RIVAROXABAN AUROVITAS 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Rivaroxaban Aurovitas 10 mg Film-Coated Tablets EFG

Read the entire package leaflet carefully before starting to use 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, ask 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, pharmacist, or nurse, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Rivaroxaban Aurovitas and what is it used for
2. What you need to know before taking Rivaroxaban Aurovitas
3. How to take Rivaroxaban Aurovitas
4. Possible side effects
5. Storage of Rivaroxaban Aurovitas
6. Contents of the pack and further information

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

Rivaroxaban Aurovitas contains the active substance rivaroxaban and is used in adults to

• Prevent the formation of blood clots in the veins after hip or knee replacement surgery. Your doctor has prescribed this medication because after surgery you have a higher risk of forming blood clots.
• 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 blood vessels of the legs and/or lungs.

Rivaroxaban belongs to a group of medications called antithrombotic agents. 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 Aurovitas

Do not take Rivaroxaban Aurovitas

• 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 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 being administered heparin through a venous or arterial catheter, so that it does not become clogged.
• 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 Aurovitas.

Be careful with Rivaroxaban Aurovitas

• 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, so that it does not become clogged (see section "Other medications and Rivaroxaban Aurovitas").
  • 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, 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 the 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 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 it may be necessary to modify 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 situationsbefore 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 surgery, exactly at the times indicated by your doctor.
• 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 rivaroxaban exactly at the times indicated by your doctor.
  • tell your doctor immediately if you experience numbness or weakness in the legs or problems in the intestine or bladder at the end of anesthesia, as urgent attention is necessary.

Children and adolescents

Rivaroxaban is not recommended for children under 18 years old. There is not enough information about its use in children and adolescents.

Other medications and Rivaroxaban Aurovitas

Tell 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 only applied to the skin.
  • Tablets with ketoconazole (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 doctor before taking rivaroxaban, as the effect of rivaroxaban 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 stomach or intestinal ulcers, they will recommend using a preventive treatment for ulcers in addition.

• If you are taking:
  • Any medication for the treatment of epilepsy (phenytoin, carbamazepine, phenobarbital).
  • St. John's Wort (Hypericum perforatum), a medicinal plant 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 decreased. Your doctor will decide if you should be treated with rivaroxaban and if you should be kept under closer observation.

Pregnancy, breastfeeding, and fertility

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 rivaroxaban. If you become pregnant while taking this medication, inform your doctor immediately, who will decide how you should be treated.

Driving and using machines

Rivaroxaban may cause dizziness (frequent 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.

Rivaroxaban Aurovitas contains lactose and sodium

This medication contains lactose. 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 film-coated tablet; this is essentially "sodium-free".

3. How to take Rivaroxaban Aurovitas

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, 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 tablet 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 happening again.

After at least 6 months of treatment for blood clots, the recommended dose is one 10 mg tablet once a day or one 20 mg tablet once a day. Your doctor has prescribed 10 mg of rivaroxaban once a day.

Swallow the tablet, preferably with water.

Rivaroxaban can be taken with or without food.

If you have difficulty swallowing the tablet whole, consult your doctor about other ways to take rivaroxaban.

The tablet can be crushed and mixed with water or apple sauce, immediately before taking it. If necessary, your doctor can also administer the crushed rivaroxaban tablet through a gastric tube.

When to take Rivaroxaban Aurovitas

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

Try to take a tablet at the same time every day, to help you remember.

Your doctor will decide how long you should continue treatment.

To prevent the formation of blood clots in the veins after hip or knee replacement surgery:

Take the first tablet 6 to 10 hours after surgery.

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

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

If you take more Rivaroxaban Aurovitas 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 medication and the amount ingested.

If you forget to take Rivaroxaban Aurovitas

If you forget to take a dose, take it as soon as you remember. Take the next tablet the next day and, after that, take one tablet every day, as usual.

Do not take a double dose to make up for forgotten doses.

If you stop taking Rivaroxaban Aurovitas

Do not stop treatment with rivaroxaban without first talking to your doctor, 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, rivaroxaban may cause bleeding, which can be life-threatening. Excessive bleeding can cause a sudden drop in blood pressure (shock). In some cases, the bleeding may not be evident.

Tell your doctor immediatelyif 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, paleness, dizziness, headache, unexplained swelling, difficulty breathing, chest pain, or angina.

Your doctor will decide to keep you under closer observation or modify 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; hives, and difficulty breathing; sudden drop in blood pressure.

The frequency of severe allergic reactions is 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:

Frequent(may affect up to 1 in 10 people):

• Decrease in red blood cells, which can cause paleness and weakness or difficulty breathing.
• Bleeding in the stomach or intestine, 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.
• 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, which causes 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 (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 granulocyte that causes inflammation in the lung (eosinophilic pneumonia).

Frequency not known(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 to function properly (anticoagulant-related nephropathy).
• Increased pressure in the muscles of the legs or arms after bleeding, which causes pain, swelling, altered sensation, numbness, or paralysis (hemorrhagic compartment syndrome).

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 package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Rivaroxaban Aurovitas

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

Do not use this medicine after the expiry date which is stated on the label, blister, packaging, or bottle after "EXP". The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Crushed tablets

Crushed tablets are 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 any unused medicines in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition ofRivaroxaban Aurovitas

• The active substance is rivaroxaban. Each tablet contains 10 mg of rivaroxaban.
• The other ingredients are:

Tablet core:microcrystalline cellulose (Grades 101 and 102), lactose monohydrate, sodium croscarmellose, hypromellose type 2910 (3cPs), sodium lauryl sulfate, magnesium stearate.

Tablet coating:polyvinyl alcohol, Macrogol 3350, talc, titanium dioxide (E171), red iron oxide (E172).

Appearance and package contents of the product

Reddish film-coated tablets, round (6.1 mm in diameter), biconvex, with "M" on one side and "10" on the other.

Rivaroxaban Aurovitas film-coated tablets are available in blister packs and HDPE bottles.

Package sizes:

Blister packs:5, 10, 14, 15, 28, 30, 42, 56, 60, 90, 98, 100, 168, 196, and 200 film-coated tablets.

HDPE bottles:30, 100, 250, and 500 film-coated tablets.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

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

Date of last revision of this leaflet:December 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/).