Zarixa

Package Leaflet: Information for the User

ZARIXA, 2.5 mg, hard capsules

Rivaroxaban

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. 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

You have been given ZARIXA because:

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

or

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

ZARIXA 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 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 changing anticoagulant treatment or when heparin is given to maintain the patency of a vein or artery catheter (see section "Other medicines and ZARIXA"),
• if you have had an acute coronary syndrome and have had bleeding or a blood clot in the brain (stroke),
• if you have coronary artery disease or peripheral arterial disease and have had bleeding in the brain (stroke) or blockage of small arteries supplying blood to the brain tissues (cerebral sinus thrombosis) or have had a blood clot in the brain (ischemic stroke) in the last month,
• if you have liver disease that leads to an increased risk of bleeding,
• if you are pregnant or breastfeeding.

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

Warnings and precautions

Before taking ZARIXA, consult your doctor or pharmacist. ZARIXA should not be taken with other anticoagulant medicines, except for aspirin, clopidogrel or ticlopidine.

When to be extra careful when taking ZARIXA

• if you have an increased risk of bleeding, such as:
• severe kidney disease, as kidney function may affect the amount of medicine that works in your body,
• taking other anticoagulant medicines (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 section "Other medicines and ZARIXA"),
• bleeding disorders,
• very high blood pressure that does not decrease despite taking medicines,
• stomach or intestinal diseases that may 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

regurgitation of stomach acid into the esophagus) or tumors located in the stomach or intestines or genital or urinary system,

• vascular disease of the back of the eye (retinopathy),
• pulmonary disease in which the airways are enlarged and filled with pus (bronchiectasis) or previous bleeding from the lungs,
• if you are over 75 years old,
• if you weigh less than 60 kg,
• coronary artery disease with severe symptomatic heart failure,
• 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 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 need to be closely monitored.

If you need to have surgery:

• you must carefully follow your doctor's instructions regarding the intake of ZARIXA 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 ZARIXA before and after the puncture or catheter removal, according to your doctor's instructions, and due to the need for special caution, you should immediately inform your doctor if you experience numbness or weakness in your legs, bowel or bladder problems after anesthesia.

Children and adolescents

ZARIXA 2.5 mg hard capsules are not recommended for persons under 18 years of age. There is a lack of sufficient 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 or have recently taken, as well as any medicines you plan to take, including those available without a prescription.

• If you are taking
• certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only topically on the skin,
• ketokonazole in tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol),
• certain antibacterial medicines (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 section "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 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 need to be closely monitored.
If your doctor thinks that you are at risk of developing stomach or intestinal ulcers, they may use a treatment to prevent ulcers.

• If you are taking
• certain medicines used to treat epilepsy (phenytoin, carbamazepine, phenobarbital),
• St. John's Wort ( Hypericum perforatum), a herbal medicine used to treat 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 need to 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

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

How many capsules to take

The recommended dose is one 2.5 mg capsule twice a day. ZARIXA should be taken at approximately the same time every day (e.g. one capsule in the morning and one in the evening). This medicine can be taken with or without food.
If you have difficulty swallowing the whole capsule, you should 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 you the contents of the ZARIXA capsule through a gastric tube.
ZARIXA will not be given to you as the only medicine.
Your doctor will also prescribe you to take aspirin. If you are taking ZARIXA after an acute coronary syndrome, your doctor may also prescribe clopidogrel or ticlopidine for you to take.
If you are taking ZARIXA after a procedure to open up a narrowed or blocked artery in your leg to restore blood flow, your doctor may also prescribe clopidogrel for you to take for a short time in addition to aspirin.
Your doctor will tell you how much 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 take ZARIXA

Treatment with ZARIXA after an acute coronary syndrome should be started as soon as possible after stabilization of the acute coronary syndrome, at the earliest 24 hours after hospitalization and at the time when parenteral (by injection) anticoagulant treatment would normally be discontinued.
Your doctor will tell you when to start treatment with ZARIXA if you have been diagnosed with coronary artery disease or peripheral arterial disease.
Your doctor will decide how long to continue treatment.

Taking more ZARIXA than prescribed

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

Missing a dose of ZARIXA

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

Stopping ZARIXA treatment

ZARIXA should be taken regularly and for the duration prescribed by your doctor.
You should not stop taking ZARIXA without first consulting your doctor.
If you stop taking this medicine, you may increase the risk of having 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, 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 that reduce blood clotting, ZARIXA may cause bleeding, which can be life-threatening. Excessive bleeding can lead to a sudden drop in blood pressure (shock). These may not always be obvious or visible signs of bleeding.
You should immediately inform your doctorif you experience any of the following side effects:

Signs of bleeding:

• bleeding into the brain or skull (symptoms may include headache, one-sided weakness, vomiting, seizures, decreased level of consciousness, and stiffness of the neck. A serious medical emergency. You should immediately seek medical help!),
• prolonged or excessive bleeding,
• unusual weakness, fatigue, pallor, dizziness, headache, swelling of unknown cause, 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, acute skin rash, blistering or changes in the mucous membranes, e.g. on 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 severe allergic reactions

• 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(may affect up to 1 in 10 people)

• decrease in red blood cell count, which may cause pallor 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 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 up),
• general weakness and lack of energy (weakness, fatigue), headache, dizziness,
• skin rash, itching,
• 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 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,
• liver function disorders (can be observed in tests performed by your doctor),
• blood test results may show increased bilirubin levels, 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 muscles,
• cholestasis (bile stasis), hepatitis, including liver cell damage,
• jaundice (yellowing of the skin and eyes),
• local swelling,
• blood accumulation (hematoma) 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,
• 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, you should inform 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, 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 this 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 no longer required. This will help protect the environment.

6. Contents of the pack and other information

What ZARIXA contains

• The active substance is rivaroxaban. One hard capsule contains 2.5 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). Black ink: shellac, propylene glycol, potassium hydroxide, iron oxide, black (E 172).

What ZARIXA looks like and contents of the pack

ZARIXA 2.5 mg hard capsules are size "3", white body and white cap with black printing "2.5" on the body and are filled with white or almost white powder.
HDPE container with a child-resistant closure and a guarantee ring or PVC/PVDC/Aluminum blisters containing 28 hard capsules in a cardboard box.

Marketing Authorization Holder:

Celon Pharma S.A.
ul. Ogrodowa 2A Kiełpin
05-092 Łomianki
tel.: +48 22 75-15-933
e-mail: [email protected]

Manufacturer:

Celon Pharma S.A.
ul. Marymoncka 15
05-152 Kazuń Nowy
To obtain more detailed information on 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: [email protected]

Date of last revision of the leaflet: