1-FORM AND PRESENTATION:

BEXTEL

are yellow -white hard capsule. Box of 30.

2-COMPOSITION:

Each hard capsule of BEXTEL

contains celecoxib 200mg.

Inactive ingredients: lactose anhydrous, PVPK 30, croscarmellose sodium,

sodium lauryl sulfate, magnesium stearate.

3-THERAPEUTIC INDICATIONS:

BEXTEL

belongs to nonsteroidal anti-inflammatory drugs (NSAID), selective

cyclooxygenase-2 (COX-2) inhibitors. Your body makes prostaglandins

that may cause pain and inflammation. In conditions such as rheumatoid

arthritis and osteoarthritis your body makes more of these. BEXTEL

acts by

reducing the production of prostaglandins, thereby reducing the pain and

inflammation.

BEXTEL

is used in adults for the relief of signs and symptoms of rheumatoid

arthritis, osteoarthritis and ankylosing spondylitis.

You should expect your medicine to start working within hours of taking the

first dose, but you may not experience a full effect for several days.

4-POSOLOGY :

Always take this medicine exactly as your doctor or pharmacist has told

you. Check with your doctor or pharmacist if you are not sure.

Your doctor will tell you what dose you should take. As the risk of side effects

associated with heart problems may increase with dose and duration of

use, it is important that you use the lowest dose that controls your pain and

you should not take BEXTEL

for longer than necessary to control

symptoms.

Method of administration

BEXTEL

can be taken at any time of the day, with or without food. However,

try to take each dose of BEXTEL

at the same time each day.

If you have difficulty swallowing capsules: The entire capsule contents can

be sprinkled onto a level teaspoon of semi-solid food (such as cool or room

temperature applesauce, rice gruel, yogurt or mashed banana) and

swallowed immediately with a drink approximately 240 ml of water.

To open the capsule, hold upright to contain the granules at the bottom

then gently squeeze the top and twist to remove, taking care not to spill the

contents. Do not chew or crush the granules.

Contact your doctor within two weeks of starting treatment if you do not

experience any benefit.

The recommended dose is 200 mg each day, increased by your doctor to

a maximum of 400 mg, if needed.

For osteoarthritis, the dose is usually:

• one 200 mg capsule once a day; or

• one 100 mg capsule twice a day.

For rheumatoid arthritis, the dose is usually:

• one 100 mg capsule twice a day.

For ankylosing spondylitis, the dose is usually:

• one 200 mg capsule once a day; or

• one 100 mg capsule twice a day.

Kidney or liver problems: make sure your doctor knows if you have liver or

kidney problems as you may need a lower dose.

The elderly, especially those with a weight less than 50 kg: if you are over 65

years of age and especially if you weigh less than 50 kg, your doctor may

want to monitor you more closely.

You should not take more than 400 mg per day.

Use in children

BEXTEL® is for adults only, it is not for use in children.

If you take more BEXTEL

than you should

You should not take more capsules than your doctor tells you to. If you take

too many capsules contact your doctor, pharmacist or hospital and take

your medicine with you.

If you forget to take BEXTEL

If you forget to take a capsule, take it as soon as you remember. Do not take

a double dose to make up for a forgotten dose.

If you stop taking BEXTEL

Suddenly stopping your treatment with BEXTEL

may lead to your symptoms

getting worse. Do not stop taking BEXTEL

unless your doctor tells you to. Your

doctor may tell you to reduce the dose over a few days before stopping

completely.

If you have any further questions on the use of this medicine, ask your doctor

or pharmacist.

