RIVAROXABAN ARISTO 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Rivaroxaban Aristo 10 mg film-coated tablets EFG

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, 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 or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

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

Rivaroxaban 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 Aristo

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 bleed excessively
• if you have a disease or problems 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 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 your case.

Warnings and precautions

Consult your doctor or pharmacist before starting to take rivaroxaban.

Be careful with Rivaroxaban

• 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 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 clogged (see section "Other medications and Rivaroxaban")
• 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 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 doctorif 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 Aristo 10 mg tablets are not recommended for children under 18 years of age.There is not enough information about its use in children and adolescents.

Other medications and Rivaroxaban

Tell your doctor or pharmacist if you are using, have recently used, or may need to use 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
• 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,tell your doctorbefore taking rivaroxaban, as the effect of rivaroxaban may increase. 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 to rivaroxaban.

• 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, 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 breastfeeding

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, tell 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"). You should not drive, ride a bicycle, or use tools or machines if you are affected by these symptoms.

Rivaroxaban contains lactose

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

Rivaroxaban contains sodium

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

3. How to take Rivaroxaban Aristo

Follow the instructions for administration of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

What doseto take

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

The recommended dose is one rivaroxaban 10 mg 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 rivaroxaban 10 mg once a day.

Swallow the tablet, preferably with water.

Rivaroxaban can be taken with or without food.

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

If necessary, your doctor can also administer the crushed rivaroxaban tablet through a gastric tube.

When to take Rivaroxaban

Take one tablet every day, until your doctor tells you to stop.

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

Your doctor will decide how long you should continue taking the 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 tablets for 5 weeks.

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

If you take more Rivaroxaban 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

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

Do not stop taking rivaroxaban without talking to your doctor first, 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, rivaroxaban can cause side effects, although not everyone gets them.

Like other similar medications to reduce blood clot formation, rivaroxaban can 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 apparent.

Tell your doctor immediately if 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, hematological abnormalities, and systemic disease (DRESS syndrome).

The frequency of this side effect is very rare (up to 1 in 10,000).

• 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 these side effects 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 side effects:

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

• decrease in red blood cells that can cause paleness and weakness or difficulty breathing
• stomach or intestinal bleeding, 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
• oozing of blood or fluid from a surgical wound
• swelling of the limbs
• limb pain
• 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 patients):

• 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 patients):

• bleeding into a muscle
• cholestasis (decreased bile flow), hepatitis, including traumatic hepatocellular injury (inflammation or liver damage)
• localized swelling
• yellowing of the skin and eyes (jaundice)
• 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 (anticoagulant-related nephropathy)
• increased pressure in the muscles of the legs or arms after bleeding, causing 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 Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Rivaroxaban Aristo

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 carton and on each blister after “EXP”. The expiry date refers to 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 sauce for up to 2 hours.

Medicines should not be disposed of via wastewater or household waste. Return all unused medicines to your pharmacist, or take them to a designated collection point (SIGRE point) in your pharmacy. Ask your pharmacist how to dispose of medicines no longer required. This will help to protect the environment.

6. Package contents and additional information

Composition of Rivaroxaban Aristo

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

Tablet core: microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, hypromellose 2910, sodium laurilsulfate, magnesium stearate. See section 2 “Rivaroxaban Aristo contains lactose and sodium”.

Tablet film coating: hypromellose 2910, titanium dioxide (E 171), macrogol 3350, red iron oxide (E 172).

Appearance and package contents

Rivaroxaban Aristo 10 mg film-coated tablets are pink, round, biconvex (6 mm in diameter) and engraved with “10” on one side, and smooth on the other.

They are available in transparent PVC/PVDC aluminium blisters in cardboard boxes.

Boxes of 5, 7, 10, 14, 28, 30, 42, 45, 56, 98 or 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

Manufacturer

S.C. Labormed-Pharma S.A.

Bd. Theodor Pallady nr. 44B, sector 3

Bucharest cod 032266

Romania

Or

Saneca Pharmaceuticals a.s.

Nitrianska 100

920 27 Hlohovec

Slovakia

For further information about this medicine, please contact the local representative of the marketing authorisation holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

This medicine is authorised in the Member States of the EEA and in the United Kingdom (Northern Ireland) under the following names:

Austria Rivaroxaban Aristo 10 mg Filmtabletten

Italy Rivaroxaban Aristo

Norway Rivaroxaban Aristo 10 mg film-coated tablets

Spain Rivaroxaban Aristo 10 mg film-coated tablets EFG

Sweden Rivaroxaban Aristo 10 mg film-coated tablets

Portugal Rivaroxaban Aristo

Denmark Rivaroxaban Aristo

Germany Rivaroxaban Aristo 10 mg Filmtabletten

United Kingdom Rivaroxaban

(Northern Ireland)

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/