Xaboplax

Patient Information Leaflet

XABOPLAX, 2.5 mg, coated tablets
Rivaroxaban
Read the entire 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 share it with others.
This medicine may harm someone else, even if their symptoms are the same.
If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Leaflet Contents:

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 prescribed XABOPLAX because:

• You have been diagnosed with acute coronary syndrome (a condition including heart attack and unstable angina, i.e. acute chest pain) and elevated levels of cardiac biomarkers have been detected. XABOPLAX reduces the risk of subsequent heart attack or the risk of death due to heart or blood vessel disease in adults. XABOPLAX will not be given to you as the only medication. Your doctor will also prescribe you to take:
  • acetylsalicylic acid, or
  • acetylsalicylic acid and clopidogrel or ticlopidine.

or

• You have been diagnosed with a high risk of blood clots due to coronary artery disease or peripheral artery disease causing symptoms. XABOPLAX reduces the risk of blood clots (atherosclerotic thrombotic events) in adults. XABOPLAX will not be given to you as the only medication. Your doctor will also prescribe you to take acetylsalicylic acid.

In certain cases, if you are receiving XABOPLAX after a procedure to unblock a narrowed or blocked artery in the lower limb to restore blood flow, your doctor may additionally prescribe clopidogrel for a short period alongside acetylsalicylic acid.
XABOPLAX contains the active substance rivaroxaban and 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 XABOPLAX

When not to use XABOPLAX
if the patient is allergic to rivaroxaban or to any of the other ingredients of this
medicine (listed in section 6);
if the patient has major bleeding;
if the patient has a disease or condition affecting any organ that increases the risk of
serious bleeding (e.g. peptic ulcer, trauma or intracranial haemorrhage, recent
surgery involving the brain or eyes);
if the patient is taking anticoagulant medicines (i.e. warfarin, dabigatran, apixaban,
or heparin); the exception is during transition between anticoagulant therapies or when
administering heparin to maintain catheter patency in a vein or artery;
if the patient has been diagnosed with acute coronary syndrome and has previously had bleeding or blood clot in the brain (stroke),
if the patient has been diagnosed with coronary artery disease or peripheral arterial disease and previously experienced brain haemorrhage (stroke) or occlusion of small arteries supplying blood to tissues in deep brain structures (lacunar stroke), or if the patient had a blood clot in the brain (ischaemic non-lacunar stroke) within the last month,
if the patient has liver disease that increases the risk of bleeding;
if the woman is pregnant or breastfeeding.
Do not take XABOPLAX and consult a doctor if any of these situations apply to the patient.

Warnings and precautions
Before starting XABOPLAX, discuss this with your doctor or pharmacist.
XABOPLAX should not be used in combination with anticoagulant medicines other than acetylsalicylic acid, clopidogrel, or ticlopidine, such as prasugrel or ticagrelor.
Special caution is required while taking XABOPLAX

• if the patient has an increased risk of bleeding, which may occur in situations such as:
• severe kidney disease, as kidney function may affect the amount of active drug in the patient's body;
• concomitant use of other medicines preventing blood clotting (i.e. warfarin, dabigatran, apixaban or heparin) during transition between anticoagulant therapies or when using heparin to maintain catheter patency in a vein or artery (see section "XABOPLAX with other medicines");
• coagulation disorders;
• very high blood pressure not controlled by medication;
• stomach or intestinal diseases that may cause bleeding, e.g. inflammatory bowel disease or gastritis, oesophagitis (e.g. due to gastro-oesophageal reflux disease, where acidic gastric juice flows back into the oesophagus) or tumours located in the stomach, intestines, genital or urinary tract;
• vascular disease of the posterior segment of the eyeball (retinopathy);
• lung disease with bronchiectasis and pus-filled bronchi (bronchiectasis) or previous pulmonary haemorrhage;
• if the patient is over 75 years of age,
• if the patient weighs less than 60 kg,
• coronary artery disease with severe symptomatic heart failure,
• if the patient has a heart valve prosthesis;
• if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing increased risk of clot formation), the patient should inform the doctor, who will decide whether a change in treatment is necessary.

