Revibra 100mg Capsule 10'S

Introduction About REVIBRA 100MG CAPSULE

REVIBRA 100MG CAPSULE contains Celecoxib which belongs to group of medicines
called Non-steroidal anti-inflammatory drugs.REVIBRA 100MG CAPSULE is used in
adults to manage osteoarthritis (degenerative joint disease), rheumatoid
arthritis (inflammatory disease of joints), ankylosing spondylitis (chronic back
pain), acute pain and primary dysmenorrhea (menstrual cramps).

REVIBRA 100MG CAPSULE is also used to manage juvenile rheumatoid arthritis (in
children aged 2 years and above).

REVIBRA 100MG CAPSULE is not recommended for use in patients allergic to
Celecoxib, sulfonamides, aspirin and/or other NSAIDs. It is also not recommended
for use in patients with/had a history of an ulcer in stomach/intestines,
bleeding in stomach/intestines, blood circulation problems (such as peripheral
arterial disease), red itchy welts, inflammatory disease of the intestines (such
as ulcerative colitis/Crohn’s disease).

The medicine is also not indicted for use in patients suffering from lung
problems (such as asthma), heart diseases (such as heart failure, recent heart
attack, heart block), severe liver disease (such as advanced hepatic
insufficiency) and/or kidney disease (such as advanced renal insufficiency).

Before taking REVIBRA 100MG CAPSULE, inform your doctor if you have diabetes,
raised blood pressure, increased cholesterol, signs of fluid retention (such as
swollen ankles and feet) and/or hyperkalemia (increased potassium level in
blood).

REVIBRA 100MG CAPSULE is not recommended for use in pregnant and breast-feeding
women.

REVIBRA 100MG CAPSULE should be used with caution in children and adolescents
(aged 2 to 17 years) to manage only juvenile rheumatoid arthritis and is advised
to be used with caution in elderly patients (aged 65 years/above) after
consulting the doctor.

The most common side effects of taking REVIBRA 100MG CAPSULE are high blood
pressure, shortness of breath, sore throat, cough, headache, nausea and
dizziness. Consult your doctor if any of these symptoms worsen.

Uses Of REVIBRA 100MG CAPSULE

• Manage osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, acute pain, primary dysmenorrhea and familial adenomatous polyposis in adults
• Manage juvenile rheumatoid arthritis in children (aged 2 years and above)

How REVIBRA 100MG CAPSULE Works

REVIBRA 100MG CAPSULE works by blocking the release of COX-2 enzyme (responsible
for pain and inflammation) which provides relief from the pain and inflammation
due to arthritis and primary dysmenorrhea in affected individuals.

How to use REVIBRA 100MG CAPSULE

Capsule:

Take REVIBRA 100MG CAPSULE 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.

Mouth Dissolving Tablet:

Place REVIBRA 100MG CAPSULE inside your mouth and allow it to dissolve
completely. Do not swallow or chew the medicine. Your doctor will decide the
correct dose and duration of therapy for you depending upon your age, body
weight and disease condition.

Side Effects Of REVIBRA 100MG CAPSULE

Common

• high blood pressure (including worsening of existing high blood pressure)
• fluid buildup with swollen ankles, legs and/or hands
• urinary infections
• shortness of breath
• sinus inflammation/infection
• blocked/painful sinuses
• blocked/runny nose, sore throat, cough
• cold
• upper respiratory infection or flu like symptoms such as runny nose, sore throat and cough
• dizziness, headache
• difficulty sleeping
• stomach-ache, indigestion, nausea, vomiting, diarrhea, wind
• rash, itching
• muscle stiffness
• difficulty swallowing
• painful joints
• worsening of existing allergies
• accidental injury