5-WARNINGS AND PRECAUTONS:

Do not take BEXTEL

Tell your doctor if any of the following are true for you as patients with these

conditions should not take BEXTEL

If you are allergic to celecoxib or any of the other ingredients of this

medicine (listed in section 2)

If you have had an allergic reaction to a group of medicines called

“sulfonamides” (e.g. some antibiotics used to treat infections)

If you currently have an ulcer in your stomach or intestines, or bleeding in

your stomach or intestines

If as a result of taking acetylsalicylic acid or any other anti-inflammatory

and pain- relieving medicine (NSAID) you have had asthma, nose polyps,

severe nose congestion, or an allergic reaction such as an itchy skin rash,

swelling of the face, lips, tongue or throat, breathing difficulties or wheezing

If you are pregnant. If you can become pregnant during ongoing treatment

you should discuss methods of contraception with your doctor

If you are breast-feeding

If you have severe liver disease

If you have severe kidney disease

If you have an inflammatory disease of the intestines such as ulcerative

colitis or Crohn’s disease

If you have heart failure, established ischemic heart disease, or

cerebrovascular disease, e.g. you have been diagnosed with a heart attack,

stroke, or transient ischemic attack (temporary reduction of blood flow to

the brain; also known as “mini-stroke”), angina, or blockages of blood vessels

to the heart or brain

If you have or have had problems with your blood circulation (peripheral

arterial disease) or if you have had surgery on the arteries of your legs

Talk to your doctor or pharmacist before taking BEXTEL

If you have previously had an ulcer or bleeding in your stomach or

intestines. (Do not take BEXTEL

if you currently have an ulcer or bleeding in

your stomach or intestine)

If you are taking acetylsalicylic acid (even at low dose for heart protective

purposes)

If you are taking antiplatelet therapies

If you use medicines to reduce blood clotting (e.g. warfarin/warfarin like

anticoagulants or novel oral anti-clotting medicines, e.g. apixaban)

If you use medicines called corticosteroids (e.g. prednisone)

If you are using BEXTEL

at the same time as other non-acetylsalicylic

NSAIDs such as ibuprofen or diclofenac. The use of these medicines together

should be avoided

If you smoke, have diabetes, raised blood pressure or raised cholesterol

If your heart, liver or kidneys are not working well your doctor may want to

keep a regular check on you

If you have fluid retention (such as swollen ankles and feet)

If you are dehydrated, for instance due to sickness, diarrhea or the use of

diuretics (used to treat excess fluid in the body)

If you have had a serious allergic reaction or a serious skin reaction to any

medicines

If you feel ill due to an infection or think you have an infection, as BEXTEL®

may mask a fever or other signs of infection and inflammation

If you are over 65 years of age your doctor will want to monitor you

regularly

the consumption of alcohol and NSAIDs may increase the risk of

gastrointestinal problem

As with other NSAIDs (e.g. ibuprofen or diclofenac) this medicine may lead

to an increase in blood pressure, and so your doctor may ask to monitor

your blood pressure on a regular basis.

Some cases of severe liver reactions, including severe liver inflammation,

liver damage, liver failure (some with fatal outcome or requiring liver

transplant), have been reported with celecoxib. Of the cases that reported

time to onset, most severe liver reactions occurred within one month of

start of treatment.

Other medicines and BEXTEL

Tell your doctor or pharmacist if you are taking, have recently taken or

might take any other medicines:

-Dextromethorphan (used to treat coughs)

-ACE inhibitors, angiotensin II antagonists, beta blockers and diuretics

(used for high blood pressure and heart failure)

-Fluconazole and rifampicin (used to treat fungal and bacterial infections)

-Warfarin or other warfarin like medicines (“blood-thinning” agents that

reduce blood clotting) including newer medicines like apixaban

-Lithium (used to treat some types of depression)

-Other medicines to treat depression, sleep disorders, high blood pressure

or an irregular heartbeat

-Neuroleptics (used to treat some mental disorders)

-Methotrexate (used to treat rheumatoid arthritis, psoriasis and

leukaemia)

-Carbamazepine (used to treat epilepsy/seizures and some forms of pain

or depression)

-Barbiturates (used to treat epilepsy/seizures and some sleep disorders)

-Ciclosporin and tacrolimus (used for immune system suppression e.g.

after transplants)

BEXTEL

can be taken with low dose acetylsalicylic acid (75 mg or less

daily). Ask your doctor for advice before taking both medicines together.

BEXTEL

contains lactose : If you have been told by your doctor that you

have an intolerance to some sugars, contact your doctor before taking

this medicinal product..

6-PREGNANCY, BREAST-FEEDING AND FERTILITY:

If you are pregnant or breast-feeding, think you may be pregnant or are

planning to have a baby, ask your doctor or pharmacist for advice before

taking this medicine.

