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CELECOXIB 200 MG HARD CAPSULES

Active substance(s): CELECOXIB

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504139/PL1c
®

Celebrex 200 mg Hard Capsules
(celecoxib)
Patient Information Leaflet
®
The name of your medicine is Celebrex 200 mg Hard
Capsules. Throughout this leaflet it will be referred to as
®
Celebrex .
Read all of this leaflet carefully before you start taking
this medicine
- Keep this leaflet. You may need to read it again.
- If you have any further questions, please ask your
doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass
it on to others. It may harm them, even if their
symptoms are the same as yours.
- If any of the side effects gets serious or if you notice any
side effects not listed in this leaflet, please tell your
doctor or pharmacist.
In this leaflet:
®
1) What Celebrex is and what it is used for
®
2) Before you take Celebrex
®
3) How to take Celebrex
4) Possible side effects
®
5) How to store Celebrex
6) Further information
®

1) WHAT CELEBREX IS AND WHAT IT IS USED FOR
®
Celebrex is used for the relief of signs and symptoms of
rheumatoid arthritis, osteoarthritis and ankylosing
spondylitis.
®

Celebrex belongs to a group of medicinal products called
nonsteroidal anti-inflammatory drugs (NSAID), and specifically
a sub-group known as (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. Celebrex acts by reducing the
production of prostaglandins, thereby reducing the pain and
inflammation.

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.
®

Celebrex may make it more difficult to become pregnant.
You should inform your doctor if you are planning to become
pregnant or if you have problems to become pregnant (see
section on Pregnancy and breast-feeding).
Taking other medicines
Some medicines can affect the way other medicines work.
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines
obtained without a prescription:
• Dextromethorphan (used to treat coughs)
• ACE inhibitors or angiotensin II antagonists (used for high
blood pressure and heart failure)
• Diuretics (used to treat excess fluid in the body)
• Fluconazole and rifampicin (used to treat fungal and
bacterial infections)
• Warfarin or other oral anticoagulants (“blood-thinning”
agents that reduce blood clotting)
• 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)
®

Celebrex can be taken with low dose acetylsalicylic acid
(75mg or less daily). Ask your doctor for advice before taking
both medicines together.

®

2) BEFORE YOU TAKE CELEBREX
®
You have been prescribed Celebrex by your doctor. The
following information will help you get the best results with
®
Celebrex . If you have any further questions please ask your
doctor or pharmacist.
®

Do not take Celebrex
Tell your doctor if any of the following are true for you as
®
patients with these conditions should not take Celebrex .
• if you are allergic (hypersensitive) to celecoxib or any of
®
the other ingredients of Celebrex
• if you have had an allergic reaction to a group of
medicines called “sulphonamides” (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 ischaemic heart
disease, or cerebrovascular disease, e.g. you have been
diagnosed with a heart attack, stroke, or transient
ischaemic 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
®

Take special care with Celebrex
Check with your doctor if any of the following applies to
you:
• if you have previously had an ulcer or bleeding in your
®
stomach or intestines. (Do not take Celebrex 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 use medicines to reduce blood clotting (e.g.
warfarin)
®
• if you are using Celebrex at the same time as other nonacetylsalicylic 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,
diarrhoea 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 Celebrex may mask a fever or other signs
of infection and inflammation
• if you are over 65 years of age your doctor may want to
keep a regular check on you
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.

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any
medicine.
®

Celebrex must not be used by women who are pregnant or
can become pregnant (i.e. women of child bearing potential
who are not using adequate contraception) during ongoing
treatment. If you become pregnant during treatment with
®
Celebrex you should discontinue the treatment and contact
your doctor for alternative treatment.
®

Celebrex must not be used during breast-feeding.
Driving and using machines
®
You should be aware of how you react to Celebrex before
you drive or operate machinery. If you feel dizzy or drowsy
®
after taking Celebrex , do not drive or operate machinery until
these effects wear off.
Important information about some of the ingredients of
®
Celebrex
®
Celebrex contains lactose (a type of sugar). If you have
been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicinal
product.
®

3) HOW TO TAKE CELEBREX
®
Always take Celebrex exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are
®
unsure. If you think or feel that the effect of Celebrex is too
strong or too weak, talk to your doctor or pharmacist.
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 Celebrex for longer than necessary to control
symptoms.
®

