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CELEBREX 100 MG HARD CAPSULE

Active substance(s): CELECOXIB / CELECOXIB

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Package leaflet:
Information for the user

Celebrex 100 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.
The name of your medicine is Celebrex 100 mg hard
capsule, but will be referred to as Celebrex in this
leaflet.
This product is also available in 200 mg strength.
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 in adults 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.
You should expect your medicine to start working
within hours of taking the first dose, but you may
not experience a full effect for several days.

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 “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

Warnings and precautions
Talk to your doctor or pharmacist 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 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 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, 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
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.

3. How to take Celebrex
Always take this medicine exactly as your doctor or
pharmacist 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.
Method of administration
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 level
teaspoon of semi-solid food (such as cool or room
temperature applesauce, rice gruel, yogurt or
mashed banana) and swallowed immediately with
a drink approximately 240 ml of water.
To open the capsule, hold upright to contain the
granules at the bottom then gently squeeze the top
and twist to remove, taking care not to spill the
contents. Do not chew or crush the granules.
Contact your doctor within two weeks of starting
treatment if you do not experience any benefit.
The recommended dose is:
For osteoarthritis the recommended 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.

Pregnancy

For rheumatoid arthritis the recommended 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.

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.

For ankylosing spondylitis the recommended 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.

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

Fertility

Kidney or liver problems: make sure your doctor
knows if you have liver or kidney problems as you
may need a lower dose.

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.

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.

Driving and using machines

You should not take more than 400 mg per day.

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.

Use in children Celebrex is for adults only, it is not
for use in children.

Celebrex contains lactose

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.

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.

If you take more Celebrex than you
should

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 discolouration (bruising)
 Chest pain (generalised pain not related to the
heart)
 Face swelling
Rare: may affect up to 1 in 1,000 people
 Ulcers (bleeding) in the stomach, gullet or
intestines; or rupture of the intestine (can cause
stomach ache, fever, nausea, vomiting, intestinal
blockage), dark or black stools, inflammation of the
pancreas (can lead to stomach pain), inflammation
of the gullet (oesophagus)
 Low levels of sodium in the blood (a condition
known as hyponatraemia)
 Reduced number of white blood cells (which help to
protect the body from infection) or blood platelets
(increased chance of bleeding or bruising)
 Difficulty coordinating muscular movements
 Feeling confused, changes in the way things taste
 Increased sensitivity to light
 Loss of hair
 Hallucinations
 Bleeding in the eye
 Acute reaction that may lead to lung inflammation
 Irregular heartbeat
 Flushing
 Blood clot in the blood vessels in the lungs.
Symptoms may include sudden breathlessness,
sharp pains when you breathe or collapse
 Bleeding of the stomach or intestines (can lead to
bloody stools or vomiting), inflammation of the
intestine or colon
 Severe liver inflammation (hepatitis). Symptoms
may include nausea (feeling sick), diarrhoea,
jaundice (yellow discolouration of the skin or eyes),
dark urine, pale stools, bleeding easily, itching or
chills
 Acute kidney failure
 Menstrual disturbances
 Swelling of the face, lips, mouth, tongue or throat, or
difficulty swallowing
Very rare: may affect up to 1 in 10,000 people
 Serious allergic reactions (including potentially fatal
anaphylactic shock)
 Serious skin conditions such as Stevens-Johnson
syndrome, exfoliative dermatitis and toxic epidermal
necrolysis (can cause rash, blistering or peeling of
the skin) and acute generalised exanthematous
pustulosis (symptoms include the skin becoming red
with swollen areas covered in numerous small
pustules)
 A delayed allergic reaction with possible symptoms
such as rash, swelling of the face, fever, swollen
glands, and abnormal test results (e.g., liver, blood
cell (eosinophilia, a type of raised white blood cell
count))

