Xanirva

Package Leaflet: Information for the Patient

Xanirva, 10 mg, hard capsules

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

• You should keep this leaflet, so you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 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.

Contents of the pack:

• 1. What is Xanirva and what is it used for
• 2. Important information 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 is Xanirva and what is it used for

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

• prevent the formation of blood clots in the veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because after surgery, the risk of forming blood clots is increased.
• treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism) and prevent the formation of new blood clots in the veins of the legs and/or lungs.

Xanirva belongs to a group of medicines called anticoagulants. Its action is based on blocking the blood clotting factor (factor Xa) and thus reducing the tendency to form blood clots.

2. Important information before taking Xanirva

When not to take Xanirva:

• -if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6);
• -if you have excessive bleeding;
• -if you have a disease or condition of the body that leads to an increased risk of serious bleeding (e.g., stomach ulcer, injury or bleeding into the brain, recent brain or eye surgery);
• -if you are taking other medicines that prevent blood clotting (e.g., warfarin, dabigatran, apixaban, or heparin), except when switching anticoagulant therapy or when heparin is given to maintain the patency of a venous or arterial catheter;
• -if you have liver disease that leads to an increased risk of bleeding;
• -if you are pregnant or breastfeeding.

Do not take Xanirva and inform your doctorif you suspect that any of the above circumstances apply to you.

Warnings and precautions

Before taking Xanirva, you should consult your doctor or pharmacist.

When to be particularly careful when taking Xanirva

• -if you have an increased risk of bleeding, such as:
• •moderate or severe kidney disease, as kidney function may affect the amount of medicine that works in your body;
• •if you are taking other medicines that prevent blood clotting (e.g., warfarin, dabigatran, apixaban, or heparin), except when switching anticoagulant therapy or when heparin is given to maintain the patency of a venous or arterial catheter (see section "Other medicines and Xanirva");
• •bleeding disorders;
• •very high blood pressure that does not decrease despite taking medicines;
• •stomach or intestinal diseases that may cause bleeding, e.g., inflammation of the intestines and stomach or inflammation of the esophagus (throat and esophagus) e.g., due to reflux disease of the esophagus (stomach acid flowing back into the esophagus) or tumors located in the stomach or intestines or the reproductive or urinary system;
• •disease of the blood vessels in the back of the eye (retinopathy);
• •lung disease in which the bronchi are dilated and filled with pus (bronchiectasis) or previous bleeding from the lungs;
• -in patients with heart valve prostheses;
• -in patients with antiphospholipid syndrome (disorders of the immune system that increase the risk of blood clots). You should inform your doctor, who will decide whether to change the treatment if necessary;
• -if you have abnormal blood pressure or are scheduled for surgery or other treatment to remove a blood clot from the lungs.

If you suspect that any of the above applies to you, you should inform

your doctorbefore taking Xanirva. Your doctor will decide whether to use this medicine and whether you should be under close observation.

If you are going to have surgery:

• it is very important to take Xanirva before and after surgery exactly at the times specified by your doctor;
• if catheterization or lumbar puncture (e.g., for spinal anesthesia or pain relief) is planned:
• it is very important to take Xanirva before and after the procedure exactly at the times specified by your doctor;
• you should immediately inform your doctor if, after the anesthesia, you experience numbness or weakness in your legs, bowel or bladder problems, as immediate treatment may be necessary.

Children and adolescents

Xanirva 10 mg capsules are not recommended for persons under 18 years of age. There is a lack of sufficient data on the use of the medicine in children and adolescents.

Xanirva and other medicines

You should tell your doctor or pharmacist about all medicines you are 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 medicines for fungal infections (e.g., fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only topically on the skin;
• ketokonazole in tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol);
• certain medicines for bacterial infections (e.g., clarithromycin, erythromycin);
• certain antiviral medicines used to treat HIV or AIDS (e.g., ritonavir);
• other medicines that prevent 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 and noradrenaline reuptake inhibitors (SNRIs)).

