Rivaroxaban Sandoz 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Rivaroxaban Sandoz 10 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, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if the side effects are 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 veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because you have a higher risk of developing blood clots after surgery.
• 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 reoccurring in the blood vessels of the legs and/or lungs.

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

2. What you need to know before taking 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 serious bleeding (e.g., stomach ulcer, injury or bleeding in the brain, or recent surgery on the brain or eyes),
• if you are taking medicines 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 blockage,
• if you have a liver disease that could increase your 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 rivaroxaban.

Take special care with Rivaroxaban Sandoz

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

• moderate or severe kidney impairment, 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 could cause bleeding, such as inflammation of the stomach or intestines, inflammation of the oesophagus (e.g., due to gastroesophageal reflux disease (a condition in which stomach acid flows back up into the oesophagus), or tumours in the stomach, intestines, genital or urinary tract,

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

• a lung disease with dilated bronchi 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, who will decide whether your treatment needs to be adjusted,

• if your doctor determines your blood pressure is unstable or you are scheduled to receive another treatment or undergo a procedure to remove a blood clot from your lungs.

Inform your doctor if any of these situations apply to you 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 instructs.

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

• It is very important to take rivaroxaban 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 for children and adolescents under 18 years of age. There is insufficient information on its use in children and adolescents.

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 obtained without a prescription.

• If you are taking

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

• ketoconazole tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol),

• any medicine for bacterial infections (e.g., clarithromycin, erythromycin),

• antiviral medicines 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 for 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 could 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 to be 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 could 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. Your doctor 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 informed 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 colouring agents. This medicine may cause allergic reactions as 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 in doubt, consult your doctor or pharmacist again.

What dose to take

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

The recommended dose is one tablet (10 mg) once daily.

• To treat blood clots in the veins of the legs and in the blood vessels of the lungs, and to prevent blood clots from recurring:

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

Swallow the tablet whole, preferably with water.

Rivaroxaban may be taken with or without food.

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 administration.

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

When to take Rivaroxaban Sandoz

Take the tablet every day as directed by your doctor.

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

Your doctor will decide how long you should continue treatment.

To prevent 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 Sandoz than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 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 forget to take Rivaroxaban Sandoz

If you forget to take a dose, take it as soon as you remember. Take the next tablet the following day and then continue taking one tablet daily as usual.

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

If you stop taking Rivaroxaban Sandoz

Do not stop treatment with rivaroxaban without first talking to your doctor, because rivaroxaban prevents the development of 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, this medicine may cause bleeding that could be life-threatening. Excessive bleeding can lead to a sudden drop in blood pressure (shock). In some cases, bleeding may not be obvious.

Tell your doctor immediately if you experience any of the following adverse effects:

• Signs of bleeding

• bleeding in the brain or within the skull (symptoms may include headache, weakness on one side of the body, 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 keep you under closer monitoring or change your treatment.

• Signs of serious 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 with eosinophilia and systemic symptoms (DRESS syndrome), which causes rash, fever, internal organ inflammation, blood abnormalities, and systemic illness. The frequency of these adverse effects is very rare (affecting up to 1 in 10,000 people).

• Signs of serious 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

Frequent (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), nosebleeds, bleeding from the gums,
• bleeding in the eye (including bleeding in the white part of the eye),
• bleeding into a tissue or body cavity (bruising, hematoma),
• coughing up blood,
• bleeding from or under the skin,
• bleeding after surgery,
• oozing of blood or fluid from a surgical wound,
• swelling of the limbs,
• limb pain,
• impaired kidney function (may be detected in blood tests performed by your doctor),
• fever,
• stomach pain, indigestion, dizziness or feeling dizzy, constipation, diarrhea,
• low blood pressure (symptoms may include dizziness or faintness 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 to clot),
• allergic reaction, including skin allergic reactions,
• impaired liver function (may be detected in blood tests performed by your doctor),
• blood tests may show increased bilirubin, increased 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 traumatic hepatocellular 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 insertion of a catheter 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)

• renal 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, altered sensation, numbness, or paralysis (compartment syndrome following 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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: 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 pack, blister, or bottle after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rivaroxaban Sandoz

• The active substance is rivaroxaban. Each film-coated tablet contains 10 mg of rivaroxaban.
• The other components are:

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

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

Appearance of the product and contents of the pack

The Rivaroxaban Sandoz 10 mg film-coated tablets are peach-coloured, round, biconvex, marked with “10” 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 also 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 caps and desiccant, containing 56, 100, 105, 112 and 200 film-coated tablets.

Only some 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 medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es