RIVAROXABAN STADA 15 mg + 20 mg FILM-COATED TABLETS

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Rivaroxaban Stada and what is it used for
2. What you need to know before taking Rivaroxaban Stada
3. How to take Rivaroxaban Stada
4. Possible side effects
5. Storage of Rivaroxaban Stada
6. Package contents and additional information

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

This medication contains the active ingredient rivaroxaban and is used in adults to

• 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 recurring in the blood vessels of the legs and/or lungs.

Rivaroxaban belongs to a group of medications called antithrombotic medications. It works by blocking a clotting factor (factor Xa) and thus reducing the tendency of blood to form clots.

2. What you need to know before taking Rivaroxaban Stada

Do not take Rivaroxaban

• 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 obstructed
• 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 this medication.

Be particularly careful with this medication

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

• severe kidney failure, 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 obstructed (see section "Other medications and Rivaroxaban Stada")
• bleeding disorder
• uncontrolled high blood pressure
• 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 previously had 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 plans to receive another treatment or undergo a surgical procedure to remove a blood clot from your lungs.

Inform your doctor if you have any of these situationsbefore taking this medication. Your doctor will decide if you should be treated with this medication and if you should be kept under closer observation.

If you need to undergo surgery:

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

• It is very important to take this medication 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

The initial treatment pack of Rivaroxaban Stada is not recommended for children under 18 years of age,as it is specifically designed for initial treatment in adult patients and is not suitable for use in children and adolescents.

Other medications and Rivaroxaban Stada

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication, including medications purchased 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 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 this medication, 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 for ulcers in addition to this medication.

• If you are taking:

• any medication for the treatment of epilepsy(phenytoin, carbamazepine, phenobarbital)
• St. John's Wort (Hypericum perforatum), a herbal remedy 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 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 breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

If you are pregnant or breastfeeding, do not take this medication. If there is any possibility that you may become pregnant, use a reliable contraceptive while taking this medication. If you become pregnant while taking this medication, inform your doctor immediately, who will decide how you should be treated.

Driving and using machines

This medication may cause dizziness (common 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.

This medication contains lactose

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

This medication contains sodium

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

3. How to take Rivaroxaban Stada

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

You must take this medication with food.

Swallow the tablets, preferably with water.

If you have difficulty swallowing the tablet whole, consult your doctor about other ways to take this medication. The tablet can be crushed and mixed with water or apple sauce, 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

The recommended dose is one 15 mg tablet twice a day for the first 3 weeks. After the first 3 weeks, the recommended dose is one 20 mg tablet once a day.

This initial treatment pack of Rivaroxaban Stada 15 mg and 20 mg is only for the first 4 weeks of treatment. Once this pack is finished, treatment will continue with rivaroxaban 20 mg once a day, as indicated by your doctor.

If you have kidney problems, your doctor may decide to reduce the treatment dose after 3 weeks to one rivaroxaban 15 mg tablet once a day if the risk of bleeding is greater than the risk of having another blood clot.

When to take Rivaroxaban Stada

Take the tablets every day, until your doctor indicates otherwise.

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

Your doctor will decide how long you should continue treatment.

If you take more Rivaroxaban Stada than you should

Call your doctor immediately if you have taken too many tablets of this medication. 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 medication and the amount ingested.

If you forget to take Rivaroxaban Stada

• If you are taking one 15 mg tablet twicea 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 one 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 one day. The next day, you should continue taking one 15 mg tablet twice a day.
• If you are taking one 20 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 one day to make up for a forgotten dose. Take the next tablet the following day and, after that, continue taking one tablet every day.

If you interrupt treatment with Rivaroxaban Stada

Do not interrupt treatment with this medication without talking to your doctor first, as this medication treats and prevents serious diseases.

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 for reducing blood clot formation, this medicine 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 adverse 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 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 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

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)
• bloody cough
• 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 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 (decreased 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).

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 leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency: 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 that appears on the blister pack and on the outer packaging after CAD. The expiration date is the last day of the month indicated.

This medicine 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 disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at 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.

Rivaroxaban Stada 15 mg: each tablet contains 15 mg of rivaroxaban.

Rivaroxaban Stada 20 mg: each tablet contains 20 mg of rivaroxaban.

• The other ingredients 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 yellow 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.

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

Starter pack for the first 4 weeks: each package contains 49 tablets: 42 film-coated tablets of 15 mg and 7 film-coated tablets of 20 mg.

Only certain package sizes may be marketed.

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08028 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 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.