Uncommon

• stroke
• heart failure
• pounding heartbeat
• fast heart rate
• anemia
• drowsiness, anxiety, depression, tiredness, tingling sensations
• signs of hyperkalemia (high potassium level in blood) such as nausea, fatigue, muscle weakness
• impaired/blurred vision
• ringing in the ears
• mouth pain and sores
• difficulty hearing
• constipation, burping,
• signs of stomach inflammation such as indigestion, stomach-ache or vomiting
• worsening of inflammation of the stomach/intestine
• leg cramps
• raised itchy rash
• eye inflammation
• difficulty breathing
• skin discoloration
• generalized chest pain not related to heart
• face swelling
• diverticulitis (inflammation/infection of one/more small pouches of digestive tract)
• inflammation of esophagus (tube connecting the mouth to stomach)
• gastroenteritis (inflammation and infection of digestive system)
• gastroesophageal reflux (digestive disease that irritates food pipe lining)
• piles
• hiatal hernia
• dark stools
• tenesmus (feeling to pass stools)
• heart disorder
• signs of hypersensitivity/allergic reaction such as difficulty swallowing/breathing, wheezing, fear/anxiety
• tiredness
• fever
• hot flushes
• peripheral pain (disorder of peripheral nerves)
• leg cramps, hypertonia (muscle overactivity)
• spinning sensation
• deafness
• joint pain
• muscle pain
• inflamed joint
• inflammation/irritation of joint
• nose bleeding
• thrombocythemia (blood disorder)
• eating disorder
• depression
• increase in appetite
• nervousness
• bronchitis (inflammation of bronchial tube that carry air to lungs)
• wheezing

Rare

• ulcers (bleeding) in the stomach, gullet or intestines
• signs of intestine rupture such as can cause stomach ache, fever, nausea, vomiting, intestinal blockage
• dark or black stools
• inflammation of the pancreas (that can lead to stomach pain)
• inflammation of the gullet (esophagus)
• signs of hyponatremia (low sodium level in blood) such as nausea and vomiting, headache, confusion
• signs of reduced number of white blood cells such as repeated fevers and infections, bladder infections, mouth sores
• signs of reduced number of platelets such as easy or excessive bruising, superficial bleeding, prolonged bleeding from cuts
• difficulty coordinating muscular movements
• feeling confused
• abnormal taste
• increased sensitivity to light
• loss of hair
• hallucinations
• bleeding in the eye
• acute reaction which may cause lung inflammation
• flushing
• signs of blood clot in lung such as sudden breathlessness, sharp pains when you breathe or collapse
• inflammation of the intestine or colon,
• signs of bleeding of the stomach or intestine such as bloody stools or vomiting
• signs liver inflammation (hepatitis) such as nausea, diarrhea, jaundice (yellow discolouration of the skin or eyes), dark urine, pale stools, bleeding easily, itching or chills
• acute kidney failure
• menstrual disturbances
• swelling of the lips, mouth, tongue or throat or difficulty swallowing

Stop taking REVIBRA 100MG CAPSULE and contact your doctor immediately if you
experience any of the signs of a severe allergic events such as:

• signs of an allergic or hypersensitivity reaction such as skin rash, swelling of the face, wheezing or difficulty breathing
• heart problems such as pain in the chest
• signs of severe stomach pain/any signs of bleeding in the stomach or intestines such as passing black/bloodstained stools or vomiting blood
• skin reaction such as rash, blistering or peeling of the skin
• signs of liver failure/hepatoxicity such as nausea, diarrhea, jaundice (yellow discolouration of the skin or eyes), tiredness
• signs of exfoliative dermatitis with symptoms such as severe inflammation of the entire skin surface
• signs of stevens-johnson syndrome with symptoms such as serious disorder of the skin and mucous membranes
• signs of toxic epidermal necrolysis with symptoms such as blistering and peeling of the skin
• signs of erythema multiforme with symptoms such as skin reaction that can be triggered by an infection
• signs of drug reaction with systemic symptoms and eosinophilia
• signs of acute generalized exanthematous pustulosis with symptoms of red skin studded with pinhead-sized bumps with white pus

How To Manage Side Effects

Diarrhea:

Drink plenty of water and stay hydrated. Try to avoid taking any medicine on
your own to manage diarrhea. Consult your doctor and inform them if the symptom
gets worse.

Dizziness:

Try to rest and get enough sleep. Try to avoid driving or operating any tools or
machines while you feel dizzy. Limit consum
dizziness. Consult and inform your doctor if the symptom worsens.

Nausea and vomiting:

Try to take REVIBRA 100MG CAPSULE with or just after a meal or a snack. Stick to
simple meals. Avoid eating rich or spicy food. Consult your doctor if symptom
gets worse.

Indigestion:

Try to have smaller and more frequent meals and drink slowly. Reduce consum
of coffee, cola, tea or alcohol and lose weight if you are obese.  Try to avoid
smoking and don’t have rich, fatty or spicy foods. Consult your doctor and
inform if the symptom does not improve.

