Rivaroxaban Sandoz 15 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Rivaroxaban Sandoz 15 mg film-coated tablets EFG

Rivaroxaban Sandoz 20 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Rivaroxaban Sandoz contains the active substance rivaroxaban and is used in adults for:

• preventing the formation of blood clots in the brain (stroke) or in other blood vessels of the body if you have a type of irregular heartbeat called non-valvular atrial fibrillation.
• treating blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and for preventing these blood clots from recurring in the blood vessels of the legs and/or lungs.

Rivaroxaban Sandoz is used in children and adolescents under 18 years of age and with a body weight of 30 kg or more for:

• treating blood clots and preventing the recurrence of these blood clots in the veins or in the blood vessels of the lungs, following an initial treatment of at least 5 days with injectable medicines used to treat blood clots.

Rivaroxaban belongs to a group of medicines called antithrombotic medicines. It works by blocking a clotting factor (factor Xa), thereby reducing the tendency of the blood to clot.

2. What you need to know before starting to take Rivaroxaban Sandoz

Do not take Rivaroxaban Sandoz

• if you are allergic to rivaroxaban or to any of the other ingredients of this medicine (listed in section 6),
• if you are bleeding excessively,
• if you have a disease or condition affecting an organ in your body that increases the risk of severe bleeding (e.g., stomach ulcer, injury or bleeding in the brain, or recent surgery on the brain or eyes),
• if you are taking medications to prevent blood clots (e.g., warfarin, dabigatran, apixaban, or heparin), except when switching between anticoagulant treatments or while receiving heparin through a venous or arterial catheter to prevent it from becoming blocked,
• 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 doctor if any of these situations apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take rivaroxaban.

Take special care with Rivaroxaban Sandoz

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

• severe renal impairment in adults or moderate to severe renal impairment in children and adolescents, as kidney function may affect the amount of medicine active in your body,

• if you are taking other medicines to prevent blood clots (e.g., warfarin, dabigatran, apixaban, or heparin), when switching to another anticoagulant treatment or while receiving heparin through a venous or arterial catheter to prevent blockage (see section “Other medicines and Rivaroxaban Sandoz”),

• bleeding disorders,

• 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 oesophagus (e.g., due to gastroesophageal reflux disease [a condition where stomach acid rises up into the oesophagus]), or tumours located in the stomach, intestines, genital tract, or urinary tract,

• a problem in the blood vessels at the back of your eyes (retinopathy),

• a lung disease in which the bronchi are dilated and filled with pus (bronchiectasis), or if you have previously had bleeding in the lungs,

• if you have a heart valve prosthesis,

• if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor so they can decide whether treatment adjustment may be necessary,

• if your doctor determines that your blood pressure is unstable or if you are scheduled 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 conditions before taking rivaroxaban. Your doctor will decide whether you should be treated with this medicine and whether you need closer monitoring.

If you need surgery:

• It is very important to take rivaroxaban before and after surgery exactly at the times your doctor tells you.

• If your surgery requires placement of a catheter or injection into the spine (e.g., for epidural or spinal anaesthesia, or pain relief):

• It is very important to take rivaroxaban before and after the injection or removal of the catheter exactly at the times your doctor has instructed.

• Inform your doctor immediately if you experience numbness or weakness in your legs or problems with your bowel or bladder after the anaesthesia, as urgent medical attention is required.

Children and adolescents

Rivaroxaban is not recommended in children weighing less than 30 kg. There is insufficient information on its use in children and adolescents for the indications approved in adults.

Other medicines and Rivaroxaban Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those not requiring a prescription.

• If you are taking:

• any medicine for fungal infections (e.g., fluconazole, itraconazole, voriconazole, posaconazole), except when applied only to the skin,

• ketoconazole tablets (used to treat Cushing's syndrome, a condition 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 medicines and pain relievers (e.g., naproxen or acetylsalicylic acid),

• dronedarone, a medicine used to treat irregular heartbeat,

• certain medicines used to treat depression (selective serotonin reuptake inhibitors [SSRIs] or serotonin-norepinephrine reuptake inhibitors [SNRIs]).

