RIVAROXABAN SANDOZ 15 mg FILM-COATED TABLETS

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

Do not take Rivaroxaban Sandoz Pharmaceutical:

• 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 keep it from getting blocked,
• if you have a liver disease that increases the risk of bleeding,
• if you are pregnant or breast-feeding.

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

Warnings and precautions

Talk to your doctor or pharmacist before taking rivaroxaban.

Be careful with Rivaroxaban Sandoz Pharmaceutical

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

• severe kidney problems in adults and moderate or severe kidney problems in children and adolescents, as kidney function may 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 from one anticoagulant treatment to another or when being treated with heparin through a venous or arterial catheter to keep it from getting blocked (see section "Other medicines and Rivaroxaban Sandoz Pharmaceutical"),
• bleeding disorders,
• very high blood pressure that is not controlled by medical treatment,
• stomach or intestinal diseases that may cause bleeding, such as inflammatory bowel disease or stomach inflammation, esophageal inflammation (e.g. due to gastroesophageal reflux disease), or tumors in the stomach, intestines, genital or urinary tract
• a problem in the blood vessels of the back of your eyes (retinopathy),
• a lung disease where the bronchi are dilated and filled with pus (bronchiectasis) or previous lung bleeding,

• 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 the 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.

Tell your doctor if any of these situations apply to youbefore taking rivaroxaban. 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 your doctor tells you.
• If your operation requires the insertion of a catheter or injection into your spine (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 your doctor has told you.
• Tell your doctor immediately if you experience numbness or weakness in your legs or problems with your bowel or bladder after anesthesia, as urgent attention is needed.

Children and adolescents

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

Other medicines and Rivaroxaban Sandoz Pharmaceutical

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), except if only applied to the skin,
• tablets with ketoconazole (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 and painkillers (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 applies to you, tell your doctorbefore taking rivaroxaban, 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 thinks you are at higher risk of developing a stomach or intestinal ulcer, they may recommend that you also take a medicine to prevent ulcers.

• If you are taking:

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

If any of the above applies to you, tell your doctorbefore taking rivaroxaban, as the effect of rivaroxaban 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 breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

Driving and using machines

Rivaroxabanmay 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.

Rivaroxaban Sandoz Pharmaceutical contains lactose and sodium.

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 film-coated tablet; this is essentially "sodium-free".

3. How to take Rivaroxaban Sandoz Pharmaceutical

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

You should take rivaroxaban with food. Swallow the tablets with water.

If you have difficulty swallowing the tablet whole, ask your doctor about other ways to take rivaroxaban. The tablet can be crushed and mixed with water or apple puree, immediately before taking it. Then take food.

If necessary, your doctor may also administer the crushed tablet 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 20 mg rivaroxaban tablet once a day.

If you have kidney problems, the dose may be reduced to one 15 mg rivaroxaban tablet 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 15 mg rivaroxaban tablet once a day (or to one 10 mg rivaroxaban tablet once a day if your kidneys do not work 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 15 mg rivaroxaban tablet twice a day for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one 20 mg rivaroxaban tablet once a day.

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

If you have kidney problems and are taking one 20 mg rivaroxaban tablet once a day, your doctor may decide to reduce the dose of the treatment, after 3 weeks, to one 15 mg rivaroxaban tablet 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 your doctor.

• The recommended dose for children and adolescents with a body weight of 30 kg to less than 50 kgis a 15 mg rivaroxaban tabletonce a day.
• The recommended dose for children and adolescents with a body weight of 50 kg or moreis a 20 mg rivaroxaban tabletonce a day.

Take each dose of rivaroxaban with a drink (e.g. water or juice) during a meal.

Take the tablets every day at about the same time. Consider setting an alarm to remind you.

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

Since the dose of rivaroxaban is based on body weight, it is important to attend scheduled visits with your 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 split the tablet to try to get a fraction of the tablet dose. If a smaller dose is required, please use the alternative rivaroxaban granule presentation for oral suspension available under different brand names. In children and adolescents who cannot swallow whole tablets, please use the granules for oral suspension available under different brand names.

If the oral suspension is not available, you can crush the rivaroxaban tablet and mix it with water or apple puree immediately before taking it. Take some food after taking this mixture. If necessary, your doctor may also administer the crushed rivaroxaban tablet through a gastric tube.

If you spit out the dose or vomit

• Less than 30 minutes after taking rivaroxaban, take a new tablet.
• 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 out or vomit the dose repeatedly after taking rivaroxaban.

When to take Rivaroxaban Sandoz Pharmaceutical

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

Try to take the tablets at the same time each day, to remember when you should take them.