 Bleeding within the brain causing death
 Meningitis (inflammation of the membrane around
the brain and spinal cord)
 Liver failure, liver damage and severe liver
inflammation (fulminant hepatitis) (sometimes fatal
or requiring liver transplant). Symptoms may include
nausea (feeling sick), diarrhoea, jaundice (yellow
discolouration of the skin or eyes), dark urine, pale
stools, bleeding easily, itching or chills
 Liver problems (such as cholestasis and cholestatic
hepatitis, which may be accompanied by symptoms
such as discoloured stools, nausea and yellowing of
the skin or eyes)
 Inflammation of the kidneys and other kidney
problems (such as nephrotic syndrome and minimal
change disease, which may be accompanied by
symptoms such as water retention (oedema), foamy
urine, fatigue and a loss of appetite)
 Worsening of epilepsy (possible more frequent
and/or severe seizures)
 Blockage of an artery or vein in the eye leading to
partial or complete loss of vision
 Inflamed blood vessels (can cause fever, aches,
purple blotches on the skin)
 A reduction in the number of red and white blood
cells and platelets (may cause tiredness, easy
bruising, frequent nose bleeds and increased risk of
infections)
 Muscle pain and weakness
 Impaired sense of smell
 Loss of taste

Reporting of side effects

Not known: frequency cannot be estimated from
the available data
 Decreased fertility in females, which is usually
reversible on discontinuation of the medicine

The other ingredients are:
lactose monohydrate, sodium lauryl sulphate,
povidone K30, croscarmellose sodium, magnesium
stearate. Capsule shells contain gelatin, titanium
dioxide E171. Ink contains indigotine.

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

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 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.
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 your medicine gets discoloured or shows any other
signs of deterioration, seek the advice of your
pharmacist.

6. Contents of the pack and other
information
What Celebrex contains
The active substance is celecoxib.
Each hard capsule contains 100 mg celecoxib

What Celebrex looks like and contents of the
pack
Celebrex is available as hard capsules.
Celebrex 100 mg hard capsules are opaque, white
with two blue bands marked 7767 and 100.
The capsules are packaged in clear and opaque PVC
blisters or aluminium blisters.
Celebrex is contained in blister packs of 30.
Manufactured by:
Pfizer Manufacturing Deutschland GmbH, HeinrichMack-Strasse 35, 89257 Illertissen, Germany.
Procured from within the EU & repackaged by PL
holder: Kosei Pharma UK Ltd., 956 Buckingham
Avenue, Slough Trading Estate, SL1 4NL, United
Kingdom.

Celebrex® 100 mg hard capsules,
PL 39352/0112
Celebrex® is a registered trademark of the
G.D. Searle LLC.
POM

Leaflet date: 03/11/2016

Package leaflet:
Information for the user

Celecoxib 100 mg 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.
The name of your medicine is Celecoxib 100 mg
hard capsule, but will be referred to as Celecoxib
Capsules in this leaflet. This product is also
available in 200 mg strength.
What is in this leaflet:
1. What Celecoxib Capsules are and what it is
used for
2. What you need to know before you take
Celecoxib Capsules
3. How to take Celecoxib Capsules
4. Possible side effects
5. How to store Celecoxib Capsules
6. Contents of the pack and other information

1. What Celecoxib Capsules are and
what it is used for
Celecoxib Capsules are used in adults for the relief of
signs and symptoms of rheumatoid arthritis,
osteoarthritis and ankylosing spondylitis.
Celecoxib Capsules belong 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 Capsules acts
by reducing the production of prostaglandins, thereby
reducing the pain and inflammation.
You should expect your medicine to start working
within hours of taking the first dose, but you may
not experience a full effect for several days.

2. What you need to know before
you take Celecoxib Capsules
You have been prescribed Celecoxib Capsules by
your doctor.
The following information will help you get the best
results with Celecoxib Capsules. If you have any
further questions please ask your doctor or
pharmacist.

Do not take Celecoxib Capsules
Tell your doctor if any of the following are true for
you as patients with these conditions should not
take Celecoxib Capsules.
 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 “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

Warnings and precautions
Talk to your doctor or pharmacist before taking
Celecoxib Capsules:
 if you have previously had an ulcer or bleeding in
your stomach or intestines.
(Do not take Celecoxib Capsules 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 medicines called corticosteroids (e.g.
prednisone)
 if you are using Celecoxib Capsules 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 Capsules 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 Capsules.

