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, as you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the 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

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 form of irregular heart rhythm called atrial fibrillation not caused by a heart valve problem;
• treat blood clots in the veins of the legs (deep vein thrombosis) and blood vessels in 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 with a body weight of 30 kg or more to
• treat and prevent the recurrence of blood clots in the veins or blood vessels in the 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 thereby 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 an organ 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 administered to maintain the patency of a vein or artery 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 particularly careful when taking Rivaroxaban Ranbaxy:

• if the patient has an increased risk of bleeding, in such conditions 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 administered to maintain the patency of a vein or artery 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,
• vascular disease of the back of the eye (retinopathy),
• pulmonary disease in which the bronchi are dilated and filled with pus (bronchiectasis) or previous bleeding from the lungs,
• in patients with prosthetic valves,
• if the patient has a disorder called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), the patient should inform their doctor, who will decide on possible changes to the treatment,
• if the patient has been diagnosed with abnormal blood pressure or is scheduled for surgery or other treatment 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 administer this medicine and whether the patient should be subject to particularly close monitoring.

If the patient needs to undergo surgery:

• they should strictly follow the doctor's recommendations regarding the intake of Rivaroxaban Ranbaxy at a precisely 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 recommendations;
• the patient should immediately inform their doctor if they experience numbness or weakness of the legs, bowel or bladder disorders after the anesthesia is completed, as immediate treatment may be necessary.

Children and adolescents

Rivaroxaban Ranbaxy tablets are not recommended for children with a body weight below 30 kg. There is insufficient 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 that are available 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 effect of Rivaroxaban Ranbaxy may be enhanced. The doctor will decide whether to administer this medicine and whether the patient should be subject to particularly close monitoring.
If the doctor believes that the patient is at increased risk of developing stomach or intestinal ulcers, they may use preventive treatment to prevent the formation of ulcers.

• If the patient is 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 effect of Rivaroxaban Ranbaxy may be reduced. The doctor will decide whether to administer Rivaroxaban Ranbaxy and whether the patient should be subject to particularly close monitoring.

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, you should immediately inform your doctor, 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 vehicles, ride bicycles, or operate tools or machines.

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

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

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

If you have previously been diagnosed with intolerance to certain sugars, you should contact your doctor before taking this medicine.
This 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.
Rivaroxaban Ranbaxy should be taken with food.
Swallow the tablet(s) whole, preferably with water.
If you have difficulty swallowing whole tablets, you should talk to your doctor about other ways of taking Rivaroxaban Ranbaxy. The tablet can be crushed and mixed with water or apple puree, just before taking it. After such a mixture, you should eat a meal immediately. If necessary, your doctor may also administer the 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 open up blood vessels in the heart (called percutaneous coronary intervention - PCI with stent placement), 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 medicine 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 either 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 clots.
• 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's a good idea to set an alarm to remind you. For parents or caregivers: you should observe the child to make sure they take the entire dose.
The dose of Rivaroxaban Ranbaxy is dependent on body weight, so it's essential to attend scheduled doctor's appointments, as it may be necessary to adjust the dose due to changes in body weight.
Never adjust the dose yourself.If necessary, your doctor will adjust the dose.
Do not divide the tablet to obtain a partial dose of the tablet. If a smaller dose is necessary, you should use other medicines in the form of granules for oral suspension.
For children and adolescents who are unable to swallow whole tablets, you should 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 it. After such a mixture, you should eat a meal immediately. If necessary, your doctor may also administer the crushed tablet through a gastric tube.

If a dose is spat out or vomited

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

You should contact your doctor in case of repeated spitting out or vomiting of the dose after taking Rivaroxaban Ranbaxy.

When to take Rivaroxaban Ranbaxy

Tablet(s) should be taken every day until the doctor decides to stop the treatment.
It's best to take the tablet(s) at the same time every day, as it's easier to remember.
The doctor will decide how long to continue the treatment.
Prevention of blood clot formation in the brain (stroke) and other blood vessels in the body:
If the heart rhythm needs to be restored with a procedure called cardioversion, Rivaroxaban Ranbaxy should be taken at the time recommended by the 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, you should 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, you should take it as soon as possible. Do not take more than two 15 mg tablets in one day. If you forget to take 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, you should contact your doctor immediately. Taking too much Rivaroxaban Ranbaxy increases the risk of bleeding.

Stopping treatment with Rivaroxaban Ranbaxy

You should not stop taking Rivaroxaban Ranbaxy without first consulting your doctor, as Rivaroxaban Ranbaxy prevents a serious condition.
If you have any further questions about 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 effect of reducing blood clot formation, Rivaroxaban Ranbaxy may cause bleeding, which can be life-threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). Not all of these will be obvious or visible signs of bleeding.
You should 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. This is a serious medical emergency. You should immediately seek medical help!),
• prolonged or excessive bleeding,
• unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain, or angina pectoris. Your doctor may decide that you need to be closely monitored 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 that causes a rash, fever, inflammation of internal organs, hematological disorders, and systemic disorders (DRESS syndrome). The frequency of these side effects is very rare (less than 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 less than 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 paleness of the skin and be the cause of 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 from the 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), 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 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 certain liver or pancreatic 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 stagnation), hepatitis, including liver cell damage,
• jaundice (yellowing of the skin and eyes),
• localized swelling,
• hematoma (collection of blood) 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 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).

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 any side effects not listed in this leaflet, you should 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 the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the 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 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 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 croscarmellose (E486), sodium lauryl sulfate (E487), magnesium stearate (E572). Tablet coating: Rivaroxaban Ranbaxy 15 mg: hypromellose 2910 (E464), lactose monohydrate, macrogol 4000 (E1521), titanium dioxide (E171), red iron oxide (E172), carmine (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), red iron oxide (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 shape
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
square shape
"20" on the other side.
Rivaroxaban Ranbaxy, 15 mg, film-coated tablets are available in transparent PVC/PVDC/Aluminum blisters, packed 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, packed 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