Rivaroxaban ranbaxy

Patient Information Leaflet

Rivaroxaban Ranbaxy, 2.5 mg, film-coated tablets
Rivaroxabanum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

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

Table of contents

1. What Rivaroxaban Ranbaxy is and what it is used for
2. What you need to know 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

You have been prescribed Rivaroxaban Ranbaxy because:

• You have been diagnosed with acute coronary syndrome (a condition including heart attack and unstable angina, i.e. acute chest pain) and elevated levels of cardiac biomarkers have been confirmed. Rivaroxaban Ranbaxy reduces the risk of further heart attack or the risk of death due to heart or blood vessel disease in adults. Rivaroxaban Ranbaxy will not be given to you as a single treatment. Your doctor will also prescribe:
  • acetylsalicylic acid, or
  • acetylsalicylic acid and clopidogrel or ticlopidine.
• You have been diagnosed with a high risk of blood clots due to coronary artery disease or peripheral artery disease causing symptoms. Rivaroxaban Ranbaxy reduces the risk of blood clots (atherothrombotic events) in adults. Rivaroxaban Ranbaxy will not be given to you as a single treatment. Your doctor will also prescribe acetylsalicylic acid. In some cases, if you are receiving Rivaroxaban Ranbaxy after a procedure to open a narrowed or blocked artery in the lower limb to restore blood flow, your doctor may additionally prescribe clopidogrel to be taken for a short period alongside acetylsalicylic acid.

Rivaroxaban Ranbaxy contains the active substance rivaroxaban and 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. 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 is experiencing excessive bleeding,
• if the patient has a disease or condition of a body organ that leads to an increased risk of serious bleeding (e.g. gastric ulcer, trauma or intracranial haemorrhage, 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 catheter patency in a vein or artery,
• if the patient has been diagnosed with acute coronary syndrome and previously experienced bleeding or blood clot in the brain (stroke),
• if the patient has coronary artery disease or peripheral arterial disease and previously had intracranial bleeding (stroke) or occlusion of small arteries supplying blood to tissues in deep brain structures (lacunar stroke), or if the patient had a blood clot in the brain (ischaemic, non-lacunar stroke) within the past month,
• if the patient has a liver disease that leads to an increased risk of bleeding,
• if the patient is pregnant or breastfeeding. Do not use Rivaroxaban Ranbaxy, and inform the doctor if the patient suspects any of the above conditions apply.

Warnings and precautions
Before starting Rivaroxaban Ranbaxy, discuss this with your doctor or
pharmacist. Rivaroxaban Ranbaxy should not be used in combination with other than acetylsalicylic acid, clopidogrel or ticlopidine, medicines that inhibit blood coagulation, such as
prasugrel or ticagrelor.
Exercise special caution when using Rivaroxaban Ranbaxy:

• if the patient has an increased risk of bleeding, such as in the following conditions:

  • severe kidney disease, 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 switching anticoagulant therapy or when heparin is administered to maintain catheter patency in a vein or artery (see section “Rivaroxaban Ranbaxy and other medicines”),
  • coagulation disorders,
  • very high blood pressure that does not decrease despite medication,
  • stomach or intestinal diseases that may cause bleeding, e.g. intestinal and gastric inflammation 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 or
    intestines or in the genital or urinary system,

• blood vessel disease of the posterior part of the eyeball (retinopathy),

• lung disease in which bronchi are dilated and filled with pus (bronchiectasis) or previous pulmonary haemorrhage,

• if the patient is over 75 years of age,

• if the patient weighs less than 60 kg,

• coronary artery disease with severe symptomatic heart failure,

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

• strictly follow the doctor's instructions regarding the timing of taking Rivaroxaban Ranbaxy before or after surgery,
• if spinal catheterisation or spinal puncture (e.g. for epidural or intrathecal anaesthesia or pain relief) is planned during surgery:
  • it is very important to take Rivaroxaban Ranbaxy before and after the puncture or catheter removal, as directed by the doctor;
  • due to the need for special caution, immediately inform the doctor if numbness or weakness in the legs, or bowel or bladder dysfunction occurs after the anaesthesia wears off.

Children and adolescents
Rivaroxaban Ranbaxy 2.5 mg tablets are not recommended for patients under 18 years of age. There is insufficient data on the use of the 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, ketoconazole tablets (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, prasugrel and ticagrelor (see section “Warnings and precautions”)), 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-norepinephrine reuptake inhibitors (SNRIs)).
If the patient suspects any of the above apply, inform the doctor before taking 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 treatment to prevent ulcer formation.
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,
rifampicin, which belongs to the group of antibiotics.
If the patient suspects any of the above apply, inform the doctor before taking 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 operating machinery
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 contains lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, they should contact the doctor before taking the medicine.
The 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

