XARIVA 10 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Xariva 10 mg Hard Capsules EFG

rivaroxaban

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Xariva and what is it used for

Xariva 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 an operation you are at a higher risk of forming blood clots.
• 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 these blood clots from happening again in the veins of the legs and/or lungs.

Xariva belongs to a group of medicines called antithrombotic agents. It works by blocking a factor involved in blood clotting (factor Xa) and thus reducing the tendency of blood to form clots.

2. What you need to know before you take Xariva

Do not takeXariva

• if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6)
• if you have bleeding problems
• if you have a disease or condition that increases the risk of serious bleeding (e.g. stomach ulcer, recent injury or bleeding in the brain, or recent brain or eye surgery)
• if you are taking medicines to prevent blood clots (e.g. warfarin, dabigatran, apixaban or heparin), except when switching from one anticoagulant treatment to another or when being treated with heparin through a venous or arterial catheter to prevent blockage
• if you have a liver disease that increases the risk of bleeding
• if you are pregnant or breastfeeding

Do not take Xariva and inform your doctorif any of these apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine.

Be particularly careful withXariva

• if you have an increased risk of bleeding, such as:

• moderate or severe kidney problems, as kidney function may affect the amount of medicine that works in your body
• if you are taking other medicines to prevent blood clots (e.g. warfarin, dabigatran, apixaban or heparin) when switching to another anticoagulant treatment or while receiving heparin through a venous or arterial catheter to prevent blockage (see section "Other medicines and Xariva")
• bleeding disorders
• uncontrolled high blood pressure
• stomach or intestinal diseases that may cause bleeding, such as inflammation of the stomach or intestine, inflammation of the esophagus (e.g. due to gastroesophageal reflux disease) or tumors in the stomach, intestines, genital or urinary tract
• problems with blood vessels in the back of the eyes (retinopathy)
• a lung disease where the bronchi are dilated and filled with pus (bronchiectasis) or have had previous bleeding in the lungs

• if you have a heart valve prosthesis
• if you know you have a disease called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor to decide if treatment modification is necessary
• if your doctor determines that your blood pressure is unstable or if you are scheduled to receive another treatment or undergo surgery to remove a blood clot from your lungs

Tell your doctor if you have any of these conditionsbefore taking this medicine. Your doctor will decide if you should be treated with this medicine and if you should be kept under closer observation.

If you need to have surgery

• It is very important to take rivaroxaban before and after surgery, exactly at the times indicated by your doctor.
• If your operation requires the placement of a catheter or injection into the spine (e.g. for epidural or spinal anesthesia, or pain relief):

• It is very important to take rivaroxaban exactly at the times indicated by your doctor.
• Tell your doctor immediately if you experience numbness or weakness in your legs or problems with your intestines or bladder after anesthesia, as urgent attention is needed.

Children and adolescents

This medicine is not recommended for children under 18 years. There is not enough information on its use in children and adolescents.

Other medicines and Xariva

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

• If you are taking:

• any medicine for a fungal infection (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless only applied to the skin
• ketoconazole tablets (used to treat Cushing's syndrome, where the body produces too much cortisol)
• any medicine for bacterial infections (e.g. clarithromycin, erythromycin)
• any antiviral medicine for HIV/AIDS (e.g. ritonavir)
• other medicines to reduce blood clotting (e.g. enoxaparin, clopidogrel or vitamin K antagonists, such as warfarin or acenocoumarol)
• anti-inflammatory medicines or pain relievers (e.g. naproxen or acetylsalicylic acid)
• dronedarone, a medicine for treating irregular heartbeat
• certain medicines for treating depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs))

If any of the above applies to you, tell your doctorbefore taking this medicine, as the effect of rivaroxaban may be increased. Your doctor will decide if you should be treated with this medicine and if you should be kept under closer observation.

If your doctor considers that you have a higher risk of developing stomach or intestinal ulcers, they will recommend that you also use a treatment to prevent ulcers.

• If you are taking

• any medicine for epilepsy (phenytoin, carbamazepine, phenobarbital)
• St. John's Wort (Hypericum perforatum), a herbal medicine for treating depression
• rifampicin, an antibiotic

If any of the above applies to you, tell your doctorbefore taking this medicine, as the effect of rivaroxaban may be reduced. Your doctor will decide if you should be treated with this medicine and if you should be kept under closer observation.

Pregnancy and breastfeeding

Do not take rivaroxaban if you are pregnant or breastfeeding. If there is a possibility that you may become pregnant, use a reliable contraceptive while taking rivaroxaban. If you become pregnant while taking this medicine, tell your doctor immediately, who will decide how you should be treated.

Driving and using machines

This medicine may cause dizziness (a common side effect) or fainting (an uncommon side effect) (see section 4, "Possible side effects"). You should not drive, ride a bicycle, or use tools or machines if you are affected by these symptoms.

Xariva contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; this is essentially "sodium-free".

3. How to take Xariva

Follow exactly the instructions for taking this medicine as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

What dose to take

• To prevent the formation of blood clots in the veins after hip or knee replacement surgery.

The recommended dose is one rivaroxaban 10 mg capsule once a day.

• To treat blood clots in the veins of the legs and in the blood vessels of the lungs, and to prevent blood clots from happening again.

After 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 rivaroxaban 10 mg once a day.

Swallow the capsule, preferably with water.

Rivaroxaban can be taken with or without food.

If you have difficulty swallowing the capsule whole, consult your doctor about other ways to take rivaroxaban. The contents of the capsule can be mixed with water or apple sauce, immediately before taking it.

