RIVAROXABAN STADA 15 mg FILM-COATED TABLETS

1. What is Rivaroxaban Stada and what is it used for

This medicine contains the active substance rivaroxaban.

Rivaroxaban 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 veins or lungs.

This medicine 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 lungs after at least 5 days of initial treatment with injectable medicines used to treat blood clots.

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

2. What you need to know before you take Rivaroxaban Stada

Do not take Rivaroxaban Stada

• 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, 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 to another or when being treated with heparin through a venous or arterial catheter to prevent blockage
• 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 conditions apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before starting this medicine.

Be particularly careful with this medicine

• if you have an increased risk of bleeding, as may occur 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 to another anticoagulant or while receiving heparin through a venous or arterial catheter to prevent blockage (see section "Other medicines and Rivaroxaban Stada")
• bleeding disorders
• very high blood pressure, not controlled by medical treatment
• stomach or intestinal diseases that may 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 in the stomach, intestines, genital tract, or urinary tract
• a problem with the blood vessels in 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 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 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 this medicine before and after surgery, exactly at the times your doctor indicates.
• 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 this medicine before and after the injection or removal of the catheter, exactly at the times your doctor has indicated.
• 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 in children with a body weight below 30 kg.

There is not enough information about the use of this medicine in children and adolescents for the indications in adults.

Other medicines and Rivaroxaban Stada

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 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 and pain-relieving medicines (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 these conditions apply to you,tell your doctorbefore taking this medicine, as the effect of this medicine 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 treatment 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 these conditions apply to you,tell your doctorbefore taking this medicine, as the effect of this medicine 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

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

Do not take this medicine if you are pregnant or breastfeeding. If there is a possibility that you may become pregnant, use a reliable contraceptive while taking this medicine. If you become pregnant while taking this medicine, tell 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.

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 sodium

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

3. How to take Rivaroxaban Stada

Follow the instructions for administration of this medicine exactly as your doctor has told you. If you are unsure, ask your doctor or pharmacist.

You must take this medicine with food.

Swallow the tablets, preferably with water.

If you have difficulty swallowing the tablet whole, ask your doctor about other ways to take this medicine. The tablet can be crushed and mixed with water or apple sauce, immediately before taking it. The mixture should be taken immediately, accompanied by food.

If necessary, your doctor may also administer the crushed tablet of this medicine 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 daily.

If you have kidney problems, the dose may be reduced to one 15 mg rivaroxaban tablet once daily.

If you need to undergo a procedure to treat blocked blood vessels in your heart (called percutaneous coronary intervention - PCI with stent placement), there is limited evidence to reduce the dose to one 15 mg rivaroxaban tablet once daily (or to one 10 mg rivaroxaban tablet once daily in case your kidneys do not work properly) in addition to an antiplatelet medicine like 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 daily for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one 20 mg rivaroxaban tablet once daily.

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

If you have kidney problems and are taking one 20 mg rivaroxaban tablet once daily, your doctor may decide to reduce the treatment dose to one 15 mg rivaroxaban tablet once daily 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 your doctor.

• The recommended dose for children and adolescents with a body weight of 30 kg to less than 50 kgis one rivaroxaban 15 mgtablet once daily.
• The recommended dose for children and adolescents with a body weight of 50 kg or moreis one rivaroxaban 20 mgtablet once daily.

Take each dose of rivaroxaban with a drink (e.g. water or juice) during a meal. Take the tablets 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 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 divide the tablet to try to obtain a fraction of the tablet dose. If a smaller dose is required, please use the alternative rivaroxaban granule presentation for oral suspension.

In children and adolescents who cannot swallow whole tablets, please use rivaroxaban granules for oral suspension.

If the oral suspension is not available, you can crush the rivaroxaban tablet 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 crushed rivaroxaban tablet 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 nottake 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 Rivaroxaban Stada

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

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

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 this medicine at the times your doctor has indicated.

If you forget to take Rivaroxaban Stada

• Adults, children, and adolescents:

If you are taking one 20 mg or one 15 mg tablet oncedaily, and you miss a dose, take it as soon as you remember. Do not take more than one tablet in one day to make up for a missed dose. Take the next tablet the next day and, after that, take one tablet every day.

• Adults:

If you are taking one 15 mg tablet twicedaily, and you miss a dose, take it as soon as you remember. Do not take more than two 15 mg tablets in one day. If you miss a dose, you can take two 15 mg tablets at the same time, for a total of two tablets (30 mg) in one day.

The next day, you should continue taking one 15 mg tablet twice daily.

If you take more Rivaroxaban Stada than you should

Call your doctor immediately if you have taken too many tablets of this medicine. 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 ingested.

If you stop taking Rivaroxaban Stada

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

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

4. Possible side effects

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

Like other medicines that reduce blood clotting, this medicine can cause bleeding that 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 or your child 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 of the neck. 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

• severe skin rashes that spread, blisters, or lesions on the mucous membranes, e.g. in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis).
• a drug reaction that causes a 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).

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• 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 from 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
• Purulent discharge 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 in 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 in a muscle
• Cholestasis (decrease in bile flow), hepatitis, including traumatic hepatocellular injury (inflammation or liver damage)
• Yellowish discoloration 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)

• Kidney 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 sensitivity, 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 this medication 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 heart rate
• 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, pharmacist, or nurse, 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 medication.

5. Storage of Rivaroxaban Stada

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the blister pack and carton after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Crushed tablets

Crushed tablets are stable in water or apple sauce 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 pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Rivaroxaban Stada

• The active ingredient is rivaroxaban. Each tablet contains 15 mg or 20 mg of rivaroxaban.
• The other components are:

Tablet core:microcrystalline cellulose, lactose monohydrate, povidone, pregelatinized starch (from corn), crospovidone, sodium lauryl sulfate, and magnesium stearate.

Tablet coating:hypromellose E464, titanium dioxide E171, macrogol 4000 E1521, and red iron oxide E172.

Appearance of the product and package contents

The 15 mg film-coated tablets are red, round, biconvex, with a diameter of approximately 6 mm.

They are packaged in blisters and unit-dose blisters, in boxes of 10, 14, 15, 28, 30, 42, 45, 56, 98, and 100 film-coated tablets.

The 20 mg film-coated tablets are reddish-brown, round, biconvex, with a diameter of approximately 7 mm.

They are packaged in blisters and unit-dose blisters, in boxes of 10, 14, 15, 28, 30, 42, 56, 98, and 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2 - 18

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36

1190 Wien

Austria

or

Centrafarm Services B.V.

Van de Reijtstraat 31 E

4814NE Breda

Netherlands

or

Clonmel Healthcare Ltd.

Waterford Road

Clonmel, Co. Tipperary

Ireland

or

Laboratorios Liconsa, S.A.

Avda. Miralcampo, Nº 7,

Polígono Industrial Miralcampo

19200 Azuqueca de Henares - Guadalajara

Spain

This medication is authorizedin the Member States of the European Economic Area under the following names:

Date of last revision of this prospectus:November 2023

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