Package leaflet: Information for the patient

Rivaroxaban Ranbaxy, 15 mg, film-coated tablets
Rivaroxaban Ranbaxy, 20 mg, film-coated tablets
Rivaroxabanum
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you personally. 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

What Rivaroxaban Ranbaxy is and what it is used for
What you need to know before taking Rivaroxaban Ranbaxy
How to take Rivaroxaban Ranbaxy
Possible side effects
How to store Rivaroxaban Ranbaxy
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 blood clots in the brain (stroke) and in other blood vessels of the body in patients who have a type of irregular heartbeat called non-valvular atrial fibrillation;
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 the recurrence of blood clots in the veins 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 blood clots and to prevent recurrence of blood clots in the veins or in the blood vessels of the lungs, after at least 5 days of initial treatment with injectable anticoagulant medicines.

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 active 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 when heparin is administered to maintain the patency of an intravenous or arterial catheter,
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 that any of the above circumstances apply.

Warnings and precautions
Before starting treatment with Rivaroxaban Ranbaxy, discuss this 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:
- severe kidney disease in adults, or moderate to severe kidney disease in children and adolescents, as kidney function may affect the amount of medicine acting in the patient's body,
- use of other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin) when switching anticoagulant therapy or when heparan is administered to maintain the patency of an intravenous or arterial catheter (see section "Rivaroxaban Ranbaxy and other medicines"),
- coagulation disorders,
- very high blood pressure that does not decrease despite medication,
- diseases of the stomach or intestines that may cause bleeding, e.g. inflammation of the intestines and stomach or inflammation of the oesophagus (throat and oesophagus), e.g. due to gastro-oesophageal 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 in the back of the eye (retinopathy),
- lung disease in which the bronchi are dilated and filled with pus (bronchiectasis) or previous bleeding from the lungs,
in patients with prosthetic heart valves,
if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing an 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, 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 to undergo surgery:

strictly follow the doctor's instructions regarding the timing of taking Rivaroxaban Ranbaxy before or after surgery,
if 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 removal of the catheter, at the time specified by the doctor;
- 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 tablets are not recommended for children weighing less than 30 kg. There is
insufficient data on the use of the medicine in children and adolescents for the indications approved for
adults.
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 antibacterial medicines (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-relieving medicines (e.g. naproxen or acetylsalicylic acid), dronedarone, a medicine used to treat heart rhythm disorders, or certain medicines used to treat depression (selective serotonin reuptake inhibitors (SSRI) or serotonin-noradrenaline reuptake inhibitors (SNRI)).

If the patient suspects any of the above points apply, 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 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, or rifampicin, which belongs to the group of antibiotics.

If the patient suspects any of the above points apply, 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 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 15 mg film-coated tablets contain lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should
consult the 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".
Rivaroxaban Ranbaxy 20 mg film-coated tablets contain lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should
consult the 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

This medicine should always be taken as instructed by the doctor. If in doubt, consult the
doctor or pharmacist.
Rivaroxaban Ranbaxy should be taken with food.
The tablet(s) should be swallowed whole, preferably with water.
If a patient has difficulty swallowing the whole tablet, they should speak with the doctor about
alternative ways of taking Rivaroxaban Ranbaxy. The tablet may be crushed and mixed with water
or apple puree immediately before administration. A meal should be taken promptly after this mixture.
If necessary, the doctor may administer crushed Rivaroxaban Ranbaxy tablets via a gastric tube.

How many tablets to take

Adults
- For prevention of blood clots in the brain (stroke) and other blood vessels in the body: The recommended dose is one Rivaroxaban Ranbaxy 20 mg tablet once daily.
  If the patient has kidney disease, the dose may be reduced to one Rivaroxaban Ranbaxy 15 mg tablet once daily.
  If the patient requires a procedure to open blocked blood vessels in the heart (called percutaneous coronary intervention – PCI with stent placement), there is limited evidence supporting dose reduction to one Rivaroxaban Ranbaxy 15 mg tablet once daily (or one Rivaroxaban Ranbaxy 10 mg tablet once daily in case of kidney impairment), in combination with an antiplatelet medicine such as clopidogrel.
- For treatment of blood clots in the veins of the legs, blood clots in the blood vessels of the lungs, and prevention of recurrence of blood clots: The recommended dose is one Rivaroxaban Ranbaxy 15 mg tablet twice daily for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one Rivaroxaban Ranbaxy 20 mg tablet once daily. After at least 6 months of treatment for blood clots, the doctor may decide to continue treatment with either one 10 mg tablet once daily or one 20 mg tablet once daily. If the patient has kidney disease and is taking one Rivaroxaban Ranbaxy 20 mg tablet once daily, the doctor may decide to reduce the dose after 3 weeks of treatment to one Rivaroxaban Ranbaxy 15 mg tablet once daily, if the risk of bleeding is greater than the risk of further blood clots.
Children and adolescents
The dose of Rivaroxaban Ranbaxy depends on body weight and will be calculated by the doctor.
- Recommended dose for children and adolescents with a body weight of 30 kg to less than 50 kg is one Rivaroxaban Ranbaxy 15 mg tablet once daily.
- Recommended dose for children and adolescents with a body weight of 50 kg or more is one Rivaroxaban Ranbaxy 20 mg tablet once daily.

