Xaboplax

Leaflet accompanying the packaging: patient information

XABOPLAX, 2.5 mg, film-coated tablets

Rivaroxaban

You should read the contents of this leaflet carefully before taking the medicine, as it contains important information for you.

You should keep this leaflet, so you can read it again if you need to.
In case of any doubts, you should consult a doctor or pharmacist.
This medicine has been prescribed to you specifically. Do not pass it on to others.
The medicine may harm another person, even if their symptoms are the same as yours.
If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What XABOPLAX is and what it is used for

You have been given XABOPLAX because

• you have been diagnosed with acute coronary syndrome (a condition that includes heart attack and unstable angina, severe chest pain) and have elevated levels of cardiac biomarkers. XABOPLAX reduces the risk of another heart attack or reduces the risk of death due to heart or blood vessel disease in adults. XABOPLAX 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. XABOPLAX reduces the risk of blood clots (atherothrombotic events) in adults. XABOPLAX 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 XABOPLAX 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.
XABOPLAX contains the active substance rivaroxaban and belongs to a group of medicines called anticoagulants. Its action is based on blocking a blood clotting factor (factor Xa) and thus reducing the tendency to form blood clots.

2. Important information before taking XABOPLAX

When not to take XABOPLAX

if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6);
if you have a severe bleeding disorder;
if you have a disease or disorder that increases the risk of serious bleeding (e.g. stomach ulcer, injury or bleeding into the brain, recent surgical procedure in the brain or eyes);
if you are taking medicines that prevent blood clotting (i.e. warfarin, dabigatran, apixaban or heparin); an exception is the period of changing anticoagulant treatment or when heparin is used to maintain the patency of a vein or artery catheter (see section "XABOPLAX and other medicines");
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 if you have had a blood clot in the brain (ischemic stroke) in the last month,
if you have liver disease that increases the risk of bleeding;
if you are pregnant or breastfeeding.
Do not take XABOPLAX and consult your doctorif any of these situations apply to you.

Warnings and precautions

Before starting XABOPLAX, you should discuss it with your doctor or pharmacist.
XABOPLAX should not be taken with other medicines that prevent blood clotting, such as prasugrel or ticagrelor, except for aspirin, clopidogrel or ticlopidine.

While taking XABOPLAX, you should be particularly careful

• if your risk of bleeding is increased, which may occur in situations such as:
• severe kidney disease, as kidney function may affect the amount of medicine that works in your body;
• taking other medicines that prevent blood clotting (i.e. warfarin, dabigatran, apixaban or heparin) during the change of anticoagulant treatment or when heparin is used to maintain the patency of a vein or artery catheter (see section "XABOPLAX and other medicines");
• bleeding disorders;
• very high blood pressure, uncontrolled by medication;
• stomach or intestinal diseases that may cause bleeding, e.g. inflammation of the intestines or stomach or esophagitis (e.g. due to gastroesophageal reflux disease, in which acidic stomach juice flows back into the esophagus) or tumors located in the stomach or intestines or genital or urinary system;
• vascular disease in the back of the eye (retinopathy);
• pulmonary disease with bronchiectasis and filling of the bronchi 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
• if you have a heart valve prosthesis;
• 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 your treatment.

If any of these situations apply to you, you should consult your doctorbefore taking XABOPLAX. Your doctor will decide whether you should take this medicine and whether you need close monitoring at that time.

If you need to have surgery

• It is very important to take XABOPLAX before and after surgery at a time strictly determined by your doctor.
• If catheterization or spinal puncture is planned during surgery (e.g. for epidural or spinal anesthesia or to relieve pain):
• it is very important to take XABOPLAX at the time prescribed by your doctor,
• you should immediately inform your doctor if, after the anesthesia is finished, you experience numbness or weakness in your legs or problems with bowel or bladder function, as immediate treatment may be necessary.

Children and adolescents

XABOPLAX 2.5 mg is not recommendedfor patients under 18 years of age. There is not enough information about its use in children and adolescents.

