Rivaroxaban ranbaxy

Package leaflet: Information for the patient

Rivaroxaban Ranbaxy, 10 mg, coated tablets
Rivaroxabanum
Please read carefully all the information in this leaflet before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the 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 veins following hip or knee replacement surgery. Your doctor has prescribed this medicine because the risk of developing 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 to prevent recurrence of blood clots in the blood vessels of the legs and/or lungs.

Rivaroxaban Ranbaxy belongs to a group of medicines called anticoagulants. It works by blocking a blood clotting factor (factor Xa), thereby reducing the tendency for blood clots to form.

2. Important information before using Rivaroxaban Ranbaxy

When not to use 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, trauma or bleeding into the brain, recent surgery 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 switching anticoagulant therapy or if heparin is administered to maintain the patency of a catheter in a vein or artery,
• if the patient has liver disease leading to an increased risk of bleeding,
• if the patient is pregnant or breastfeeding. Do not use Rivaroxaban Ranbaxy, and inform your doctor if you suspect any of the above circumstances apply.

Warnings and precautions
Before starting treatment with Rivaroxaban Ranbaxy, discuss it with your doctor or
pharmacist.
Exercise special caution when using Rivaroxaban Ranbaxy:

• if the patient has an increased risk of bleeding, such as in the following conditions:
  • moderate or severe kidney disease, as kidney function may affect the amount of drug active in the patient's body,
  • if the patient is taking other medicines that prevent blood clots (e.g. warfarin, dabigatran, apixaban or heparin) when switching anticoagulant therapy or when heparin is administered to maintain the patency of a catheter in a vein or artery (see section "Rivaroxaban Ranbaxy and other medicines"),
  • blood clotting disorders,
  • very high blood pressure that does not decrease despite medication,
  • diseases of the stomach or intestines that may cause bleeding, e.g. inflammatory bowel disease or gastritis, or oesophagitis (inflammation of the throat and oesophagus), e.g. due to gastroesophageal reflux disease (backflow of stomach acid into the oesophagus), or tumours located in the stomach, intestines, genital or urinary system,
  • blood vessel disease in the back of the eye (retinopathy),
  • lung disease with dilated and pus-filled airways (bronchiectasis) or previous lung bleeding,
• in patients with prosthetic heart valves,
• if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing increased risk of blood clots), the patient should inform the doctor, who will decide whether a change in treatment is necessary,
• if the patient has abnormal blood pressure or is scheduled for surgery or other treatment aimed at removing a blood clot from the lungs.

If the patient suspects any of the above conditions apply, they should inform the
doctor before using Rivaroxaban Ranbaxy. The doctor will decide whether to use this medicine
and whether the patient requires particularly close monitoring.
If the patient needs surgery:

• strictly follow the doctor's instructions regarding the timing of taking Rivaroxaban Ranbaxy before or after surgery,
• if catheterization or spinal puncture (e.g. for epidural or spinal anaesthesia or pain relief) is planned during surgery:
  • it is very important to strictly follow the doctor's instructions regarding the timing of taking Rivaroxaban Ranbaxy;
  • immediately inform the doctor if numbness or weakness in the legs or disturbances in bowel or bladder function occur after the anaesthesia ends, as immediate treatment may be necessary.

Children and adolescents
Rivaroxaban Ranbaxy 10 mg tablets are not recommended for patients under 18 years of age. There is
insufficient data on the use of this medicine in children and adolescents.
Rivaroxaban Ranbaxy and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken,
as well as any medicines the patient plans to take, including those available without a prescription.

• If the patient is taking: certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only topically on the skin, oral ketoconazole (used in the treatment of Cushing's syndrome, in which the body produces too much cortisol), certain antibiotics (e.g. clarithromycin, erythromycin), certain antiviral medicines used in HIV infection or AIDS treatment (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 medicines (e.g. naproxen or acetylsalicylic acid), dronedarone (a medicine used to treat heart rhythm disorders), or certain antidepressants (selective serotonin reuptake inhibitors (SSRIs) or serotonin-noradrenaline reuptake inhibitors (SNRIs)).

