Rivaroxaban Ranbaxi

Leaflet attached to the packaging: patient information

Rivaroxaban Ranbaxy, 10 mg, film-coated tablets

Rivaroxabanum

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

• Please keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, please consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform 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 packaging 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 veins after hip or knee replacement surgery. The doctor has prescribed this medicine because the risk of blood clot formation 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 recurrence of blood clots in the veins of the legs and/or lungs.

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 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 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 used 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.

Particular caution should be exercised when taking Rivaroxaban Ranbaxy:

• if the patient has an increased risk of bleeding, such as:
• moderate or severe kidney disease, as kidney function may affect the amount of medicine acting in the patient's body,
• if the patient is taking other medicines that prevent blood clotting (e.g., warfarin, dabigatran, apixaban, or heparin) when changing anticoagulant treatment or when heparin is used 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 gastroesophageal reflux disease (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 eye (retinopathy),
• pulmonary disease in which the airways are dilated and filled with pus (bronchiectasis) or previous bleeding from the lungs,
• in patients with prosthetic heart valves,
• if the patient has a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clot formation), the patient should inform their doctor, who will decide whether to change 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 any of the above conditions apply to them, they should

inform their doctorbefore taking Rivaroxaban Ranbaxy. The doctor will decide whether to prescribe this medicine and whether the patient should be subject to particularly close monitoring.

If the patient needs to undergo surgery:

• they should follow their doctor's instructions 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 follow the doctor's instructions regarding the intake of Rivaroxaban Ranbaxy at a precisely specified time;
• the patient should immediately inform their doctor if they experience numbness or weakness in their legs or bowel or bladder dysfunction after the anesthesia has worn off, as immediate treatment may be necessary.

Children and adolescents

Rivaroxaban Ranbaxy 10 mg film-coated tablets are not recommended for persons under 18 years of age. There are insufficient data on the use of the medicine in children and adolescents.

Rivaroxaban Ranbaxy and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription.

• If the patient is 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 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 prescribe 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.

• 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 action of Rivaroxaban Ranbaxy may be reduced. The doctor will decide whether to prescribe Rivaroxaban Ranbaxy and whether the patient should be subject to particularly close monitoring.

Pregnancy and breastfeeding

Do not take Rivaroxaban Ranbaxy if the patient is pregnant or breastfeeding. If there is a risk that the patient may become pregnant, they should use an effective method of contraception while taking Rivaroxaban Ranbaxy. If the patient becomes pregnant while taking this medicine, they should immediately inform their 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 10 mg film-coated tablets contain lactose and sodium.

If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their 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".

3. How to take Rivaroxaban Ranbaxy

This medicine should always be taken according to the doctor's instructions. In case of doubts, the patient should consult their 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 Rivaroxaban Ranbaxy 10 mg tablet taken once a day.
• To treat 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. 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. The doctor has prescribed Rivaroxaban Ranbaxy 10 mg once a day for the patient.

The tablet should be swallowed, preferably with water.
Rivaroxaban Ranbaxy can be taken with or without food.
If the patient has difficulty swallowing the whole tablet, they should discuss other ways of taking Rivaroxaban Ranbaxy with their doctor. The tablet can be crushed and mixed with water or apple puree, just before taking it.
If necessary, the doctor may administer the crushed Rivaroxaban Ranbaxy tablet through a gastric tube.

When to start taking Rivaroxaban Ranbaxy

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

The first tablet should be taken 6 to 10 hours after the surgical procedure.
In patients after major hip replacement surgery, treatment usually lasts 5 weeks.
In patients after major knee replacement surgery, treatment usually lasts 2 weeks.

Taking a higher dose of Rivaroxaban Ranbaxy than recommended

If the patient has taken a higher dose of Rivaroxaban Ranbaxy than recommended, they should immediately contact their doctor. Taking too high a dose of Rivaroxaban Ranbaxy increases the risk of bleeding.

Missing a dose of Rivaroxaban Ranbaxy

If the patient has forgotten to take a dose, they should take the tablet as soon as they remember.
The next tablet should be taken the next day, and then the tablets should be taken as usual, once a day.
The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Rivaroxaban Ranbaxy

The patient should not stop taking Rivaroxaban Ranbaxy without first consulting their doctor, as Rivaroxaban Ranbaxy prevents the occurrence of a serious disease.
In case of any further doubts regarding the use of this medicine, the patient should consult their 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 that reduces blood clot formation, Rivaroxaban Ranbaxy may cause bleeding, which can potentially 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.
The patient should immediately inform their doctor if they 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, sudden medical condition. The patient should immediately call for medical help!),
• prolonged or excessive bleeding,
• unusual weakness, fatigue, pallor, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina. The doctor may decide to monitor the patient very closely or change the 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).
• drug reaction causing 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:

Common(may affect up to 1 in 10 people)

• decrease 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 system (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding from the gums,
• bleeding into the eye (including bleeding from the sclera),
• 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 function disorders (can be observed in tests performed by the doctor),
• fever,
• stomach pain, nausea, feeling of nausea (nausea) or vomiting, constipation, diarrhea,
• low blood pressure (symptoms may include dizziness or fainting when standing up),
• general decrease in strength and 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 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,
• liver function disorders (can be observed in tests performed by the doctor),
• blood test results may show increased bilirubin levels, 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 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 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 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 side effects occur, including any side effects not listed in this leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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, more information can be gathered on the safety of the medicine.

5. How to store Rivaroxaban Ranbaxy

The medicine should be stored out of 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 specified 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
The 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. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Rivaroxaban Ranbaxy contains

• The active substance of the medicine is rivaroxaban. Each film-coated tablet contains 10 mg of rivaroxaban.
• The 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: hypromellose 2910 (E464), lactose monohydrate, macrogol 4000 (E1521), titanium dioxide (E171), yellow iron oxide (E172), carmines (E120). See also section 2 "Rivaroxaban Ranbaxy 10 mg film-coated tablets contain lactose and sodium".

What Rivaroxaban Ranbaxy looks like and contents of the pack

Rivaroxaban Ranbaxy, 10 mg, are pink, round, film-coated tablets with a diameter of 6 mm, with a square shape
with the number "10" embossed on the other side.
The tablets are in transparent blisters made of PVC/PVDC/Aluminum, packed in cardboard boxes, containing 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