XABOPLAX and other medicines

You should tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as about medicines you plan to take, including those available without a prescription.

If you are taking:

• certain medicines used to treat fungal infections (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only locally on the skin
• ketoconazole in tablets (used to treat Cushing's syndrome, when the body produces too much cortisol)
• certain medicines used to treat bacterial infections (e.g. clarithromycin, erythromycin)
• certain antiviral medicines used to treat HIV/AIDS (e.g. ritonavir)
• other medicines that reduce blood clotting (e.g. enoxaparin, clopidogrel or vitamin K antagonists, such as warfarin and 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 norepinephrine reuptake inhibitors [SNRIs])

If any of the above applies to you, you should tell your

doctorbefore taking XABOPLAX, as it may increase the effect of the medicine. Your doctor will decide whether you should take XABOPLAX and whether you need close monitoring at that time.
If your doctor thinks you are at increased risk of stomach or intestinal ulcers, they may also prescribe medicines to prevent the development of 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 (an antibiotic).

If any of the above applies to you, you should tell your

doctorbefore taking XABOPLAX, as it may reduce its effect. Your doctor will decide whether you should take XABOPLAX and whether you need close monitoring at that time.

Pregnancy and breastfeeding

XABOPLAX should not be taken if you are pregnant or breastfeeding. Women of childbearing age should use effective contraception while taking XABOPLAX.
If you become pregnant during treatment, you should immediately inform your doctor, who will decide on further treatment.

Driving and using machines

XABOPLAX may cause dizziness (a common side effect) or fainting (an uncommon side effect), see section 4 "Possible side effects". If you experience these symptoms, you should not drive, ride a bike or operate tools or machines.

XABOPLAX contains lactose and sodium

If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which means it is considered "sodium-free".

3. How to take XABOPLAX

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

How many tablets to take

The recommended dose is one tablet (2.5 mg) twice a day. XABOPLAX should be taken at approximately the same time every day (e.g. one tablet in the morning and one in the evening). The medicine can be taken with or without food.
If you have difficulty swallowing the whole tablet, you should talk to your doctor about other ways to take XABOPLAX. The tablet can be crushed, mixed with water or apple sauce and taken immediately.
If necessary, your doctor may administer the crushed XABOPLAX tablet through a gastric tube.
XABOPLAX will not be given to you as the only medicine. Your doctor will also prescribe you to take aspirin. If you are taking XABOPLAX after an acute coronary syndrome, your doctor may also prescribe clopidogrel or ticlopidine.
If you are taking XABOPLAX 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 start taking XABOPLAX

Treatment with XABOPLAX 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 when parenteral (by injection) anticoagulant treatment would normally be discontinued. Your doctor will tell you when to start treatment with XABOPLAX if you have been diagnosed with coronary artery disease or peripheral arterial disease. Your doctor will decide how long to continue treatment.

Taking a higher dose of XABOPLAX than recommended

If you have taken more XABOPLAX tablets than recommended, you should immediately contact your doctor due to the increased risk of bleeding.

Missing a dose of XABOPLAX

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

Stopping XABOPLAX treatment

XABOPLAX should be taken regularly and for the time prescribed by your doctor.
You should not stop taking XABOPLAX without first consulting your doctor.
If you stop taking this medicine, you may increase the risk of another heart attack, stroke or death due to heart or blood vessel disease.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, XABOPLAX can cause side effects, although not everybody gets them.
Like other similar medicines with a similar blood clot-reducing effect, XABOPLAX may cause bleeding, which can be life-threatening. Excessive bleeding can lead to a sudden drop in blood pressure (shock). In some cases, bleeding may be invisible.

