Rivaroxaban Ranbaxi

Package Leaflet: Information for the Patient

Rivaroxaban Ranbaxy, 15 mg, film-coated tablets

Rivaroxaban Ranbaxy, 20 mg, film-coated tablets

Rivaroxabanum

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

• 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, tell your doctor or pharmacist. See section 4.

Contents of the Package Leaflet

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

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

• prevent the formation of blood clots in the brain (stroke) and other blood vessels in the patient's body, if the patient has a type of irregular heartbeat called atrial fibrillation not caused by heart valve problems;
• 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 recurrence of blood clots in the blood vessels of the legs and/or lungs. Rivaroxaban Ranbaxy is used in children and adolescents under 18 years of age and weighing 30 kg or more to
• treat and prevent the recurrence of blood clots in the veins or lungs, after at least 5 days of initial treatment with injectable medicines used to treat blood clots.

Rivaroxaban Ranbaxy 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 Ranbaxy

When not to take Rivaroxaban Ranbaxy:

• if the patient is allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6),
• if the patient has excessive bleeding,
• if the patient has 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 surgical procedure on the brain or eyes),
• if the patient is 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 venous or arterial catheter,
• if the patient has liver disease that leads to an increased risk of bleeding,
• if the patient is 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.

Be careful when taking Rivaroxaban Ranbaxy:

• if the patient has an increased risk of bleeding, in conditions such as:
• severe kidney disease in adults and moderate or severe kidney disease in children and adolescents, as kidney function may affect the amount of medicine acting in the patient's 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 venous or arterial catheter (see "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, e.g. inflammation of the intestines and stomach or inflammation of the esophagus (throat and esophagus) e.g. due to reflux disease of the esophagus (backflow of stomach acid into the esophagus) or tumors located in the stomach or intestines or genital or urinary system,
• disease of the blood vessels in the back of the eyeballs (retinopathy),
• pulmonary disease, in which the bronchi are dilated and filled with pus (bronchiectasis) or previous bleeding from the lungs,
• in patients with artificial heart valves,
• if the patient has a disorder called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clot formation), the patient should inform the doctor, who will decide on possible changes to the treatment,
• if the patient has been diagnosed with abnormal blood pressure or a surgical procedure is planned to remove a blood clot from the lungs.

If the patient suspects that they have any of the above conditions, they should

inform their doctorbefore taking Rivaroxaban Ranbaxy. The doctor will decide whether to use this medicine and whether the patient should be closely monitored.

If the patient needs to undergo surgery:

• they should carefully follow the doctor's instructions regarding the intake of Rivaroxaban Ranbaxy at a strictly specified 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, at a time in accordance with the doctor's instructions;
• the patient should immediately inform the doctor if they experience numbness or weakness of the legs, bowel or bladder disorders after the end of anesthesia, as immediate treatment will be necessary.

Children and adolescents

Rivaroxaban Ranbaxy tablets are not recommended for children with a body weight below 30 kg. There is limited data on the use of the medicine in children and adolescents for indications in adults.

Rivaroxaban Ranbaxy 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 used to treat fungal infections (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only topically 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 the patient suspects that any of the above points apply to them, they should

inform their doctorbefore taking Rivaroxaban Ranbaxy, as the action of Rivaroxaban Ranbaxy may be enhanced. The doctor will decide whether to use this medicine and whether the patient should be closely monitored.
If the doctor believes that the patient is at increased risk of developing stomach or intestinal ulcers, they may use preventive treatment.

• 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 the patient suspects that any of the above points apply to them, they should

inform their doctorbefore taking Rivaroxaban Ranbaxy, as the action of Rivaroxaban Ranbaxy may be reduced. The doctor will decide whether to use Rivaroxaban Ranbaxy and whether the patient 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, 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 effect) or fainting (uncommon side effect) (see section 4 "Possible side effects"). Patients who experience these side effects should not drive, ride a bicycle, or operate tools or machines.

Rivaroxaban Ranbaxy 15 mg film-coated tablets contain lactose and sodium

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. the medicine is considered "sodium-free".

Rivaroxaban Ranbaxy 20 mg film-coated tablets contain lactose and sodium

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. 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.
Rivaroxaban Ranbaxy should be taken with food.
Swallow the tablet(s) whole, preferably with water.
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. After such a mixture, eat a meal immediately. If necessary, your doctor may also give you a crushed tablet through a gastric tube.

