Rivaroxaban Reddi

Package Leaflet: Information for the User

Rivaroxaban Reddy, 10 mg, Film-Coated Tablets

rivaroxaban
Read the package leaflet carefully before taking the medicine, as 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the Package Leaflet:

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

Rivaroxaban Reddy contains the active substance rivaroxaban and is used in adults to

• prevent the formation of blood clots in the veins, after hip or knee replacement surgery. Your doctor has prescribed this medicine because the risk of forming blood clots is increased after surgery.
• treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism) and prevent the formation of new blood clots in the veins of the legs and/or lungs.

Rivaroxaban Reddy belongs to a group of medicines called anticoagulants. Its action is based on blocking the blood clotting factor (factor Xa) and thus reducing 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 that increases the risk of serious bleeding (e.g. stomach ulcer, injury or bleeding in 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 switching anticoagulant therapy or when heparin is given to maintain the patency of a venous or arterial catheter,
• if you have liver disease that increases the risk of bleeding,
• if you are pregnant or breastfeeding. Do not take Rivaroxaban Reddy and inform your doctorif you think you may be pregnant or are planning to become pregnant.

Warnings and precautions

Before starting treatment with rivaroxaban, discuss it with your doctor or pharmacist.

When to be extra careful when taking Rivaroxaban Reddy

• if you have an increased risk of bleeding, such as:
• moderate or severe kidney disease, as kidney function may affect the amount of medicine that works in your body,
• if you are taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), when switching anticoagulant therapy or when heparin is given to maintain the patency of a venous or arterial catheter (see section "Rivaroxaban Reddy and other medicines"),
• bleeding disorders,
• very high blood pressure that does not decrease despite treatment,
• stomach or intestinal diseases that may cause bleeding, such as inflammation of the stomach and intestines or esophageal inflammation (e.g. due to gastroesophageal reflux disease) or tumors in the stomach, intestines, genital or urinary tract,
• vascular disease in the back of the eye (retinopathy),
• pulmonary disease with dilated bronchi and pus (bronchiectasis) or previous bleeding from the lungs,
• 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 have abnormal blood pressure or are scheduled for surgery to remove a blood clot from the lungs.

If you think you may have any of the above conditions, inform

your doctorbefore taking rivaroxaban. Your doctor will decide whether to prescribe this medicine and whether you need to 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 you are scheduled to have a lumbar puncture or spinal catheter insertion (e.g. for epidural or spinal anesthesia or pain relief):
• you should carefully follow your doctor's instructions regarding the intake of rivaroxaban at a specific time,
• you should immediately inform your doctor if you experience symptoms such as numbness, weakness of the lower limbs, disturbances in bowel or bladder function, or bladder control problems after anesthesia, as immediate treatment may be necessary.

Children and adolescents

Rivaroxaban 10 mg is not recommended for people under 18 years of age. There is not enough data on its use in children and adolescents.

Rivaroxaban Reddy and other medicines

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

If you are taking:

• certain medicines used to treat fungal infections (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only locally on the skin,
• ketoconazole tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol),
• certain medicines used to treat bacterial infections (e.g. clarithromycin, erythromycin),
• certain antiviral medicines used to treat HIV or AIDS (e.g. ritonavir),
• other medicines used to reduce blood clotting (e.g. enoxaparin, clopidogrel or vitamin K antagonists, such as warfarin or acenocoumarol),
• anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid),
• dronedarone, a medicine used to treat heart rhythm disorders,
• certain medicines used to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs)).

If you think you may have any of the above conditions, inform

your doctorbefore taking rivaroxaban, as the effect of rivaroxaban may be increased. Your doctor will decide whether to prescribe this medicine and whether you need to be closely monitored.

If you are taking

• certain medicines used to treat epilepsy (e.g. phenytoin, carbamazepine, phenobarbital),
• St. John's Wort (Hypericum perforatum), a herbal medicine used to treat depression,
• rifampicin, an antibiotic.