If any of the above apply to you, inform your doctor before taking rivaroxaban, as the effect of this medicine may be increased. Your doctor will decide whether you should be treated with this medicine and whether you need closer monitoring.

If your doctor considers you at higher risk of developing a stomach or intestinal ulcer, they may recommend additional preventive treatment.

• If you are taking:

• any medicine for epilepsy (phenytoin, carbamazepine, phenobarbital),

• St John's wort (Hypericum perforatum), a herbal remedy used to treat depression,

• rifampicin, an antibiotic.

If any of the above apply to you, inform your doctor before taking rivaroxaban, as the effect of this medicine may be reduced. Your doctor will decide whether you should be treated with rivaroxaban and whether you need closer monitoring.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, do not take rivaroxaban. If there is any possibility you could become pregnant, use a reliable method of contraception while taking this medicine. If you become pregnant while taking rivaroxaban, inform your doctor immediately, who will decide on the appropriate treatment.

Driving and using machines

Rivaroxaban may cause dizziness (a common side effect) or fainting (an uncommon side effect) (see section 4, “Possible side effects”). You should not drive, ride a bicycle, or operate tools or machinery if you are affected by these symptoms.

Rivaroxaban Sandoz contains lactose.

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

Rivaroxaban Sandoz contains sodium.

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; hence, it is essentially “sodium-free”.

Rivaroxaban Sandoz contains azo dyes.

This medicine may cause allergic reactions because it contains Sunset Yellow FCF (E 110).

3. How to take Rivaroxaban Sandoz

Follow exactly the instructions given by your doctor for taking this medicine. 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 tablet whole, consult your doctor about other ways of taking rivaroxaban. The tablet may be crushed and mixed with water or apple puree immediately before taking. This mixture must be followed immediately by food.

If necessary, your doctor may also administer the crushed tablet via a gastric tube.

What dose to take

• Adults

• To prevent the formation of blood clots in the brain (stroke) or in other blood vessels in the body:

The recommended dose is one 20 mg rivaroxaban tablet once daily.

If you have kidney problems, the dose may be reduced to one 15 mg rivaroxaban tablet once daily.

If you need to undergo a procedure to treat blocked blood vessels in your heart (called percutaneous coronary intervention - PCI with stent placement), there is limited evidence supporting reducing the dose to one 15 mg rivaroxaban tablet once daily (or to one 10 mg rivaroxaban tablet once daily if your kidneys are not functioning 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 recurrence of blood clots:

The recommended dose is one 15 mg rivaroxaban tablet twice daily for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one 20 mg rivaroxaban tablet once daily.

After at least 6 months of treatment for blood clots, your doctor may decide to continue treatment with either one 10 mg tablet once daily or one 20 mg tablet once daily.

If you have kidney problems and are taking one 20 mg rivaroxaban tablet once daily, your doctor may decide, after 3 weeks, to reduce your treatment dose to one 15 mg rivaroxaban tablet once daily if your risk of bleeding is higher than the risk of developing 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 between 30 kg and less than 50 kg is one 15 mg rivaroxaban tablet once daily.
• The recommended dose for children and adolescents with a body weight of 50 kg or more is one 20 mg rivaroxaban tablet once daily.

Take each dose of rivaroxaban with a drink (e.g. water or juice) during a meal. Take the tablets every day at approximately the same time. Consider setting an alarm to remind you. For parents or caregivers: observe the child to ensure the full dose is taken.

Since the dose of rivaroxaban is based on body weight, it is important to attend scheduled visits with your doctor, as the dose may need to be adjusted as weight changes.

Never adjust the dose of rivaroxaban on your own. Your doctor will adjust the dose if necessary.

Do not split the tablet in an attempt to obtain a fraction of the tablet dose. If a lower dose is required, please use the alternative formulation of rivaroxaban granules for oral suspension.

For children and adolescents who cannot swallow the tablets whole, please use rivaroxaban granules for oral suspension.

If the oral suspension is not available, you may crush the rivaroxaban tablet and mix it with water or apple puree immediately before taking. Take some food after taking this mixture. If necessary, your doctor may also administer crushed rivaroxaban tablet via a tube inserted into the stomach.

