REBLESS 10 Tablet 10's

Introduction About REBLESS 10 TABLET

REBLESS 10 TABLET contains Rivaroxaban, which belongs to the group of medicines
called Antithrombotic agents. It is used to manage deep vein thrombosis (DVT),
pulmonary embolism (PE), and venous thromboembolism (VTE). It is also used to
reduce the risk of stroke, systemic embolism in nonvalvular atrial fibrillation,
recurrence of DVT or PE, major cardiovascular events in patients with coronary
artery disease (CAD), and major thrombotic vascular events in patients with
peripheral artery disease (PAD). Venous thromboembolism is a condition that
occurs due to clot formation in the venous circulation. It can also be used for
THE management of DVT in patients undergoing knee or hip replacement surgery,
VTE in acutely ill medical patients, and thrombosis in children (older than 2
years) with congenital heart disease post the Fontan procedure.

Before taking REBLESS 10 TABLET, inform your doctor if you have any liver,
kidney, or bleeding problems or antiphospholipid syndrome. REBLESS 10 TABLET is
not recommended for use in pregnant or breast-feeding women, so consult your
doctor before taking it. REBLESS 10 TABLET is not studied and is not recommended
in children less than 6 months of age who were less than 37 weeks of growth at
birth, had less than 10 days of oral feeding, or weigh less than 2.6 kg. REBLESS
10 TABLET should be used with caution in elderly patients (65 years or older).
Consult your doctor before taking it.

The most common side effects of taking REBLESS 10 TABLET are bleeding, pain and
swelling in the limbs, fever, stomach pain, indigestion, nausea, vomiting,
constipation, diarrhea, low blood pressure (feeling dizzy or fainting when
standing up), weakness, tiredness, headache, dizziness, rash, and itchy skin.
Contact your doctor if any of your symptoms worsen.

Uses Of REBLESS 10 TABLET

It is used:

• To manage deep vein thrombosis (DVT), pulmonary embolism (PE), venous thromboembolism (VTE)
• To reduces the risk of stroke, systemic embolism in nonvalvular atrial fibrillation, recurrence of DVT or PE, major cardiovascular events in patients with coronary artery disease (CAD), and major thrombotic vascular conditions in patients with peripheral artery disease (PAD)
• To manage DVT in patients undergoing knee or hip replacement surgery, VTE in acutely ill medical patients, and thrombosis in children (2 years and older) with congenital heart disease post the Fontan procedure

How REBLESS 10 TABLET Works

REBLESS 10 TABLET works by competitively inhibiting factor Xa (a clotting
factor) and managing the progression of the coagulation cascade through the
final common pathway, thus managing thrombin generation.

How to use REBLESS 10 TABLET

Take REBLESS 10 TABLET as advised by your physician. Swallow the medicine with a
glass of water. Do not crush or chew the medicine. Your doctor will decide the
correct dose and duration for you depending upon your age, body weight and
disease condition. Do not stop taking REBLESS 10 TABLET unless your doctor
advise.

Side Effects Of REBLESS 10 TABLET

Common

• Decrease in red blood cells (pale skin, weakness, or breathlessness)
• Bleeding in the stomach or intestine, urogenital bleeding (including blood in the urine and heavy menstrual bleeding), nosebleed, bleeding in the gum
• Bleeding into the eye (including from the whites of the eyes)
• Hematoma, bruising (bleeding into tissue or a cavity of the body)
• Coughing up blood
• Bleeding from or under the skin
• Oozing of blood or fluid from surgical injury
• Impaired kidney function
• Pain and swelling in the limbs
• Fever
• Stomach pain, indigestion, nausea, vomiting, constipation, diarrhea
• Low blood pressure (feeling dizzy or fainting when standing up)
• Weakness
• Tiredness
• Headache
• Dizziness
• Rash
• itchy skin

Uncommon

• Bleeding into the brain or inside the skull, or into a joint (pain and swelling)
• Low number of platelets
• Allergic reactions including skin reactions
• Fainting
• Feeling unwell
• Rapid heartbeat
• Dry mouth
• Hives

Rare

• Bleeding into a muscle
• Decreased bile flow, inflamed liver including liver injury
• Yellowing of the skin and eye
• Localized swelling
• Accumulation of blood in the groin as a complication of the cardiac procedure where a catheter is inserted in your leg artery

Stop taking REBLESS 10 TABLET and contact your doctor immediately if you
experience any of the following side effects:

