RIVAROXABAN SANDOZ FARMACEUTICA 15 mg + 20 mg FILM-COATED TABLETS

2. What you need to know before taking Rivaroxaban Sandoz Pharmaceutical

Do not take Rivaroxaban Sandoz Pharmaceutical:

• 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 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 another 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 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 Sandoz Pharmaceutical

• 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 the 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 Sandoz Pharmaceutical"),
• bleeding disorder,
• 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 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 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 if you are scheduled to receive another treatment or undergo surgery to remove a blood clot from your lungs.

Inform 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 before and after the injection or catheter removal, exactly at the times indicated by your doctor.
• Inform 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 starting treatment pack is not recommended for children under 18 years of ageas it is specifically designed for starting treatment in adult patients and is not suitable for use in children.

Other medications and Rivaroxaban Sandoz Pharmaceutical

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication, including those purchased without a prescription.

• If you are taking:

• any medication for a fungal infection (e.g., fluconazole, itraconazole, voriconazole, posaconazole), except if 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 and 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 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 a stomach or intestinal ulcer, they may recommend that you also use a preventive treatment for the ulcer.

• 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 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 rivaroxaban. If there is any possibility that you may become pregnant, use a reliable contraceptive while taking this medication. If you become pregnant while taking rivaroxaban, inform your doctor immediately, who will decide how you should be treated.

Driving and using machines

Rivaroxabanmay cause dizziness (frequent side effect) or fainting (uncommon side effect) (see section 4, "Possible side effects"). You should not drive or ride a bicycle or use tools or machines if you are affected by these symptoms.

Rivaroxaban Sandoz Pharmaceutical contains lactose and sodium

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 Sandoz Pharmaceutical

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 should take rivaroxaban with food.

Swallow the tablets preferably with water.

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 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 rivaroxaban tablet twice a day for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one 20 mg rivaroxaban tablet once a day.

This starting treatment pack of rivaroxaban 15 mg and 20 mg is only for the first 4 weeks of treatment. After completing this pack, treatment will continue with rivaroxaban 20 mg once a day as indicated by your doctor.

If you have kidney problems and take one 20 mg rivaroxaban tablet once a day, your doctor may decide to reduce the dose of treatment, after 3 weeks, to one 15 mg rivaroxaban tablet once a day if the risk of bleeding is higher than the risk of having another blood clot.

When to take Rivaroxaban Sandoz Pharmaceutical

Take the tablet(s) 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.

If you take more Rivaroxaban Sandoz Pharmaceutical 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 Sandoz Pharmaceutical

• If you are taking one 15 mg tablet twice a day, 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 a day.

• If you are taking one 20 mg tablet or one 15 mg tablet once a day, 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 then continue taking one tablet every day.

If you stop taking Rivaroxaban Sandoz Pharmaceutical

Do not stop taking rivaroxaban without consulting your doctor first, as rivaroxaban treats and prevents serious conditions.

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 to reduce 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.

Tell your doctor immediatelyif 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 neck stiffness. It is a serious medical emergency. Seek medical help 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

• 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,
• bleeding in the stomach or intestine, urogenital hemorrhage (including blood in the urine and heavy menstrual bleeding), nasal bleeding, bleeding from the gums,
• 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 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 (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 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 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),
• 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).

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 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 medicine.

5. Storage of Rivaroxaban Sandoz Farmaceutica

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

Do not use this medicine after the expiration date that appears on the packaging and on each blister or vial after CAD/EXP. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Rivaroxaban Sandoz Farmaceutica

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

Core of the tablet: sodium lauryl sulfate, lactose, poloxamer, microcrystalline cellulose (E 460), sodium croscarmellose, magnesium stearate (E 470b), anhydrous colloidal silica (E 551). See section 2 "Rivaroxaban Sandoz Farmaceutica contains lactose and sodium".

Coating of the tablet: hypromellose (E 464), titanium dioxide (E 171), macrogol (E 1521), red iron oxide (E 172).

Appearance of the Product and Package Contents

Rivaroxaban Sandoz Farmaceutica 15 mg are red, round, biconvex tablets, with a diameter of 5.6 mm, marked with "15" on one side and smooth on the other.

Rivaroxaban Sandoz Farmaceutica 20 mg are brown-red, round, biconvex tablets, with a diameter of 6.6 mm, marked with "20" on one side and smooth on the other side.

Initial treatment package for the first 4 weeks: each package contains 49 film-coated tablets for the first 4 weeks of treatment:

42 tablets of 15 mg of rivaroxaban and 7 tablets of 20 mg of rivaroxaban in a wallet.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmaceutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Rontis Hellas Medical and

Pharmaceutical S.A

Products Area of Larissa,

P.O. Box 3012

GR-41004 Larissa

Greece

or

Lek Pharmaceuticals d.d.

Verovškova, 57

SLO-1526 Ljubljana

Slovenia

or

PharOS MT Ltd.

HF62X, Hal Far Industrial Estate,

Birzebbugia BBG3000,

Malta

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

Netherlands Rivaroxaban Sandoz 15mg, 20 mg treatment initiation pack, filmomhulde tabletten

Germany Rivaroxaban HEXAL 15 mg und 20 mg Filmtabletten Starterpackung

Belgium Rivaroxaban Sandoz GmbH 15 mg +20 mg filmomhulde tabletten

Denmark Rivaroxaban Hexal

Spain Rivaroxabán Sandoz Farmacéutica 15 mg + 20 mg comprimidos recubiertos con película EFG

Finland Rivaroxaban Hexal 15 mg tabletit, kalvopäällysteiset

Rivaroxaban Hexal 20 mg tabletit, kalvopäällysteiset

Hungary Rivaroxaban 1 A Pharma 15 mg filmtabletta+Rivaroxaban 1 A Pharma 20 mg filmtabletta

Iceland Rivaroxaban Hexal 15 mg filmuhúðaðar töflur

Rivaroxaban Hexal 20 mg filmuhúðaðar töflur

Norway Rivaroxaban Hexal

Sweden Rivaroxaban Hexal 15 mg filmdragerade tabletter

Rivaroxaban Hexal 20 mg filmdragerade tabletter

Date of the Last Revision of this Leaflet:January 2024

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