Xaboplax

Package leaflet: Information for the patient

XABOPLAX, 15 mg, film-coated tablets
XABOPLAX, 20 mg, film-coated tablets
Rivaroxaban
Starter pack.
Not for use in children.
Read the entire leaflet before taking this medicine, as it contains important information
for the patient.
Keep this leaflet for future reference.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others.
This medicine may harm others, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Contents of the leaflet:

1. What XABOPLAX is and what it is used for
2. What you need to know 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

XABOPLAX contains the active substance rivaroxaban. This medicine is used in adults to:

• 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 veins of the legs and (or) lungs.

XABOPLAX 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 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 is experiencing major bleeding;
if the patient has a disease or disorder affecting any organ that increases the risk of
major bleeding (e.g. stomach 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); an exception is the period of switching anticoagulant therapy or when
heparin is administered to maintain catheter patency in a vein or artery;
if the patient has liver disease that increases the risk of bleeding;
if the patient is pregnant or breastfeeding.
If any of these situations apply to the patient, do not take XABOPLAX and consult a doctor.
Warnings and precautions
Before using XABOPLAX, discuss this with a doctor or pharmacist.
Special caution is required while taking XABOPLAX

• if the risk of bleeding is increased in the patient, which may occur in the following situations:
• severe kidney disease, as kidney function may affect the amount of active drug in the patient's body;
• taking other anticoagulant medicines (i.e. warfarin, dabigatran, apixaban or heparin) during transition of anticoagulant therapy or when using heparin to maintain catheter patency in a vein or artery (see section "XABOPLAX and 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 gastroesophageal reflux disease, in which 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 eye (retinopathy);
• lung disease with bronchiectasis and purulent sputum or previous pulmonary haemorrhage;
• if the patient has a heart valve prosthesis;
• if the patient has a condition called antiphospholipid syndrome (an autoimmune disorder causing increased risk of thrombosis), the patient should inform the doctor, who will decide whether a change in treatment is necessary;
• if the doctor considers the patient's blood pressure unstable or if surgery or other treatment to remove a pulmonary clot is planned.

If any of these situations apply to the patient, before taking XABOPLAX consult a doctor.
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 before and after surgery as directed by the doctor.
• If spinal catheterisation or puncture (e.g. for epidural or spinal anaesthesia or for pain relief) is planned during surgery:
• it is very important to strictly follow the doctor's instructions regarding the timing of taking XABOPLAX before or after lumbar puncture or catheter removal;
• immediately inform the doctor if, after the anaesthesia ends, the patient experiences numbness or weakness in the legs or disturbances in bowel or bladder function, as immediate treatment is required.

Children and adolescents
The starter pack XABOPLAX is not recommended for patients under 18 years of age,
as it is specifically designed for initiating treatment in adult patients and is not suitable for use in children and adolescents.
XABOPLAX and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription.
If the patient is taking:

• certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless used only topically on the skin;
• ketoconazole tablets (used in the treatment of Cushing's syndrome when the body produces too much cortisol);
• certain antibiotics (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);
• 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 [SSRI] or serotonin-noradrenaline reuptake inhibitors [SNRI])

If any of the above 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 the patient to be at increased risk of gastric or intestinal ulceration, they may also prescribe medicines to prevent peptic ulcer disease.
If the patient is taking:

• certain antiepileptic medicines (phenytoin, carbamazepine, phenobarbital);
• St John's wort (Hypericum perforatum), a herbal remedy used to treat depression;
• rifampicin (an antibiotic)

If any of the above 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
If the woman is pregnant or breastfeeding, do not use XABOPLAX. Women of childbearing potential should use effective contraception during treatment with XABOPLAX.
If the patient becomes pregnant during treatment, she should immediately inform the doctor, who will decide on further management.
Driving and operating machinery
XABOPLAX may cause dizziness (common side effect) or fainting (uncommon side effect), see section 4 "Possible side effects". If the patient experiences such symptoms, do 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, the patient 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 use XABOPLAX
This medicine should always be used exactly as prescribed by the doctor. If in doubt, consult the doctor or pharmacist.
XABOPLAX should be taken with food.
The tablet(s) should be swallowed, preferably with water.
If the patient has difficulty swallowing the whole tablet, discuss alternative ways of taking XABOPLAX with the doctor. The tablet may be crushed, mixed with water or apple puree, and taken immediately. A meal should be consumed directly afterwards. If necessary, the doctor may administer crushed XABOPLAX tablets via a gastric tube.
How many tablets to take
The recommended dose is one XABOPLAX 15 mg tablet twice daily for the first 3 weeks.
For treatment after 3 weeks, the recommended dose is one XABOPLAX 20 mg tablet once daily.
The XABOPLAX 15 mg and 20 mg starter pack is intended only for the first 4 weeks of treatment. After completing the tablets from this pack, treatment will continue with XABOPLAX 20 mg once daily following consultation with the doctor.
If the patient has kidney problems, the doctor may decide to reduce the dose after 3 weeks of treatment to one XABOPLAX 15 mg tablet once daily, if the risk of bleeding is greater than the risk of further thrombosis.
When to take XABOPLAX
The tablet(s) should be taken daily until the doctor advises stopping the medicine. It is best to take the tablet(s) at the same time each day, as this makes it easier to remember. The duration of treatment is determined by the doctor.
Taking more than the recommended dose of XABOPLAX
If the patient has taken too many XABOPLAX tablets, contact a doctor immediately.
Taking an excessive dose of XABOPLAX increases the risk of bleeding.
Missed dose of XABOPLAX