If you suspect that any of the above applies to you, you should inform

your doctorbefore taking Xanirva, as the effect of Xanirva may be enhanced if it is taken with the above medicines. Your doctor will decide whether to use this medicine and whether you should be under close observation. If your doctor believes that you are at increased risk of stomach or intestinal ulcers, they may use a treatment to prevent ulcers.

• - If you are taking:
• certain medicines for epilepsy (phenytoin, carbamazepine, phenobarbital);
• St. John's Wort (Hypericum perforatum), a herbal medicine used for depression;
• rifampicin, which belongs to a group of antibiotics.

If you suspect that any of the above applies to you, you should

inform your doctorbefore taking Xanirva, as the effect of Xanirva may be reduced if it is taken with the above medicines. Your doctor will decide whether to use Xanirva and whether you should be under close observation.

Pregnancy and breastfeeding

Do not take Xanirva if you are pregnant or breastfeeding. If there is a risk that you may become pregnant, you should use effective contraception while taking Xanirva. If you become pregnant while taking this medicine, you should immediately inform your doctor, who will decide on further treatment.

Driving and using machines

Xanirva may cause dizziness (frequent side effects) and fainting (uncommon side effects) (see section 4 "Possible side effects"). Patients who experience these side effects should not drive, ride a bicycle, or operate tools or machines.

Xanirva contains lactose monohydrate (a type of sugar) and sodium

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

3. How to take Xanirva

This medicine should always be taken exactly as your doctor has told you. If you are not sure, you should ask your doctor or pharmacist.

How many capsules to take

• To prevent blood clots in the veins after hip or knee replacement surgeryThe recommended dose is one Xanirva 10 mg capsule taken once a day.
• For the treatment of blood clots in the veins of the legs and blood clots in the lungs, and to prevent the formation of new blood clotsAfter at least 6 months of treatment for blood clots, the recommended dose is one 10 mg capsule once a day or one 20 mg capsule once a day. Your doctor has prescribed Xanirva 10 mg once a day for you.

The capsule should be swallowed whole, preferably with water. Xanirva can be taken with or without food. If you have difficulty swallowing the whole capsule, you should talk to your doctor about other ways to take Xanirva. The contents of the capsule can be mixed with water or apple sauce, just before taking. If necessary, your doctor may give the contents of the Xanirva capsule through a gastric tube.

When to start taking Xanirva

You should take one capsule every day until your doctor decides to stop the treatment. It is best to take the capsule at the same time every day, as it is easier to remember. Your doctor will decide how long you should continue the treatment. To prevent blood clots in the veins of the legs after hip or knee replacement surgery:

The first capsule should be taken 6 to 10 hours after surgery. In patients after major hip replacement surgery, treatment usually lasts 5 weeks. In patients after major knee replacement surgery, treatment usually lasts 2 weeks.

Taking more Xanirva than prescribed

If you have taken more Xanirva than prescribed, you should immediately contact your doctor. Taking too much Xanirva increases the risk of bleeding.

Missing a dose of Xanirva

If you miss a dose, you should take it as soon as you remember. The next capsule should be taken the next day, and then the capsules should be taken as usual, once a day. Do not take a double dose to make up for the missed capsule.

Stopping Xanirva treatment

You should not stop taking Xanirva without first talking to your doctor, as Xanirva prevents a serious disease. If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Xanirva can cause side effects, although not everybody gets them. Like other medicines that reduce blood clotting, Xanirva can cause bleeding, which can be life-threatening. Excessive bleeding can lead to a sudden drop in blood pressure (shock). The signs of bleeding may not always be obvious or visible. You should immediately inform your doctorif you experience any of the following side effects:

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 stiffness of the neck. This is a serious medical emergency. You should immediately seek medical help!)
• prolonged or heavy bleeding
• unusual weakness, fatigue, pallor, dizziness, headache, unexplained swelling, shortness of breath, chest pain, or angina .Your doctor may decide to closely monitor you or change the treatment.