Pregnancy

BEXTEL

must not be used by women who are pregnant or can become

pregnant during ongoing treatment. If you become pregnant during

treatment with BEXTEL

you should discontinue the treatment and contact

your doctor for alternative treatment.

Breast-feeding

BEXTEL

must not be used during breast-feeding.

Fertility

NSAIDs, including BEXTEL

, may make it more difficult to become pregnant.

You should tell your doctor if you are planning to become pregnant or if

you have problems becoming pregnant.

7- DRIVING AND USING MACHINES:

You should be aware of how you react to BEXTEL

before you drive or

operate machinery. If you feel dizzy or drowsy after taking BEXTEL

, do not

drive or operate machinery until these effects wear off.

8-ADVERSE EFFECTS:

Like all medicines, this medicine can cause side

effects, although not everybody gets them.

Very common: may affect more than 1 in 10

people

• High blood pressure, including worsening of

existing high blood pressure

Common: may affect up to 1 in 10 people

• Heart attack

• Fluid build up with swollen ankles, legs and/or

hands

• Urinary infections

• Shortness of breath, sinusitis (sinus

inflammation, sinus infection, blocked or painful

sinuses), blocked or runny nose, sore throat,

coughs, colds, flu-like symptoms

• Dizziness, difficulty sleeping

•Vomiting, stomach ache, diarrhea, indigestion,

wind

• Rash, itching

• Muscle stiffness

• Difficulty swallowing

• Headache

• Nausea (feeling sick)

• Painful joints

• Worsening of existing allergies

• Accidental injury

Uncommon: may affect up to 1 in 100 people

• Stroke

• Heart failure, palpitations (awareness of heart

beat), fast heart rate

• Abnormalities in liver-related blood tests

• Abnormalities in kidney-related blood tests

• Anaemia (changes in red blood cells that can

cause fatigue and breathlessness)

• Anxiety, depression, tiredness, drowsiness,

tingling sensations (pins and needles)

• High levels of potassium in blood test results

(can cause nausea (feeling sick), fatigue,

muscle weakness or palpitations)

• Impaired or blurred vision, ringing in the ears,

mouth pain and sores, difficulty hearing

• Constipation, burping, stomach inflammation

(indigestion, stomach ache or vomiting),

worsening of inflammation of the stomach or

intestine

• Leg cramps

• Raised itchy rash (hives)

• Eye inflammation

• Difficulty breathing

• Skin discolouration (bruising)

• Chest pain (generalised pain not related to the

heart)

• Face swelling

Rare: may affect up to 1 in 1,000 people

• Ulcers (bleeding) in the stomach, gullet or

intestines; or rupture of the intestine (can cause

stomach ache, fever, nausea, vomiting,

intestinal blockage), dark or black stools,

inflammation of the pancreas (can lead to

stomach pain), inflammation of the gullet

(oesophagus)

• Low levels of sodium in the blood (a condition

known as hyponatraemia)

• Reduced number of white blood cells (which

help to protect the body from infection) or

blood platelets (increased chance of bleeding or bruising)

• Difficulty coordinating muscular movements

• Feeling confused, changes in the way things taste

• Increased sensitivity to light

• Loss of hair

• Hallucinations

• Bleeding in the eye

• Acute reaction that may lead to lung inflammation

• Irregular heartbeat

• Flushing

• Blood clot in the blood vessels in the lungs. Symptoms may include sudden

breathlessness, sharp pains when you breathe or collapse

• Bleeding of the stomach or intestines (can lead to bloody stools or

vomiting), inflammation of the intestine or colon

• Severe liver inflammation (hepatitis). Symptoms may include nausea

(feeling sick), diarrhoea, 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 face, lips, mouth, tongue or throat, or difficulty swallowing

Very rare: may affect up to 1 in 10,000 people

• Serious allergic reactions (including potentially fatal anaphylactic shock)

• Serious skin conditions such as Stevens-Johnson syndrome, exfoliative

dermatitis and toxic epidermal necrolysis (can cause rash, blistering or

peeling of the skin) and acute generalised exanthematous pustulosis

(symptoms include the skin becoming red with swollen areas covered in

numerous small pustules)