If you think you may have any of the above conditions, inform

your doctorbefore taking rivaroxaban, as the effect of rivaroxaban may be decreased. Your doctor will decide whether to prescribe rivaroxaban and whether you need to 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 during treatment with rivaroxaban. If you become pregnant during treatment with this medicine, you should immediately inform your doctor, who will decide on further 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"). 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 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 it is essentially "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

• To prevent blood clots in the veins after hip or knee replacement surgery, the recommended dose is one 10 mg tablet once a day.
• To treat blood clots in the veins of the legs, blood clots in the lungs, and to prevent new blood clots from forming, after at least 6 months of treatment for blood clots, the recommended dose is one 10 mg tablet once a day or one 20 mg tablet once a day. Your doctor has prescribed one 10 mg tablet once a day.

Swallow the tablet with water. 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 soft food, such as apple sauce, just before taking it. If necessary, your doctor may give you a crushed rivaroxaban tablet through a nasogastric tube.

When to start taking Rivaroxaban Reddy

Take one tablet every day until your doctor decides to stop treatment. It is best to take the tablet at the same time every day, as it will be easier to remember. Your doctor will decide how long you should continue treatment. To prevent blood clots after hip or knee replacement surgery:

Take the first tablet 6 to 10 hours after surgery. In patients after major hip surgery, treatment usually lasts 5 weeks. In patients after major knee surgery, treatment usually lasts 2 weeks.

If you take more Rivaroxaban Reddy than you should

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

If you forget to take Rivaroxaban Reddy

If you forget to take a dose, take it as soon as you remember. Take the next tablet the next day and then take one tablet once a day as usual. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Rivaroxaban Reddy

Do not stop taking rivaroxaban without first talking to your doctor, as rivaroxaban prevents serious illness. 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). Not all of these will be obvious or visible signs of bleeding. Tell your doctor immediatelyif you experience any of the following side effects:

Signs of bleeding

• bleeding into the brain or inside the skull (symptoms may include headache, one-sided weakness, vomiting, seizures, decreased level of consciousness, and stiffness of the neck. This is a serious medical emergency. You should immediately seek medical help!),

• prolonged or excessive bleeding,
• unusual weakness, fatigue, pallor, dizziness, headache, swelling of unknown cause, 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, acute skin rash, blistering, or changes to the mucous membranes, such as 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; 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 pallor and be the cause of weakness or shortness of breath,
• bleeding from the stomach or intestines, bleeding from the urinary or genital tract (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding gums,
• bleeding into the eye (including bleeding from the conjunctiva),
• bleeding into tissues or body cavities (hematoma, bruising),
• presence of blood in sputum (hemoptysis) when coughing,
• bleeding from the skin or subcutaneous bleeding,
• bleeding after surgery,
• oozing of blood or fluid from the wound after surgery,
• swelling of the limbs,
• limb pain,
• kidney function disorders (can be observed 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,
• rash, itching of the skin,
• 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 inside the 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,
• 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,
• liver function disorders (can be observed in tests performed by your doctor).

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

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

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

• accumulation of eosinophils, a type of white granulocytic 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 therapy),
• 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, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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 that month. There are no special storage instructions for 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 10 mg of rivaroxaban.
• The other ingredients are: Tablet core: microcrystalline cellulose, lactose monohydrate, sodium carmellose, hypromellose, sodium lauryl sulfate, magnesium stearate. See section 2 "Rivaroxaban Reddy contains lactose and sodium".

Coating: macrogol, hypromellose, titanium dioxide (E 171), iron oxide red (E 172).

What Rivaroxaban Reddy looks like and contents of the pack

Pink, round, biconvex tablets (about 6 mm in diameter) marked with the number "10" on one side. Available in packs of 10 or 30 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 10 mg Filmtabletten, France: RIVAROXABAN REDDY PHARMA 10 mg, comprimé pelliculé, Italy: RIVAROXABAN DR. REDDY'S, Austria: Rivaroxaban Reddy 10 mg Filmtabletten, Netherlands: Rivaroxaban Reddy 10 mg filmomhulde tabletten, Spain: Rivaroxaban Dr. Reddys 10 mg comprimidos recubiertos con película EFG, Slovakia: Rivaroxaban Reddy 10 mg filmom obalené tablety, Czech Republic: Rivaroxaban Reddy, Poland: Rivaroxaban Reddy, Sweden: Rivaroxaban Reddy 10 mg filmdragerad tablett, United Kingdom (Northern Ireland): Rivaroxaban Dr. Reddy’s 10 mg Film-Coated Tablets

Date of last revision of the leaflet:10/2023