Headache:

If REVIBRA 100MG CAPSULE causes headache, then take rest and drink plenty of
fluids. Try to avoid drinking alcohol. Ask your doctor to recommend a
painkiller. Headaches should usually go away after the first week of taking
REVIBRA 100MG CAPSULE. If it lasts more than a week or severe, inform your
doctor.

Constipation:

Try to eat high-fiber foods such as vegetables, cereals, fresh fruit and drink
plenty of water. Involve in regular exercise (going for a daily walk or run) and
if this does not help, consult and inform your doctor for receiving alternate
managements for constipation.

Tiredness:

Make sure you take rest and drink plenty of fluids. Avoid or limit the
consum
sit down (or lie down) when the symptoms are at their worst. Avoid driving or
using tools or machinery until you feel well.

Warning & Precautions

!### Pregnancy

REVIBRA 100MG CAPSULE is not recommended for use during pregnancy and in women
planning for pregnancy. Consult your doctor before taking the medicine.

!### Breastfeeding

REVIBRA 100MG CAPSULE is not recommended for use in breastfeeding women. Consult
your doctor before taking the medicine.

!### Driving and Using Machines

Do not take drive or operate machines if you feel dizzy or drowsy after taking
REVIBRA 100MG CAPSULE.

!### Alcohol

Avoid consum
increase the risk of getting a stomach ulcer/intestinal bleeding.

!### Kidney

REVIBRA 100MG CAPSULE is not recommended in patients with kidney disease such as
severe renal insufficiency. It should be used with caution in patients with
kidney disease. Consult your doctor before taking the medicine.

!### Liver

REVIBRA 100MG CAPSULE is not recommended for use in patients with liver disease
such as severe hepatic impairment. It should be used with caution in patients
with elevated liver enzymes, hepatotoxicity, moderate hepatic impairment.
Consult your doctor before taking.

!### Allergy

Do not take REVIBRA 100MG CAPSULE if you are allergic to Celecoxib,
sulfonamides, aspirin, other NSAIDs and/or any of the other ingredients of this
medicine.

!### Lungs

REVIBRA 100MG CAPSULE is not recommended for use in patients with asthma.
Consult your doctor before taking the medicine.

!### Heart Disease

REVIBRA 100MG CAPSULE is not recommended for use in patients with heart problems
such as heart failure, ischemic heart disease, recent heart attack, heart block,
perioperative period in the setting of coronary artery bypass graft surgery. It
should be used with caution in patients with cardiovascular (CV) thrombotic
events, myocardial infarction, stroke and congestive heart failure. Consult your
doctor before taking.

Others

REVIBRA 100MG CAPSULE is not recommended for use if you:

• have/had an ulcer in stomach/intestines
• have/had suffered from bleeding in stomach/intestines
• suffer from an inflammatory disease of the intestines such as ulcerative colitis/Crohn’s disease
• had problems with your blood circulation such as peripheral arterial disease
• had surgery on the arteries of your legs
• have urticaria (red itchy skin)

Before taking REVIBRA 100MG CAPSULE, inform your doctor if you:

• new onset or worsening of hypertension
• have diabetes
• have raised blood pressure
• have increased cholesterol
• are taking antiplatelet therapies
• have signs of fluid retention such as swollen ankles and feet
• are dehydrated due to sickness or diarrhea
• are a smoker
• have serious allergic reaction or a serious skin reaction to any medicines
• feel ill due to an infection or think you have an infection
• have hyperkalemia (increased potassium level in blood)
• signs of anaphylaxis (life threatening allergic reaction) such as lightheadedness, faint, breathing difficulties, wheezing
• disseminated intravascular coagulation (serious blood disorder)
• are suffering from skin reactions such as exfoliative dermatitis, stevens-johnson syndrome and toxic epidermal necrolysis
• have lactose intolerance

Use in Pediatrics:

REVIBRA 100MG CAPSULE should be used with caution in children and adolescents
(aged 2 to 17 years) only to manage juvenile rheumatoid arthritis. It is not
recommended to manage other conditions in children except juvenile rheumatoid
arthritis. Consult your doctor before takingthe medicine.

Use in Geriatrics:

REVIBRA 100MG CAPSULE should be used with caution in elderly patients (aged
above 65-years.) Consult your doctor before taking the medicine.