How many tablets to take

• Adults
• In the prevention of blood clot formation in the brain (stroke) and other blood vessels in the body: The recommended dose is one Rivaroxaban Ranbaxy 20 mg tablet once a day.

If the patient has kidney disease, the dose may be reduced to one Rivaroxaban Ranbaxy 15 mg tablet once a day.
If the patient requires a procedure to clear the blood vessels in the heart (called percutaneous coronary intervention - PCI with stent placement) then there is limited evidence to support a dose reduction to one Rivaroxaban Ranbaxy 15 mg tablet once a day (or one Rivaroxaban Ranbaxy 10 mg tablet once a day in case of kidney function impairment) in combination with an antiplatelet agent such as clopidogrel.

• In the treatment of blood clots in the veins of the legs, blood clots in the blood vessels of the lungs, and to prevent the recurrence of blood clots: The recommended dose is one Rivaroxaban Ranbaxy 15 mg tablet twice a day for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one Rivaroxaban Ranbaxy 20 mg tablet once a day. After at least 6 months of treatment for blood clots, your doctor may decide to continue treatment with one 10 mg tablet once a day or one 20 mg tablet once a day. If the patient has kidney disease and is taking one Rivaroxaban Ranbaxy 20 mg tablet once a day, the doctor may decide to reduce the dose after 3 weeks of treatment to one Rivaroxaban Ranbaxy 15 mg tablet once a day, if the risk of bleeding is greater than the risk of further blood clot formation.
• Children and adolescentsThe dose of Rivaroxaban Ranbaxy depends on body weight and will be calculated by your doctor. o The recommended dose for children and adolescents with a body weight from 30 kg to less than 50 kgis one Rivaroxaban Ranbaxy 15 mgtablet once a day. o The recommended dose for children and adolescents with a body weight of 50 kgor more is one Rivaroxaban Ranbaxy 20 mgtablet once a day.

Each Rivaroxaban Ranbaxy dose should be taken with food, with a drink (e.g. water or juice). Tablets should be taken daily at approximately the same time. It is a good idea to set an alarm to remind you. For parents or caregivers: you should check that the child has taken the entire dose.
The dose of Rivaroxaban Ranbaxy is dependent on body weight, so it is important to attend scheduled doctor's appointments, as it may be necessary to adjust the dose based on changes in body weight.
Never adjust the dose yourself.If necessary, your doctor will adjust the dose.
Do not divide the tablet to get a partial dose of the tablet. If a smaller dose is necessary, use other medicines in the form of granules for oral suspension.
For children and adolescents who are unable to swallow whole tablets, use other medicines in the form of granules for oral suspension.
If an oral suspension is not available, you can crush the Rivaroxaban Ranbaxy tablet and mix it with water or apple puree, just before taking. After such a mixture, eat a meal immediately. If necessary, your doctor may also give you a crushed tablet through a gastric tube.

If a dose is spat out or vomited

• less than 30 minutes after taking Rivaroxaban Ranbaxy, take a new dose.
• more than 30 minutes after taking Rivaroxaban Ranbaxy, do nottake a new dose. In this case, take the next dose of Rivaroxaban Ranbaxy at the usual time.

Contact your doctor if you spit out or vomit a dose or vomit after taking Rivaroxaban Ranbaxy.

When to take Rivaroxaban Ranbaxy

Take the tablet(s) every day until your doctor decides to stop treatment.
It is best to take the tablet(s) at the same time every day, as it will be easier to remember.
Your doctor will decide how long to continue treatment.
Preventing blood clot formation in the brain (stroke) and other blood vessels in the body:
If your heart rhythm needs to be restored to normal using a procedure called cardioversion, take Rivaroxaban Ranbaxy at the time specified by your doctor.

Missing a dose of Rivaroxaban Ranbaxy

• Adults, children, and adolescents: If you take one 20 mg or one 15 mg tablet once a day and miss a dose, take it as soon as possible. Do not take more than one tablet in one day to make up for the missed dose. Take the next tablet the next day, and then take one tablet once a day.
• Adults: If you take one 15 mg tablet twice a day and miss a dose, take it as soon as possible. Do not take more than two 15 mg tablets in one day. If you miss a dose, you can take two 15 mg tablets at the same time to get a total of two tablets (30 mg) taken in one day. The next day, continue taking one 15 mg tablet twice a day.