If you spit out or vomit the dose

• If you spit out or vomit less than 30 minutes after taking rivaroxaban, take a new dose.
• If you spit out or vomit 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 repeatedly spit out or vomit the dose after taking rivaroxaban.

When to take Rivaroxaban Sandoz

Take the tablet(s) every day until your doctor tells you otherwise.

Try to take the tablets at the same time each day to help you remember.

Your doctor will decide how long you should continue treatment.

To prevent the formation of blood clots in the brain (stroke) and in other blood vessels of the body:

If it becomes necessary to restore normal heart rhythm using a procedure called cardioversion, take rivaroxaban at the times indicated by your doctor.

If you forget to take Rivaroxaban Sandoz

• Adults, children and adolescents
  • If you are taking one 20 mg or one 15 mg tablet once daily, and you miss a dose, take it as soon as you remember. Do not take more than one tablet in a single day to make up for a missed dose. Take the next tablet the following day, and then continue taking one tablet each day.
• Adults
  • If you are taking one 15 mg tablet twice daily, and you miss a dose, take it as soon as you remember. Do not take more than two 15 mg tablets in a single day. If you missed a dose, you may take two 15 mg tablets at once to achieve a total of two tablets (30 mg) in one day. The following day, resume taking one 15 mg tablet twice daily.

If you take more Rivaroxaban Sandoz than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

Call your doctor immediately if you have taken too many rivaroxaban tablets. Taking too much rivaroxaban increases the risk of bleeding.

If you stop taking Rivaroxaban Sandoz

Do not stop treatment with rivaroxaban without first talking to your doctor, because rivaroxaban treats and prevents a serious condition.

If you have any further questions about 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 everyone will experience them.

Like other similar medicines used to reduce blood clot formation, rivaroxaban can cause bleeding that may be life-threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). In some cases, bleeding may not be obvious.

Immediately inform your doctor if your child experiences any of the following symptoms:

• Signs of bleeding

• bleeding in the brain or within the skull (symptoms may include headache, one-sided weakness, vomiting, seizures, decreased level of consciousness, and neck stiffness. This is a serious medical emergency. Seek immediate medical attention!).

• prolonged or excessive bleeding,

• unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, difficulty breathing, chest pain or angina.

Your doctor will decide whether to maintain closer monitoring or change your treatment.

• Signs of severe skin reactions

• severe skin rashes that spread, blisters or mucosal lesions, e.g., in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis).

• drug reaction causing rash, fever, internal organ inflammation, blood abnormalities, and systemic illness (DRESS syndrome). The frequency of this adverse effect is very rare (affecting 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 these serious adverse 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 reported in adults, children and adolescents:

Common (may affect up to 1 in 10 people)

• decrease in red blood cells that may cause paleness, weakness or difficulty breathing,
• bleeding from the stomach or intestines, urogenital hemorrhage (including blood in urine and heavy menstrual bleeding), gastrointestinal hemorrhage, nosebleeds, bleeding from gums,
• bleeding in the eye (including bleeding in the white part of the eye),
• bleeding into tissue or body cavity (hematoma, bruising),
• coughing up blood,
• bleeding from or under the skin,
• bleeding after surgery,
• discharge of blood or fluid from a surgical wound,
• swelling of limbs,
• limb pain,
• impaired kidney function (may be detected in blood tests performed by the doctor),
• fever,
• stomach pain, indigestion, dizziness or lightheadedness, constipation, diarrhea,
• low blood pressure (symptoms may include dizziness or fainting upon standing),
• general decrease in strength and energy (weakness, fatigue), headache, dizziness,
• rash, skin itching,
• blood tests may show increased levels of certain liver enzymes.

Uncommon (may affect up to 1 in 100 people)

• bleeding in the brain or within the skull (see above, signs of bleeding),
• bleeding into a joint, causing pain and swelling,
• thrombocytopenia (low platelet count, the cells that help blood clot),
• allergic reaction, including skin allergic reaction,
• impaired liver function (may be detected in blood tests performed by the doctor),
• blood tests may show increased levels of bilirubin, certain pancreatic or liver enzymes, or increased platelet count,
• fainting,
• feeling unwell,
• increased heart rate,
• dry mouth,
• hives.