You should immediately inform your doctor if 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
• extreme weakness, fatigue, pallor, dizziness, headache, swelling of unknown cause, shortness of breath, chest pain or angina pectoris Your doctor may decide to subject you to close monitoring or change your treatment.
• Signs of a severe skin reaction
• skin reactions, such as widespread, intense rash, blistering or changes in the mucous membranes, e.g. in the mouth or eyes (Stevens-Johnson syndrome or toxic epidermal necrolysis).
• a drug reaction causing rash, fever, inflammation of internal organs, hematological and systemic disorders (DRESS syndrome). These side effects are very rare (less than 1 in 10,000 patients).
• Signs of a severe allergic reaction:
• swelling of the face, lips, mouth, tongue or throat; difficulty swallowing; hives and difficulty breathing; sudden drop in blood pressure. Severe allergic reactions are very rare (anaphylactic reactions, including anaphylactic shock, may occur in less than 1 in 10,000 patients) and uncommon (angioedema and allergic edema may occur in less than 1 in 100 patients).

General list of possible side effects:
Common(may occur in less than 1 in 10 patients)

• decrease in red blood cell count, which may cause pallor, 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 sclera)
• bleeding into tissues or body cavities (hematoma, bruising)
• coughing up blood (hemoptysis)
• bleeding from the skin or subcutaneous bleeding
• bleeding after surgery
• oozing of blood or fluid from the surgical wound
• swelling of the limbs
• limb pain
• kidney function disorders (which may be indicated by test results ordered by your doctor)
• fever
• stomach pain, indigestion, 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
• rash, itching
• increased activity of certain liver enzymes shown in blood tests

Uncommon(may occur in less than 1 in 100 patients)

• 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 skin allergic reactions
• liver function disorders (which may be indicated by test results ordered by your doctor)
• increased bilirubin levels, increased activity of certain pancreatic or liver enzymes, or increased platelet count shown in blood tests
• fainting
• malaise
• rapid heartbeat
• dry mouth
• hives

Rare(may occur in less than 1 in 1,000 patients)

• bleeding into muscles
• bile flow disorders (reduced bile flow), liver inflammation, including liver cell damage
• jaundice (yellowing of the skin and eyes) liver inflammation, including liver cell damage
• local swelling
• blood accumulation (hematoma) in the groin as a complication of a heart catheterization procedure involving the insertion of a catheter into an artery in the leg (pseudoaneurysm)

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

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

Frequency not known(cannot be estimated from the available data):
kidney failure after severe bleeding
bleeding in the kidneys, 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 after bleeding, causing 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 tell your doctor, pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store XABOPLAX

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on each blister and bottle after "EXP". The expiry date refers to the last day of the month.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. You should 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 XABOPLAX contains

The active substance of XABOPLAX is rivaroxaban. Each film-coated tablet contains 2.5 mg of rivaroxaban.
The other ingredients are: sodium lauryl sulfate, lactose, poloxamer 188, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, anhydrous colloidal silica. See section 2 "XABOPLAX contains lactose and sodium".
Coating:hypromellose (type 2910) ,titanium dioxide (E 171) ,macrogol 400 ,yellow iron oxide (E 172)

What XABOPLAX looks like and contents of the pack

The tablets are round, biconvex, light yellow, 8.6 mm in diameter, with the marking '2.5' on one side and smooth on the other.
The film-coated tablets are available in:

• blister packs in a carton containing 28 film-coated tablets or
• perforated unit dose blisters in a carton containing 28 x 1.

Marketing authorization holder and manufacturer

Marketing authorization holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl
Austria
Manufacturer
Lek Pharmaceuticals d.d.
Verovškova ulica 57
1526 Ljubljana
Slovenia
Rontis Hellas S.A.
P.O. Box 3012, Larissa Industrial Area
410 04 Larisa
Greece
PharOS MT Ltd.
HF62X, Hal Far Industrial Estate
BBG3000 Birzebbugia
Malta

To obtain more detailed information about this medicine, you should contact the local representative of the marketing authorization holder:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50C
02-672 Warszawa
tel. +48 22 209 70 00
Date of last revision of the leaflet:01/2024
Sandoz logo