• If the patient is taking one 15 mg tablet twice daily and misses a dose, the patient should take it as soon as possible after remembering. Do not take more than two 15 mg tablets in one day. If the patient forgot to take a dose, the patient may take two 15 mg tablets at the same time to achieve a total of two tablets (30 mg) taken within one day. The next day, continue taking one 15 mg tablet twice daily.
• If the patient is taking one 20 mg tablet once daily and misses a dose, the patient should take the tablet as soon as possible. Do not take more than one tablet on the same day to make up for the missed dose. Take the next tablet the following day, then continue taking one tablet once daily.

Stopping treatment with XABOPLAX
Do not stop taking XABOPLAX without consulting the doctor, as this medicine treats serious conditions and prevents their recurrence.
If there are any further questions about the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, rivaroxaban may cause adverse reactions, although not everyone experiences them.
As with other medicines with a similar anticoagulant effect, 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 contact 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, reduced level of consciousness, and neck stiffness. This is a serious 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 reactions:

• 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 with eosinophilia and systemic symptoms (DRESS), characterized by rash, fever, internal organ inflammation, hematological disorders, and systemic involvement. 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; urticaria 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 people)

• reduced number of red blood cells, which may cause pale skin, weakness, or shortness of breath,
• gastrointestinal bleeding, urinary or genital tract bleeding (including blood in urine and heavy menstrual bleeding), nosebleeds, gum bleeding,
• bleeding into the eye (including conjunctival hemorrhage),
• bleeding into tissues or body cavities (hematoma, bruising),
• coughing up blood (hemoptysis),
• skin bleeding or subcutaneous bleeding,
• postoperative bleeding,
• oozing of blood or fluid from the surgical wound,
• limb swelling,
• limb pain,
• kidney function disorders (as 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 upon standing),
• general weakness and lack of energy (asthenia, fatigue), headache, dizziness,
• rash, skin itching,
• increased activity of certain liver enzymes detected in blood tests.

Uncommon (may affect fewer than 1 in 100 people)

• 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 the clotting process),
• allergic reactions, including allergic skin reactions,
• liver function disorders (as indicated by test results ordered by your doctor),
• increased bilirubin levels, increased activity of certain pancreatic or liver enzymes, or increased platelet count detected in blood tests,
• fainting,
• malaise,
• dry mouth,
• rapid heartbeat,
• urticaria.

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

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

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

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

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

Reporting of adverse reactions
If any adverse reactions 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 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 XABOPLAX

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and on each
"wallet-type" pack after EXP. The expiry date refers to the last day of the stated month.
No special storage instructions apply.
Medicines must 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 XABOPLAX contains

• The active substance is rivaroxaban. Each tablet contains either 15 mg or 20 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), polyethylene glycol 3350, iron oxide red (E 172).

What XABOPLAX looks like and contents of the pack
XABOPLAX 15 mg
The tablets are red, round, biconvex, with a diameter of 5.6 mm, marked with ‘15’ on one side and smooth on the other side.
XABOPLAX 20 mg
The tablets are brownish-red, round, biconvex, with a diameter of 6.6 mm, marked with ‘20’ on one side and smooth on the other side.
The starter pack for the first 4 weeks of treatment contains single-dose blisters or perforated blisters:
Each pack containing 49 coated tablets for the first 4 weeks of treatment includes: 42 coated tablets of XABOPLAX 15 mg and 7 coated tablets of XABOPLAX 20 mg in a wallet-type pack within a cardboard box; or 49 x 1 coated tablet: 42 x 1 coated tablet of XABOPLAX 15 mg and 7 x 1 coated tablets of XABOPLAX 20 mg in a wallet-type pack within a cardboard box.

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

Manufacturers
Lek Pharmaceuticals d.d.
Verovškova ulica 57
Ljubljana, 1526
Slovenia
Rontis Hellas Medical and Pharmaceutical Products S.A.
P.O. Box 3012, Larissa Industrial Area
Larisa, 410 04
Greece
PharOS MT Ltd.
HF62X, Hal Far Industrial Estate
Birzebbugia, BBG3000
Malta

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

This medicinal product is authorised in the European Economic Area countries under the following names:
Netherlands XABOPLAX 15 mg, filmomhulde tabletten
XABOPLAX 20 mg, filmomhulde tabletten
Austria XABOPLAX
Poland XABOPLAX