XARIVA 15 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Xariva 15 mg hard capsules EFG

Xariva 20 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. Storing 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 brain (stroke) or in other blood vessels of the body if you have a type of irregular heartbeat called non-valvular atrial fibrillation.
• 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 blood vessels of the legs and/or lungs.

Xariva is used in children and adolescents under 18 years of age and with a body weight of 30 kg or more to:

• treat and prevent blood clots in the veins or in the blood vessels of the lungs after at least 5 days of initial treatment with injectable medicines used to treat blood clots.

This medicine belongs to a group of medicines called antithrombotic agents. It works by blocking a factor in the blood clotting process (factor Xa) and thus reducing the tendency of the 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 bleeding or lesions 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 while receiving heparin through a venous or arterial catheter to prevent blockage
• if you have 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 circumstances apply to you.

Warnings and precautions

Consult your doctor or pharmacist before starting this medicine.

Be particularly careful withXariva

• if you have an increased risk of bleeding, such as in the following situations:

• severe kidney problems in adults and moderate or severe kidney problems in children and adolescents, as kidney function can affect the amount of medicine that works in the 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
• very high blood pressure that is not controlled by medical treatment
• stomach or intestinal diseases that can cause bleeding, such as inflammation of the intestine or stomach, inflammation of the esophagus (throat), e.g. due to gastroesophageal reflux disease (a disease in which stomach acid rises up into the esophagus) or tumors located in the stomach, intestines, genital tract, or urinary tract
• a problem in the blood vessels of the back of your eyes (retinopathy)
• a lung disease in which the bronchi are dilated and filled with pus (bronchiectasis) or previous bleeding in the lungs

• if you have a heart valve replacement
• if you know you have a disease called antiphospholipid syndrome (a disorder of the immune system that increases the risk of blood clots), inform your doctor to decide if it may be necessary to modify treatment
• 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

Inform 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 surgery

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

1. It is very important to take rivaroxaban before and after the injection or removal of the catheter, exactly at the times indicated by your doctor.
2. Inform your doctor immediately if you experience numbness or weakness in your legs or problems in your intestines or bladder after anesthesia, as urgent attention is necessary.

Children and adolescents

This medicine is not recommended in children with a body weight below 30 kg.There is not enough information about the use of rivaroxaban in children and adolescents for the indications in adults.

Other medicines and Xariva

Inform 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 it is only applied to the skin
• tablets with ketoconazole (used to treat Cushing's syndrome, in which 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 and pain relievers (e.g. naproxen or acetylsalicylic acid)
• dronedarone, a medicine for the treatment of irregular heartbeat
• certain medicines for the treatment of depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs))

If any of the above circumstances apply to you, inform 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 a stomach or intestinal ulcer, they may recommend that you also use a preventive treatment.

If you take:

1. any medicine for the treatment of epilepsy(phenytoin, carbamazepine, phenobarbital)
2. St. John's Wort (Hypericum perforatum), a herbal medicine for the treatment of depression
3. rifampicin, an antibiotic

If any of the above circumstances apply to you, inform 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 andbreastfeeding

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

Driving and using machines

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

You must take Xariva with food.

Swallow the capsules, preferably with water.

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. Then take food.

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

What dose to take

• Adults
• To prevent the formation of blood clots in the brain (stroke) or in other blood vessels of the body.

The recommended dose is one rivaroxaban 20 mg capsule once a day.

If you have kidney problems, the dose may be reduced to one rivaroxaban 15 mg capsule once a day.

If you need to undergo a procedure to treat blocked blood vessels in your heart (called percutaneous coronary intervention - PCI with stent insertion), there is limited evidence to reduce the dose to one rivaroxaban 15 mg capsule once a day (or to one rivaroxaban 10 mg capsule once a day if your kidneys do not function properly) in addition to an antiplatelet medicine such as clopidogrel.

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

The recommended dose is one rivaroxaban 15 mg capsule twice a day for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one rivaroxaban 20 mg capsule once a day.

After at least 6 months of treatment for blood clots, your doctor may decide to continue treatment with one 10 mg capsule once a day or one 20 mg capsule once a day.

If you have kidney problems and are taking one rivaroxaban 20 mg capsule once a day, your doctor may decide to reduce the treatment dose to one rivaroxaban 15 mg capsule once a day after 3 weeks if the risk of bleeding is higher than the risk of having another blood clot.

• Children and adolescents

The dose of rivaroxaban depends on body weight and will be calculated by the doctor.

The recommended dose for children and adolescents with a body weight between 30 kg and less than 50 kgis one rivaroxaban 15 mgcapsule once a day.

The recommended dose for children and adolescents with a body weight of 50 kgor more is one rivaroxaban 20 mgcapsule once a day.

Take each dose of rivaroxaban with a drink (e.g. water or juice) during a meal. Take the capsules every day at approximately the same time. Consider setting an alarm to remind you.

For parents or caregivers: observe the child to ensure they take the entire dose.

Since the dose of rivaroxaban is based on body weight, it is important to attend scheduled visits with the doctor, as it may be necessary to adjust the dose as weight changes.

Never adjust the dose of Xariva on your own. Your doctor will adjust the dose if necessary.

If a lower dose is required, please use an alternative presentation of rivaroxaban granules for oral suspension.

