Zarixa

Leaflet attached to the packaging: information for the user

ZARIXA, 10 mg, hard capsules

Rivaroxaban

Read carefully the contents of this leaflet 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed to you by a doctor. 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, please inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is ZARIXA and what is it used for

ZARIXA 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 forming 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 prevent the recurrence of blood clots in the blood vessels of the legs and/or lungs.

ZARIXA contains the active substance rivaroxaban and belongs to a group of medicines called anticoagulants. Its action is based on blocking the blood clotting factor (factor Xa) and thereby reducing the tendency to form blood clots.

2. Important information before taking ZARIXA

When not to take ZARIXA

• 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 switching anticoagulant therapy or when heparin is given to maintain the patency of a venous or arterial catheter,
• if you have liver disease that leads to an increased risk of bleeding,
• if you are pregnant or breastfeeding.

Do not take ZARIXA, and inform your doctorif you suspect that you have any of the above conditions.

Warnings and precautions

Before taking ZARIXA, consult your doctor or pharmacist.

When to be particularly careful when taking ZARIXA

• if you have an increased risk of bleeding, such as:
• moderate or severe kidney disease, as kidney function may affect the amount of medicine that works in your body,
• if you are taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant therapy or when heparin is given to maintain the patency of a venous or arterial catheter (see "Other medicines and ZARIXA"),
• bleeding disorders,
• very high blood pressure that does not decrease despite treatment,
• stomach or intestinal diseases that may cause bleeding, such as inflammation of the stomach and intestines or esophagitis (throat and esophagus), such as reflux esophagitis (stomach acid flowing back into the esophagus), or tumors located in the stomach, intestines, genital or urinary system,
• vascular disease of 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 prosthetic heart valves,
• if you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), you should inform your doctor, who will decide whether to change the treatment,
• if you have abnormal blood pressure or are scheduled for surgery to remove a blood clot from the lungs.

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

your doctorbefore taking ZARIXA. Your doctor will decide whether to use this medicine and whether you should be closely monitored.

If you need to have surgery:

• you must carefully follow your doctor's instructions regarding the intake of ZARIXA at a specific time before or after surgery,
• if a lumbar puncture or spinal catheter insertion is planned during surgery (e.g. for epidural or spinal anesthesia or to relieve pain):
• you must carefully follow your doctor's instructions regarding the intake of ZARIXA at a specific time,
• you should immediately inform your doctor if you experience symptoms such as numbness, weakness of the lower limbs, disorders of bowel or bladder function after anesthesia, as immediate treatment may be necessary.

Children and adolescents

ZARIXA 10 mg capsules are not recommended for people under 18 years of age. There is insufficient data on the use of the medicine in children and adolescents.

Other medicines and ZARIXA

Tell your doctor or pharmacist about all 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 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 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, inform

your doctorbefore taking ZARIXA, as the effect of ZARIXA may be increased. Your doctor will decide whether to use this medicine and whether you should be closely monitored.
If your doctor considers that you have an increased risk of stomach or duodenal ulcers, they may use treatment to prevent stomach ulcers.

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, inform

your doctorbefore taking ZARIXA, as the effect of ZARIXA may be reduced. Your doctor will decide whether to use ZARIXA and whether you should be closely monitored.

Pregnancy and breastfeeding

Do not take ZARIXA if you are pregnant or breastfeeding. If there is a risk that you may become pregnant, you should use effective contraception while taking ZARIXA. If you become pregnant while taking this medicine, you should immediately inform your doctor, who will decide on further treatment.

Driving and using machines

ZARIXA may cause dizziness (frequent side effects) and fainting (uncommon side effects) (see section 4, "Possible side effects"). Patients who experience these side effects should not drive, ride a bicycle, or operate tools or machines.

ZARIXA contains sodium.

The medicine contains less than 1 mmol of sodium (23 mg) per hard capsule, which means it is essentially "sodium-free".

3. How to take ZARIXA

This medicine should always be taken exactly as directed by your doctor. If you are unsure, consult your doctor or pharmacist.

How many capsules to take

• To prevent blood clots in the veins after hip or knee replacement surgery: the recommended dose is one ZARIXA 10 mg capsule taken once a day.
• To treat 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 capsule once a day or one 20 mg capsule once a day. Your doctor has prescribed ZARIXA 10 mg once a day for you.

Swallow the capsule whole, preferably with water.
ZARIXA can be taken with or without food.
If you have difficulty swallowing the whole capsule, talk to your doctor about other ways to take ZARIXA. The contents of the capsule can be mixed with water or soft food, such as apple puree, immediately before taking it.
If necessary, your doctor may give the contents of the ZARIXA capsule through a gastric tube.