If the patient suspects any of the above points apply, they should
inform the doctor before using Rivaroxaban Ranbaxy, as the effect of Rivaroxaban Ranbaxy may be enhanced. The doctor will decide whether to use this medicine and whether the patient requires particularly close monitoring.
If the doctor considers that the patient has an increased risk of developing stomach or intestinal ulcers, they may prescribe 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 for depression, or rifampicin, an antibiotic.

If the patient suspects any of the above points apply, they should
inform the doctor before using Rivaroxaban Ranbaxy, as the effect of Rivaroxaban Ranbaxy may be reduced. The doctor will decide whether to use Rivaroxaban Ranbaxy and whether the patient requires particularly close monitoring.
Pregnancy and breastfeeding
Do not use Rivaroxaban Ranbaxy if the patient is pregnant or breastfeeding. If there is a risk that the patient may become pregnant, an effective method of contraception should be used during treatment with Rivaroxaban Ranbaxy. If the patient becomes pregnant while taking this medicine, inform the 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 experiencing these side effects should not drive, ride a bicycle, or operate tools or machinery.
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, i.e. the medicine is considered "sodium-free".

3. How to take Rivaroxaban Ranbaxy

This medicine should always be taken exactly as your doctor has instructed. If you are unsure, you should
consult 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 Rivaroxaban Ranbaxy 10 mg tablet taken once daily.
• For the treatment of blood clots in the legs, blood clots in the blood vessels of the lungs, and to prevent recurrence of blood clots: After at least 6 months of treatment for blood clots, the recommended dose is one 10 mg tablet once daily or one 20 mg tablet once daily. Your doctor has prescribed Rivaroxaban Ranbaxy 10 mg once daily for you.

Swallow the tablet whole, preferably with water.
Rivaroxaban Ranbaxy can be taken with or without food.
If you have difficulty swallowing the whole tablet, talk to your doctor about other ways of taking
Rivaroxaban Ranbaxy. The tablet can be crushed and mixed with water or apple puree, immediately before taking.
If necessary, your doctor may administer crushed Rivaroxaban Ranbaxy tablets via a gastric tube.
When to start taking Rivaroxaban Ranbaxy
Take one tablet every day until your doctor decides to stop treatment.
It is best to take the tablet at the same time each day, as this makes it easier to remember.
Your doctor will decide how long treatment should continue.
To prevent blood clots in the veins after hip or knee replacement surgery:
The first tablet should be taken between 6 and 10 hours after surgery.
For patients undergoing major hip surgery, treatment usually lasts for 5 weeks.
For patients undergoing major knee surgery, treatment usually lasts for 2 weeks.
If you take more Rivaroxaban Ranbaxy than you should
If you take more Rivaroxaban Ranbaxy than recommended, contact your doctor immediately.
Taking too high a dose of Rivaroxaban Ranbaxy increases the risk of bleeding.
If you forget to take Rivaroxaban Ranbaxy
If you forget to take a dose, take the tablet as soon as you remember.
Take the next tablet the following day, and then continue taking the tablets as usual, once daily.
Do not take a double dose to make up for a forgotten dose.
Stopping Rivaroxaban Ranbaxy
Do not stop taking Rivaroxaban Ranbaxy without first discussing it with your doctor, as Rivaroxaban Ranbaxy helps prevent a serious condition.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
As with other medicines with a similar mechanism of action that reduce blood clot formation, Rivaroxaban
Ranbaxy may cause bleeding, which potentially could be life-threatening. Excessive
bleeding may lead to a sudden drop in blood pressure (shock). Signs of bleeding are not always
obvious or visible.
You should contact your doctor immediately if any of the following
adverse reactions occur:

• Signs of bleeding:
  • bleeding into the brain or inside the skull (symptoms may include headache, one-sided weakness, vomiting, seizures, reduced level of consciousness and neck stiffness. This is a serious medical emergency. Seek immediate medical help!),
  • prolonged or excessive bleeding,
  • unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina. Your doctor may decide that close monitoring or a change in treatment is necessary.
• Signs of severe skin reactions:
  • widespread, acute skin rash, blistering or mucosal lesions, e.g. in the mouth or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
  • drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), characterized by rash, fever, internal organ inflammation, hematological abnormalities and systemic involvement.