If any of these situations apply to the patient, consult a doctor before
taking XABOPLAX. The doctor will decide whether the patient should take this medicine and whether close monitoring is required.
If the patient needs to undergo surgery

• It is very important to take XABOPLAX at the exact times prescribed by the doctor before and after surgery.
• If catheterisation or spinal puncture (e.g. for epidural or spinal anaesthesia or for pain relief) is planned during surgery:
• it is very important to take XABOPLAX exactly at the time recommended by the doctor,
• the patient should immediately inform the doctor if numbness or weakness in the legs, or disturbances in bowel or bladder function occur after the anaesthesia ends, as immediate treatment will then be necessary.

Children and adolescents
XABOPLAX 2.5 mg is not recommended for patients under 18 years of age.
There is insufficient information on its use in children and adolescents.

XABOPLAX with other medicines
Tell your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take, including those available without prescription.
If the patient is taking:

• certain medicines used to treat fungal infections (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only topically on the skin;
• ketoconazole tablets (used to treat Cushing's syndrome, when the body produces too much cortisol);
• certain antibiotics used to treat bacterial infections (e.g. clarithromycin, erythromycin);
• certain antiviral medicines used to treat HIV/AIDS infection (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 acetylsalicylic acid);
• dronedarone (a medicine used to treat heart rhythm disorders);
• certain antidepressants (selective serotonin reuptake inhibitors [SSRIs] or serotonin-noradrenaline reuptake inhibitors [SNRIs]).

If any of the above situations apply, tell the doctor
before taking XABOPLAX, as the effect of the medicine may be enhanced. The doctor
will decide whether the patient should take XABOPLAX and whether close monitoring is required.
If the doctor considers that the patient has an increased risk of stomach or intestinal ulceration, they may also prescribe medicines to prevent peptic ulcer disease.

If the patient is 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 situations apply, tell the doctor
before taking XABOPLAX, as the effect of the medicine may be reduced. The doctor
will decide whether the patient should take XABOPLAX and whether close monitoring is required.

Pregnancy and breastfeeding
Do not use XABOPLAX if the woman is pregnant or breastfeeding. Women of childbearing potential should use effective contraception while taking XABOPLAX.
If a woman becomes pregnant during treatment, she should immediately inform her doctor, who will decide on further management.

Driving and operating machinery
XABOPLAX may cause dizziness (a common adverse effect) or fainting (an uncommon adverse effect), see section 4 "Possible side effects". If such symptoms occur, the patient should not drive, ride a bicycle, or operate tools or machinery.

XABOPLAX contains lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to take XABOPLAX

Always take this medicine exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

How many tablets to take
The recommended dose is one tablet (2.5 mg) twice daily. XABOPLAX should be taken at approximately the same time each day (e.g. one tablet in the morning and one in the evening). The medicine can be taken with or without food.
If the patient has difficulty swallowing the whole tablet, they should discuss alternative ways of taking XABOPLAX with their doctor. The tablet may be crushed, mixed with water or apple puree, and taken immediately.
If necessary, the doctor may administer crushed XABOPLAX tablets via a gastric tube.
XABOPLAX will not be given to the patient as the only medicine. The doctor will prescribe acetylsalicylic acid for the patient to take. If the patient is receiving XABOPLAX after an acute coronary syndrome, the doctor may also prescribe clopidogrel or ticlopidine.
If the patient is receiving XABOPLAX after a procedure to unblock a narrowed or blocked artery in the lower limb to restore blood flow, the doctor may also prescribe clopidogrel to be taken for a short period in addition to acetylsalicylic acid.
The doctor will inform the patient of the dosage (usually 75–100 mg acetylsalicylic acid daily, or a daily dose of 75–100 mg acetylsalicylic acid plus a daily dose of 75 mg clopidogrel, or the standard daily dose of ticlopidine).

When to start taking XABOPLAX
Treatment with XABOPLAX after acute coronary syndrome should be initiated as soon as possible after stabilisation of the acute event, no earlier than 24 hours after hospital admission, and at the time when parenteral (injected) anticoagulant therapy would normally be discontinued. The doctor will inform the patient when to start XABOPLAX treatment if coronary artery disease or peripheral arterial disease has been diagnosed. The doctor will decide how long treatment should continue.

Taking more XABOPLAX than prescribed
If the patient has taken more tablets than prescribed, contact a doctor immediately due to increased risk of bleeding.

