RIVAROXABAN 2.5 mg Film-coated tablets

Contents of the leaflet

1. Introduction
2. What is Rivaroxaban Dr. Reddys and what is it used for
3. What you need to know before you take Rivaroxaban Dr. Reddys
4. How to take Rivaroxaban Dr. Reddys
5. Possible Adverse Effects
6. Storage of Rivaroxaban Dr. Reddys
7. Package contents and additional information
8. Appearance of the product and package contents
9. Marketing authorization holder and manufacturer
11. Marketing authorization holder
12. This medicine is authorized in the Member States of the European Economic Area under the following names

Introduction

Package Leaflet: Information for the User

Rivaroxaban Dr. Reddys 2.5 mg Film-Coated Tablets EFG

rivaroxaban

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Rivaroxaban Dr. Reddys and what is it used for
2. What you need to know before you take Rivaroxaban Dr. Reddys
3. How to take Rivaroxaban Dr. Reddys
4. Possible side effects
5. Storing Rivaroxaban Dr. Reddys

1. Contents of the pack and other information

1. What is Rivaroxaban Dr. Reddys and what is it used for

You have been prescribed Rivaroxaban Dr. Reddys because

• you have been diagnosed with acute coronary syndrome (a group of disorders that include myocardial infarction and unstable angina, a type of severe chest pain) and your blood tests have shown high results in certain heart tests.
• Rivaroxaban Dr. Reddys reduces the risk of having another myocardial infarction in adults, or reduces the risk of death due to heart or blood vessel disease.
• You will be prescribed Rivaroxaban Dr. Reddys along with another medicine. Your doctor will also tell you to take:
• aspirin, or
• aspirin plus clopidogrel or ticlopidine

or

• you have been diagnosed with a high risk of blood clot formation due to coronary artery disease or peripheral artery disease that causes symptoms. Rivaroxaban Dr. Reddys reduces the risk of blood clot formation (atherothrombotic events) in adults.
• You will be prescribed Rivaroxaban along with another medicine. Your doctor will also tell you to take aspirin. In some cases, if you take Rivaroxaban Dr. Reddys after a procedure to open a narrowed or blocked artery in your leg to restore blood flow, your doctor may also prescribe clopidogrel for you to take in addition to aspirin for a short period of time.

Rivaroxaban Dr. Reddys contains the active substance rivaroxaban, which belongs to a group of medicines called antithrombotic medicines. 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 you take Rivaroxaban Dr. Reddys

Do not take Rivaroxaban Dr. Reddys

• if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6)
• if you have excessive bleeding

• 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 medicines to prevent blood clot formation (e.g. warfarin, dabigatran, apixaban or heparin), except when switching to another anticoagulant treatment or while receiving heparin through a venous or arterial catheter, so that it does not become blocked
• if you have acute coronary syndrome and have previously had a bleeding or blood clot in the brain (stroke)
• if you have coronary artery disease or peripheral artery disease and have previously had a bleeding in the brain (stroke) or an obstruction of the small arteries that carry blood to the deep tissues of the brain (lacunar stroke) or have had a blood clot in the brain (non-lacunar ischemic stroke) in the last month
• if you have a liver disease that may increase the risk of bleeding
• if you are pregnant or breastfeeding.

Do not take Rivaroxaban Dr. Reddys and inform your doctorif any of these circumstances apply to you.

Warnings and precautions

Consult your doctor or pharmacist before starting to take rivaroxaban.

Rivaroxaban Dr. Reddys should not be used in combination with other medicines that reduce blood clotting, other than aspirin or clopidogrel/ticlopidine, such as prasugrel or ticagrelor.

Be careful with Rivaroxaban Dr. Reddys

• 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 medicine that works in your body
• if you are taking other medicines 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 blocked (see section "Other medicines and Rivaroxaban Dr. Reddys")
• bleeding disorder
• very high blood pressure, not controlled by medical treatment
• stomach or intestinal diseases that may cause bleeding, such as stomach or intestinal inflammation, esophageal inflammation (e.g. due to gastroesophageal reflux disease), or tumors located in the stomach or intestines or genital 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 have previously had a bleeding in the lungs
• you are over 75 years old
• your weight is less than 60 kg
• you have coronary artery disease with severe symptomatic heart failure

• 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 clots), inform your doctor who will decide if it is necessary to change the treatment.

Tell your doctor if you have any of these situationsbefore taking Rivaroxaban Dr. Reddys. Your doctor will decide if you should be treated with this medicine and if you should be kept under closer observation.

If you need surgery

• It is very important to take Rivaroxaban Dr. Reddys before and after the operation, exactly at the times indicated by your doctor.
• If your operation requires the placement of a catheter or injection in 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.
• Tell your doctor immediately if you experience numbness or weakness in your legs or problems in your intestines or bladder at the end of anesthesia, as urgent attention is needed.

Children and adolescents

Rivaroxaban 2.5 mg is not recommended in children and adolescents under 18 years of age.There is not enough information on its use in children and adolescents.