Celebrex should be swallowed whole with a drink of
water. The capsules can be taken at any time of the day, with
®
or without food. However, try to take each dose of Celebrex
at the same time each day.
Contact your doctor within two weeks of starting treatment if
you do not experience any benefit.
For osteoarthritis the usual dose is 200 mg each day,
increased by your doctor to a maximum of 400 mg, if needed.
The dose is usually:
• one 200 mg capsule once a day; or
• one 100 mg capsule twice a day.
For rheumatoid arthritis the usual dose is 200 mg each day,
increased by your doctor to a maximum of 400 mg, if needed.
The dose is usually:
• one 100 mg capsule twice a day.
For ankylosing spondylitis the usual dose is 200 mg each
day, increased by your doctor to a maximum of 400 mg, if
needed.
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.
®

Children: Celebrex
children.

is for adults only, it is not for use in

You should not take more than 400 mg per day.

®

If you take more Celebrex 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 Celebrex :
If you forget to take a capsule, take it as soon as you
remember. Do not take a double dose to make up for
forgotten doses.
®

If you stop taking Celebrex :
®
Suddenly stopping your treatment with Celebrex may lead to
®
your symptoms getting worse. Do not stop taking Celebrex
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 product,
ask your doctor or pharmacist.
4) POSSIBLE SIDE EFFECTS
®
Like all medicines, Celebrex can have side-effects, although
not everybody gets them.
If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, tell your doctor or pharmacist.
The side effects listed below were observed in arthritis
®
patients who took Celebrex . Side effects marked with an
asterisk (*) are listed below at the higher frequencies that
®
occurred in patients who took Celebrex to prevent colon
®
polyps. Patients in these studies took Celebrex at high
doses and for a long duration.
®

If any of the following happen, stop taking Celebrex and
tell your doctor immediately:
If you have:
• an allergic reaction such as skin rash, swelling of the
face, wheezing or difficulty breathing
• heart problems such as pain in the chest
• severe stomach pain or any sign of bleeding in the
stomach or intestines, such as passing black or
bloodstained stools, or vomiting blood
• a skin reaction such as rash, blistering or peeling of the
skin
• liver failure (symptoms may include nausea (feeling sick),
diarrhoea, jaundice (your skin or the whites of your eyes
look yellow))
Very common: affects more than 1 user in 10:
• High blood pressure*
Common: affects 1 to 10 users in 100:
• 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, diarrhoea, indigestion, wind
• Rash, itching
• Muscle stiffness
• Difficulty swallowing*
• Worsening of existing allergies
Uncommon: affects 1 to 10 users in 1,000:
• Stroke*
• Heart failure, palpitations (awareness of heart beat), fast
heart rate
• Worsening of existing high blood pressure
• 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)
Rare: affects 1 to 10 users in 10,000:
• 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 gullet (can cause difficulty in
swallowing), inflammation of the pancreas (can lead to
stomach pain)
• Reduced number of white blood cells (which help protect
the body from infection) and 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
Not known: frequency cannot be estimated from the
available data:
• Bleeding within the brain causing death
• Serious allergic reactions (including potentially fatal
anaphylactic shock) which can cause skin rash, swelling
of the face, lips, mouth, tongue or throat, wheezing or
difficulty breathing; difficulty swallowing
• Bleeding of the stomach or intestines (can lead to bloody
stools or vomiting), inflammation of the intestine or colon,
nausea (feeling sick)
• 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
(red swollen area with 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)).
• Liver failure, liver damage and severe liver inflammation
(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
• Kidney problems (possible kidney failure, inflammation of
the kidneys)
• Blood clot in the blood vessels in the lungs. Symptoms
may include sudden breathlessness, sharp pains when
you breathe or collapse
• Irregular heartbeat
• Meningitis (inflammation of the membrane around the
brain and spinal cord)
• Hallucinations
• Worsening of epilepsy (possible more frequent and/or
severe seizures)
• Inflamed blood vessels (can cause fever, aches, purple
blotches on the skin)
• Blockage of an artery or vein in the eye leading to partial
or complete loss of vision, inflammation of the
conjunctiva, bleeding in the eye
• 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)
• Chest pain
• Impaired sense of smell
• Skin discolouration (bruising), muscle pain and
weakness, painful joints
• Menstrual disturbances
• Headache, flushing
• Low levels of sodium in blood test results (can cause loss
of appetite, headache, nausea (feeling sick), muscle
cramps and weakness)
In clinical studies not associated with Arthritis or other
®
arthritic conditions, where Celebrex was taken at doses
of 400 mg per day for up to 3 years, the following
additional side effects have been observed:
Common: affects 1 to 10 users in 100:
• 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: affects 1 to 10 users in 1,000:
• 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
If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, tell your doctor or pharmacist.
®

