Rivaroxaban Reddi

Leaflet accompanying the packaging: information for the user

Rivaroxaban Reddy, 2.5 mg, film-coated tablets

rivaroxaban
Read the contents of the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

You have been given Rivaroxaban Reddy because

• you have been diagnosed with acute coronary syndrome (a condition that includes heart attack and unstable angina, severe chest pain) and have elevated levels of cardiac biomarkers. Rivaroxaban Reddy reduces the risk of having another heart attack or reduces the risk of death due to heart or blood vessel disease in adults. Rivaroxaban Reddy will not be given to you as the only medicine. Your doctor will also prescribe you to take:
• aspirin or
• aspirin and clopidogrel or ticlopidine.

or

• you have been diagnosed with a high risk of blood clots due to coronary artery disease or peripheral arterial disease, which causes symptoms. Rivaroxaban Reddy reduces the risk of blood clots (atherothrombotic events) in adults. Rivaroxaban Reddy will not be given to you as the only medicine. Your doctor will also prescribe you to take aspirin. In some cases, if you are taking Rivaroxaban Reddy after a procedure to open up a narrowed or blocked artery in your leg to restore blood flow, your doctor may also prescribe clopidogrel for you to take for a short time in addition to aspirin.

Rivaroxaban Reddy contains the active substance rivaroxaban and belongs to a group of medicines called anticoagulants. Its action is to block the blood clotting factor (factor Xa) and thereby reduce the tendency to form blood clots.

2. Important information before taking Rivaroxaban Reddy

When not to take Rivaroxaban Reddy

• 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 condition of the body that leads to an increased risk of serious bleeding (e.g., stomach ulcer, injury or bleeding into the brain, recent brain or eye surgery),
• if you are taking other medicines that prevent blood clotting (e.g., warfarin, dabigatran, apixaban, or heparin), except when changing anticoagulant treatment or when heparin is given to maintain the patency of a vein or artery catheter,
• if you have been diagnosed with acute coronary syndrome and have had bleeding or blood clots in the brain (stroke),
• if you have been diagnosed with coronary artery disease or peripheral arterial disease and have had bleeding in the brain (stroke) or blockage of small arteries supplying blood to the brain tissues (cerebral venous sinus thrombosis) or if you have had a blood clot in the brain (ischemic stroke) in the last month),
• if you have liver disease that leads to an increased risk of bleeding,
• if you are pregnant or breastfeeding.

Do not take Rivaroxaban Reddy, and inform your doctorif you suspect that you have any of the above conditions.

Warnings and precautions

Before starting to take rivaroxaban, discuss it with your doctor or pharmacist. Rivaroxaban should not be taken with other blood clotting inhibitors, such as prasugrel or ticagrelor, except for aspirin, clopidogrel, or ticlopidine.

When to be extra careful when taking Rivaroxaban Reddy

• if you have an increased risk of bleeding, in conditions such as:
• severe kidney disease, as kidney function may affect the amount of medicine that works in your body,
• taking other medicines that prevent blood clotting (e.g., warfarin, dabigatran, apixaban, or heparin) when changing anticoagulant treatment or when heparin is given to maintain the patency of a vein or artery catheter (see section "Rivaroxaban Reddy and other medicines"),
• bleeding disorders,
• very high blood pressure that does not decrease despite taking medicines,
• stomach or intestinal diseases that may cause bleeding, e.g., inflammation of the intestines and stomach or inflammation of the esophagus (throat and esophagus) e.g., due to gastroesophageal reflux disease (stomach acid flowing back into the esophagus) or tumors located in the stomach or intestines or genital or urinary system,
• blood vessel disease in the back of the eye (retinopathy),
• lung disease in which the airways are enlarged and filled with pus (bronchiectasis) or previous bleeding from the lungs,
• if you are over 75 years old,
• if you weigh less than 60 kg,
• coronary artery disease with severe symptomatic heart failure,
• in patients with artificial heart valves,
• if you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), you should inform your doctor, who will decide whether to change your treatment.

If you suspect that you have any of the above conditions, you should tell your doctorbefore taking Rivaroxaban Reddy. Your doctor will decide whether to use this medicine and whether you should be closely monitored.

If you need to have surgery:

• you should carefully follow your doctor's instructions regarding the intake of rivaroxaban at a specific time before or after surgery,
• if catheterization or spinal puncture is planned during surgery (e.g., for epidural or spinal anesthesia or pain relief):
• it is very important to take rivaroxaban before and after the puncture or catheter removal, according to your doctor's instructions
• due to the need for extra caution, you should immediately inform your doctor if you experience numbness or weakness in your legs, bowel or bladder problems after anesthesia.

