RIVAROXABAN STADA 15 mg HARD CAPSULES

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, recent bleeding or injury in the brain or spinal 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 receiving heparin through a venous or arterial catheter to prevent blockage
• if you have a liver disease that increases 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 Stada

• 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 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 receiving heparin through a venous or arterial catheter to prevent blockage (see section "Other medicines and Rivaroxaban Stada")
• bleeding disorders
• uncontrolled high blood pressure
• 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 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 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 so that he can decide if it is 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 doctorif you have any of these conditionsbefore 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 surgery

• it is very important to take rivaroxaban before and after surgery, exactly at the times indicated by your doctor
• if your operation requires the insertion 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
• 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

Rivaroxaban capsules are not recommended in children with a body weight of less than 30 kg.

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

Other medicines and Rivaroxaban Stada

Tell your doctor or pharmacist if you are using, have recently used or might use 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
• ketoconazole tablets (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 the above circumstances apply to you, tell your doctorbefore taking rivaroxaban, because 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, he may recommend that you also use a preventive treatment.

• 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 circumstances apply to you, tell your doctorbefore taking rivaroxaban, because 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 and breastfeeding

Do not take rivaroxaban if you are pregnant or breastfeeding. If there is a possibility that you may become pregnant, use a reliable contraceptive while taking rivaroxaban. 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 (common side effect) or fainting (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 Stada contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult him before taking this medicine.

Rivaroxaban Stada contains sodium

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

3. How to take Rivaroxaban Stada

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

You must take rivaroxaban with food.

Swallow the tablets, 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 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 10 mg of rivaroxaban 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 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 of between 30 kg and less than 50 kgis one rivaroxaban 15 mg capsule once a day.
• The recommended dose for children and adolescents with a body weight of 50 kg or moreis one rivaroxaban 20 mg capsule 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 that 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.

If a lower dose is required, or children or adolescents cannot swallow the capsule whole, there are other rivaroxaban medicines available on the market, e.g. granules for oral suspension.

If the oral suspension is not available, you can mix the contents of the rivaroxaban capsule 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 rivaroxaban, take a new dose.
• more than 30 minutes after taking rivaroxaban, do not take a new dose. In this case, take the next dose of rivaroxaban at the usual time.

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

When to take Rivaroxaban Stada

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

Try to take the capsule(s) 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 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 forget to take Rivaroxaban Stada

• Adults, children and adolescents:

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

• Adults:

If you are taking one 15 mg capsule twicea day, and you forget to take a dose, take it as soon as you remember. Do not take more 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 take more Rivaroxaban Stada than you should

Call your doctor immediately if 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 ingested.

If you stop taking Rivaroxaban Stada

Do not stop taking rivaroxaban without consulting your doctor first, because 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 for reducing blood clot formation, rivaroxaban 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 evident.

Inform 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 stiffness of the neck. This is a serious medical emergency. Seek medical attention 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

• intensive 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

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
• 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 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)
• 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 white blood cell granulocytes 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)
• increase in 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 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 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 Medicines Monitoring System for Human Use: 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 Stada

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the packaging and on the blister pack after "EXP". The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

The dissolved content of the capsule is stable in water or apple puree for up to 4 hours.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

Marketing authorization holder and manufacturer

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

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

Date of last revision of this leaflet:November 2023

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/.