• A delayed allergic reaction with possible symptoms such as rash, swelling

of the face, fever, swollen glands, and abnormal test results (e.g., liver, blood

cell (eosinophilia, a type of raised white blood cell count))

• Bleeding within the brain causing death

• Meningitis (inflammation of the membrane around the brain and spinal

cord)

• Liver failure, liver damage and severe liver inflammation (fulminant

hepatitis) (sometimes fatal or requiring liver transplant). Symptoms may

include nausea (feeling sick), diarrhoea, jaundice (yellow discolouration of

the skin or eyes), dark urine, pale stools, bleeding easily, itching or chills

• Liver problems (such as cholestasis and cholestatic hepatitis, which may

be accompanied by symptoms such as discoloured stools, nausea and

yellowing of the skin or eyes)

• Inflammation of the kidneys and other kidney problems (such as nephrotic

syndrome and minimal change disease, which may be accompanied by

symptoms such as water retention (oedema), foamy urine, fatigue and a

loss of appetite)

• Worsening of epilepsy (possible more frequent and/or severe seizures)

• Blockage of an artery or vein in the eye leading to partial or complete loss

of vision

• Inflamed blood vessels (can cause fever, aches, purple blotches on the

skin)

• A reduction in the number of red and white blood cells and platelets (may

cause tiredness, easy bruising, frequent nose bleeds and increased risk of

infections)

• Muscle pain and weakness

• Impaired sense of smell

• Loss of taste

Not known: frequency cannot be estimated from the available data

• Decreased fertility in females, which is usually reversible on discontinuation

of the medicine

In clinical studies not associated with arthritis or other arthritic

conditions, where BEXTEL

was taken at doses of 400 mg per day for up to

3 years, the following additional side effects have been observed:

Common: may affect up to 1 in 10 people

• Heart problems: angina (chest pain)

• Stomach problems: irritable bowel syndrome (can include stomach ache,

diarrhoea, indigestion, wind)

• Kidney stones (which may lead to stomach or back pain, blood in urine),

difficulty passing urine

• Weight gain

Read all of this leaflet carefully before you start taking this

medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor or

pharmacist.

• This medicine has been prescribed for you only. Do not pass

it onto others, it may harm them even if their signs of illness

are the same as yours.

If you get any side effects talk to you doctor or pharmacist.

This includes any possible side effects not listed in this leaflet.

®

Celecoxib 200 mg hard capsules

Uncommon: may affect up to 1 in 100 people

• Deep vein thrombosis (blood clot usually in the leg, which may cause pain,

swelling or redness of the calf or breathing problems)

• Stomach problems: stomach infection (which can cause irritation and

ulcers of the stomach and intestines)

• Lower limb fracture

• Shingles, skin infection, eczema (dry itchy rash), pneumonia (chest infection

(possible cough, fever, difficulty breathing))

• Floaters in the eye causing blurred or impaired vision, vertigo due to inner

ear troubles, sore, inflamed or bleeding gums, mouth sores

• Excessive urination at night, bleeding from piles/ haemorrhoids, frequent

bowel movements

• Fatty lumps in skin or elsewhere, ganglion cyst (harmless swellings on or

around joints and tendons in the hand or foot), difficulty speaking, abnormal

or very heavy bleeding from the vagina, breast pain

• High levels of sodium in blood test results

9.STORAGE CONDITONS:

Keep all medicines out of the reach of children.

Do not use this medicine after the expiry date which is stated on the blister

and carton. The expiry date refers to the last day of that month.

Store in a dry place below 30°C.

Do not throw away any medicines via wastewater or household waste. Ask

your pharmacist how to throw away medicines you no longer use. These

measures will help protect the environment.

Manufacturer

LIVEALTH BIOPHARMA PVT LTD,

PANCHMAHAL 389 350,

GUJARAT STATE, INDIA

Marketing Authorization Holder :

1-FORM AND PRESENTATION:

BEXTEL

are yellow -white hard capsule. Box of 30.