Children and adolescents

Rivaroxaban Reddy 2.5 mg is not recommended for people under 18 years old. There is not enough data on its use in children and adolescents.

Rivaroxaban Reddy and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription.

If you are taking:

• certain medicines for fungal infections (e.g., fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only locally on the skin,
• oral ketoconazole (used to treat Cushing's syndrome, in which the body produces too much cortisol),
• certain medicines for bacterial infections (e.g., clarithromycin, erythromycin),
• certain antiviral medicines for HIV or AIDS treatment (e.g., ritonavir),
• other medicines that 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 heart rhythm disorders,
• certain medicines for depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs)).

If you suspect that you have any of the above conditions, you should tell your doctorbefore taking Rivaroxaban Reddy, as the effect of the medicine may be increased. Your doctor will decide whether to use this medicine and whether you should be closely monitored.

Pregnancy and breastfeeding

Do not take rivaroxaban if you are pregnant or breastfeeding. If there is a risk that you may become pregnant, you should use effective contraception while taking rivaroxaban. If you become pregnant while taking this medicine, you should immediately inform your doctor, who will decide on further treatment.

Driving and using machines

Rivaroxaban Reddy may cause dizziness (common side effects) or fainting (uncommon side effects) (see section 4, "Possible side effects"). Patients who experience these side effects should not drive, ride a bike, or operate tools or machines.

Rivaroxaban Reddy contains lactose and sodium

If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine. The medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, which means that the medicine is considered "sodium-free".

3. How to take Rivaroxaban Reddy

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

How many tablets to take

The recommended dose is one 2.5 mg tablet twice a day. Rivaroxaban should be taken at approximately 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, you should talk to your doctor about other ways of taking rivaroxaban. The tablet can be crushed and mixed with water or soft food, such as apple sauce, immediately before taking it. If necessary, your doctor may give you a crushed rivaroxaban tablet through a gastric tube. Rivaroxaban Reddy will not be given to you as the only medicine. Your doctor will also prescribe you to take aspirin. If you are taking Rivaroxaban Reddy after acute coronary syndrome, your doctor may also prescribe clopidogrel or ticlopidine for you to take. If you are taking Rivaroxaban Reddy after a procedure to open up a narrowed or blocked artery in your leg to restore blood flow, your doctor may prescribe clopidogrel for you to take for a short time in addition to aspirin. Your doctor will tell you what dose of these medicines to take (usually 75-100 mg of aspirin per day or a daily dose of 75-100 mg of aspirin plus a daily dose of 75 mg of clopidogrel or a standard daily dose of ticlopidine).

When to start taking Rivaroxaban Reddy

Treatment with rivaroxaban after acute coronary syndrome should be started as soon as possible after stabilization of the acute coronary syndrome, at the latest 24 hours after hospital admission, and at the time when parenteral (by injection) anticoagulant treatment would normally be discontinued. Your doctor will tell you when to start treatment with Rivaroxaban Reddy if you have been diagnosed with coronary artery disease or peripheral arterial disease. Your doctor will decide how long to continue treatment.

Taking more than the recommended dose of Rivaroxaban Reddy

If you have taken more than the recommended number of rivaroxaban tablets, you should immediately contact your doctor. Taking too much rivaroxaban increases the risk of bleeding.

Missing a dose of Rivaroxaban Reddy

Do not take a double dose to make up for a missed dose. If you miss a dose, you should take the next dose at the scheduled time.

Stopping treatment with Rivaroxaban Reddy

Rivaroxaban should be taken regularly and for the time prescribed by your doctor. Do not stop taking rivaroxaban without first discussing it with your doctor. If you stop taking this medicine, you may increase the risk of having another heart attack, stroke, or death due to heart or blood vessel disease. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Like other medicines that reduce blood clotting, rivaroxaban can cause bleeding, which can be life-threatening. Excessive bleeding can lead to a sudden drop in blood pressure (shock). These may not always be obvious or visible signs of bleeding. You should immediately tell your doctorif you experience any of the following side effects:

Signs of bleeding

• bleeding into the brain or skull (symptoms may include headache, one-sided weakness, vomiting, seizures, decreased level of consciousness, and stiffness of the neck. A serious, sudden medical condition. You should immediately seek medical help!),
• prolonged or excessive bleeding,
• unusual weakness, tiredness, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain, or angina. Your doctor may decide to closely monitor you or change your treatment.

Signs of severe skin reactions

• widespread, severe skin rash, blistering, or changes to the mucous membranes, e.g., on the tongue or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• a drug reaction that causes a rash, fever, inflammation of internal organs, blood disorders, and systemic disorders (DRESS syndrome). The frequency of these side 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; hives, and difficulty breathing; a sudden drop in blood pressure.