This medicine should always be taken exactly as prescribed by your doctor. If in doubt,
consult your doctor or pharmacist.
How many tablets to take
The recommended dose is one 2.5 mg tablet twice daily. Rivaroxaban Ranbaxy should be
taken at approximately the same time each day (for example, one tablet in the morning and one
in the evening). This medicine may be taken with or without food.
If a patient has difficulty swallowing the whole tablet, they should discuss alternative
methods of taking Rivaroxaban Ranbaxy with their doctor. The tablet may be crushed and mixed with water
or apple puree immediately before administration. If necessary, the doctor may administer
crushed Rivaroxaban Ranbaxy tablets via a gastric tube.
Rivaroxaban Ranbaxy will not be given to the patient as the only medication.
Your doctor will prescribe acetylsalicylic acid to be taken alongside. If the patient is receiving
Rivaroxaban Ranbaxy after an acute coronary syndrome, the doctor may also prescribe
clopidogrel or ticlopidine.
If the patient is receiving Rivaroxaban Ranbaxy after a procedure to restore blood flow in a narrowed or blocked
artery of the lower limb, the doctor may additionally prescribe clopidogrel to be taken for a short period
alongside acetylsalicylic acid.
The doctor will inform the patient of the appropriate dose of these medications (usually 75–100 mg of acetylsalicylic
acid per day, or a daily dose of 75–100 mg acetylsalicylic acid plus a daily dose of 75 mg clopidogrel, or the standard
daily dose of ticlopidine).
When to start taking Rivaroxaban Ranbaxy
Treatment with Rivaroxaban Ranbaxy after an acute coronary syndrome should be initiated as soon as possible
after stabilization of the acute event, no earlier than 24 hours after hospital admission and at the time when parenteral
(injected) anticoagulant therapy would normally be discontinued.
The doctor will inform the patient when to start treatment with Rivaroxaban Ranbaxy if coronary artery disease or peripheral
arterial disease has been diagnosed. The doctor will decide how long treatment should continue.
Taking more than the recommended dose of Rivaroxaban Ranbaxy
If a patient takes more than the prescribed dose of Rivaroxaban Ranbaxy, they should contact their doctor immediately.
Taking too high a dose of 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 a dose is missed, the patient should take the next dose at the
scheduled time.
Stopping Rivaroxaban Ranbaxy
Rivaroxaban Ranbaxy should be taken regularly and for the duration prescribed by the doctor.
Do not stop taking Rivaroxaban Ranbaxy without first consulting your doctor.
Stopping this medicine may increase the risk of another heart attack, stroke, or death due to heart or blood vessel disease.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
As with other medicines with a similar mechanism of action that reduce blood clot formation, Rivaroxaban
Ranbaxy can cause bleeding, which may potentially 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 immediately contact your doctor if any of the following side effects occur:

• Signs of bleeding:
  • bleeding into the brain or inside the skull (symptoms may include headache, one-sided paralysis, vomiting, seizures, decreased level of consciousness and neck stiffness. 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, formation of blisters or mucosal lesions, e.g. on the tongue or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
  • drug reaction causing rash, fever, internal organ inflammation, haematological and systemic disorders (DRESS syndrome). The frequency of these adverse reactions is very rare (occurring in 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 oedema may occur in 1 in 100 people).

General list of possible side effects:
Common (may occur in up to 1 in 10 patients)

• decrease in red blood cells which may cause paleness of the skin and lead to weakness or shortness of breath,
• bleeding from the stomach or intestines, bleeding from the genitourinary system (including blood in urine and heavy menstrual bleeding), nosebleeds, bleeding from the gums,
• bleeding into the eye (including bleeding from the white part of the eye),
• bleeding into tissues or body cavities (haematoma, bruising),
• presence of blood in sputum (haemoptysis) during coughing,
• bleeding from the skin or subcutaneous bleeding,
• bleeding after surgery,
• oozing of blood or fluid from the 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, diarrhoea,
• low blood pressure (symptoms may include dizziness or fainting upon standing),
• general decrease in strength and energy (weakness, fatigue), headache, dizziness,
• rash, itching of the skin,
• increased activity of certain liver enzymes, which may be seen in blood test results.

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

• bleeding into the brain or inside the skull (see bleeding signs above),
• bleeding into a joint causing pain and swelling,
• thrombocytopenia (low platelet count, the blood cells involved in blood 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,
• dry mouth,
• urticaria.

Rare (may occur in up to 1 in 1,000 patients)

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

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

• accumulation of eosinophils, a type of white granulocytic 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 the kidneys being unable to function properly (anticoagulant-related nephropathy),
• increased pressure in the muscles of the arms and legs occurring after bleeding, which may lead to pain, swelling, altered sensation, numbness or paralysis (compartment syndrome following bleeding).

Reporting of side effects
If any adverse effects occur, including any not listed in this leaflet, you should inform your doctor or pharmacist. Side effects 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
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects helps to provide more information on the safety of the medicine.

5. How to store Rivaroxaban Ranbaxy

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and blister pack. 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" or "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 2.5 mg of rivaroxaban.
• Other ingredients are:
  Tablet core: microcrystalline cellulose (E460), hypromellose 2910 (E464), monohydrate lactose, low-substituted hydroxypropyl cellulose (E463), sodium croscarmellose (E486), sodium lauryl sulfate (E487), magnesium stearate (E572).
  Tablet coating: hypromellose 2910 (E464), monohydrate lactose, 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, are light yellow, round, film-coated tablets with a diameter of 6 mm,
imprinted with a square " " on one side and the number “2.5” on the other side.
The tablets are contained in transparent PVC/PVDC/Aluminium blister packs, packed in cardboard cartons containing 28 or 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Ranbaxy (Poland) Sp. z o.o.
Idzikowskiego Street 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 No. 124
400632 Cluj-Napoca, Cluj
Romania