Signs of severe skin reactions:

• widespread, acute skin rash, blistering, or changes in the mucous membranes, e.g., on the tongue or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis)
• drug reaction causing rash, fever, inflammation of internal organs, hematological disorders, and systemic disorders (DRESS syndrome). These side effects are very rare (may occur in less than 1 in 10,000 people)

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. 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 side effects:

Common(may affect up to 1 in 10 people)

• decrease in red blood cell count, which may cause pallor and be the cause of weakness or shortness of breath
• bleeding from the stomach or intestine, bleeding from the urinary or reproductive 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)
• presence of blood in sputum when coughing (hemoptysis)
• bleeding from the skin or subcutaneous bleeding
• bleeding after surgery
• oozing of blood or fluid from the wound after surgery
• swelling of the limbs
• limb pain
• kidney problems (which can be observed in tests performed by your doctor)
• fever
• stomach pain, nausea (nausea), 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 of the skin
• increased activity of certain liver enzymes, which can be seen in blood test results

Uncommon(may affect up to 1 in 100 people)

• bleeding into the brain or inside the skull (see above signs of bleeding)
• bleeding into the joint, causing pain and swelling
• thrombocytopenia (low platelet count, cells involved in blood clotting)
• allergic reactions, including allergic skin reactions
• blood test results may show increased bilirubin levels, activity of certain pancreatic or liver enzymes, or platelet count
• fainting
• malaise
• rapid heartbeat
• dry mouth
• hives

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

• bleeding into the muscles
• cholestasis (bile stasis), hepatitis, including liver cell damage
• jaundice (yellowing of the skin and eyes)
• local swelling
• blood accumulation (hematoma) in the groin as a complication of heart catheterization, when the catheter is inserted into an artery in the leg (pseudoaneurysm)

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

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

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

• kidney failure after severe bleeding
• kidney bleeding, sometimes with blood in the urine, leading to kidney failure (nephropathy associated with anticoagulant therapy)
• increased pressure in the muscles of the legs and arms after bleeding, which can lead to 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 or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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. By reporting side effects, you can help provide more information on the safety of this medicine. Side effects can also be reported to the marketing authorization holder or its representative in Poland.

5. How to store Xanirva

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the blister pack and carton after EXP. The expiry date refers to the last day of the month stated. Blister packs of PVC/PVDC/Aluminum: Store in a temperature below 30°C. Store in the original package to protect from moisture. Blister packs of OPA/Aluminum/PVC/Aluminum: No special storage precautions.

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 Xanirva contains

• The active substance of Xanirva is rivaroxaban. Each capsule contains 10 mg of rivaroxaban.
• The other ingredients are: capsule contents:lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, hypromellose, sodium lauryl sulfate, 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: light brown, opaque, capsules filled with white or almost white powder, size "3" (approximately 16 mm long). The hard capsules are packaged in blister packs of PVC/PVDC/Aluminum or OPA/Aluminum/PVC/Aluminum and a cardboard box. Available in packs of 10, 15, 20, 30, or 100 hard capsules. Not all pack sizes may be marketed.

Marketing authorization holder

Zentiva, k.s. U kabelovny 130, Dolní Mĕcholupy 102 37 Prague 10 Czech Republic

Importer

Zentiva SA B-dul Theodor Pallady nr. 50, Sector 3 032266 Bucharest, Romania Pharmadox Healthcare Ltd. KW20A Kordin Industrial Park Paola PLA3000, Malta

This medicine is authorized in the Member States of 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 more information, you should contact your local representative of the marketing authorization holder:

Zentiva Polska Sp. z o.o. ul. Bonifraterska 17 00-203 Warsaw Tel. (22) 375 92 00 Date of last revision of the leaflet:January 2024