When to take ZARIXA

Take one capsule every day until your doctor decides to stop the treatment.
It is best to take the capsule at the same time every day, as it will be easier to remember.
Your doctor will decide how long to continue the treatment.
To prevent blood clots in the veins of the legs after hip or knee replacement surgery:
The first capsule 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 ZARIXA than prescribed

If you have taken more ZARIXA than prescribed, contact your doctor immediately. Taking too much ZARIXA increases the risk of bleeding.

Missing a dose of ZARIXA

If you forget to take a dose, take the capsule as soon as you remember.
Take the next capsule the next day, and then take the capsules as usual, once a day.
Do not take a double dose to make up for the missed dose.

Stopping ZARIXA treatment

Do not stop taking ZARIXA without first talking to your doctor, as ZARIXA prevents a serious disease.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, ZARIXA can cause side effects, although not everybody gets them.
Like other medicines with a similar anticoagulant effect, ZARIXA may cause bleeding, which can be life-threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). These may not always be obvious or visible signs of bleeding.
Tell your doctor immediatelyif you experience any of the following side effects:

Signs of bleeding:

• 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. Seek medical help immediately!),
• prolonged or excessive bleeding,
• unusual weakness, fatigue, pallor, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina. Your doctor may decide to closely monitor you or change the treatment.

Signs of severe skin reactions:

• widespread, severe skin rash, blistering, or changes to the mucous membranes, such as the tongue or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis),
• 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 (up to 1 in 10,000 people).

Signs of serious allergic reactions 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; 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 people) and uncommon (angioedema and allergic edema may occur in 1 in 100 people).

General list of possible side effects

Common side effects(may affect up to 1 in 10 people)

• reduced red blood cell count, which may cause pallor and be the cause of weakness or shortness of breath,
• bleeding from the stomach or intestines, bleeding from the urinary or genital system (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding 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, feeling of nausea (nausea) or vomiting, constipation, diarrhea,
• low blood pressure (symptoms may include dizziness or fainting when standing),
• general weakness and lack of energy (weakness, fatigue), headache, dizziness,
• rash, itching of the skin,
• increased activity of certain liver enzymes, which can be seen in blood test results.

Uncommon side effects(may affect up to 1 in 100 people)

• bleeding into the brain or inside the skull (see above signs of bleeding),
• bleeding into a joint causing pain and swelling,
• thrombocytopenia (low platelet count, cells involved in blood clotting),
• allergic reactions, including allergic skin reactions,
• blood test results may show increased bilirubin levels, activity of certain pancreatic or liver enzymes, or platelet count,
• fainting,
• malaise,
• rapid heartbeat,
• dry mouth,
• hives,
• liver function disorders (can be observed in tests performed by your doctor).

Rare side effects(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,
• blood accumulation (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 affect up to 1 in 10,000 people)

• accumulation of eosinophils, a type of granular white blood cell, which causes inflammation in the lungs (eosinophilic pneumonia).

Side effects of unknown frequency(frequency cannot be estimated from available data):

• kidney failure after severe bleeding,
• kidney bleeding, 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, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ZARIXA

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: EXP. The expiry date refers to the last day of the month stated.
Do not store above 30°C.
Contents of the capsule:
The contents of the capsule are stable in water or apple puree for up to 4 hours.
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 ZARIXA contains

• The active substance of ZARIXA is rivaroxaban. One hard capsule contains 10 mg of rivaroxaban.
• The other ingredients are: Capsule contents: mannitol, sodium lauryl sulfate, magnesium stearate. See section 2 "ZARIXA contains sodium". Capsule shell: gelatin, titanium dioxide (E 171).

What ZARIXA looks like and contents of the pack

ZARIXA 10 mg hard capsules are size "0", with a white body and white cap, and are filled with a white or almost white powder.
A HDPE container with a child-resistant closure and a guarantee ring or PVC/PVDC/Aluminum blisters containing 10 or 30 hard capsules in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder:

Celon Pharma S.A.
ul. Ogrodowa 2A Kiełpin
05-092 Łomianki
tel.: +48 22 75-15-933
e-mail: info@celonpharma.com

Manufacturer:

Celon Pharma S.A.
ul. Marymoncka 15
05-152 Kazuń Nowy
To obtain more detailed information about this medicine, please contact the local representative of the marketing authorization holder:
Celon Pharma SA
ul. Ogrodowa 2A Kiełpin
05-092 Łomianki
tel.: +48 22 75 15 933
e-mail: info@celonpharma.com

Date of last revision of the leaflet: