Xanirva

Package leaflet: Information for the patient

Xanirva, 10 mg, hard capsules
Rivaroxabanum
Read the entire leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, so that you can read it again if necessary.
• Consult your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any side effects, including any that are not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

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

1. What Xanirva is and what it is used for

Xanirva contains the active substance rivaroxaban and is used in adults to:

• prevent blood clots from forming in the veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because the risk of developing blood clots is increased after surgery.
• 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 blood vessels of the legs and (or) lungs.

Xanirva 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 taking Xanirva

When not to take Xanirva:

• if the patient is allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6);
• if the patient is experiencing excessive bleeding;
• if the patient has a disease or organ condition leading to an increased risk of serious bleeding (e.g. stomach ulcer, injury or bleeding into the brain, recent brain or eye surgery);
• 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 a liver disease that leads to an increased risk of bleeding;
• if the patient is pregnant or breastfeeding.

Do not use Xanirva and inform your doctor if you suspect that any of the above circumstances apply to you.
Warnings and precautions
Consult your doctor or pharmacist before starting to take Xanirva.
When to exercise special caution when taking Xanirva

• if the patient has an increased risk of bleeding, such as in the following conditions:
  • moderate or severe kidney disease, as kidney function may affect the amount of medicine acting in the patient's body;
  • 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 (see section "Other medicines and Xanirva");
  • coagulation disorders;
  • very high blood pressure that does not decrease despite medication;
  • stomach or intestinal diseases that may cause bleeding, e.g. inflammation of the intestine and stomach or inflammation of the oesophagus (throat and oesophagus), e.g. due to gastro-oesophageal reflux disease (acid reflux into the oesophagus), or tumours located in the stomach, intestines, genital or urinary system;
  • blood vessel disease in the back of the eye (retinopathy);
  • lung disease with dilated airways filled with pus (bronchiectasis) or previous lung bleeding;
• in patients with heart valve prostheses;
• in patients with antiphospholipid syndrome (immune system disorders causing increased risk of blood clots). Inform your doctor, who will decide whether a change in treatment is necessary;
• if the patient has abnormal blood pressure or if surgery or another treatment to remove a pulmonary clot is planned.

If you suspect that any of the above applies to you, inform your doctor before taking Xanirva.
Your doctor will decide whether to use this medicine and whether you require particularly close monitoring.
If you are scheduled for surgery:

• it is very important to take Xanirva exactly at the times prescribed by your treating doctor, both before and after surgery;
• if catheterisation or lumbar puncture of the spine is planned during surgery (e.g. for epidural or spinal anaesthesia or for pain relief):
  • it is very important to take Xanirva exactly at the times prescribed by your treating doctor, both before and after the puncture or catheter removal;
  • inform your doctor immediately if, after the anaesthesia ends, you experience numbness or weakness in the legs, or disturbances in bowel or bladder function, as immediate treatment may be required.

Children and adolescents
Xanirva 10 mg capsules are not recommended for patients under 18 years of age. There is insufficient data on the use of the medicine in children and adolescents.
Xanirva and 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 you are taking:
  • certain antifungal medicines (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 antibacterial medicines (e.g. clarithromycin, erythromycin);
  • certain antiviral medicines used in HIV infection or AIDS treatment (e.g. ritonavir);
  • other medicines used to reduce blood clotting (e.g. enoxaparin, clopidogrel, or vitamin K antagonists such as warfarin or acenocoumarol);
  • anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid);
  • dronedarone, a medicine used to treat heart rhythm disorders;
  • certain medicines used to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin-noradrenaline reuptake inhibitors (SNRIs)).

If you suspect that any of the above applies to you, inform your doctor before taking Xanirva, as the effect of Xanirva may be enhanced when taken together with the above-mentioned medicines. Your doctor will decide whether to use this medicine and whether you require particularly close monitoring. If your doctor considers that you are at increased risk of developing stomach or intestinal ulcers, preventive treatment may be prescribed.

• If you are 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 Xanirva, as the effect of Xanirva may be reduced when taken together with the above-mentioned medicines. Your doctor will decide whether to use Xanirva and whether you require particularly close monitoring.
Pregnancy and breastfeeding
Do not use Xanirva if you are pregnant or breastfeeding. If there is a risk that you may become pregnant, you should use an effective method of contraception during treatment with Xanirva. If you become pregnant while taking this medicine, inform your doctor immediately, who will decide on further management.
Driving and operating machinery
Xanirva 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.
Xanirva contains lactose monohydrate (a type of sugar) and sodium
If you have previously been diagnosed with intolerance to certain sugars, you should consult your doctor before taking this medicine.
The medicine contains less than 1 mmol of sodium (23 mg) per capsule, meaning it is essentially "sodium-free".

3. How to take Xanirva

This medicine should always be taken as directed by your doctor. If you have any doubts, you should
consult your doctor or pharmacist.
How many capsules to take

• To prevent the formation of blood clots in veins after hip or knee replacement surgery
  The recommended dose is one 10 mg Xanirva capsule taken once daily.
• For the treatment of blood clots in the legs and blood clots in the blood vessels of the lungs, and to prevent recurrence of blood clots
  After at least 6 months of treatment for blood clots, the recommended dose is one 10 mg capsule once daily or one 20 mg capsule once daily. Your doctor has prescribed Xanirva 10 mg once daily.

The capsule should be swallowed whole, preferably with water.
Xanirva can be taken with or without food.
If a patient has difficulty swallowing the entire capsule, they should speak with their doctor about alternative ways of taking Xanirva. The contents of the capsule may be mixed with water or apple puree immediately before administration.
If necessary, a doctor may administer the contents of the Xanirva capsule via a gastric tube.
When to start treatment with Xanirva
Take one capsule each day until your doctor decides to stop treatment.
It is best to take the capsule at the same time each day, as this makes it easier to remember.
Your doctor will decide how long treatment should continue.
To prevent blood clots in the legs after hip or knee replacement surgery:
The first capsule should be taken 6 to 10 hours after surgery.
For patients undergoing major hip surgery, treatment usually lasts 5 weeks.
For patients undergoing major knee surgery, treatment usually lasts 2 weeks.
Taking more than the recommended dose of Xanirva
If a patient takes more than the recommended dose of Xanirva, they should contact their doctor immediately. Taking too high a dose of Xanirva increases the risk of bleeding.
Missing a dose of Xanirva
If a patient misses a dose, they should take it as soon as they remember. The next capsule should be taken the following day, and then capsules should be taken as usual, once daily.
Do not take a double dose to make up for a missed capsule.
Stopping Xanirva treatment
Do not stop taking Xanirva without first talking to your doctor, as Xanirva helps prevent a serious condition.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Like other medicines with a similar mechanism of action reducing blood clot formation, Xanirva may
cause bleeding, which may be life-threatening. Excessive bleeding may lead to
a sudden drop in blood pressure (shock). Signs of bleeding are not always obvious or
visible.
You should contact your doctor immediately 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 paralysis, vomiting, seizures, decreased level of consciousness, and neck stiffness. This is a serious medical emergency. Seek immediate medical help!).
• Prolonged or heavy bleeding.
• Unusual weakness, fatigue, paleness, dizziness, headache, development of unexplained swelling, shortness of breath, chest pain, or angina. Your doctor may decide that close monitoring of the patient or a change in treatment is necessary.

Signs of severe skin reactions:

• Widespread, acute skin rash, blistering, or mucosal lesions (e.g., in the mouth or eyes) (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Drug reaction with eosinophilia and systemic symptoms (DRESS), characterized by rash, fever, internal organ inflammation, hematological abnormalities, and systemic involvement. These adverse reactions are very rare (may occur in less than 1 in 10,000 people).

Signs of serious allergic reaction:

• Swelling of the face, lips, oral cavity, 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 less than 1 in 10,000 people) and uncommon (angioedema and allergic edema may occur in 1 in 100 people).

General list of possible adverse reactions:
Common (may occur in 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 urinary or genital tract (including blood in urine and heavy menstrual bleeding), nosebleeds, bleeding gums
• Bleeding into the eye (including bleeding from the white part of the eye)
• Bleeding into tissues or body cavities (hematoma, bruising)
• Presence of blood in sputum during coughing (hemoptysis)
• Bleeding from the skin or under the skin
• 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, diarrhea
• Low blood pressure (symptoms may include dizziness or fainting upon standing)
• Generalized weakness and fatigue, headache, dizziness
• Rash, itching of the skin
• Increased activity of certain liver enzymes, which may be seen in blood test results.

Uncommon (may occur in 1 in 100 people)

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

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

• Bleeding into muscles
• Cholestasis (bile stasis), hepatitis including liver cell damage
• Yellowing of the skin and eyes (jaundice)
• Localized swelling
• Blood accumulation (hematoma) in the groin as a complication of cardiac catheterization when the catheter is inserted into an artery in the leg (pseudoaneurysm)

Very rare (may occur in 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 urine, leading to impaired kidney function (anticoagulant-related nephropathy)
• Increased pressure in the muscles of arms or legs following bleeding, which may lead to pain, swelling, altered sensation, numbness, or paralysis (compartment syndrome following bleeding)

Reporting of adverse reactions
If any adverse symptoms occur, including any possible adverse reactions
not listed in this leaflet, consult your doctor or pharmacist. 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 22 492 1301,
fax: +48 22 492 1309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.
Adverse reactions can also be reported to the marketing authorization holder or its representative
in Poland.

5. How to store Xanirva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and the outer
cardboard box following: EXP. The expiry date refers to the last day of the stated month.
PVC/PVDC/Aluminium foil blisters: Store below 30°C.
Keep in the original packaging to protect from moisture.
OPA/Aluminium/PVC/Aluminium foil blisters: No special storage conditions required.
Medicines should 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 pack and other information

What Xanirva contains

• The active substance is rivaroxaban. Each capsule contains 10 mg of rivaroxaban.
• The other ingredients are: capsule contents: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, hypromellose, sodium lauryl sulphate, magnesium stearate. capsule shell: gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172).

What Xanirva looks like and contents of the pack
Xanirva 10 mg: beige, opaque capsules filled with white or almost white powder,
size “3” (approximately 16 mm in length).
The hard capsules are packed in blisters made of PVC/PVDC/Aluminium or OPA/Aluminium/PVC/Aluminium foil, and placed in a cardboard box.
Available pack sizes: 10, 15, 20, 30 or 100 hard capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Zentiva, k.s.
U kabelovny 130, Dolní Měcholupy
102 37 Prague 10
Czech Republic
Importer
Zentiva SA
B-dul Theodor Pallady no. 50, Sector 3
Bucharest 032266, Romania
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola PLA3000, Malta
This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Czech Republic, Estonia, Latvia, Poland, Romania, Slovakia, United Kingdom (Northern Ireland):
Xanirva
For any further information, please contact the local representative of the Marketing Authorisation Holder:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel. (22) 375 92 00