Taking more than the recommended dose of Rivaroxaban Ranbaxy

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

Stopping treatment with Rivaroxaban Ranbaxy

Do not stop taking Rivaroxaban Ranbaxy without first consulting your doctor, as Rivaroxaban Ranbaxy prevents a serious disease.
If you have any further questions on the use of 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 with a similar action to reduce blood clot formation, Rivaroxaban Ranbaxy may cause bleeding, which can be life-threatening. Excessive bleeding can lead to a sudden drop in blood pressure (shock). These will not always be obvious or visible signs of bleeding.
You must immediately inform your doctor if 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. 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 pectoris. 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, e.g. on the tongue or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• a drug reaction causing a rash, fever, inflammation of internal organs, hematological 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 in adults, children, and adolescents:

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 intestine, bleeding from the urinary or reproductive system (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 when coughing (hemoptysis),
• 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),
• 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 inside the skull (see above signs of bleeding),
• bleeding into a joint, causing pain and swelling,
• thrombocytopenia (low platelet count, cells involved in blood clotting),
• allergic reactions, including allergic skin reactions,
• liver function disorders (can be observed in tests performed by your doctor),
• blood test results may show increased bilirubin levels, increased 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 muscles,
• cholestasis (bile stasis), hepatitis, including liver cell damage,
• jaundice (yellowing of the skin and eyes),
• local swelling,
• hematoma (blood accumulation) in the groin as a complication of heart 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 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 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).

Side effects in children and adolescents

Generally, the side effects observed in children and adolescents treated with rivaroxaban were similar in type to those observed in adults and were mostly mild to moderate.
Side effects observed more frequently in children and adolescents:
Very common(may affect more than 1 in 10 people)

• headache,
• fever,
• nosebleeds, vomiting.

Common(may affect up to 1 in 10 people)

• rapid heartbeat,
• blood test results may show increased bilirubin levels, thrombocytopenia (low platelet count),
• excessive menstrual bleeding.

Uncommon(may affect up to 1 in 100 people)

• blood test results may show increased levels of a bilirubin subtype (direct bilirubin).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell 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
Phone: +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 inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
There are no special precautions for storing the medicine.
Crushed tablets
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 no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Rivaroxaban Ranbaxy contains

• The active substance of Rivaroxaban Ranbaxy is rivaroxaban. Each film-coated tablet contains 15 mg or 20 mg of rivaroxaban.
• Other ingredients are: Tablet core: microcrystalline cellulose (E460), hypromellose 2910 (E464), lactose monohydrate, low-substituted hydroxypropylcellulose (E463), sodium lauryl sulfate (E487), magnesium stearate (E572). Tablet coating: Rivaroxaban Ranbaxy 15 mg: hypromellose 2910 (E464), lactose monohydrate, macrogol 4000 (E1521), titanium dioxide (E171), iron oxide red (E172), carmines (E120). See also section 2 "Rivaroxaban Ranbaxy 15 mg film-coated tablets contain lactose and sodium". Rivaroxaban Ranbaxy 20 mg: hypromellose 2910 (E464), lactose monohydrate, macrogol 4000 (E1521), titanium dioxide (E171), iron oxide red (E172). See also section 2 "Rivaroxaban Ranbaxy 20 mg film-coated tablets contain lactose and sodium”.

What Rivaroxaban Ranbaxy looks like and contents of the pack

Rivaroxaban Ranbaxy, 15 mg are red, round, film-coated tablets with a diameter of 6 mm, with a
square engraved with the number "15" on the other side.
Rivaroxaban Ranbaxy, 20 mg are dark red, round, film-coated tablets with a diameter of 6 mm, with a
"20" engraved on the other side.
Rivaroxaban Ranbaxy, 15 mg film-coated tablets are available in transparent PVC/PVDC/Aluminum blisters, packaged in cardboard boxes, containing 14, 28, 42, and 100 film-coated tablets.
Rivaroxaban Ranbaxy, 20 mg film-coated tablets are available in transparent PVC/PVDC/Aluminum blisters, packaged in cardboard boxes, containing 14, 28, and 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
Phone: 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:05.02.2024