Xerdoxo

Package leaflet: Information for the patient

Xerdoxo, 2.5 mg, coated tablets
Rivaroxabanum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as 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 personally. Do not pass it on to others. It may harm someone else even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Xerdoxo is and what it is used for

You have been prescribed Xerdoxo 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 confirmed. Xerdoxo reduces in adults the risk of another heart attack or reduces the risk of death due to heart or blood vessel disease. Xerdoxo 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 arterial disease causing symptoms. Xerdoxo reduces in adults the risk of blood clots (atherosclerotic thrombotic events). Xerdoxo will not be given to you as the only medication. Your doctor will also prescribe you to take acetylsalicylic acid. In some cases, if you are receiving Xerdoxo after a procedure to unblock a narrowed or blocked artery in the lower limb to restore blood flow, your doctor may also prescribe clopidogrel for you to take in addition to acetylsalicylic acid for a short period.

Xerdoxo 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 for blood clots to form.

2. Important information before using Xerdoxo

When not to use Xerdoxo

• if the patient is allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6),
• if the patient has excessive bleeding,
• if the patient has a disease or condition of an organ that leads to an increased risk of serious bleeding (e.g. stomach ulcer, trauma or bleeding in the brain, recent surgery on the brain or eyes),
• if the patient is taking other anticoagulant medicines (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant therapy or if heparin is administered to maintain catheter patency in a vein or artery,
• if the patient has been diagnosed with acute coronary syndrome and previously experienced bleeding or blood clot in the brain (stroke),
• if the patient has been diagnosed with coronary artery disease or peripheral arterial disease and previously had brain bleeding (stroke), blockage 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 stroke, non-lacunar) within the past month,
• if the patient has liver disease leading to an increased risk of bleeding,
• if the patient is pregnant or breastfeeding.

Do not use Xerdoxo, and inform your doctor if you suspect that any of the above circumstances apply to you.
Warnings and precautions
Before starting Xerdoxo, consult your doctor or pharmacist.
Xerdoxo should not be used in combination with anticoagulant medicines other than acetylsalicylic acid, clopidogrel or ticlopidine, such as prasugrel or ticagrelor.
When to exercise particular caution when using Xerdoxo

• if the patient has an increased risk of bleeding, such as in the following conditions:
• severe kidney disease, as kidney function may affect the amount of medicine acting in the patient's body,
• taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin) when switching anticoagulant therapy or when heparin is administered to maintain catheter patency in a vein or artery (see section "Xerdoxo with other medicines"),
• blood clotting disorders,
• very high blood pressure that does not decrease despite medication,
• stomach or intestinal diseases that may cause bleeding, e.g. inflammation of the intestines and stomach or oesophagitis (inflammation of the oesophagus), e.g. due to gastro-oesophageal reflux disease (acid reflux into the oesophagus) or tumours located in the stomach or intestines or in the genital or urinary system,
• blood vessel disease in the posterior part of the eyeball (retinopathy),
• lung disease in which bronchi are dilated and filled with pus (bronchiectasis) or previous lung bleeding,
• 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,
• in patients with heart valve prostheses,
• if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing increased risk of blood clots), the patient should inform the doctor, who will decide whether treatment should be changed.

If you suspect that any of the above conditions apply to you, inform your doctor before taking Xerdoxo. The doctor will decide whether to use this medicine and whether the patient requires particularly close monitoring.
If the patient needs to undergo surgery

• strictly follow the doctor's instructions regarding the timing of taking Xerdoxo before or after surgery,
• if catheterisation or spinal puncture (e.g. for epidural or intrathecal anaesthesia, or pain relief) is planned during surgery:
• it is very important to take Xerdoxo before and after the puncture or catheter removal, as directed by the doctor,
• due to the need for special caution, immediately inform the doctor if numbness or weakness of the legs, or disturbances in bowel or bladder function occur after the anaesthesia ends.

