Rivaroxaban Sandoz 2.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Rivaroxaban Sandoz 2.5 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 adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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 is Rivaroxaban Sandoz and what is it used for

You have been prescribed rivaroxaban because:

• you have been diagnosed with acute coronary syndrome (a group of disorders that includes myocardial infarction and unstable angina, a type of severe chest pain), and your blood tests have shown elevated levels in certain cardiac markers.

Rivaroxaban reduces the risk of another myocardial infarction in adults, or reduces the risk of death due to heart or vascular disease.

You will be prescribed rivaroxaban together with another medicine. Your doctor will also instruct you to take:

• acetylsalicylic acid, or
• acetylsalicylic acid plus clopidogrel or ticlopidine

or

• you have been diagnosed with a high risk of blood clot formation due to coronary artery disease or peripheral arterial disease causing symptoms.

Rivaroxaban Sandoz reduces the risk of blood clots (atherothrombotic events) in adults. You will be prescribed rivaroxaban together with another medicine. Your doctor will also instruct you to take acetylsalicylic acid.

In some cases, if you are given rivaroxaban after a procedure to open a narrowed or blocked artery in the leg to restore blood flow, your doctor may also prescribe clopidogrel for you to take in addition to acetylsalicylic acid for a short period of time.

Rivaroxaban Sandoz contains the active substance rivaroxaban and 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 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 organ condition that increases the risk of serious bleeding (for example, 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 acute coronary syndrome and have previously had a bleed or a blood clot in the brain (stroke),
• if you have coronary artery disease or peripheral artery disease and have previously had a brain bleed (stroke) or a blockage in the small arteries supplying blood to deep brain tissues (lacunar stroke), or if you had a blood clot in the brain (non-lacunar ischaemic stroke) within the past month,
• 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 taking rivaroxaban.

Rivaroxaban should not be taken with other medicines that reduce blood clotting, other than acetylsalicylic acid, such as prasugrel, ticagrelor, clopidogrel, or ticlopidine.

Take special care with Rivaroxaban Sandoz

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

• severe renal 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 may cause bleeding, such as inflammation of the stomach or intestine, oesophagitis (inflammation of the oesophagus), for example due to gastroesophageal reflux disease (a condition in which stomach acid rises up into the oesophagus), or tumours in the stomach, intestine, 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 lung bleeding,

• if you are over 75 years old,

• if your weight is less than 60 kg,

• if you have coronary artery disease with severe symptomatic heart failure.

• 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 your treatment needs to be adjusted.

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 as your doctor instructs.

• If your surgery requires 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 catheter removal exactly as your doctor has instructed.

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

Children and adolescents

Rivaroxaban Sandoz is not recommended for people 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 fungal infections (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 excess 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, prasugrel and ticagrelor (see section “Warnings and precautions”)),

• 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 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 at higher risk of developing a stomach or intestinal ulcer, they may recommend you also use 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 rivaroxaban could be reduced. Your doctor will decide whether you should be treated with rivaroxaban and whether you need closer monitoring.

Pregnancy and breastfeeding

Do not take rivaroxaban if you are pregnant or breastfeeding. If there is any possibility you could become pregnant, use a reliable method of contraception while taking rivaroxaban. If you become pregnant while taking rivaroxaban, inform your doctor immediately, who will decide how you should be treated.

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 azo dyes. This medicine may cause allergic reactions because it contains sunset yellow FCF (E 110) and tartrazine.

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

3. How to take Rivaroxaban Sandoz

Follow exactly your doctor's instructions on how to take this medicine. If you are unsure, consult your doctor or pharmacist again.

What dose to take

The recommended dose is one 2.5 mg tablet twice daily. Take rivaroxaban at the same time each day (for example, one tablet in the morning and one in the evening).

This medicine can 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 taking.

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

You will be prescribed rivaroxaban together with another medicine.