If necessary, your doctor may also administer the contents of the capsule of this medicine dissolved through a gastric tube.

When to take Xariva

Take this medicine every day, until your doctor tells you to stop.

Try to take this medicine at the same time every day, to help you remember.

Your doctor will decide how long you should continue taking the treatment.

To prevent the formation of blood clots in the veins after hip or knee replacement surgery:

Take the first dose 6 to 10 hours after the operation.

If you have had major hip surgery, you will usually take rivaroxaban for 5 weeks.

If you have had major knee surgery, you will usually take rivaroxaban for 2 weeks.

If you take more Xariva than you should

Call your doctor immediately if you have taken too many rivaroxaban capsules. Taking too much rivaroxaban increases the risk of bleeding.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Xariva

If you forget to take a dose, take it as soon as you remember. Take the next dose the following day and, after that, take one capsule every day, as usual.

Do not take a double dose to make up for forgotten doses.

If you stop taking Xariva

Do not stop taking rivaroxaban without talking to your doctor first, as rivaroxaban prevents the development of a serious condition.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, rivaroxaban can cause side effects, although not everybody gets them.

Like other similar medicines to reduce blood clotting, rivaroxaban can cause bleeding, which can be life-threatening. Excessive bleeding can cause a sudden drop in blood pressure (shock). In some cases, the bleeding may not be visible.

Tell your doctor immediately if you experience any of the following side effects:

• Signs of bleeding

• bleeding in the brain or inside the skull (symptoms can include headache, weakness on one side of the body, vomiting, seizures, decreased level of consciousness, and stiffness in the neck. This is a serious medical emergency. Seek medical attention immediately!)
• prolonged or excessive bleeding
• exceptional weakness, fatigue, paleness, dizziness, headache, unexplained swelling, difficulty breathing, chest pain or angina

Your doctor will decide whether to keep you under closer observation or modify your treatment.

• Signs of severe skin reactions

• severe skin rash that spreads, blisters, or lesions on the mucous membranes, e.g. in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis)
• drug reaction that causes rash, fever, inflammation of internal organs, blood abnormalities, and systemic disease (DRESS syndrome)

The frequency of these side effects is very rare (up to 1 in 10,000 people).

• Signs of severe allergic reactions

• 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 affect up to 1 in 10,000 people) and uncommon (angioedema and allergic edema; may affect up to 1 in 100 people).

General list of possible side effects:

Common(may affect up to 1 in 10 people):

• decrease in red blood cells that can cause paleness and weakness or difficulty breathing
• stomach or intestinal bleeding, urogenital bleeding (including blood in the urine and heavy menstrual bleeding), nosebleeds
• bleeding in the eye (including bleeding in the white of the eye)
• bleeding into tissue or a body cavity (hematoma, bruising)
• coughing up blood
• bleeding from the skin or under the skin
• bleeding after surgery
• oozing of blood or fluid from a surgical wound
• swelling of the limbs
• pain in the limbs
• kidney function changes (may be seen in tests performed by your doctor)
• fever
• stomach pain, indigestion, dizziness or feeling of dizziness, constipation, diarrhea
• low blood pressure (symptoms may include dizziness or fainting when standing up)
• general decrease in strength and energy (weakness, fatigue), headache, dizziness
• rash, itching of the skin
• blood tests may show an increase in some liver enzymes

Uncommon(may affect up to 1 in 100 people):

• bleeding in the brain or inside the skull (see above, signs of bleeding)
• bleeding into a joint, causing pain and swelling
• thrombocytopenia (low platelet count, cells that help blood clotting)
• allergic reaction, including skin allergic reaction
• liver function changes (may be seen in tests performed by your doctor)
• blood tests may show an increase in bilirubin, some pancreatic or liver enzymes, or platelet count
• fainting
• feeling unwell
• increased heart rate
• dry mouth
• hives

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

• bleeding into a muscle
• cholestasis (decreased bile flow), hepatitis, including traumatic hepatocellular injury (inflammation or liver damage)
• yellowing of the skin and eyes (jaundice)
• localized swelling
• blood accumulation (hematoma) in the groin as a complication after heart surgery where a catheter is inserted into the leg artery (pseudoaneurysm)

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

• accumulation of eosinophils, a type of white blood cell granulocyte that causes inflammation in the lung (eosinophilic pneumonia)

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

• kidney failure after severe bleeding
• bleeding in the kidney, sometimes with blood in the urine, which causes the kidneys to fail (anticoagulant-related nephropathy)
• increased pressure in the muscles of the legs or arms after bleeding, causing pain, swelling, altered sensation, numbness, or paralysis (hemorrhagic compartment syndrome)

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Xariva

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on each blister, after "CAD" or "EXP". The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofXariva

• The active ingredient is rivaroxaban. Each capsule contains 10 mg of rivaroxaban.
• The other ingredients are:

Capsule content:lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, hypromellose, sodium laurilsulfate, and magnesium stearate;

Capsule shell:gelatin, titanium dioxide (E-171), yellow iron oxide (E-172), red iron oxide (E-172), and black iron oxide (E-172).

Appearance of the Product and Package Contents

The hard capsules of Xariva 10 mg are 15.9 mm in length (size "3") with opaque cap and body of beige color.

Xariva 10 mg is available in packs of 30 hard capsules in PVC/PVdC - aluminum blister packs.

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa, Barcelona

Spain

Manufacturer

Zentiva, S.A.

B-dul Theodor Pallady nr.50, sector 3,

Bucharest, 032266,

Romania

or

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park,

Paola, PLA3000,

Malta

Date of the Last Revision of this Leaflet:May 2024

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/