Rivaroxaban Ranbaxi

Package Leaflet: Information for the Patient

Rivaroxaban Ranbaxy, 2.5 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.

Table of Contents of the Package Leaflet

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

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

You have been given Rivaroxaban Ranbaxy 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 Ranbaxy reduces the risk of having another heart attack or reduces the risk of death due to heart or blood vessel disease in adults. Rivaroxaban Ranbaxy 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.
• you have been diagnosed with a high risk of blood clots due to coronary artery disease or peripheral arterial disease, which causes symptoms. Rivaroxaban Ranbaxy reduces the risk of blood clots (atherothrombotic events) in adults. Rivaroxaban Ranbaxy 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 Ranbaxy 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 Ranbaxy 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 Ranbaxy

When not to take Rivaroxaban Ranbaxy:

• 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 switching anticoagulant therapy or when heparin is given to maintain the patency of a venous or arterial catheter,
• if you have had an acute coronary syndrome and have had bleeding or a blood clot in the brain (stroke),
• if you have 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, non-sinus) 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 Ranbaxy, and also inform your doctorif you suspect that you have any of the above conditions.

Warnings and precautions

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

Special caution when taking Rivaroxaban Ranbaxy:

• if you have an increased risk of bleeding, such as:
• severe kidney disease, as kidney function may affect the amount of medicine that works in your body,
• taking other blood clotting inhibitors (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 Ranbaxy and other medicines"),
• bleeding disorders,
• very high blood pressure that does not decrease despite taking medicines,
• stomach or intestinal diseases that may cause bleeding, such as inflammation of the intestines and stomach or inflammation of the esophagus (throat and esophagus) e.g. due to reflux disease of the esophagus

(reflux of stomach acid into the esophagus) or tumors located in the stomach or intestines or genital or urinary tract,

• vascular disease of the back of the eye (retinopathy),
• pulmonary disease in which the airways are dilated 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 on possible changes to your treatment.

If you suspect that you have any of the above conditions, inform your

doctorbefore taking Rivaroxaban Ranbaxy. Your doctor will decide whether to use this medicine and whether you should be closely monitored.

If you need to have surgery:

• you must carefully follow your doctor's instructions regarding the intake of Rivaroxaban Ranbaxy at a strictly defined 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 Ranbaxy before and after the puncture or catheter removal, according to your doctor's instructions;
• due to the need for special caution, you should immediately inform your doctor if you experience numbness or weakness of the legs, bowel or bladder disorders after anesthesia.

Children and adolescents

Rivaroxaban Ranbaxy 2.5 mg film-coated tablets are not recommended for people under 18 years of age. There is not enough data on the use of the medicine in children and adolescents.

Rivaroxaban Ranbaxy and other medicines

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

• If you are taking certain antifungal medicines (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 antibacterial medicines (e.g. clarithromycin, erythromycin), certain antiviral medicines used to treat HIV infection or AIDS (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 painkillers (e.g. naproxen or aspirin), dronedarone, a medicine used to treat heart rhythm disorders,

certain medicines used to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and noradrenaline reuptake inhibitors (SNRIs)). If you suspect that any of the above points apply to you, inform your doctorbefore taking Rivaroxaban Ranbaxy, as the effect of Rivaroxaban Ranbaxy may be enhanced. Your doctor will decide whether to use this medicine and whether you should be closely monitored. If your doctor believes that you are at risk of developing stomach or intestinal ulcers, they may use a treatment to prevent ulcers. If you are taking certain medicines used to treat epilepsy (phenytoin, carbamazepine, phenobarbital), St. John's wort ( Hypericum perforatum), a herbal medicine used to treat depression, rifampicin, which belongs to a group of antibiotics. If you suspect that any of the above points apply to you, inform your doctorbefore taking Rivaroxaban Ranbaxy, as the effect of Rivaroxaban Ranbaxy may be reduced. Your doctor will decide whether to use Rivaroxaban Ranbaxy and whether you should be closely monitored.

Pregnancy and breastfeeding

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

Driving and using machines

Rivaroxaban Ranbaxy 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 Ranbaxy contains lactose and sodium

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

3. How to take Rivaroxaban Ranbaxy

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 Ranbaxy 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 whole tablets, talk to your doctor about other ways to take Rivaroxaban Ranbaxy. The tablet can be crushed and mixed with water or apple puree, just before taking it. If necessary, your doctor may give you a crushed Rivaroxaban Ranbaxy tablet through a nasogastric tube. Rivaroxaban Ranbaxy will not be given to you as the only medicine. Your doctor will also prescribe you to take aspirin. If you are taking Rivaroxaban Ranbaxy after an acute coronary syndrome, your doctor may also prescribe clopidogrel or ticlopidine. If you are taking Rivaroxaban Ranbaxy 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. Your doctor will inform 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 Ranbaxy

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

Taking a higher dose of Rivaroxaban Ranbaxy than recommended

If you have taken a higher dose of Rivaroxaban Ranbaxy than recommended, contact your doctor immediately. Taking too much Rivaroxaban Ranbaxy increases the risk of bleeding.

Missing a dose of Rivaroxaban Ranbaxy

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

Stopping treatment with Rivaroxaban Ranbaxy

Rivaroxaban Ranbaxy should be taken regularly and for the duration recommended by your doctor. Do not stop taking Rivaroxaban Ranbaxy without first consulting 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 taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rivaroxaban Ranbaxy can cause side effects, although not everybody gets them. Like other medicines that reduce blood clotting, Rivaroxaban Ranbaxy may cause bleeding, which can be life-threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). These may not always be obvious or visible signs of bleeding. Inform your doctor immediatelyif 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 medical emergency. Seek medical help immediately!),
• prolonged or excessive bleeding,
• unusual weakness, fatigue, pallor, 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).
• drug reaction causing rash, fever, inflammation of internal organs, hematological 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)

• reduction in red blood cell count, which may cause pallor and be the cause of weakness or shortness of breath,
• bleeding from the stomach or intestine, bleeding from the urinary or genital tract (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding from the gums,
• bleeding into the eye (including bleeding from the conjunctiva),
• bleeding into tissues or body cavities (hematoma, bruising),
• appearance of blood in sputum (hemoptysis) while 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,
• pain in the limbs,
• kidney 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 certain 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 disorders (can be observed in tests performed by your doctor),
• blood test results may show increased levels of bilirubin, activity of certain 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,
• jaundice (yellowing of the skin and eyes),
• local swelling,
• accumulation of blood (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,
• bleeding in the kidneys, 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 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 Adverse Reaction 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 Ranbaxy

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 and blister. The expiry date refers to the last day of that month. The packaging is marked with the expiry date and batch number after the abbreviations EXP and Lot/LOT, respectively. There are no special precautions for storing the medicine. Crushed tablets are stable in water or apple puree for up to 4 hours. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Rivaroxaban Ranbaxy contains

• The active substance is rivaroxaban. Each film-coated tablet contains 2.5 mg of rivaroxaban.
• The other ingredients are: Tablet core: microcrystalline cellulose (E460), hypromellose 2910 (E464), lactose monohydrate, hydroxypropylcellulose, low-substituted (E463), sodium lauryl sulfate (E487), magnesium stearate (E572) Tablet coating: hypromellose 2910 (E464), lactose monohydrate, macrogol 4000 (E1521), titanium dioxide (E171), yellow iron oxide (E172), black iron oxide (E172), See also section 2 "Rivaroxaban Ranbaxy contains lactose and sodium".

What Rivaroxaban Ranbaxy looks like and contents of the pack

Rivaroxaban Ranbaxy 2.5 mg film-coated tablets are light yellow, round, film-coated tablets with a diameter of 6 mm, with a square "
" embossed on one side and the number "2.5" embossed on the other side. The tablets are in transparent blisters made of PVC/PVDC/Aluminum, packed in cardboard boxes containing 28 or 100 film-coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Ranbaxy (Poland) Sp. z o.o., ul. Idzikowskiego 16, 00-710 Warsaw, Tel.: 22 642 07 75

Manufacturer/Importer

Sun Pharmaceutical Industries Europe B.V., Polarisavenue 87, 2132 JH Hoofddorp, Netherlands, Terapia S.A., Strada Fabricii Nr 124, 400632 Cluj-Napoca, Cluj, Romania

Date of last revision of the leaflet: