Xanirva

Patient Information Leaflet

Xanirva, 10 mg, film-coated tablets
Rivaroxaban
Read the entire leaflet before taking this medicine , because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• Contact your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them 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.

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 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 liver disease that increases the 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. intestinal and stomach inflammation or oesophagitis (throat and oesophagus), e.g. due to gastroesophageal reflux disease (acid reflux into the oesophagus); or tumours located in the stomach, intestines, reproductive or urinary system;
  • vascular disease of the posterior part of the eyeball (retinopathy);
  • lung disease with bronchiectasis and pus-filled airways (bronchiectasis) or previous pulmonary haemorrhage;
• in patients with prosthetic heart valves;
• in patients with antiphospholipid syndrome (immune system disorders causing increased risk of thrombosis). Inform your doctor, who will decide whether treatment adjustment is necessary;
• if the patient has abnormal blood pressure or is scheduled for surgery or other treatment aimed at removing a pulmonary embolus.

If you suspect that any of the above apply to you, you should inform your doctor
before taking Xanirva. The doctor will decide whether to use this medicine and whether the patient
should be placed under particularly close observation.
If the patient is scheduled for surgery:

• it is very important to take Xanirva exactly at the times prescribed by the attending physician, both before and after surgery;
• if during surgery catheterization or lumbar puncture of the spine is planned (e.g. for epidural or spinal anaesthesia or for pain relief):
  • it is very important to take Xanirva exactly at the times prescribed by the attending physician, both before and after the puncture or catheter removal;
  • inform the doctor immediately if, after anaesthesia, numbness or weakness in the legs, or bowel or bladder dysfunction occurs, as immediate treatment is required in such cases.

Children and adolescents
Xanirva 10 mg tablets 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
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines you plan 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, 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 apply to you, inform your doctor
before taking Xanirva, as the effect of Xanirva may be enhanced when taken simultaneously with the above-mentioned medicines. The doctor will decide whether to use this medicine and whether the patient should be placed under particularly close observation.
If the doctor considers that the patient has an increased risk of developing stomach or intestinal ulcers, preventive treatment may be initiated.

• If the patient is taking:
  • certain medicines used to treat epilepsy (phenytoin, carbamazepine, phenobarbital);
  • St John's wort (Hypericum perforatum), an herbal remedy used for depression;
  • rifampicin, which belongs to the group of antibiotics.

If you suspect that any of the above conditions apply to you, you should inform your doctor
before taking Xanirva, as the effect of Xanirva may be reduced when taken together with the above-mentioned medicines.
The doctor will decide whether to use Xanirva and whether the patient should be placed under particularly close observation.
Pregnancy and breastfeeding
Do not use Xanirva if you are pregnant or breastfeeding. If there is a risk that the patient may become pregnant, an effective method of contraception should be used during treatment with Xanirva. If pregnancy occurs during treatment with 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 the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking this medicine.
The medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is essentially "sodium-free".

3. How to take Xanirva

This medicine should always be taken as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

How many tablets to take

• To prevent blood clots in veins after hip or knee replacement surgery
  The recommended dose is one Xanirva 10 mg tablet 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 tablet once daily or one 20 mg tablet once daily. Your doctor has prescribed Xanirva 10 mg once daily for you.

Swallow the tablet whole, preferably with water.
Xanirva can be taken with or without food.
If you have difficulty swallowing the whole tablet, talk to your doctor about other ways of taking Xanirva. The tablet can be crushed and mixed with water or apple puree immediately before use.
If necessary, your doctor may administer crushed Xanirva through a gastric tube.

When to start treatment with Xanirva
Take one tablet every day until your doctor decides to stop treatment.
It is best to take the tablet 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:
Take the first tablet between 6 and 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 you take more Xanirva than prescribed, contact your doctor immediately. Taking too high a dose of Xanirva increases the risk of bleeding.

Missing a dose of Xanirva
If you miss a dose, take it as soon as you remember. Take the next tablet the following day and then continue taking the tablets as usual, once daily.
Do not take a double dose to make up for a missed tablet.

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.
As with other medicines of similar action that reduce blood clot formation, Xanirva may cause bleeding, which could 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.
You should immediately contact a 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 paralysis, vomiting, seizures, decreased level of consciousness, and neck stiffness. This is a serious, acute medical emergency. Immediate medical assistance must be called!)
• prolonged or heavy bleeding
• unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain, or angina. The doctor may decide that close monitoring of the patient or a change in treatment is necessary.

Signs of severe skin reactions:

• extensive, acute skin rash, blistering, or mucosal lesions, e.g., on the tongue or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), 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, 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)

• decreased number of red blood cells, which may cause paleness of the skin and lead to weakness or shortness of breath
• gastrointestinal or intestinal bleeding, bleeding from the urinary or genital tract (including blood in urine and heavy menstrual bleeding), nosebleeds, gum bleeding
• bleeding into the eye (including bleeding from the white of the eye)
• bleeding into tissues or body cavities (hematoma, bruising)
• presence of blood in sputum during coughing (hemoptysis)
• bleeding from or under the skin
• postoperative bleeding
• oozing of blood or fluid from surgical wound
• limb swelling
• 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)
• general loss of strength and energy (weakness, fatigue), headache, dizziness
• rash, skin itching
• increased activity of certain liver enzymes, which may be evident in blood test results.

Uncommon (may occur in 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 number of platelets, blood cells involved in 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 collection (hematoma) in the groin area as a complication of heart 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 (drug-induced nephropathy associated with anticoagulant medicines)
• increased pressure in the muscles of arms and legs following bleeding, which may cause pain, swelling, altered sensation, numbness, or paralysis (compartment syndrome after bleeding)

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Reporting adverse reactions helps to gather 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.
No special storage instructions apply to this medicine.
Do not use this medicine after the expiry date stated on the carton and blister pack following EXP.
The expiry date refers to the last day of the stated month.
Medicines should 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 Xanirva contains

• The active substance is rivaroxaban. One coated tablet contains 10 mg of rivaroxaban.
• Other ingredients are: tablet core: monohydrate lactose, microcrystalline cellulose, sodium croscarmellose, hypromellose 2910, sodium lauryl sulfate, magnesium stearate. coating: hypromellose 2910, titanium dioxide (E 171), macrogol, iron oxide red (E 172).

What Xanirva looks like and contents of the pack
Xanirva 10 mg: pink, round, biconvex coated tablets with a diameter of approximately 8.4 mm,
imprinted with "10" on one side and smooth on the other.
Available pack sizes: 10, 15, 20, 30, 98 and 100 coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Zentiva, k.s.
U kabelovny 130, Dolní Měcholupy
102 37 Prague 10
Czech Republic
Manufacturer / Importer
S.C. Zentiva S.A.
B-dul Theodor Pallady nr. 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 member states under the following names:
Czech Republic, Bulgaria, Estonia, Lithuania, Latvia, Poland, Romania, Slovakia, United Kingdom, Greece: Xanirva
For further information about this medicinal product, please contact:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel. (22) 375 92 00