Children and adolescents
Xerdoxo 2.5 mg tablets are not recommended for patients under 18 years of age. There is insufficient data on the use of this medicine in children and adolescents.
Xerdoxo with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those available without a 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 in the treatment of Cushing's syndrome, in which the body produces too much cortisol),
• certain antibiotics (e.g. clarithromycin, erythromycin),
• certain antiviral medicines used to treat HIV infection 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 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 you suspect that any of the above conditions apply to you, inform your doctor before taking Xerdoxo, as the effect of Xerdoxo may be enhanced. The doctor will decide whether to use this medicine and whether the patient requires particularly close monitoring.
If the doctor considers that the patient has an increased risk of developing stomach or intestinal ulcers, preventive treatment may be prescribed.

• If the patient is taking
• certain medicines used to treat epilepsy (phenytoin, carbamazepine, phenobarbital),
• St John's wort ( Hypericum perforatum ), a herbal remedy used for depression,
• rifampicin, an antibiotic.

If you suspect that any of the above conditions apply to you, inform your doctor before taking Xerdoxo, as the effect of Xerdoxo may be reduced. The doctor will decide whether to use Xerdoxo and whether the patient requires particularly close monitoring.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.
Do not use Xerdoxo if you are pregnant or breastfeeding. If there is a risk that you could become pregnant, you should use an effective method of contraception during treatment with Xerdoxo. If you become pregnant while taking this medicine, inform your doctor immediately, who will decide on further treatment.
Driving and operating machinery
Xerdoxo may cause dizziness (common side effects) and fainting (uncommon side effects) (see section 4, "Possible side effects").
Patients experiencing these side effects should not drive, ride a bicycle or operate tools or machinery.
Xerdoxo contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is considered "sodium-free".

3. How to take Xerdoxo

This medicine should always be taken exactly as instructed by your doctor. If in doubt, consult
your doctor or pharmacist.
How many tablets to take
The recommended dose is one 2.5 mg tablet twice daily. Xerdoxo should be taken at approximately
the same time each day (for example, one tablet in the morning and one in the evening).
This medicine may be taken with or without food.
If a patient has difficulty swallowing the whole tablet, discuss alternative ways of taking
Xerdoxo with your doctor. The tablet may be crushed and mixed with water or soft food such as
apple puree immediately before administration.
If necessary, your doctor may administer crushed Xerdoxo tablets through a gastric tube.
Xerdoxo will not be given to the patient as the only medication.
Your doctor will prescribe acetylsalicylic acid to be taken alongside Xerdoxo.
If a patient is receiving Xerdoxo following an acute coronary syndrome, the doctor may also
prescribe clopidogrel or ticlopidine.
If a patient is receiving Xerdoxo after a procedure to restore blood flow in a narrowed or blocked
artery of the lower limb, the doctor may also prescribe clopidogrel to be taken for a short period
in addition to acetylsalicylic acid.
Your doctor will inform you of the doses to take (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 Xerdoxo
Treatment with Xerdoxo after an acute coronary syndrome should be initiated as soon as possible
after stabilization 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.
Your doctor will advise you when to start treatment with Xerdoxo if you have been diagnosed
with coronary artery disease or peripheral arterial disease.
Your doctor will decide how long treatment should continue.
Taking more Xerdoxo than prescribed
If a patient takes more Xerdoxo than prescribed, contact a doctor immediately. Taking too high
a dose of Xerdoxo increases the risk of bleeding.
Missed dose of Xerdoxo
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 Xerdoxo
Xerdoxo should be taken regularly and for the duration prescribed by your doctor.
Do not stop taking Xerdoxo without first consulting your 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 the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will
experience them.
As with other medicines with a similar anticoagulant effect, Xerdoxo may cause bleeding, which
can potentially be life-threatening. Excessive bleeding may lead to a sudden drop in blood
pressure (shock). Signs of bleeding are not always obvious or visible.
Contact your doctor immediately if any of the following adverse effects 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,
• Unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina. Your doctor may decide that close monitoring or a change in treatment is necessary.

Signs of severe skin reaction

• Widespread, acute skin rash, blistering or mucosal lesions, e.g. in the mouth or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Drug reaction causing rash, fever, internal organ inflammation,

haematological disorders and systemic involvement (DRESS syndrome).
The frequency of these adverse effects is very rare (occurring in up to 1 in 10,000 patients).