Rare (may affect up to 1 in 1,000 people)

• bleeding into a muscle,
• cholestasis (reduced bile flow), hepatitis, including hepatocellular liver injury (liver inflammation or damage),
• yellowing of the skin and eyes (jaundice),
• localized swelling,
• accumulation of blood (hematoma) in the groin as a complication after cardiac surgery involving catheter insertion 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 causing lung inflammation (eosinophilic pneumonia).

Frequency not known (frequency cannot be estimated from available data)

• kidney failure following severe bleeding,
• bleeding in the kidney, sometimes with blood in the urine, leading to impaired kidney function (anticoagulant-related nephropathy),
• increased pressure in the muscles of the legs or arms after bleeding, causing pain, swelling, sensory disturbances, numbness or paralysis (compartment syndrome following bleeding).

Adverse effects in children and adolescents

In general, adverse effects observed in children and adolescents treated with rivaroxaban were similar in type to those seen in adults, and their severity was mainly mild to moderate.

Adverse effects observed more frequently in children and adolescents:

Very common (may affect more than 1 in 10 people)

• headache,
• fever,
• nosebleeds,
• vomiting.

Common (may affect up to 1 in 10 people)

• increased heart rate,
• blood tests may show increased bilirubin (bile pigment),
• thrombocytopenia (low platelet count, the cells that help blood clot),
• heavy menstrual bleeding.

Uncommon (may affect up to 1 in 100 people)

• blood tests may show increased levels 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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rivaroxaban Sandoz

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

Do not use this medicine after the expiry date stated on the container, blister pack, or bottle after EXP/CAD. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rivaroxaban Sandoz

Rivaroxaban Sandoz 15 mg film-coated tablets

• The active substance is rivaroxaban. Each film-coated tablet contains 15 mg of rivaroxaban.
• The other components are:

Tablet core: lactose monohydrate, sodium lauryl sulfate, hypromellose, sodium croscarmellose, magnesium stearate, microcrystalline cellulose, colloidal anhydrous silica.

Tablet coating: hypromellose, titanium dioxide (E-171), macrogol, orange yellow S (E-110), iron oxide red (E-172).

Rivaroxaban Sandoz 20 mg film-coated tablets

• The active substance is rivaroxaban. Each film-coated tablet contains 20 mg of rivaroxaban.
• The other components are:

Tablet core: lactose monohydrate, sodium lauryl sulfate, hypromellose, sodium croscarmellose, magnesium stearate, microcrystalline cellulose, colloidal anhydrous silica.

Tablet coating: hypromellose, titanium dioxide (E-171), macrogol, orange yellow S (E-110), iron oxide red (E-172), iron oxide yellow (E-172), iron oxide black (E-172).

Appearance of the product and contents of the pack

Rivaroxaban Sandoz 15 mg are light orange, round, biconvex, film-coated tablets marked with “15” on one side.

Rivaroxaban Sandoz 20 mg are orange, round, biconvex, film-coated tablets marked with “20” on one side.

The tablets are available in blisters (OPA/Aluminium/PVC/Aluminium; Transparent or opaque PVC//PVDC/Aluminium) containing 5, 10, 14, 20, 28, 30, 42, 50, 98 and 100 film-coated tablets.

The tablets are available in perforated unit-dose blisters (OPA/Aluminium/PVC/Aluminium; Transparent or opaque PVC//PVDC/Aluminium) containing 5x1, 10x1, 14x1, 28x1, 30x1, 42x1, 56x1, 98x1 and 100x1 film-coated tablets.

The tablets are also available in HDPE bottles with child-resistant screw cap and desiccant, containing 56, 100, 105 and 112 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Salutas Pharma GmbH

Otto von Guericke Allee 1

39179 Barleben

Germany

or

Delorbis Pharmaceuticals Limited

17 Athinon Str, Ergates

Industrial Area,

Ergates, Lefkosia,

2643, Cyprus

or

Lek Pharmaceuticals d.d.

Verovškova ulica 57

SI –1526 Ljubljana

Slovenia

Date of the most recent revision of this leaflet: March 2024

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