The frequency of severe allergic reactions is very rare (anaphylactic reactions, including anaphylactic shock, may occur in up to 1 in 10,000 people) and uncommon (angioedema and allergic edema may occur in 1 in 100 people).

General list of possible side effects

Common(may affect up to 1 in 10 people)

• reduced red blood cell count, which may cause pale skin and be the reason for weakness or shortness of breath,
• bleeding from the stomach or intestines, bleeding from the urinary or genital system (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding gums,
• bleeding into the eye (including bleeding from the white of the eye),
• bleeding into tissues or body cavities (hematoma, bruising),
• appearance of blood in sputum (hemoptysis) while coughing,
• bleeding from the skin or bleeding under the skin,
• bleeding after surgery,
• oozing of blood or fluid from the wound after surgery,
• swelling of the limbs,
• limb pain,
• kidney problems (which can be seen in tests performed by your doctor),
• fever,
• stomach pain, nausea (nausea) or vomiting, constipation, diarrhea,
• low blood pressure (symptoms may include dizziness or fainting when standing up),
• general weakness and lack of energy (weakness, fatigue), headache, dizziness,
• skin rash, itching,
• increased activity of some liver enzymes, which can be seen in blood test results.

Uncommon(may affect up to 1 in 100 people)

• bleeding into the brain or skull (see above signs of bleeding),
• bleeding into the joint, causing pain and swelling,
• thrombocytopenia (low platelet count, cells involved in blood clotting),
• allergic reactions, including allergic skin reactions,
• liver problems (which can be seen in tests performed by your doctor),
• blood test results may show increased bilirubin levels, activity of some pancreatic or liver enzymes, or platelet count,
• fainting,
• malaise,
• rapid heartbeat,
• dry mouth,
• hives.

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

• bleeding into the muscles,
• cholestasis (bile stasis), hepatitis, including liver cell damage,
• yellowing of the skin and eyes (jaundice),
• local swelling,
• blood accumulation (hematoma) in the groin as a complication of heart catheterization, when a catheter is inserted into an artery in the leg.

Very rare(may affect up to 1 in 10,000 people)

• accumulation of eosinophils, a type of white granular blood cells, which can cause inflammation in the lungs (eosinophilic pneumonia).

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

• kidney failure after severe bleeding,
• kidney bleeding, sometimes with blood in the urine, leading to kidney failure (nephropathy associated with anticoagulant drugs),
• increased pressure in the muscles of the legs and arms, occurring after bleeding, which can lead to pain, swelling, changes in sensation, numbness, or paralysis (compartment syndrome after bleeding).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rivaroxaban Reddy

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date, which is stated on the carton after EXP. and on each blister after EXP. The expiry date refers to the last day of the month stated. There are no special precautions for storing this medicine. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Rivaroxaban Reddy contains

• The active substance is rivaroxaban. One film-coated tablet contains 2.5 mg of rivaroxaban.
• The other ingredients are: Tablet core: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, hypromellose, sodium lauryl sulfate, magnesium stearate. See section 2 "Rivaroxaban Reddy contains lactose and sodium". Tablet coating: macrogol, hypromellose, titanium dioxide (E 171), yellow iron oxide (E 172).

What Rivaroxaban Reddy looks like and contents of the pack

Light yellow, round, biconvex tablets (about 6 mm in diameter) marked with "2.5" on one side. Available in packs of 28, 56, or 196 film-coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Reddy Holding GmbH, Kobelweg 95, 86156 Augsburg, Germany, Tel.: +49 821 74881 0

Manufacturer

Betapharm Arzneimittel GmbH, Kobelweg 95, 86156 Augsburg, Germany

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Denmark: Rivaroxaban Reddy, Germany: Rivaroxaban beta 2.5 mg Filmtabletten, France: RIVAROXABAN REDDY PHARMA 2.5 mg, comprimé pelliculé, Italy: RIVAROXABAN DR. REDDY'S, Austria: Rivaroxaban Reddy 2.5 mg Filmtabletten, Netherlands: Rivaroxaban Reddy 2.5 mg filmomhulde tabletten, Spain: Rivaroxaban Dr. Reddys 2.5 mg comprimidos recubiertos con película EFG, Slovakia: Rivaroxaban Reddy 2.5 mg filmom obalené tablety, Czech Republic: Rivaroxaban Reddy, Poland: Rivaroxaban Reddy, Sweden: Rivaroxaban Reddy 2.5 mg filmdragerad tablett, United Kingdom (Northern Ireland): Rivaroxaban Dr. Reddy’s 2.5 mg Film-Coated Tablets

Date of last revision of the leaflet:10/2023