RIVAROXABAN SANDOZ FARMACEUTICA 15 mg HARD CAPSULES

2. What you need to know before taking Rivaroxaban Sandoz Pharmaceutical

Do not takeRivaroxaban Sandoz Pharmaceutical

• if you are allergic to rivaroxaban or any of the other ingredients of this medication (listed in section 6),
• if you have excessive bleeding,
• if you have a disease or problem in an organ of the body that increases the risk of severe bleeding (e.g., stomach ulcer, injury or bleeding in the brain, or recent surgery in the brain or eyes),
• if you are taking medications to prevent blood clot formation (e.g., warfarin, dabigatran, apixaban, or heparin), except when switching to anticoagulant treatment or while being administered heparin through a venous or arterial catheter, so that it does not become clogged,
• if you have a liver disease that may increase the risk of bleeding,
• if you are pregnant or breastfeeding.

Do nottake rivaroxaban and inform your doctorif any of these circumstances apply to your case.

Warnings and precautions

Consult your doctor or pharmacist before starting to take rivaroxaban.

Be careful with Rivaroxaban Sandoz Pharmaceutical

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

• severe kidney failure in adults and moderate or severe kidney failure in children and adolescents, as kidney function may affect the amount of medication that acts in your body,
• if you are taking other medications to prevent blood clot formation (e.g., warfarin, dabigatran, apixaban, or heparin), when switching to another anticoagulant treatment or while receiving heparin through a venous or arterial catheter, so that it does not become clogged (see section "Other medications and Rivaroxaban Sandoz Pharmaceutical"),
• bleeding disorder,
• very high blood pressure, not controlled by medical treatment,
• stomach or intestinal diseases that may cause bleeding, such as inflammation of the stomach or intestine, 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 have had a 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 clot formation), inform your doctor so that they can decide if it is necessary to modify the treatment,
• if your doctor determines that your blood pressure is unstable or 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 situationsbefore taking rivaroxaban. Your doctor will decide if you should be treated with this medication and if you should be kept under closer observation.

If you need surgery:

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

• 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,
• Inform your doctor immediately if you experience numbness or weakness in your legs or problems in your intestine or bladder at the end of anesthesia, as urgent attention is necessary.

Children and adolescents

Rivaroxaban is not recommended in children with a body weight of less than 30 kg. There is not enough information about its use in children and adolescents for the indications in adults.

Other medications and Rivaroxaban Sandoz Pharmaceutical

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication, including those purchased without a prescription.

• If you are taking:

• any medication for a fungal infection (e.g., fluconazole, itraconazole, voriconazole, posaconazole), except if only applied to the skin,
• tablets with ketoconazole (used to treat Cushing's syndrome, in which the body produces excess cortisol),
• any medication for bacterial infections (e.g., clarithromycin, erythromycin),
• any antiviral medication for HIV/AIDS (e.g., ritonavir),
• other medications to reduce blood clotting (e.g., enoxaparin, clopidogrel, or vitamin K antagonists, such as warfarin or acenocoumarol),
• anti-inflammatory medications and pain relievers (e.g., naproxen or acetylsalicylic acid),
• dronedarone, a medication for the treatment of irregular heartbeat,
• certain medications 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 rivaroxaban, as the effect of this medication may be increased. Your doctor will decide if you should be treated with this medication 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 using a preventive treatment in addition.

• If you are taking:

• any medication for the treatment of epilepsy (phenytoin, carbamazepine, phenobarbital),
• St. John's Wort (Hypericum perforatum) a medicinal plant for the treatment of depression,
• rifampicin, an antibiotic.

If any of the above circumstances apply to you, inform your doctorbefore taking rivaroxaban, as the effect of this medication may be reduced. Your doctor will decide if you should be treated with rivaroxaban 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 any possibility that you may become pregnant, use a reliable contraceptive while taking this medication. 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 (frequent side effect) or fainting (uncommon side effect) (see section 4, "Possible side effects"). Do not drive, ride a bicycle, or use tools or machines if you are affected by these symptoms.

Rivaroxaban Sandoz Pharmaceutical contains lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

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

3. How to take/use Rivaroxaban Sandoz Pharmaceutical

Follow the instructions for administration of this medication exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

You must take rivaroxaban 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. This mixture should be followed by food immediately.

If necessary, your doctor may also administer the contents of the capsule 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 in case your kidneys do not function properly) in addition to an antiplatelet medication 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 recurring.

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, after 3 weeks, to one rivaroxaban 15 mg capsule once a day 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 of between 30 kg and less than 50 kgis one rivaroxaban15 mgcapsule once a day.
• The recommended dose for children and adolescents with a body weight of 50 kgor more is one rivaroxaban20 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 the weight changes.