Interactions

A. Drug - Drug interactions:

Before taking REVIBRA 100MG CAPSULE, inform your doctor if you are taking,

• dextromethorphan (used to manage coughs)
• fluconazole, rifampicin, ketoconazole (used to manage fungal infections)
• warfarin (used to manage blood clots)
• lithium (used to manage depressive disorders)
• antidepressants (medicines used to manage depression) such as SSRI (Ex. fluoxetine, paroxetine), SNRI (Ex. duloxetine)
• barbiturates (used to manage epilepsy/seizures, sleep disorders) Ex. phenobarbital
• medicines used to manage irregular heartbeat (Ex. digoxin, flecainide, amiodarone)
• neurole
• methotrexate (used to manage rheumatoid arthritis, psoriasis and leukemia)
• carbamazepine (used to manage epilepsy, pain or depression)
• ciclosporin and tacrolimus (used for immune system suppression)
• sulfonamides (used to manage bacterial infections) Ex. sulfadiazine
• NSAIDS (used to reduce pain, fever or inflammation) Ex. aspirin, ibuprofen, diclofenac
• glyburide, tolbutamide (medicines used to manage type 2 diabetes)
• phenytoin (medicine used to manage seizures)
• corticosteroids (used to provide relief from inflammation) Ex. prednisolone
• pemetrexed (used to manage metastatic non squamous small lung cancer)
• medicines used to manage hypertension and other disorders such as ACE inhibitors (Ex. benazepril), angiotensin II antagonists (Ex. azilsartan), beta blockers (Ex. acebutolol), diuretics (Ex. chlorothiazide)

Overdosage:

If you or anyone else accidentally take too much of REVIBRA 100MG CAPSULE,
consult your doctor immediately or visit the nearby hospital. Symptoms of
overdose include lethargy, drowsiness, nausea, vomiting, epigastric pain
(pain/discomfort in upper abdominal region), gastrointestinal bleeding, high
blood pressure, acute renal failure, respiratory depression and coma.

Synopsis

Drug	:	Celecoxib
Pharmacological Category	:	COX-2 Inhibitor
Therapeutic Indication	:	Osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, in patients 2 years and older, ankylosing spondylitis, acute pain, primary dysmenorrhea, familial adenomatous polyposis
Dosage Forms	:	Capsule, Mouth Dissolving Tablet

More Information

• Keep REVIBRA 100MG CAPSULE out of reach of children
• Store the medicine below 30°C

FAQs About REVIBRA 100MG CAPSULE

What REVIBRA 100MG CAPSULE is used for?

REVIBRA 100MG CAPSULE is used in adults to manage osteoarthritis (joint
disease), rheumatoid arthritis, ankylosing spondylitis (inflammatory disease
affecting spine and large joints), acute pain, primary dysmenorrhea (menstrual
cramps), familial adenomatous polyposis (inherited disorder due to cancer of
large intestine and rectum) which is also used to manage juvenile rheumatoid
arthritis (type of joint pain) in children (aged 2 years and above).

Does REVIBRA 100MG CAPSULE cause dizziness?

Yes, you may feel dizzy after taking REVIBRA 100MG CAPSULE since dizziness is
the most common side effect associated with the use of the medicine. If you feel
dizzy, then try to keep your eyes closed or lie down and try not to
drive/operate machinery. Consult your doctor if the symptom worsens or does not
improve.

Can REVIBRA 100MG CAPSULE be used during pregnancy?

No, [GNBKEYWORD] is not recommended to be used during pregnancy and in women
planning for pregnancy since it may cause harm to the developing baby. Consult
your doctor before taking the medicine.

How much dose shouldREVIBRA 100MG CAPSULE be taken in a day?

Take REVIBRA 100MG CAPSULE as advised by your physician. Do not crush or chew
the medicine. Swallow the medicine with glass of water. Your doctor will decide
the correct dose and duration for you depending upon your age, body weight and
disease condition.

Can alcohol be consumed after taking REVIBRA 100MG CAPSULE?

No, alcohol should be avoided after taking REVIBRA 100MG CAPSULE since it
increases the risk of getting a stomach ulcer or intestinal bleeding in patients
receiving management with the medicine. Consult your doctor before taking the
medicine to avoid undesirable effects due to intake of alcohol.

Useful Diagnostic Tests

• X-Ray
• Blood test