2-COMPOSITION:

Each hard capsule of BEXTEL

contains celecoxib 200mg.

Inactive ingredients: lactose anhydrous, PVPK 30, croscarmellose sodium,

sodium lauryl sulfate, magnesium stearate.

3-THERAPEUTIC INDICATIONS:

BEXTEL

belongs to nonsteroidal anti-inflammatory drugs (NSAID), selective

cyclooxygenase-2 (COX-2) inhibitors. Your body makes prostaglandins

that may cause pain and inflammation. In conditions such as rheumatoid

arthritis and osteoarthritis your body makes more of these. BEXTEL

acts by

reducing the production of prostaglandins, thereby reducing the pain and

inflammation.

BEXTEL

is used in adults for the relief of signs and symptoms of rheumatoid

arthritis, osteoarthritis and ankylosing spondylitis.

You should expect your medicine to start working within hours of taking the

first dose, but you may not experience a full effect for several days.

4-POSOLOGY :

Always take this medicine exactly as your doctor or pharmacist has told

you. Check with your doctor or pharmacist if you are not sure.

Your doctor will tell you what dose you should take. As the risk of side effects

associated with heart problems may increase with dose and duration of

use, it is important that you use the lowest dose that controls your pain and

you should not take BEXTEL

for longer than necessary to control

symptoms.

Method of administration

BEXTEL

can be taken at any time of the day, with or without food. However,

try to take each dose of BEXTEL

at the same time each day.

If you have difficulty swallowing capsules: The entire capsule contents can

be sprinkled onto a level teaspoon of semi-solid food (such as cool or room

temperature applesauce, rice gruel, yogurt or mashed banana) and

swallowed immediately with a drink approximately 240 ml of water.

To open the capsule, hold upright to contain the granules at the bottom

then gently squeeze the top and twist to remove, taking care not to spill the

contents. Do not chew or crush the granules.

Contact your doctor within two weeks of starting treatment if you do not

experience any benefit.

The recommended dose is 200 mg each day, increased by your doctor to

a maximum of 400 mg, if needed.

For osteoarthritis, the dose is usually:

• one 200 mg capsule once a day; or

• one 100 mg capsule twice a day.

For rheumatoid arthritis, the dose is usually:

• one 100 mg capsule twice a day.

For ankylosing spondylitis, the dose is usually:

• one 200 mg capsule once a day; or

• one 100 mg capsule twice a day.

Kidney or liver problems: make sure your doctor knows if you have liver or

kidney problems as you may need a lower dose.

The elderly, especially those with a weight less than 50 kg: if you are over 65

years of age and especially if you weigh less than 50 kg, your doctor may

want to monitor you more closely.

You should not take more than 400 mg per day.

Use in children

BEXTEL® is for adults only, it is not for use in children.

If you take more BEXTEL

than you should

You should not take more capsules than your doctor tells you to. If you take

too many capsules contact your doctor, pharmacist or hospital and take

your medicine with you.

If you forget to take BEXTEL

If you forget to take a capsule, take it as soon as you remember. Do not take

a double dose to make up for a forgotten dose.

If you stop taking BEXTEL

Suddenly stopping your treatment with BEXTEL

may lead to your symptoms

getting worse. Do not stop taking BEXTEL

unless your doctor tells you to. Your

doctor may tell you to reduce the dose over a few days before stopping

completely.

If you have any further questions on the use of this medicine, ask your doctor

or pharmacist.

5-WARNINGS AND PRECAUTONS:

Do not take BEXTEL

Tell your doctor if any of the following are true for you as patients with these

conditions should not take BEXTEL

If you are allergic to celecoxib or any of the other ingredients of this

medicine (listed in section 2)

If you have had an allergic reaction to a group of medicines called

“sulfonamides” (e.g. some antibiotics used to treat infections)