5) HOW TO STORE CELEBREX
Keep out of the sight and reach of children.
®
Do not use Celebrex after the expiry date stated on the
blister and carton. The expiry date refers to the last day of that
month.
Do not store above 30° C.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.
If you notice any sign of discolouration or deterioration of your
medicine, please tell your pharmacist immediately.
6) FURTHER INFORMATION
®
What Celebrex contains
The active substance is celecoxib. Each capsule contains 200
mg celecoxib.
The other ingredients are: lactose
monohydrate, sodium lauryl sulphate, povidone K30,
croscarmellose sodium, magnesium stearate. Capsule shells
contain gelatin, titanium dioxide E171, sodium lauryl sulfate
and sorbitan monolaurate. Ink contains yellow iron oxide
E172, shellac and propylene glycol.
®

What Celebrex looks like and contents of the pack
®
Celebrex is available as opaque, white capsules with two
gold bands marked ‘7767’ and ‘200’. The capsules are
packaged in clear and opaque PVC blisters or aluminium
blisters, and come in packs of 20 or 30 capsules.
Product Licence Holder:
Procured from within the EU. Product Licence Holder Ginova
Ltd and repackager Ginova UK Ltd both of St James’ House,
8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufacturers:
Pfizer Manufacturing Deutschland GmbH, Heinrich-MackStrasse 35, D-89257, Illertissen, Germany.
®

Celebrex 200 mg Hard Capsules
PL No: 18067/0427
POM
®

Celebrex is a registered trademark.
th

This leaflet was last approved on 17 June 2014.
To request a copy of this leaflet in Braille, large print or audio
please call 01622 690172.
504139/PL1c