Each dose of Rivaroxaban Ranbaxy should be taken with a meal and with a drink (e.g. water or juice). Tablets should be taken every day at approximately the same time. Consider setting an alarm to remind you. For parents or caregivers: observe the child to ensure the full dose has been taken.
The dose of Rivaroxaban Ranbaxy is based on body weight; therefore, it is important to attend scheduled doctor’s appointments, as the dose may need to be adjusted due to changes in body weight.
Never adjust the dose on your own. If necessary, the doctor will adjust the dose.
Do not split the tablet to achieve a partial dose. If a lower dose is required, other medicines in the form of granules for oral suspension should be used.
For children and adolescents who are unable to swallow whole tablets, other medicines in the form of granules for oral suspension should be used.
If the oral suspension is not available, the Rivaroxaban Ranbaxy tablet may be crushed and mixed with water or apple puree immediately before administration. A meal should be taken promptly after this mixture. If necessary, the doctor may also administer the crushed tablet via a gastric tube.

If a dose is vomited or spat out

Within 30 minutes of taking Rivaroxaban Ranbaxy, take a new dose.
More than 30 minutes after taking Rivaroxaban Ranbaxy, do not take a new dose. In this case, take the next dose at the usual time.

Contact the doctor if the patient repeatedly spits out doses or vomits after taking Rivaroxaban Ranbaxy.

When to take Rivaroxaban Ranbaxy
The tablet(s) should be taken every day until the doctor decides to stop treatment.
It is best to take the tablet(s) at the same time each day, as this makes it easier to remember.
The doctor will decide how long treatment should continue.
Prevention of blood clots in the brain (stroke) and other blood vessels in the body:
If a procedure called cardioversion is required to restore normal heart rhythm, Rivaroxaban Ranbaxy should be taken as directed by the doctor.

Missed dose of Rivaroxaban Ranbaxy

Adults, children and adolescents: If the patient takes one 20 mg tablet or one 15 mg tablet once daily and a dose is missed, take the tablet 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 following day, then continue taking one tablet once daily.
Adults: If the patient takes one 15 mg tablet twice daily and a dose is missed, take the tablet as soon as possible. Do not take more than two 15 mg tablets in one day. If the patient forgot to take a dose, they may take two 15 mg tablets at the same time to achieve a total of two tablets (30 mg) taken within one day. The next day, continue taking one 15 mg tablet twice daily.

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

Stopping Rivaroxaban Ranbaxy
Do not stop taking Rivaroxaban Ranbaxy without first consulting the doctor, as Rivaroxaban Ranbaxy helps prevent serious illness.
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 will get them.
As with other medicines with a similar mechanism of action that reduce blood clot formation, Rivaroxaban
Ranbaxy may cause bleeding, which potentially can 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 side effects occur:

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 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 causing rash, fever, internal organ inflammation, hematological disorders and systemic involvement (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 not frequently (angioedema and allergic edema may occur in 1 in 100 people).

General list of possible side effects in adults, children and adolescents:
Common (may occur in 1 out of 10 patients)

reduction in red blood cell count, which may cause paleness of the skin and lead to weakness or shortness of breath,
gastrointestinal bleeding or bleeding from the gastrointestinal tract, bleeding from the urinary or genital tract (including blood in 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 (hemoptysis) during coughing,
bleeding from the skin or subcutaneous bleeding,
postoperative bleeding,
oozing of blood or fluid from the surgical wound,
swelling of limbs,
limb pain,
kidney function disorders (may be observed in tests performed by the doctor),
fever,
stomach pain, indigestion, nausea or vomiting, constipation, diarrhea,
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 evident in blood test results.

Uncommon (may occur in 1 out of 100 patients)

bleeding into the brain or inside the skull (see signs of bleeding 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 the 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 1 out of 1,000 patients)

bleeding into muscles,
cholestasis (bile stasis), hepatitis including liver cell damage,
yellowing of the skin and eyes (jaundice),
local swelling,
accumulation of blood (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 1 out of 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 the available data)

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

Side effects in children and adolescents
Generally, 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 in severity.
Side effects observed more frequently in children and adolescents:
Very common (may occur in more than 1 out of 10 patients)

headache,
fever,
nosebleeds, vomiting.

Common (may occur in 1 out of 10 patients)

rapid heartbeat,
blood tests may show increased bilirubin levels (a bile pigment), thrombocytopenia (low platelet count, the cells that help blood to clot),
excessive menstrual bleeding.

Uncommon (may occur in 1 out of 100 patients)

blood tests may show increased levels of a subcategory of bilirubin (direct bilirubin, a bile pigment).

Reporting of side effects
If any adverse effects occur, including any adverse effects 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 authorization holder.
Reporting side effects helps provide more information on the safety of the 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 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/LOT" indicates the batch number.
No special storage instructions apply for this 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 is rivaroxaban. Each 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 sulphate (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), carmine (E120). See also section 2 "Rivaroxaban Ranbaxy 15 mg 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 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 imprint on one side and the number "15" engraved on the other side.
Rivaroxaban Ranbaxy 20 mg are dark red, round, film-coated tablets with a diameter of 6 mm, with a square imprint on one side and the number "20" engraved on the other side.
Rivaroxaban Ranbaxy 15 mg film-coated tablets are available in transparent blisters made of PVC/PVDC/Aluminium, packed in cardboard boxes containing 14, 28, 42 and 100 film-coated tablets.
Rivaroxaban Ranbaxy 20 mg film-coated tablets are available in transparent blisters made of PVC/PVDC/Aluminium, packed in cardboard boxes containing 14, 28 and 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
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

Rivaroxaban ranbaxy