If you currently have an ulcer in your stomach or intestines, or bleeding in

your stomach or intestines

If as a result of taking acetylsalicylic acid or any other anti-inflammatory

and pain- relieving medicine (NSAID) you have had asthma, nose polyps,

severe nose congestion, or an allergic reaction such as an itchy skin rash,

swelling of the face, lips, tongue or throat, breathing difficulties or wheezing

If you are pregnant. If you can become pregnant during ongoing treatment

you should discuss methods of contraception with your doctor

If you are breast-feeding

If you have severe liver disease

If you have severe kidney disease

If you have an inflammatory disease of the intestines such as ulcerative

colitis or Crohn’s disease

If you have heart failure, established ischemic heart disease, or

cerebrovascular disease, e.g. you have been diagnosed with a heart attack,

stroke, or transient ischemic attack (temporary reduction of blood flow to

the brain; also known as “mini-stroke”), angina, or blockages of blood vessels

to the heart or brain

If you have or have had problems with your blood circulation (peripheral

arterial disease) or if you have had surgery on the arteries of your legs

Talk to your doctor or pharmacist before taking BEXTEL

If you have previously had an ulcer or bleeding in your stomach or

intestines. (Do not take BEXTEL

if you currently have an ulcer or bleeding in

your stomach or intestine)

If you are taking acetylsalicylic acid (even at low dose for heart protective

purposes)

If you are taking antiplatelet therapies

If you use medicines to reduce blood clotting (e.g. warfarin/warfarin like

anticoagulants or novel oral anti-clotting medicines, e.g. apixaban)

If you use medicines called corticosteroids (e.g. prednisone)

If you are using BEXTEL

at the same time as other non-acetylsalicylic

NSAIDs such as ibuprofen or diclofenac. The use of these medicines together

should be avoided

If you smoke, have diabetes, raised blood pressure or raised cholesterol

If your heart, liver or kidneys are not working well your doctor may want to

keep a regular check on you

If you have fluid retention (such as swollen ankles and feet)

If you are dehydrated, for instance due to sickness, diarrhea or the use of

diuretics (used to treat excess fluid in the body)

If you have had a serious allergic reaction or a serious skin reaction to any

medicines

If you feel ill due to an infection or think you have an infection, as BEXTEL®

may mask a fever or other signs of infection and inflammation

If you are over 65 years of age your doctor will want to monitor you

regularly

the consumption of alcohol and NSAIDs may increase the risk of

gastrointestinal problem

As with other NSAIDs (e.g. ibuprofen or diclofenac) this medicine may lead

to an increase in blood pressure, and so your doctor may ask to monitor

your blood pressure on a regular basis.

Some cases of severe liver reactions, including severe liver inflammation,

liver damage, liver failure (some with fatal outcome or requiring liver

transplant), have been reported with celecoxib. Of the cases that reported

time to onset, most severe liver reactions occurred within one month of

start of treatment.

Other medicines and BEXTEL

Tell your doctor or pharmacist if you are taking, have recently taken or

might take any other medicines:

-Dextromethorphan (used to treat coughs)

-ACE inhibitors, angiotensin II antagonists, beta blockers and diuretics

(used for high blood pressure and heart failure)

-Fluconazole and rifampicin (used to treat fungal and bacterial infections)

-Warfarin or other warfarin like medicines (“blood-thinning” agents that

reduce blood clotting) including newer medicines like apixaban

-Lithium (used to treat some types of depression)

-Other medicines to treat depression, sleep disorders, high blood pressure

or an irregular heartbeat

-Neuroleptics (used to treat some mental disorders)

-Methotrexate (used to treat rheumatoid arthritis, psoriasis and

leukaemia)

-Carbamazepine (used to treat epilepsy/seizures and some forms of pain

or depression)

-Barbiturates (used to treat epilepsy/seizures and some sleep disorders)

-Ciclosporin and tacrolimus (used for immune system suppression e.g.

after transplants)

BEXTEL

can be taken with low dose acetylsalicylic acid (75 mg or less

daily). Ask your doctor for advice before taking both medicines together.

BEXTEL

contains lactose : If you have been told by your doctor that you

have an intolerance to some sugars, contact your doctor before taking

this medicinal product..

6-PREGNANCY, BREAST-FEEDING AND FERTILITY:

If you are pregnant or breast-feeding, think you may be pregnant or are

planning to have a baby, ask your doctor or pharmacist for advice before

taking this medicine.