504140/PL1c

Celecoxib 200 mg Hard Capsules
Patient Information Leaflet
The name of your medicine is Celecoxib 200 mg Hard
Capsules. Throughout this leaflet it will be referred to as
Celecoxib.
Read all of this leaflet carefully before you start taking
this medicine
- Keep this leaflet. You may need to read it again.
- If you have any further questions, please ask your
doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass
it on to others. It may harm them, even if their
symptoms are the same as yours.
- If any of the side effects gets serious or if you notice any
side effects not listed in this leaflet, please tell your
doctor or pharmacist.
In this leaflet:
1) What Celecoxib is and what it is used for
2) Before you take Celecoxib
3) How to take Celecoxib
4) Possible side effects
5) How to store Celecoxib
6) Further information
1) WHAT CELECOXIB IS AND WHAT IT IS USED FOR
Celecoxib is used for the relief of signs and symptoms of
rheumatoid arthritis, osteoarthritis and ankylosing
spondylitis.
Celecoxib belongs to a group of medicinal products called
nonsteroidal anti-inflammatory drugs (NSAID), and specifically
a sub-group known as (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. Celecoxib acts by reducing the
production of prostaglandins, thereby reducing the pain and
inflammation.
2) BEFORE YOU TAKE CELECOXIB
You have been prescribed Celecoxib by your doctor. The
following information will help you get the best results with
Celecoxib. If you have any further questions please ask your
doctor or pharmacist.
Do not take Celecoxib
Tell your doctor if any of the following are true for you as
patients with these conditions should not take Celecoxib.
• if you are allergic (hypersensitive) to celecoxib or any of
the other ingredients of Celecoxib
• if you have had an allergic reaction to a group of
medicines called “sulphonamides” (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 ischaemic heart
disease, or cerebrovascular disease, e.g. you have been
diagnosed with a heart attack, stroke, or transient
ischaemic 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
Take special care with Celecoxib
Check with your doctor if any of the following applies to
you:
• if you have previously had an ulcer or bleeding in your
stomach or intestines. (Do not take Celecoxib 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 use medicines to reduce blood clotting (e.g.
warfarin)
• if you are using Celecoxib at the same time as other nonacetylsalicylic 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,
diarrhoea 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 Celecoxib may mask a fever or other signs of
infection and inflammation
• if you are over 65 years of age your doctor may want to
keep a regular check on you
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.
Celecoxib may make it more difficult to become pregnant. You
should inform your doctor if you are planning to become
pregnant or if you have problems to become pregnant (see
section on Pregnancy and breast-feeding).
Taking other medicines
Some medicines can affect the way other medicines work.
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines
obtained without a prescription:
• Dextromethorphan (used to treat coughs)
• ACE inhibitors or angiotensin II antagonists (used for high
blood pressure and heart failure)
• Diuretics (used to treat excess fluid in the body)
• Fluconazole and rifampicin (used to treat fungal and
bacterial infections)
• Warfarin or other oral anticoagulants (“blood-thinning”
agents that reduce blood clotting)
• 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)
Celecoxib can be taken with low dose acetylsalicylic acid
(75mg or less daily). Ask your doctor for advice before taking
both medicines together.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any
medicine.
Celecoxib must not be used by women who are pregnant or
can become pregnant (i.e. women of child bearing potential
who are not using adequate contraception) during ongoing
treatment. If you become pregnant during treatment with
Celecoxib you should discontinue the treatment and contact
your doctor for alternative treatment.
Celecoxib must not be used during breast-feeding.
Driving and using machines
You should be aware of how you react to Celecoxib before
you drive or operate machinery. If you feel dizzy or drowsy
after taking Celecoxib, do not drive or operate machinery until
these effects wear off.
Important information about some of the ingredients of
Celecoxib
Celecoxib contains lactose (a type of sugar). If you have
been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicinal
product.
3) HOW TO TAKE CELECOXIB
Always take Celecoxib exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are
unsure. If you think or feel that the effect of Celecoxib is too
strong or too weak, talk to your doctor or pharmacist.
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 Celecoxib for longer than necessary to control
symptoms.
Celecoxib should be swallowed whole with a drink of
water. The capsules can be taken at any time of the day, with
or without food. However, try to take each dose of Celecoxib
at the same time each day.
Contact your doctor within two weeks of starting treatment if
you do not experience any benefit.
For osteoarthritis the usual dose is 200 mg each day,
increased by your doctor to a maximum of 400 mg, if needed.
The dose is usually:
• one 200 mg capsule once a day; or
• one 100 mg capsule twice a day.
For rheumatoid arthritis the usual dose is 200 mg each day,
increased by your doctor to a maximum of 400 mg, if needed.
The dose is usually:
• one 100 mg capsule twice a day.
For ankylosing spondylitis the usual dose is 200 mg each
day, increased by your doctor to a maximum of 400 mg, if
needed.
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.
Children: Celecoxib is for adults only, it is not for use in
children.
You should not take more than 400 mg per day.