Other medicines and Rivaroxaban Dr. Reddys

Tell your doctor or pharmacist if you are using, have recently used or might use 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), unless it is only applied to the skin
• tablets with ketoconazole (used to treat Cushing's syndrome, 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, prasugrel and ticagrelor (see section "Warnings and precautions"))
• anti-inflammatory and pain-relieving medicines (e.g. naproxen or aspirin)
• dronedarone, a medicine for the treatment of irregular heartbeat
• certain medicines 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 be increased. Your doctor will decide if you should be treated with this medicine 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.

• If you are taking

• any medicine for the treatment of epilepsy (phenytoin, carbamazepine, phenobarbital)
• St. John's Wort (Hypericum perforatum) a herbal medicine 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 rivaroxaban, tell 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"). Do not drive or ride a bicycle or use tools or machines if you are affected by these symptoms.

Rivaroxaban Dr. Reddys contains lactose and sodium

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

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. it is essentially "sodium-free".

3. How to take Rivaroxaban Dr. Reddys

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

What dose to take

The recommended dose is one 2.5 mg tablet twice a day. Take rivaroxaban approximately at the same time every day (e.g. 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 whole tablet, talk to your doctor about other ways to take rivaroxaban. The tablet can be crushed and mixed with water or apple sauce immediately before taking it.

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

You will not be given rivaroxaban alone. Your doctor will also tell you to take aspirin. If you are given rivaroxaban after an acute coronary syndrome, your doctor may tell you to take clopidogrel or ticlopidine as well.

If you receive rivaroxaban after a procedure to open a narrowed or blocked artery in your leg to restore blood flow, your doctor may also prescribe clopidogrel for you to take in addition to aspirin for a short period of time.

Your doctor will tell you the dose you should take (usually between 75 and 100 mg of aspirin per day or a daily dose of 75 to 100 mg of aspirin plus a daily dose of 75 mg of clopidogrel or a standard daily dose of ticlopidine).

When to start treatment with Rivaroxaban Dr. Reddys

Treatment with rivaroxaban after an acute coronary syndrome should be started as soon as possible after stabilization of the acute coronary syndrome, i.e. from 24 hours after hospital admission and at the time when parenteral anticoagulation therapy (by injection) would normally be discontinued.

Your doctor will tell you when to start treatment with Rivaroxaban Dr. Reddys if you have been diagnosed with coronary artery disease or peripheral artery disease.

Your doctor will decide how long you should continue treatment.

If you take more Rivaroxaban Dr. Reddys than you should

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 Dr. Reddys

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 Dr. Reddys

Do not stop taking rivaroxaban without talking to your doctor first, because rivaroxaban prevents the development of a serious condition.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine may cause adverse effects, although not all people suffer from them.

Like other similar medicines to reduce blood clot formation, rivaroxaban may 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.

Inform 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.

A serious medical emergency. Seek medical attention immediately!)

• prolonged or excessive bleeding
• exceptional 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 severe skin reaction:

• 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 this adverse effect is very rare (up to 1 in 10,000 people).

Signs of severe allergic reaction:

• swelling of the face, lips, mouth, tongue, or throat; difficulty swallowing; hives and difficulty breathing; sudden drop in blood pressure.

These serious adverse effects are very rare (anaphylactic reactions, including anaphylactic shock; may affect up to 1 in 10,000 patients) and uncommon (angioedema and allergic edema; may affect up to 1 in 100 patients).

General list of possible adverse effects

Frequent(may affect up to 1 in 10 patients)

• 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, gum bleeding
• bleeding in the eye (including bleeding in the white part of the eye)
• bleeding into a tissue or cavity of the body (hematoma, bruising)
• bloody cough
• 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 patients)

• bleeding in the brain or inside the skull
• bleeding in 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 patients)

• bleeding in 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 cardiac surgery in which a catheter is inserted into the leg artery (pseudoaneurysm).

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

• renal failure after severe bleeding
• 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, pharmacist, or nurse, even if it is a possible adverse effect that is not listed in this prospectus. 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 Dr. Reddys

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" or "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. 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 Dr. Reddys

• The active ingredient is rivaroxaban. Each tablet contains 2.5 mg of rivaroxaban.
• The other components are:

Core of the tablet: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, hypromellose, sodium lauryl sulfate, magnesium stearate. See section 2 "Rivaroxaban Dr. Reddys contains lactose and sodium"

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

Appearance of the product and package contents

The film-coated tablets of Rivaroxaban Dr. Reddys 2.5 mg are pale yellow, round, biconvex (approximately 6 mm in diameter) and have a "2.5" engraved on one side.

They are packaged in blisters, in boxes of 10, 14, 28, 30, 56, 98, 100, or 196 film-coated tablets

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Reddy Pharma Iberia, S.A.

Avda. Josep Tarradellas nº 38

08029 Barcelona (Spain)

Phone number: 93.355.49.16

Fax number: 93.355.49.61

Manufacturer

betapharm Arzneimittel GmbH

Kobelweg 95

86156 Augsburg

Germany

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

Date of the last revision of this prospectus:April 2023

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