Signs of severe allergic reaction

• Swelling of the face, lips, mouth, tongue or throat; difficulty swallowing; urticaria and breathing difficulties; 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 oedema may occur in up to 1 in 100 people).

General list of possible adverse effects
Common (may occur in up to 1 in 10 people)

• Decrease in red blood cells, which may cause paleness of the skin and lead to weakness or shortness of breath,
• Bleeding from the stomach or intestines, bleeding from the genitourinary system (including blood in urine and severe menstrual bleeding), nosebleeds, gum bleeding,
• Bleeding into the eye (including bleeding from the conjunctiva),
• Bleeding into tissues or body cavities (haematoma, bruising),
• Presence of blood in sputum (haemoptysis) during coughing,
• Bleeding from the skin or subcutaneous bleeding,
• Bleeding after surgery,
• Oozing of blood or fluid from a surgical wound,
• Swelling of limbs,
• Limb pain,
• Kidney function disorders (may be observed in tests performed by a doctor),
• Fever,
• Stomach pain, indigestion, nausea or vomiting, constipation, diarrhoea,
• Low blood pressure (symptoms may include dizziness or fainting upon standing),
• General loss of strength and energy (weakness, fatigue), headache, dizziness,
• Rash, itching of the skin,
• Increased activity of certain liver enzymes, which may be evident in blood test results.

Uncommon (may occur in up to 1 in 100 people)

• Bleeding into the brain or inside the skull (see signs of bleeding above),
• Bleeding into a joint causing pain and swelling,
• Thrombocytopenia (low platelet count, the blood cells involved in blood clotting),
• Allergic reactions, including allergic skin reactions,
• Liver function disorders (may be observed in tests performed by a doctor),
• Blood tests may show increased levels of bilirubin, increased activity of certain pancreatic or liver enzymes, or increased platelet count,
• Fainting,
• Malaise,
• Rapid heartbeat,
• Dryness of the mouth,
• Urticaria.

Rare (may occur in up to 1 in 1,000 people)

• Bleeding into muscles,
• Cholestasis (bile stasis), hepatitis, including liver cell damage,
• Yellowing of the skin and eyes (jaundice),
• Localised swelling,
• Blood collection (haematoma) in the groin as a complication of cardiac catheterisation procedure, when the catheter is inserted into an artery in the leg (pseudoaneurysm).

Very rare (may occur in up to 1 in 10,000 people)

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

Frequency not known (frequency cannot be estimated from available data)

• Kidney failure following severe bleeding,
• Bleeding in the kidneys, sometimes with blood in the urine, leading to impaired kidney function (drug-induced anticoagulant-related nephropathy),
• Increased pressure in the muscles of arms and legs following bleeding, which may cause pain, swelling, altered sensation, numbness or paralysis (compartment syndrome following bleeding).

Reporting of adverse effects
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, inform your doctor or pharmacist.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Xerdoxo

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following
the abbreviation "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. Such measures will help protect the environment.

6. Contents of the pack and other information

What Xerdoxo contains

• The active substance is rivaroxaban. Each coated tablet contains 2.5 mg of rivaroxaban.
• The other ingredients are: mannitol, microcrystalline cellulose, polyethylene glycol 8000, poloxamer 188, sodium lauryl sulfate, sodium croscarmellose, colloidal anhydrous silica, sodium stearyl fumarate in the tablet core; hypromellose 2910, polyethylene glycol 4000, titanium dioxide (E 171), and iron oxide, yellow (E 172) in the tablet coating. See
  point 2 "Xerdoxo contains sodium".

What Xerdoxo looks like and contents of the pack

Light brownish-yellow to brownish-yellow, round, slightly biconvex coated tablets, with the imprint "2.5" on one side of the tablet. Dimensions: diameter approximately 6.5 mm.

Xerdoxo is available in cardboard boxes containing:

• Calendar packs: 14, 28, 42 or 56 coated tablets in a blister.

A patient warning card is included in each medicine package.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer/Importer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

For further information on this medicine, please contact the local representative of the Marketing Authorisation Holder:

Krka - Polska Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw, Poland
Telephone: +48 22 573 75 00