A patient warning card is included with each package of the medicine.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
Manufacturer/Importer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

For further information about this medicine, contact the local representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Tel: +48 22 573 75 00