In children or adolescents who cannot swallow the capsule whole, rivaroxaban granules for oral suspension can be used. If the oral suspension is not available, the contents of the rivaroxaban capsule can be mixed with water or apple sauce immediately before taking it. Take some food after taking this mixture. If necessary, your doctor may also administer the contents of the capsule through a gastric tube.

If you spit out the dose or vomit

• less than 30 minutes after taking this medicine, take a new dose.
• more than 30 minutes after taking this medicine, do not take a new dose. In this case, take the next dose of this medicine at the usual time.

Call your doctor if you spit out the dose or vomit repeatedly after taking this medicine.

When to take Xariva

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

Try to take the dose at the same time every day to remember when you should take it.

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

To prevent the formation of blood clots in the brain (stroke) or in other blood vessels:

If it is necessary to normalize your heartbeat through a procedure called cardioversion, take rivaroxaban at the times indicated by your doctor.

If you take more Xariva than you should

Call your doctor immediatelyif 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

• Adults, children, and adolescents

If you are taking one 20 mg or one 15 mg capsule once a day and you forget to take a dose, take it as soon as you remember. Do not takemore than one capsule in one day to make up for a forgotten dose. Take the next dose the next day and then continue taking one capsule every day.

• Adults

If you are taking one 15 mg capsule twice a day and you forget to take a dose, take it as soon as you remember. Do not takemore than two 15 mg capsules in one day. If you forget to take a dose, you can take two 15 mg capsules at the same time, for a total of two capsules (30 mg) in one day. The next day, you should continue taking one 15 mg capsule twice a day.

If you stop takingXariva

Do not stop taking rivaroxaban without talking to your doctor first, as rivaroxaban treats and prevents serious conditions.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Like other similar medicines to reduce blood clot formation, rivaroxaban can cause bleeding that can endanger the patient's life. Excessive bleeding can cause a sudden drop in blood pressure (shock). In some cases, the bleeding may not be evident.

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

• Signs of bleeding

• bleeding in the brain or inside the skull (symptoms may include headache, unilateral weakness, vomiting, seizures, decreased level of consciousness, and neck stiffness. This is a serious medical emergency. Go to the doctor immediately!)
• prolonged or excessive bleeding
• exceptional weakness, fatigue, paleness, dizziness, headache, unexplained swelling, difficulty breathing, chest pain or angina.

Your doctor may decide to keep you under closer observation or change your treatment.

• Signs of severe skin reactions

• intense skin rashes that spread, 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 adverse 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 frequencies of severe allergic reactions are 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 adverse effects found in adults, children, and adolescents

Frequent(may affect up to 1 in 10 people)

• decrease in red blood cells that can cause paleness and weakness or difficulty breathing
• bleeding in the stomach or intestine, urogenital hemorrhage (including blood in the urine and heavy menstrual bleeding), nasal bleeding, gum bleeding
• bleeding in the eye (including bleeding in the white part of the eye)
• bleeding into a tissue or cavity of the body (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
• alteration of kidney function (may be seen in tests performed by the doctor)
• fever
• stomach pain, indigestion, dizziness or feeling of dizziness, constipation, diarrhea
• low blood pressure (symptoms may be 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
• alteration of liver function (may be seen in tests performed by the doctor)
• blood tests may show an increase in bilirubin, some pancreatic or liver enzymes, or platelet count
• fainting
• feeling of discomfort
• 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 after a complication in cardiac 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 granulocytic white blood cells that cause inflammation in the lung (eosinophilic pneumonia)

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

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

Adverse effects in children and adolescents

In general, the adverse effects observed in children and adolescents treated with rivaroxaban were similar to those observed in adults and their severity was mainly mild to moderate.

Adverse effects that were more frequently observed in children and adolescents:

Very frequent(may affect more than 1 in 10 people)

• headache
• fever
• nasal bleeding
• vomiting

Frequent(may affect up to 1 in 10 people)

• accelerated heartbeats
• blood tests may show an increase in bilirubin (bile pigment)
• thrombocytopenia (low platelet count, cells that help blood clotting)
• heavy menstrual bleeding

Uncommon(may affect up to 1 in 100 people)

• blood tests may show an increase in a subcategory of bilirubin (direct bilirubin, bile pigment)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing 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 expiration date that appears on the packaging and on each blister after "CAD" or "EXP". The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Xariva 15 mg:

• The active ingredient is rivaroxaban.

Each capsule contains 15 mg of rivaroxaban.

• The other components are:

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

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

Composition of Xariva 20 mg:

• The active ingredient is rivaroxaban.

Each capsule contains 20 mg of rivaroxaban.

• The other components are:

Capsule content:lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, hypromellose, sodium lauryl sulfate, 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

Dose of 15 mg: the hard capsules of Xariva 15 mg are 19.4 mm long (size "1") with opaque light brown cap and body.

Xariva 15 mg is presented in packages of 28 hard capsules in PVC/PVdC - aluminum blister.

Dose of 20 mg: the capsules of Xariva 20 mg are 21.7 mm long (size "0") with opaque dark brown cap and body.

Xariva 20 mg is presented in packages of 28 hard capsules in PVC/PVdC - aluminum blister.

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 prospectus:May 2024

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