RIVAROXABAN SANDOZ FARMACEUTICA 10 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 components of this medication (listed in section 6),
• if you have excessive bleeding,
• if you have a disease or problem in an organ that increases the risk of severe bleeding (e.g., stomach ulcer, brain injury or bleeding, or recent brain or eye surgery),
• 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 receiving heparin through a venous or arterial catheter to prevent it from becoming blocked,
• if you have a liver disease that may increase the risk of bleeding,
• if you are pregnant or breastfeeding.

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

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:

• moderate or severe kidney failure, as kidney function may affect the amount of medication that works 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 to prevent it from becoming blocked (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, esophageal inflammation (e.g., due to gastroesophageal reflux disease), or tumors 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 lung hemorrhage,

• 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 to decide if treatment modification is necessary,
• 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 conditionsbefore 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 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,
• inform 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 necessary.

Children and adolescents

Rivaroxaban 10 mg capsules are not recommended for children and adolescents under 18 years of age.There is not enough information about their use in children and adolescents.

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 obtained without a prescription.

• If you are taking

• any medication for a fungal infection (e.g., fluconazole, itraconazole, voriconazole, posaconazole), unless it is only applied to the skin,
• ketoconazole tablets (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 or pain relievers (e.g., naproxen or acetylsalicylic acid),
• dronedarone, a medication for treating irregular heartbeat,
• certain medications for treating 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 treating epilepsy (phenytoin, carbamazepine, phenobarbital),
• St. John's Wort (Hypericum perforatum) a herbal remedy for treating 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 (a common side effect) or fainting (an 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 Rivaroxaban Sandoz Pharmaceutical

Follow the administration instructions for this medication exactly 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 10 mg rivaroxaban 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 occurring 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 through a gastric tube.

When to take Rivaroxaban Sandoz Pharmaceutical

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

Try to take the capsule 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 capsule 6 to 10 hours after the operation.

If you have undergone major hip surgery, you will usually take capsules for 5 weeks.

If you have undergone major knee surgery, you will usually take capsules for 2 weeks.

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 forget to take Rivaroxaban Sandoz Pharmaceutical

If you forget to take a dose, take it as soon as you remember. Take the next capsule the next 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 Rivaroxaban Sandoz Pharmaceutical

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 medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Like other similar medications to reduce blood clot formation, this medication can cause bleeding that can put the patient's life at risk. Excessive bleeding can cause a sudden drop in blood pressure (shock). In some cases, the bleeding may not be apparent.

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 may 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. Go to the doctor immediately!),
• prolonged or excessive bleeding,
• exceptional weakness, fatigue, pallor, 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

• 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; urticaria and difficulty breathing; sudden drop in blood pressure.

These 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 side effects

Common(may affect up to 1 in 10 people)

• decrease in red blood cells that can cause pallor and weakness or difficulty breathing,
• stomach or intestinal bleeding, urogenital bleeding (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding gums,
• bleeding in the eye (including bleeding in the white 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 clot),
• 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,
• accumulation of blood (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 white blood cell that causes inflammation in the lung (eosinophilic pneumonia).

Frequency not known(frequency 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 (compartment syndrome after bleeding).

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

This medicine does not require special storage conditions.

Open Capsules

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

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at 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

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

Capsule content: 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

Rivaroxaban Sandoz Pharmaceutical 10 mg capsules are hard capsules of size No. 4 (14 mm long x 5 mm wide) opaque red that contain white powder.

The capsules are available in PVC/PVDC-Alu blisters

Package Sizes: 10, 30, and 98 capsules.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Pharmaceutical, 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 Prospectus: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