Missing a dose of XABOPLAX
Do not take a double dose to make up for a missed dose. If a dose is missed, take the next dose at the scheduled time.

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

4. Possible adverse reactions

Like any medicine, XABOPLAX may cause adverse reactions, although not everyone experiences them.
As with other similar medicines that reduce blood clot formation, XABOPLAX may cause bleeding, which can even be life-threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). In some cases, bleeding may be invisible.
You should immediately inform your doctor 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 weakness, vomiting, seizures, decreased level of consciousness, and neck stiffness. A serious, sudden medical emergency. Seek immediate medical help!),

• prolonged or excessive bleeding,

• extreme weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina. Your doctor may decide to place you under close observation or change your treatment.

• Signs of severe skin reaction

• skin reactions such as widespread, intense rash, blistering or mucosal lesions, e.g. in the mouth or eyes (Stevens-Johnson syndrome or toxic epidermal necrolysis).

• drug reaction causing rash, fever, internal organ inflammation, hematological and systemic disorders (DRESS syndrome). These adverse reactions are very rare (occurring in fewer than 1 in 10,000 patients).

• Signs of severe allergic reaction:

• swelling of the face, lips, mouth, tongue or throat; difficulty swallowing; hives and breathing difficulties; sudden drop in blood pressure. Severe allergic reactions are very rare (anaphylactic reactions, including anaphylactic shock, may occur in fewer than 1 in 10,000 patients) and uncommon (angioedema and allergic edema may occur in fewer than 1 in 100 patients).

General list of possible adverse reactions:
Common (may affect fewer than 1 in 10 patients)

• decreased number of red blood cells, which may cause pale skin, weakness or shortness of breath,
• bleeding from the stomach or intestine, bleeding from the urinary or genital tract (including blood in 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),
• coughing up blood (hemoptysis),
• bleeding from the skin or under the skin,
• bleeding after surgery,
• oozing of blood or fluid from the surgical wound,
• swelling of limbs,
• limb pain,
• kidney function disorders (as indicated by results of tests ordered by your doctor),
• fever,
• stomach pain, indigestion, nausea or vomiting, constipation, diarrhea,
• low blood pressure (symptoms may include dizziness or fainting upon standing),
• general weakness and lack of energy (asthenia, fatigue), headache, dizziness,
• rash, skin itching,
• increased activity of certain liver enzymes shown in blood tests.

Uncommon (may affect fewer than 1 in 100 patients)

• bleeding into the brain or within the skull (see signs of bleeding above),
• bleeding into a joint causing pain and swelling,
• thrombocytopenia (low number of platelets – blood cells involved in blood clotting),
• allergic reactions, including skin allergic reactions,
• liver function disorders (as indicated by results of tests ordered by your doctor),
• increased bilirubin levels, increased activity of certain pancreatic or liver enzymes, or increased number of blood platelets shown in blood tests,
• fainting,
• malaise,
• rapid heartbeat,
• dry mouth,
• urticaria.

Rare (may affect fewer than 1 in 1,000 patients)

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

Very rare (may affect 1 in 10,000 people)

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

Frequency not known (cannot be estimated from available data):
kidney failure following severe bleeding,
bleeding in the kidneys, sometimes with blood in the urine, leading to kidneys being unable to function properly (drug-induced anticoagulant-related nephropathy),
increased pressure in the muscles of the arms and legs following bleeding, causing pain, swelling, sensory changes, numbness or paralysis (compartment syndrome after bleeding).

Reporting of adverse reactions
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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 XABOPLAX

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard packaging, on each blister, and on each bottle after "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 packaging and other information

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

What XABOPLAX looks like and contents of the pack
The tablets are round, biconvex, light yellow in colour, 8.6 mm in diameter,
marked with ‘2.5’ on one side and smooth on the other.
Coated tablets are available in:

• blister packs contained in a cardboard box containing 28 coated tablets, or
• perforated unit dose blisters contained in a cardboard box containing 28 x 1.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl
Austria

Manufacturers
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

For further information on this medicinal product, contact the local representative of the Marketing Authorisation Holder:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50C
02-672 Warsaw
tel. +48 22 209 70 00