Your doctor will instruct you to take acetylsalicylic acid. If you are receiving rivaroxaban after an acute coronary syndrome, your doctor may also instruct you to take clopidogrel or ticlopidine.

If you are given rivaroxaban after a procedure to open a narrowed or blocked artery in the leg to restore blood flow, your doctor may prescribe clopidogrel for you to take in addition to acetylsalicylic acid for a short period of time.

Your doctor will advise you on the dose to take (usually between 75 and 100 mg of acetylsalicylic acid per day, or a daily dose of 75 to 100 mg of acetylsalicylic acid plus a daily dose of 75 mg of clopidogrel, or a standard daily dose of ticlopidine).

When to start treatment with Rivaroxaban Sandoz

Treatment with rivaroxaban after an acute coronary syndrome should be started as soon as possible once the acute coronary syndrome has stabilized, that is, at least 24 hours after hospital admission and at the time when parenteral (injection) anticoagulant treatment would be discontinued. Your doctor will advise you when to start treatment with rivaroxaban if you have been diagnosed with coronary artery disease or peripheral arterial disease.

Your doctor will decide how long you should continue treatment.

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

Do not take a double dose to make up for missed doses. If you forget to take a dose, take the next tablet at your usual time.

If you stop taking Rivaroxaban Sandoz

Take rivaroxaban regularly for as long as your doctor tells you to.

Do not stop treatment with rivaroxaban without first talking to your doctor. If you stop taking this medicine, your risk of having another heart attack, stroke, or dying from a heart or blood vessel-related disease may increase.

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 medicines used to reduce blood clot formation, rivaroxaban can cause bleeding that may 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 symptoms:

• 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 observation 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, causing rash, fever, internal organ inflammation, blood abnormalities, and systemic illness (DRESS syndrome).

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

• Signs of severe allergic reactions

• swelling of the face, lips, mouth, tongue, or throat; difficulty swallowing; hives; 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 gums
• bleeding in the eye (including bleeding in the white part of the eye)
• bleeding into a 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 the limbs
• limb pain
• impaired kidney function (may be seen in 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 an increase in 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 seen in tests performed by your doctor)
• blood tests may show an increase in bilirubin, certain pancreatic or liver enzymes, or 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 injury (liver inflammation or damage)
• yellowing of the skin and eyes (jaundice)
• localized swelling
• accumulation of blood (hematoma) in the groin as a complication following cardiac surgery where 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 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 the kidneys' inability to function properly (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 adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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. Rivaroxaban Sandoz Storage

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the container, blister pack, or bottle after CAD/EXP. 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 Point at your pharmacy. If you are unsure, 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

• The active substance is rivaroxaban. Each film-coated tablet contains 2.5 mg of rivaroxaban.
• The other components are:
• Tablet core: lactose monohydrate, sodium lauryl sulfate (E-487), hypromellose (type 2910 substitution) (E-464), sodium croscarmellose (E-468), magnesium stearate (E 470b), microcrystalline cellulose (E-460), anhydrous colloidal silica (E-551).

Tablet coating: hypromellose (type 2910 substitution) (E-464), macrogol 3350 (E-1521), titanium dioxide (E-171), tartrazine (E-102), indigo carmine (E-132), orange yellow S (E-110).

Appearance of the product and contents of the pack

Yellow, round, biconvex, film-coated tablets marked with “2.5” on one side, with a diameter of 6 mm.

Transparent or opaque PVC/PVDC-Aluminum blisters.

Pack sizes: 5, 10, 14, 20, 28, 30, 42, 56, 60, 98, 100, 168 and 196 film-coated tablets.

Single-dose perforated blisters of transparent or opaque PVC/PVDC-Aluminum.

Pack sizes: 5x1, 10x1, 14x1, 20x1, 28x1, 30x1, 42x1, 56x1, 98x1, 100x1 film-coated tablets.

HDPE bottles with child-resistant PP screw cap containing desiccant (silica gel).

Pack sizes: 100, 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 about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/