Pregnancy

BEXTEL

must not be used by women who are pregnant or can become

pregnant during ongoing treatment. If you become pregnant during

treatment with BEXTEL

you should discontinue the treatment and contact

your doctor for alternative treatment.

Breast-feeding

BEXTEL

must not be used during breast-feeding.

Fertility

NSAIDs, including BEXTEL

, may make it more difficult to become pregnant.

You should tell your doctor if you are planning to become pregnant or if

you have problems becoming pregnant.

7- DRIVING AND USING MACHINES:

You should be aware of how you react to BEXTEL

before you drive or

operate machinery. If you feel dizzy or drowsy after taking BEXTEL

, do not

drive or operate machinery until these effects wear off.

8-ADVERSE EFFECTS:

Like all medicines, this medicine can cause side

effects, although not everybody gets them.

Very common: may affect more than 1 in 10

people

• High blood pressure, including worsening of

existing high blood pressure

Common: may affect up to 1 in 10 people

• Heart attack

• Fluid build up with swollen ankles, legs and/or

hands

• Urinary infections

• Shortness of breath, sinusitis (sinus

inflammation, sinus infection, blocked or painful

sinuses), blocked or runny nose, sore throat,

coughs, colds, flu-like symptoms

• Dizziness, difficulty sleeping

•Vomiting, stomach ache, diarrhea, indigestion,

wind

• Rash, itching

• Muscle stiffness

• Difficulty swallowing

• Headache

• Nausea (feeling sick)

• Painful joints

• Worsening of existing allergies

• Accidental injury

Uncommon: may affect up to 1 in 100 people

• Stroke

• Heart failure, palpitations (awareness of heart

beat), fast heart rate

• Abnormalities in liver-related blood tests

• Abnormalities in kidney-related blood tests

• Anaemia (changes in red blood cells that can

cause fatigue and breathlessness)

• Anxiety, depression, tiredness, drowsiness,

tingling sensations (pins and needles)

• High levels of potassium in blood test results

(can cause nausea (feeling sick), fatigue,

muscle weakness or palpitations)

• Impaired or blurred vision, ringing in the ears,

mouth pain and sores, difficulty hearing

• Constipation, burping, stomach inflammation

(indigestion, stomach ache or vomiting),

worsening of inflammation of the stomach or

intestine

• Leg cramps

• Raised itchy rash (hives)

• Eye inflammation

• Difficulty breathing

• Skin discolouration (bruising)

• Chest pain (generalised pain not related to the

heart)

• Face swelling

Rare: may affect up to 1 in 1,000 people

• Ulcers (bleeding) in the stomach, gullet or

intestines; or rupture of the intestine (can cause

stomach ache, fever, nausea, vomiting,

intestinal blockage), dark or black stools,

inflammation of the pancreas (can lead to

stomach pain), inflammation of the gullet

(oesophagus)

• Low levels of sodium in the blood (a condition

known as hyponatraemia)

• Reduced number of white blood cells (which

help to protect the body from infection) or

blood platelets (increased chance of bleeding or bruising)

• Difficulty coordinating muscular movements

• Feeling confused, changes in the way things taste

• Increased sensitivity to light

• Loss of hair

• Hallucinations

• Bleeding in the eye

• Acute reaction that may lead to lung inflammation

• Irregular heartbeat

• Flushing

• Blood clot in the blood vessels in the lungs. Symptoms may include sudden

breathlessness, sharp pains when you breathe or collapse

• Bleeding of the stomach or intestines (can lead to bloody stools or

vomiting), inflammation of the intestine or colon

• Severe liver inflammation (hepatitis). Symptoms may include nausea

(feeling sick), diarrhoea, 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 face, lips, mouth, tongue or throat, or difficulty swallowing

Very rare: may affect up to 1 in 10,000 people

• Serious allergic reactions (including potentially fatal anaphylactic shock)

• Serious skin conditions such as Stevens-Johnson syndrome, exfoliative

dermatitis and toxic epidermal necrolysis (can cause rash, blistering or

peeling of the skin) and acute generalised exanthematous pustulosis

(symptoms include the skin becoming red with swollen areas covered in

numerous small pustules)