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

Do not divide the capsule to try to obtain a fraction of the dose of the capsule. If a smaller dose is required, please use the alternative pharmaceutical forms available.

If other pharmaceutical forms are not available, you can open the contents of the capsule and mix it 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 rivaroxaban capsule through a gastric tube.

If you spit up the dose or vomit

• less than 30 minutes after taking rivaroxaban, take a new dose.
• more than 30 minutes after taking rivaroxaban, do nottake a new dose. In this case, take the next dose of rivaroxaban at the usual time.

Call your doctor if you spit up the dose or vomit repeatedly after taking rivaroxaban.

When to take Rivaroxaban Sandoz Pharmaceutical

Take the capsule(s) every day, until your doctor tells you to stop.

Try to take the capsules 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 brain (stroke) and in other blood vessels of the body:

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

If you forgot to take Rivaroxaban Sandoz Pharmaceutical

• Adults, children, and adolescents
• • If you are taking one 20 mg or one 15 mg capsule oncea day, and you forgot to take a dose, take it as soon as you remember. Do not take more than one capsule in a single day to make up for a missed dose. Take the next capsule the next day and, after that, continue taking one capsule every day.
• Adults
• • If you are taking one 15 mg capsule twicea day, and you forgot to take a dose, take it as soon as you remember. Do not take more than two 15 mg capsules in a single day. If you forgot to take a dose, you can take two 15 mg capsules at the same time, for a total of two capsules (30 mg) in a day. The next day, you should continue taking one 15 mg capsule twice a day.

If you take more Rivaroxaban Sandoz Pharmaceutical than you should

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 medication and the amount taken.

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

If you interrupt treatment with Rivaroxaban Sandoz Pharmaceutical

Do not interrupt treatment with rivaroxaban without talking to your doctor first, as rivaroxaban treats and prevents the development of a serious condition.

If you have any other questions about the use of this medication, 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 your child experiences 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. 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 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 this adverse effect 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 these severe adverse 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,
• stomach or intestinal bleeding, 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 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,
• 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 (decrease in 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 in which 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 Common(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 leaflet. 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 Rivaroxaban Sandoz Pharmaceutical

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 the blister after CAD/EXP. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Opened Capsules

The contents of the capsule are stable in water or apple puree for up to 4 hours.

Medicines should not be thrown away in drains or trash. Deposit the packaging and medicines you no longer need in the SIGRE Point of 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 Rivaroxaban Sandoz Pharmaceutical

Rivaroxaban Sandoz Pharmaceutical 15 mg hard capsules

• The active ingredient is rivaroxaban. Each capsule contains 15 mg of rivaroxaban.
• The other ingredients are:

Capsule contents: microcrystalline cellulose, lactose monohydrate, calcium citrate, povidone, sodium croscarmellose, sodium lauryl sulfate, anhydrous colloidal silica, magnesium stearate. See section 2 "Rivaroxaban Sandoz Pharmaceutical contains lactose and sodium".

Capsule body: yellow iron oxide (E172), titanium dioxide (E171), carrageenan, potassium chloride, water, hypromellose.

Rivaroxaban Sandoz Pharmaceutical 20 mg hard capsules

• The active ingredient is rivaroxaban. Each capsule contains 20 mg of rivaroxaban.
• The other ingredients are:

Capsule contents: microcrystalline cellulose, lactose monohydrate, calcium citrate, povidone, sodium croscarmellose, sodium lauryl sulfate, anhydrous colloidal silica, magnesium stearate. See section 2 "Rivaroxaban Sandoz Pharmaceutical contains lactose and sodium".

Capsule body: red iron oxide (E172), titanium dioxide (E171), carrageenan, potassium chloride, water, hypromellose.

Appearance of the Product and Package Contents

The Rivaroxaban Sandoz Pharmaceutical 15 mg capsules are hard size No. 3 (16 mm long x 6 mm wide) opaque yellow capsules containing white powder.

The capsules are available in PVC/PVDC-Alu blisters

Package sizes: 10, 14, 28, 42, or 98 capsules.

The Rivaroxaban Sandoz Pharmaceutical 20 mg capsules are hard size No. 3 (16 mm long x 6 mm wide) opaque red capsules containing white powder.

The capsules are available in PVC/PVDC-Alu blisters

Package sizes: 14, 28, or 98 capsules.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Salutas Pharma GmbH

Otto von Guericke Allee 1

39179 Barleben

Germany

or

Pharmadox Healthcare Limited

KW20A Kordin Industrial Park,

Paola PLA 3000

Malta

Date of the Last Revision of this Leaflet:February 2025

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