The frequency of occurrence of these adverse reactions is very rare (up to 1 in 10,000 people).

• Signs of severe allergic reactions
  • swelling of the face, lips, oral cavity, tongue or throat; urticaria and breathing difficulties; 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 adverse reactions:
Common (may occur in up to 1 in 10 patients)

• reduction in red blood cells which may cause pale skin and lead to weakness or shortness of breath,
• gastrointestinal or intestinal bleeding, bleeding from the genitourinary system (including blood in urine and heavy menstrual bleeding), nosebleeds, bleeding gums,
• bleeding into the eye (including bleeding from the white of the eye),
• bleeding into tissues or body cavities (hematoma, bruising),
• presence of blood in sputum (hemoptysis) during coughing,
• bleeding from the skin or subcutaneous bleeding,
• postoperative bleeding,
• oozing of blood or fluid from a surgical wound,
• limb swelling,
• limb pain,
• kidney function disorders (may be observed in tests performed by a doctor),
• fever,
• stomach pain, indigestion, nausea or vomiting, constipation, diarrhea,
• low blood pressure (symptoms may include dizziness or fainting upon standing),
• general reduction in strength and energy (weakness, fatigue), headache, dizziness,
• rash, itching of the skin,
• increased activity of certain liver enzymes, which may be evident in blood test results.

Uncommon (may occur in up to 1 in 100 patients)

• bleeding into the brain or within the skull (see signs of bleeding above),
• bleeding into a joint causing pain and swelling,
• thrombocytopenia (low platelet count, the blood cells involved in clotting),
• allergic reactions, including allergic skin reactions,
• liver function disorders (may be observed in tests performed by a doctor),
• blood tests may show increased levels of bilirubin, increased activity of certain pancreatic or liver enzymes, or increased platelet count,
• fainting,
• malaise,
• rapid heartbeat,
• dryness of the mouth,
• urticaria.

Rare (may occur in up to 1 in 1000 patients)

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

Very rare (may occur in up to 1 in 10,000 patients)

• accumulation of eosinophils, a type of granulocyte white blood cells, causing lung inflammation (eosinophilic pneumonia).

Frequency not known (frequency cannot be estimated from available data)

• kidney failure following severe bleeding,
• bleeding in the kidneys, sometimes with blood in the urine, leading to impaired kidney function (anticoagulant-related nephropathy),
• increased pressure within the muscles of arms and legs following bleeding, which may cause pain, swelling, altered sensation, numbness or paralysis (compartment syndrome following bleeding).

Reporting of adverse reactions
If any adverse effects occur, including any not listed
in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can
be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps 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 stated on the carton and blister. The expiry date refers to the last day of the stated month.
The marking on the packaging following "EXP" indicates the expiry date, and following "Lot/LOT" indicates the batch number.
No special storage conditions are required for this medicine.
Crushed tablets
Crushed tablets are stable in water or apple puree for up to 4 hours.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Rivaroxaban Ranbaxy contains

• The active substance is rivaroxaban. Each coated tablet contains 10 mg of rivaroxaban.
• The other ingredients are:
  Tablet core: microcrystalline cellulose (E460), hypromellose 2910 (E464), lactose monohydrate, low-substituted hydroxypropyl cellulose (E463), sodium croscarmellose (E486), sodium lauryl sulphate (E487), magnesium stearate (E572).
  Tablet coating: hypromellose 2910 (E464), lactose monohydrate, macrogol 4000 (E1521), titanium dioxide (E171), iron oxide yellow (E172), carmine (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 and the engraved number "10" on the other side.
The tablets are contained in transparent PVC/PVDC/Aluminium blister packs, packed in cardboard boxes containing 28 and 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
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
The Netherlands

Terapia S.A.
Strada Fabricii Nr 124
400632 Cluj-Napoca, Cluj
Romania