• A delayed allergic reaction with possible symptoms such as rash, swelling

of the face, fever, swollen glands, and abnormal test results (e.g., liver, blood

cell (eosinophilia, a type of raised white blood cell count))

• Bleeding within the brain causing death

• Meningitis (inflammation of the membrane around the brain and spinal

cord)

• Liver failure, liver damage and severe liver inflammation (fulminant

hepatitis) (sometimes fatal or requiring liver transplant). Symptoms may

include nausea (feeling sick), diarrhoea, jaundice (yellow discolouration of

the skin or eyes), dark urine, pale stools, bleeding easily, itching or chills

• Liver problems (such as cholestasis and cholestatic hepatitis, which may

be accompanied by symptoms such as discoloured stools, nausea and

yellowing of the skin or eyes)

• Inflammation of the kidneys and other kidney problems (such as nephrotic

syndrome and minimal change disease, which may be accompanied by

symptoms such as water retention (oedema), foamy urine, fatigue and a

loss of appetite)

• Worsening of epilepsy (possible more frequent and/or severe seizures)

• Blockage of an artery or vein in the eye leading to partial or complete loss

of vision

• Inflamed blood vessels (can cause fever, aches, purple blotches on the

skin)

• A reduction in the number of red and white blood cells and platelets (may

cause tiredness, easy bruising, frequent nose bleeds and increased risk of

infections)

• Muscle pain and weakness

• Impaired sense of smell

• Loss of taste

Not known: frequency cannot be estimated from the available data

• Decreased fertility in females, which is usually reversible on discontinuation

of the medicine

In clinical studies not associated with arthritis or other arthritic

conditions, where BEXTEL

was taken at doses of 400 mg per day for up to

3 years, the following additional side effects have been observed:

Common: may affect up to 1 in 10 people

• Heart problems: angina (chest pain)

• Stomach problems: irritable bowel syndrome (can include stomach ache,

diarrhoea, indigestion, wind)

• Kidney stones (which may lead to stomach or back pain, blood in urine),

difficulty passing urine

• Weight gain

Uncommon: may affect up to 1 in 100 people

• Deep vein thrombosis (blood clot usually in the leg, which may cause pain,

swelling or redness of the calf or breathing problems)

• Stomach problems: stomach infection (which can cause irritation and

ulcers of the stomach and intestines)

• Lower limb fracture

• Shingles, skin infection, eczema (dry itchy rash), pneumonia (chest infection

(possible cough, fever, difficulty breathing))

• Floaters in the eye causing blurred or impaired vision, vertigo due to inner

ear troubles, sore, inflamed or bleeding gums, mouth sores

• Excessive urination at night, bleeding from piles/ haemorrhoids, frequent

bowel movements

• Fatty lumps in skin or elsewhere, ganglion cyst (harmless swellings on or

around joints and tendons in the hand or foot), difficulty speaking, abnormal

or very heavy bleeding from the vagina, breast pain

• High levels of sodium in blood test results

9.STORAGE CONDITONS:

Keep all medicines out of the reach of children.

Do not use this medicine after the expiry date which is stated on the blister

and carton. The expiry date refers to the last day of that month.

Store in a dry place below 30°C.

Do not throw away any medicines via wastewater or household waste. Ask

your pharmacist how to throw away medicines you no longer use. These

measures will help protect the environment.

Manufacturer

LIVEALTH BIOPHARMA PVT LTD,

PANCHMAHAL 389 350,

GUJARAT STATE, INDIA

Marketing Authorization Holder :

Date of Revision: 17 July, 2025

Council of Arab Health Ministers

Union of Arab pharmacists

This is a medicine:

- A medicine is a product which affects

your health and its consumption

contrary to instructions is dangerous

for you.

- Follow strictly the doctor's

prescription, the method of use and

the instructions of the pharmacist who

dispensed the medicine.

- The doctor and the pharmacist are

the experts in medicine, their benefits

and risks.

- Do not by yourself interrupt the period

of treatment prescribed.

- Do not repeat the same prescription

without consulting your doctor.

- Keep all medicine out of reach of

children.

®Celecoxib 200 mg hard capsules Reg. N°:121525/1

PI044/01