• Bleeding inside brain (headache, one-sided weakness, vomiting, seizures, decreased level of consciousness, neck stiffness); long or excessive bleeding; abnormal weakness, tiredness, paleness, dizziness, unexplained swelling, breathlessness, chest pain; frequent nose bleeds; abnormal bleeding from the gums; menstrual bleeding that is heavier than normal or vaginal bleeding; bleeding that is severe or uncontrollable; red, pink or brown urine; bright red or black tar-like stools; cough up blood or blood clots; vomit blood or your vomit looks like “coffee grounds”; pain, swelling, or new drainage at wound sites
• Severe skin reactions (spreading intense skin rash, blisters or mucosal lesions in the mouth or eyes, a drug reaction that causes rash, fever, inflammation of internal organs, blood abnormalities and systemic illness)
• Severe allergic reaction (swelling of the face, lips, mouth, tongue, or throat; trouble swallowing; hives and breathing difficulties; sudden drop in blood pressure)
• Spinal or epidural blood clots
• Back pain
• Muscle weakness (legs and feet)
• Tingling
• Bowel or bladder incontinence
• Numbness

How To Manage Side Effects

!### Constipation

Eat plenty of fiber rich foods such as fresh fruits, vegetables, and cereals and
drink plenty of water. Exercise more regularly.

Diarrhea

Drink lots of fluids, such as water or fruit juice to keep yourself hydrated. Do
not consume any medicine other than REBLESS 10 TABLET without consulting your
doctor.

!### Dizziness Or Drowsiness

Lie down until dizziness is gone, then get up slowly. Move slowly and carefully,
do not hurry. Get adequate rest. Drink plenty of water and other fluids. Avoid
coffee, cigarettes, alcohol, and drugs.

Headache

Drink ample amount of water. Get adequate rest. Try to be relaxed and stress
free. Ask your doctor before taking any medicine for headache.

!### Nausea And Vomiting

Take REBLESS 10 TABLET with, or just after meals. Stick to simple meals. Avoid
eating oily or spicy foods. Get adequate rest. Drink lots of fluids, especially
water. Have small sips if you feel sick. Eat when you feel like it – you do not
need to eat or avoid any specific foods. Do not take any medicine other than
REBLESS 10 TABLET without asking your doctor.

!### Stomach Pain

Try to rest and relax. Eat and drink slowly or try to have smaller meals more
frequently. Keep a heat pad on your stomach. If the symptom does not improve,
contact your doctor.

Warning & Precautions

!### Pregnancy

ContraindicatedREBLESS 10 TABLET is not recommended for use in pregnant women as it not known
if it causes any harm to the unborn baby. Consult your doctor before taking it.

!### Breastfeeding

ContraindicatedREBLESS 10 TABLET is not recommended for use in breastfeeding women as it may
pass through the breast milk. Consult your doctor before taking it.

!### Driving and Using Machines

Use with CautionDo not drive or operate any machines if you feel dizzy after taking REBLESS 10
TABLET.

!### Kidney

Use with CautionREBLESS 10 TABLET should be taken with caution in adults with severe kidney
disease and children with moderate or severe kidney disease. Consult your doctor
before taking REBLESS 10 TABLET.

!### Liver

ContraindicatedREBLESS 10 TABLET is not recommended for use in patients with liver disease
which leads to an increased risk of bleeding. Consult your doctor before taking
REBLESS 10 TABLET.

!### Allergy

ContraindicatedDo not take REBLESS 10 TABLET if you are allergic to Rivaroxaban or any of the
other ingredients of this medicine.

!### Lungs

Use with CautionREBLESS 10 TABLET should be used with caution in patients with lung disease
where the bronchi are widened and filled with pus, or those with previous
bleeding from the lung. Consult your doctor before taking REBLESS 10 TABLET.

!### Heart Disease

Consult your doctorREBLESS 10 TABLET is not recommended for use in patients with acute coronary
syndrome, coronary artery disease, or peripheral artery disease. REBLESS 10
TABLET should be taken with caution in patients with very high or unstable blood
pressure which is not controlled by medicines, prosthetic heart valve, or
coronary artery disease with severe symptomatic heart failure. Consult your
doctor before taking REBLESS 10 TABLET.

!### Use In Pediatrics

ContraindicatedREBLESS 10 TABLET is not studied and is not recommended for use in children less
than 6 months of age who were less than 37 weeks of growth at birth, had less
than 10 days of oral feeding, or weigh 2.6 kg. REBLESS 10 TABLET is not
recommended for use in children with moderate to severe kidney disease. Consult
your doctor before taking REBLESS 10 TABLET.

!### Use In Geriatrics

Use with CautionREBLESS 10 TABLET should be used with caution in elderly patients (aged above 75
years). Consult your doctor before taking REBLESS 10 TABLET.

