Skip to Content

UK Edition. Click here for US version.

CELECOXIB 200 MG HARD CAPSULES

Active substance(s): CELECOXIB

View full screen / Print PDF » Download PDF ⇩
Transcript
Package leaflet:
Information for the user

Celebrex® 200 mg hard
capsules
(celecoxib)
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 on to
others. It may harm them, even if
their signs of illness are the same
as yours.
• If you get any side effects, talk to
your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section
4.
This medicine is known as Celebrex
200 mg hard capsules, but will be
referred to as Celebrex. Other strength
“100 mg” is also available
What is in this leaflet:
1. What Celebrex is and what it is
used for
2. What you need to know before
you take Celebrex
3. How to take Celebrex
4. Possible side effects
5. How to store Celebrex
6. Contents of the pack and other
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.

2. What you need to know
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 to celecoxib or any
of the other ingredients of this
medicine (listed in section 6)
• 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 “ministroke”), 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

Warnings and precautions
Talk to your doctor before taking
Celebrex:
• 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 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, 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.
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).

Other medicines and Celebrex
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 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 (75 mg or less
daily). Ask your doctor for advice before
taking both medicines together.

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
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.

Breast-feeding
Celebrex must not be used during
breast-feeding.

Fertility
NSAIDs, including Celebrex, 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.

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.

Celebrex contains
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 this medicine exactly as
your doctor has told you. Check with
your doctor or pharmacist if you are not
sure. 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.
You should not take more than 400 mg
per day.
Use in children: Celebrex is for adults
only, it is not for use in children.

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 a forgotten
dose.

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 medicine, ask your doctor or
pharmacist.

4. Possible side effects
Like all medicines, this medicine can
cause side effects, although not
everybody gets them.
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: 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, flulike symptoms
• Dizziness, difficulty sleeping
• Vomiting*, stomach ache, diarrhoea,
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)

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 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
• 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

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 Celebrex 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

Reporting of side effects
If you get any side effects, talk to
your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. You can
also report side effects directly via
the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can
help provide more information on
the safety of this medicine.

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 Celebrex above 30°C.
Store in the original package.
If your tablets become discoloured or
show any other signs of deterioration,
you should seek the advice of your
pharmacist who will tell you what to do.
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.

6. Further information
What Celebrex contains
The active substance is celecoxib.
Each hard capsule contains celecoxib
200 mg.
The other ingredients are:
Lactose monohydrate, sodium lauryl
sulphate, povidone K30,
croscarmellose sodium, magnesium
stearate. Capsule shells contain gelatin,
titanium dioxide E171, printing ink.

What Celebrex looks like and
contents of the pack
Celebrex is available as hard capsules.
Hard capsules, opaque, white with two
gold bands marked 7767 on the
capsule cap and 200 on the capsule
body in a white contrast.
The capsules are packaged in clear
and opaque PVC blisters or aluminium
blisters.
Celebrex is contained in packs of 30.

Manufacturer:
Pfizer Manufacturing Deutschland
GmbH
Heinrich-Mack-Strasse 35
D-89257 Illertissen
Germany
or
Piramal Healthcare UK Limited
Walton Road
Morpeth
Northumberland NE61 3YA
UK
Procured from within the EU. Product
Licence Holder and repackaged by:
S.C.A.C. Ltd., Unit 2a, Bandeath
Industrial Estate, Throsk, Stirling, FK7
7NP, UK.
For any information about this
medicine, please contact:
Medical Information
Pfizer Ltd
Walton Oaks
Dorking Road
Tadworth
Surrey
KT20 7NS
Telephone: 01304 616161
POM

PL: 30984/0078

Celebrex® is a registered trademark
of Pfizer Limited, UK
Revision date: 06.01.2015

Package leaflet:
Information for the user

Celecoxib 200 mg hard
capsules
(celecoxib)
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 on to
others. It may harm them, even if
their signs of illness are the same
as yours.
• If you get any side effects, talk to
your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section
4.
This medicine is known as Celecoxib
200 mg hard capsules, but will be
referred to as Celecoxib. Other strength
“100 mg” is also available
What is in this leaflet:
1. What Celecoxib is and what it is
used for
2. What you need to know before
you take Celecoxib
3. How to take Celecoxib
4. Possible side effects
5. How to store Celecoxib
6. Contents of the pack and other
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. What you need to know
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 to celecoxib or any
of the other ingredients of this
medicine (listed in section 6)
• 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 “ministroke”), 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





Warnings and precautions
Talk to your doctor before taking
Celecoxib:
• 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).

Other medicines and Celecoxib
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 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 (75 mg or less
daily). Ask your doctor for advice before
taking both medicines together.

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
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.

Breast-feeding
Celecoxib must not be used during
breast-feeding.

Fertility
NSAIDs, including Celecoxib, 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.

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.

Celecoxib contains
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 this medicine exactly as
your doctor has told you. Check with
your doctor or pharmacist if you are not
sure. 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.
You should not take more than 400 mg
per day.
Use in children: Celecoxib is for adults
only, it is not for use in children.

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 a forgotten
dose.

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 medicine, ask your doctor or
pharmacist.

4. Possible side effects
Like all medicines, this medicine can
cause side effects, although not
everybody gets them.
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: 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, flulike symptoms

• Dizziness, difficulty sleeping
• Vomiting*, stomach ache, diarrhoea,
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)

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 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
• 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

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 Celecoxib 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

Reporting of side effects
If you get any side effects, talk to
your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. You can
also report side effects directly via
the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can
help provide more information on
the safety of this medicine.

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 Celecoxib above 30°C.
Store in the original package.
If your tablets become discoloured or
show any other signs of deterioration,
you should seek the advice of your
pharmacist who will tell you what to do.
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.

6. Further information
What Celecoxib contains
The active substance is celecoxib.
Each hard capsule contains celecoxib
200 mg.

croscarmellose sodium, magnesium
stearate. Capsule shells contain gelatin,
titanium dioxide E171, printing ink.

What Celecoxib looks like
and contents of the pack
Celecoxib is available as hard
capsules.
Hard capsules, opaque, white with two
gold bands marked 7767 on the
capsule cap and 200 on the capsule
body in a white contrast.
The capsules are packaged in clear
and opaque PVC blisters or aluminium
blisters.
Celecoxib is contained in packs of 30.

Manufacturer:
Pfizer Manufacturing Deutschland
GmbH
Heinrich-Mack-Strasse 35
D-89257 Illertissen
Germany
or
Piramal Healthcare UK Limited
Walton Road
Morpeth
Northumberland NE61 3YA
UK
Procured from within the EU. Product
Licence Holder and repackaged by:
S.C.A.C. Ltd., Unit 2a, Bandeath
Industrial Estate, Throsk, Stirling, FK7
7NP, UK.
For any information about this
medicine, please contact:
Medical Information
Pfizer Ltd
Walton Oaks
Dorking Road
Tadworth
Surrey
KT20 7NS
Telephone: 01304 616161

The other ingredients are:

POM

Lactose monohydrate, sodium lauryl
sulphate, povidone K30,

Revision date: 06.01.2015

PL: 30984/0078

Expand view ⇕

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.

Hide