If you take more Celecoxib 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 Celecoxib:
If you forget to take a capsule, take it as soon as you
remember. Do not take a double dose to make up for
forgotten doses.
If you stop taking Celecoxib:
Suddenly stopping your treatment with Celecoxib may lead to
your symptoms getting worse. Do not stop taking Celecoxib
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 product,
ask your doctor or pharmacist.
4) POSSIBLE SIDE EFFECTS
Like all medicines, Celecoxib can have side-effects, although
not everybody gets them.
If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, tell your doctor or pharmacist.
The side effects listed below were observed in arthritis
patients who took Celecoxib. Side effects marked with an
asterisk (*) are listed below at the higher frequencies that
occurred in patients who took Celecoxib to prevent colon
polyps. Patients in these studies took Celecoxib at high
doses and for a long duration.
If any of the following happen, stop taking Celecoxib and
tell your doctor immediately:
If you have:
• an allergic reaction such as skin rash, swelling of the
face, wheezing or difficulty breathing
• heart problems such as pain in the chest
• severe stomach pain or any sign of bleeding in the
stomach or intestines, such as passing black or
bloodstained stools, or vomiting blood
• a skin reaction such as rash, blistering or peeling of the
skin
• liver failure (symptoms may include nausea (feeling sick),
diarrhoea, jaundice (your skin or the whites of your eyes
look yellow))
Very common: affects more than 1 user in 10:
• High blood pressure*
Common: affects 1 to 10 users in 100:
• 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, diarrhoea, indigestion, wind
• Rash, itching
• Muscle stiffness
• Difficulty swallowing*
• Worsening of existing allergies
Uncommon: affects 1 to 10 users in 1,000:
• Stroke*
• Heart failure, palpitations (awareness of heart beat), fast
heart rate
• Worsening of existing high blood pressure
• 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)
Rare: affects 1 to 10 users in 10,000:
• 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 gullet (can cause difficulty in
swallowing), inflammation of the pancreas (can lead to
stomach pain)
• Reduced number of white blood cells (which help protect
the body from infection) and 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
Not known: frequency cannot be estimated from the
available data:
• Bleeding within the brain causing death
• Serious allergic reactions (including potentially fatal
anaphylactic shock) which can cause skin rash, swelling
of the face, lips, mouth, tongue or throat, wheezing or
difficulty breathing; difficulty swallowing
• Bleeding of the stomach or intestines (can lead to bloody
stools or vomiting), inflammation of the intestine or colon,
nausea (feeling sick)
• 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
(red swollen area with 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)).
• Liver failure, liver damage and severe liver inflammation
(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
• Kidney problems (possible kidney failure, inflammation of
the kidneys)
• Blood clot in the blood vessels in the lungs. Symptoms
may include sudden breathlessness, sharp pains when
you breathe or collapse
• Irregular heartbeat
• Meningitis (inflammation of the membrane around the
brain and spinal cord)
• Hallucinations
• Worsening of epilepsy (possible more frequent and/or
severe seizures)
• Inflamed blood vessels (can cause fever, aches, purple
blotches on the skin)
• Blockage of an artery or vein in the eye leading to partial
or complete loss of vision, inflammation of the
conjunctiva, bleeding in the eye
• 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)
• Chest pain
• Impaired sense of smell
• Skin discolouration (bruising), muscle pain and
weakness, painful joints
• Menstrual disturbances
• Headache, flushing
• Low levels of sodium in blood test results (can cause loss
of appetite, headache, nausea (feeling sick), muscle
cramps and weakness)
In clinical studies not associated with Arthritis or other
arthritic conditions, where Celecoxib was taken at doses
of 400 mg per day for up to 3 years, the following
additional side effects have been observed:
Common: affects 1 to 10 users in 100:
• 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: affects 1 to 10 users in 1,000:
• 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
If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, tell your doctor or pharmacist.
5) HOW TO STORE CELECOXIB
Keep out of the sight and reach of children.
Do not use Celecoxib after the expiry date stated on the
blister and carton. The expiry date refers to the last day of that
month.
Do not store above 30° C.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.
If you notice any sign of discolouration or deterioration of your
medicine, please tell your pharmacist immediately.
6) FURTHER INFORMATION
What Celecoxib contains
The active substance is celecoxib. Each capsule contains 200
mg celecoxib.
The other ingredients are: lactose
monohydrate, sodium lauryl sulphate, povidone K30,
croscarmellose sodium, magnesium stearate. Capsule shells
contain gelatin, titanium dioxide E171, sodium lauryl sulfate
and sorbitan monolaurate. Ink contains yellow iron oxide
E172, shellac and propylene glycol.
What Celecoxib looks like and contents of the pack
Celecoxib is available as opaque, white capsules with two
gold bands marked ‘7767’ and ‘200’. The capsules are
packaged in clear and opaque PVC blisters or aluminium
blisters, and come in packs of 20 or 30 capsules.
Product Licence Holder:
Procured from within the EU. Product Licence Holder Ginova
Ltd and repackager Ginova UK Ltd both of St James’ House,
8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufacturers:
Pfizer Manufacturing Deutschland GmbH, Heinrich-MackStrasse 35, D-89257, Illertissen, Germany.
Celecoxib 200 mg Hard Capsules
PL No: 18067/0427
POM
th

This leaflet was last approved on 17 June 2014.
To request a copy of this leaflet in Braille, large print or audio
please call 01622 690172.
504140/PL1c

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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