Others

REBLESS 10 TABLET is not recommended for use if you:

• Are bleeding excessively
• Have a disease or condition in an organ of the body that increases the risk of serious bleeding (Ex. stomach ulcer, injury or bleeding in the brain, recent operation of the brain or eyes)
• Had stroke (previously had a bleeding or a blood clot in your brain)
• Had lacunar stroke (blockage of the small arteries providing blood to the brain’s deep tissues) or ischemic, nonlacunar stroke (blood clot in your brain) in the previous month

Before taking REBLESS 10 TABLET, inform your doctor if you:

• Have or had bleeding problems
• Have antiphospholipid syndrome (immunity disorder that causes an increased risk of blood clots)
• Have diseases of your stomach or bowel that might result in bleeding (Ex. inflammation of the bowels, stomach, or food pipe) or tumours in the stomach, bowels, genital tract, or urinary tract)
• Have retinopathy (problem with the blood vessels in the back of your eyes)
• Need to have an operation
• Weigh less than 60 kg

Interactions

A. Drug-Drug interactions:

Before taking REBLESS 10 TABLET, inform your doctor if you are taking any of the
following medicine:

• Medicines used for fungal infections (Ex. fluconazole, itraconazole, voriconazole, posaconazole), unless they are used on the skin
• Ketoconazole (used to manage Cushing’s syndrome)
• Medicines used for bacterial infections (Ex. clarithromycin, erythromycin, rifampicin)
• Medicines used for HIV infection (Ex. ritonavir, indinavir)
• Other medicines used to reduce blood clotting (Ex. enoxaparin, clopidogrel, warfarin, apixaban, heparin, acenocoumarol, prasugrel, ticagrelor)
• Medicines used to manage inflammation and pain (Ex. naproxen, acetylsalicylic acid)
• Dronedarone (used to manage abnormal heartbeat)
• Medicines used to manage depression (Ex. citalopram, fluoxetine, venlafaxine, duloxetine, St. John’s wort)
• Medicines used to manage fits (Ex. carbamazepine, phenytoin, phenobarbital)

Overdosage:

If you or anyone else accidentally take too much of REBLESS 10 TABLET, consult
your doctor immediately or visit the nearby hospital. Symptom of overdose
include bleeding.

Synopsis

Drug	:	Rivaroxaban
Pharmacological Category	:	Factor Xa inhibitor
Therapeutic Indication	:	Manage deep Vein thrombosis (DVT), Pulmonary embolism (PE), Venous thromboembolism (VTE)
Dosage Forms	:	Tablet

More Information

Storage

• Keep REBLESS 10 TABLET out of reach from children
• Store REBLESS 10 TABLET between 15-30°C

FAQs About REBLESS 10 TABLET

Q: Can I take REBLESS 10 TABLET before surgery?

A: It is very important to take REBLESS 10 TABLET before and after any surgery
(including a catheter or injection into your spinal cord) exactly at the times
advised by your doctor. Inform your doctor immediately if you get numbness or
weakness in your legs or problems with your bowels or bladder after the end of
anesthesia, because urgent care is required.

Q: Can REBLESS 10 TABLET be crushed?

A: If you have difficulty swallowing REBLESS 10 TABLET whole, ask your doctor
about other ways to take REBLESS 10 TABLET. REBLESS 10 TABLET may be crushed and
mixed with water or a soft food such as apple puree just before you take it. If
required, your doctor may give you the crushed medicine through a stomach tube.

Q: What if I forget to take a dose of REBLESS 10 TABLET?

A: If you forget to take a dose of REBLESS 10 TABLET, take it as soon as you
remember and continue the management as per your prescribed schedule. Do not
take REBLESS 10 TABLET twice to make up for a forgotten dose.

Q: Can REBLESS 10 TABLET be used in pregnancy?

A: Before taking REBLESS 10 TABLET, inform your doctor if you are pregnant or
planning to become pregnant, as it may increase the risk of bleeding in you
(uterine) or in your unborn baby. It is not known if REBLESS 10 TABLET can harm
your unborn baby. Tell your doctor immediately if you become pregnant during
management with REBLESS 10 TABLET. If you take REBLESS 10 TABLET during
pregnancy, inform your doctor right away if you see any signs or symptoms of
bleeding or blood loss.

Q: What if I spit or vomit a dose of REBLESS 10 TABLET?

A: If you spit up or vomit a dose of REBLESS 10 TABLET less than 30 minutes
after you have taken it, take a new dose. If you spit REBLESS 10 TABLET up more
than 30 minutes after you took it, do not take a new dose and take the next one
at the usual time. Contact the doctor if you repeatedly spit up or vomit REBLESS
10 TABLET doses.

Q: Can REBLESS 10 TABLET be used in infants?

A: REBLESS 10 TABLET is not studied and is not recommended in children less than
6 months of age who were less than 37 weeks of growth at birth, had less than 10
days of oral feeding, or weigh less than 2.6 kg. REBLESS 10 TABLET is also not
recommended in children with moderate to severe kidney disease. Consult your
doctor before taking it.

Q: Can I stop taking REBLESS 10 TABLET?

A: If you need to stop taking REBLESS 10 TABLET for any reason, ask your doctor
to find out when you should stop taking it. Do not stop taking REBLESS 10 TABLET
without consulting your doctor first.

Useful Diagnostic Tests

• D-dimer blood test
• Duplex ultrasound
• Venography
• Magnetic resonance imaging (MRI) scan