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CELECOXIB 100MG HARD CAPSULE

Active substance(s): CELECOXIB

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Package leaflet: Information for the user

Celebrex® 100mg hard capsules
(celecoxib)
®
The name of your medicine is Celebrex 100mg hard
capsules but it will be referred to as Celebrex
throughout this leaflet. Please note that this leaflet
also contains information about the other strength
®
such as Celebrex 200mg hard capsules.
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.
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/ warfarin like anticoagulants or novel oral
anti-clotting medicines, e.g. apixaban)
If you use a medicines called corticosteroids
(e.g. prednisone)
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 will
want to monitor you regularly
the consumption of alcohol and NSAIDs may
increase the risk of gastrointestinal problems
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,
breast-feeding and fertility’).
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, 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 (‘bloodthinning’ 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 heart
beat
Neuroleptics (used to treat some mental disorders)
Methotrexate (used to treat rheumatoid arthritis,
psoriasis and leukaemia)
Carbamazepine (used to treat epilepsy/s’’eizures
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.
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 is for oral use. 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.
If you have difficulty swallowing capsules: The entire
capsule contents can be sprinkled onto a spoonful of
semi-solid food (such as cool or room temperature
applesauce, rice gruel, yogurt or mashed banana) and
swallowed immediately with a drink approximately
240ml 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.
For osteoarthritis the usual dose is 200mg each day,
increased by your doctor to a maximum of 400mg, if
needed.
The dose is usually:
one 200mg capsule once a day; or
one 100mg capsule twice a day.
For rheumatoid arthritis the usual dose is 200mg
each day, increased by your doctor to a maximum of
400mg, if needed.
The dose is usually:
one 100mg capsule twice a day.
For ankylosing spondylitis the usual dose is 200mg
each day, increased by your doctor to a maximum of
400mg, if needed.
The dose is usually:
one 200mg capsule once a day; or
one 100mg 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 50kg: if you are over 65 years of age and
especially if you weigh less than 50kg, your doctor
may want to monitor you more closely.
You should not take more than 400mg 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, flu-like
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 discoloration (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
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 heart beat
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 generalized
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 Celebrex was
taken at doses of 400mg 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,
pharmacist or nurse. 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 take your medicine after the expiry date which
is stated on the box after ‘Exp’. The 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.

6. Contents of the pack and other information
What Celebrex contains
The active substance is celecoxib.
Each hard capsule contains 100mg celecoxib.
The other ingredients are:
lactose monohydrate, sodium lauril sulfate, povidone
K30, croscarmellose sodium, magnesium stearate.
Capsule shell contain gelatin, titanium dioxide (E171).
Ink contains indigotine (E132), shellac, propylene
glycol.
What Celebrex looks like and contents of the pack
Celebrex 100mg hard capsules are opaque, white with
two blue bands marked ‘7767’ and ‘100’.
The capsules are packed in clear and opaque PVC
blisters or aluminium blisters in boxes of 60 capsules.
Manufactured by:
Pfizer Manufacturing Deutschland GmbH,
Heinrich-Mack-Strasse 35, D-89257 Illertissen,
Germany.
Procured from within the EU and repackaged by
the Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
®
Celebrex 100mg hard capsules;
PL 18799/2259
Leaflet date: 18.02.2016

POM

Celebrex is a registered trademark of Pfizer group of
companies.

Package leaflet: Information for the user

Celecoxib 100mg hard capsules
(celecoxib)The name of your medicine is Celecoxib
100mg hard capsules but it will be referred to as
Celecoxib throughout this leaflet. Please note that this
leaflet also contains information about the other
strength such as Celecoxib 200mg hard capsules.

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.
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/ warfarin like anticoagulants or novel oral
anti-clotting medicines, e.g. apixaban)
If you use a medicines called corticosteroids
(e.g. prednisone)
if you are using Celecoxib 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 Celecoxib 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 problems
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,
breast-feeding and fertility’).
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, 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 (‘bloodthinning’ 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 heart
beat
Neuroleptics (used to treat some mental disorders)
Methotrexate (used to treat rheumatoid arthritis,
psoriasis and leukaemia)
Carbamazepine (used to treat epilepsy/s’’eizures
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, 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 is for oral use. 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.
If you have difficulty swallowing capsules: The entire
capsule contents can be sprinkled onto a spoonful of
semi-solid food (such as cool or room temperature
applesauce, rice gruel, yogurt or mashed banana) and
swallowed immediately with a drink approximately
240ml 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.
For osteoarthritis the usual dose is 200mg each day,
increased by your doctor to a maximum of 400mg, if
needed.
The dose is usually:
one 200mg capsule once a day; or
one 100mg capsule twice a day.
For rheumatoid arthritis the usual dose is 200mg
each day, increased by your doctor to a maximum of
400mg, if needed.
The dose is usually:
one 100mg capsule twice a day.
For ankylosing spondylitis the usual dose is 200mg
each day, increased by your doctor to a maximum of
400mg, if needed.
The dose is usually:
one 200mg capsule once a day; or
one 100mg 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 50kg: if you are over 65 years of age and
especially if you weigh less than 50kg, your doctor
may want to monitor you more closely.
You should not take more than 400mg 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, flu-like
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 discoloration (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
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 heart beat
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 generalized
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 Celecoxib was
taken at doses of 400mg 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,
pharmacist or nurse. 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 take your medicine after the expiry date which
is stated on the box after ‘Exp’. The 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.

6. Contents of the pack and other information
What Celecoxib contains
The active substance is celecoxib.
Each hard capsule contains 100mg celecoxib.
The other ingredients are:
lactose monohydrate, sodium lauril sulfate, povidone
K30, croscarmellose sodium, magnesium stearate.
Capsule shell contain gelatin, titanium dioxide (E171).
Ink contains indigotine (E132), shellac, propylene
glycol.
What Celecoxib looks like and contents of the
pack
Celecoxib 100mg hard capsules are opaque, white
with two blue bands marked ‘7767’ and ‘100’.
The capsules are packed in clear and opaque PVC
blisters or aluminium blisters in boxes of 60 capsules.
Manufactured by:
Pfizer Manufacturing Deutschland GmbH,
Heinrich-Mack-Strasse 35, D-89257 Illertissen,
Germany.
Procured from within the EU and repackaged by
the Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Celecoxib 100mg hard capsules;
PL 18799/2259
Leaflet date: 18.02.2016

POM

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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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