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

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

If you need to have your heartbeat normalized through a procedure called cardioversion, take rivaroxaban at the times your doctor has told you.

If you forget to take Rivaroxaban Sandoz Pharmaceutical

• Adults, children and adolescents:

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

• Adults:

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

If you take more Rivaroxaban Sandoz Pharmaceutical than you should

Call your doctor immediately if you have taken too many rivaroxaban tablets. 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 stop taking Rivaroxaban Sandoz Pharmaceutical

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

If you have any further questions on 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. It is a serious medical emergency. Seek medical help immediately!),
• prolonged or excessive bleeding,
• exceptional weakness, fatigue, pallor, 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 pallor 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 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 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 (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 cardiac 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 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 clot),
• 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 Farmaceutica

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.

Medicines should not be disposed of 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 Rivaroxaban Sandoz Farmaceutica

Rivaroxaban Sandoz Farmaceutica 15 mg film-coated tablets

• The active ingredient is rivaroxaban. Each tablet contains 15 mg of rivaroxaban.

Rivaroxaban Sandoz Farmaceutica 20 mg film-coated tablets

• The active ingredient is rivaroxaban. Each tablet contains 20 mg of rivaroxaban.

The other components are:

Tablet core: sodium lauryl sulfate, lactose, poloxamer, microcrystalline cellulose (E 460), sodium croscarmellose, magnesium stearate (E 470b), anhydrous colloidal silica (E 551). See section 2 "Rivaroxaban Sandoz Farmaceutica contains lactose and sodium".

Tablet coating: hypromellose (E 464), titanium dioxide (E 171), macrogol (E 1521), red iron oxide (E 172).

Appearance of the product and package contents

Rivaroxaban Sandoz Farmaceutica 15 mg film-coated tablets

Rivaroxaban Sandoz Farmaceutica 15 mg are red, round, biconvex tablets with a diameter of 5.6 mm, marked with "15" on one side and smooth on the other side.

Rivaroxaban Sandoz Farmaceutica 20 mg film-coated tablets

Rivaroxaban Sandoz Farmaceutica 20 mg tablets are brown-red, round, biconvex, with a diameter of 6.6 mm, marked with "20" on one side and smooth on the other side.

The tablets are available in:

• blister packs in cardboard boxes of 5, 10, 14, 20, 28, 30, 42, 50, 60, 98, and 100 film-coated tablets or
• unit-dose blisters in cardboard boxes of 5x1, 10x1, 14x1, 28x1, 30x1, 42x1, 56x1, 98x1, and 100x1 film-coated tablets or,
• bottles of 56, 100, and 112 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Farmaceutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Rontis Hellas Medical and

Pharmaceutical S.A

Products Area of Larissa,

P.O. Box 3012

GR-41004 Larissa

Greece

or

Lek Pharmaceuticals d.d.

Verovškova, 57

SLO-1526 Ljubljana

Slovenia

or

PharOS MT Ltd.

HF62X, Hal Far Industrial Estate,

Birzebbugia BBG3000,

Malta

This medicine is authorized in the Member States of the European Economic Area under the following names:

Netherlands Rivaroxaban Sandoz 15 mg, film-coated tablets

Rivaroxaban Sandoz 20 mg, film-coated tablets

Germany Rivaroxaban Hexal 15 mg film-coated tablets

Rivaroxaban Hexal 20 mg film-coated tablets

Austria Rivaroxaban Sandoz GmbH 15 mg - film-coated tablets

Rivaroxaban Sandoz GmbH 20 mg - film-coated tablets

Belgium Rivaroxaban Sandoz GmbH 15 mg film-coated tablets

Rivaroxaban Sandoz GmbH 20 mg film-coated tablets

Denmark Rivaroxaban Hexal

France RIVAROXABAN GNR 15 mg, film-coated tablet

RIVAROXABAN GNR 20 mg, film-coated tablet

Spain Rivaroxaban Sandoz Farmaceutica 15 mg film-coated tablets EFG

Rivaroxaban Sandoz Farmaceutica 20 mg film-coated tablets EFG

Finland Rivaroxaban Hexal 15 mg tablets, film-coated

Rivaroxaban Hexal 20 mg tablets, film-coated

Hungary Rivaroxaban 1 A Pharma 15 mg film-coated tablet

Rivaroxaban 1 A Pharma 20 mg film-coated tablet

Iceland Rivaroxaban Hexal 15 mg film-coated tablets

Rivaroxaban Hexal 20 mg film-coated tablets

Norway Rivaroxaban Hexal

Sweden Rivaroxaban Hexal 15 mg film-coated tablets

Rivaroxaban Hexal 20 mg film-coated tablets

Date of last revision of this leaflet:January 2024

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