Of the cases that reported time to onset, most severe
liver reactions occurred within one month of start of
treatment.
Celecoxib Capsules 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 Capsules
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
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 Capsules 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

3. How to take Celecoxib Capsules
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure. If you think or feel that
the effect of Celecoxib Capsules 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
Capsules for longer than necessary to control
symptoms.
Method of administration
Celecoxib Capsules are for oral use only. The
capsules can be taken at any time of the day, with or
without food. However, try to take each dose of
Celecoxib Capsules at the same time each day.
If you have difficulty swallowing capsules: The
entire capsule contents can be sprinkled onto a level
teaspoon of semi-solid food (such as cool or room
temperature applesauce, rice gruel, yogurt or
mashed banana) and swallowed immediately with
a drink approximately 240 ml of water.
To open the capsule, hold upright to contain the
granules at the bottom then gently squeeze the top
and twist to remove, taking care not to spill the
contents. Do not chew or crush the granules.
Contact your doctor within two weeks of starting
treatment if you do not experience any benefit.
The recommended dose is:
For osteoarthritis the recommended 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 recommended 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.

Celecoxib Capsules 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
Capsules you should discontinue the treatment and
contact your doctor for alternative treatment.

For ankylosing spondylitis the recommended 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.

Breast-feeding

Kidney or liver problems: make sure your doctor
knows if you have liver or kidney problems as you
may need a lower dose.

Celecoxib Capsules must not be used during breastfeeding.

Fertility
NSAIDs, including Celecoxib Capsules, 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
Capsules before you drive or operate machinery. If
you feel dizzy or drowsy after taking Celecoxib
Capsules, do not drive or operate machinery until
these effects wear off.

Celecoxib Capsules contains lactose
Celecoxib Capsules contains lactose (a type of
sugar). If you have been told by your doctor that you
have intolerance to some sugars, contact your doctor
before taking this medicinal product.

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 Capsules is for adults
only, it is not for use in children.

If you take more Celecoxib Capsules
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 Capsules
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 Capsules
Suddenly stopping your treatment with Celecoxib
Capsules may lead to your symptoms getting worse.
Do not stop taking Celecoxib Capsules 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 Capsules.
Side effects marked with an asterisk (*) are listed
below at the higher frequencies that occurred in
patients who took Celecoxib Capsules to
prevent colon polyps. Patients in these studies
took Celecoxib Capsules at high doses and for a
long duration.
If any of the following happen, stop taking
Celecoxib Capsules 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 discolouration (bruising)
 Chest pain (generalised pain not related to the
heart)
 Face swelling
Rare: may affect up to 1 in 1,000 people
 Ulcers (bleeding) in the stomach, gullet or
intestines; or rupture of the intestine (can cause
stomach ache, fever, nausea, vomiting, intestinal
blockage), dark or black stools, inflammation of the
pancreas (can lead to stomach pain), inflammation
of the gullet (oesophagus)
 Low levels of sodium in the blood (a condition
known as hyponatraemia)
 Reduced number of white blood cells (which help to
protect the body from infection) or blood platelets
(increased chance of bleeding or bruising)
 Difficulty coordinating muscular movements
 Feeling confused, changes in the way things taste
 Increased sensitivity to light
 Loss of hair
 Hallucinations
 Bleeding in the eye
 Acute reaction that may lead to lung inflammation
 Irregular heartbeat
 Flushing
 Blood clot in the blood vessels in the lungs.
Symptoms may include sudden breathlessness,
sharp pains when you breathe or collapse
 Bleeding of the stomach or intestines (can lead to
bloody stools or vomiting), inflammation of the
intestine or colon
 Severe liver inflammation (hepatitis). Symptoms
may include nausea (feeling sick), diarrhoea,
jaundice (yellow discolouration of the skin or eyes),
dark urine, pale stools, bleeding easily, itching or
chills
 Acute kidney failure
 Menstrual disturbances
 Swelling of the face, lips, mouth, tongue or throat, or
difficulty swallowing
Very rare: may affect up to 1 in 10,000 people
 Serious allergic reactions (including potentially fatal
anaphylactic shock)
 Serious skin conditions such as Stevens-Johnson
syndrome, exfoliative dermatitis and toxic epidermal
necrolysis (can cause rash, blistering or peeling of
the skin) and acute generalised exanthematous
pustulosis (symptoms include the skin becoming red
with swollen areas covered in numerous small
pustules)
 A delayed allergic reaction with possible symptoms
such as rash, swelling of the face, fever, swollen
glands, and abnormal test results (e.g., liver, blood
cell (eosinophilia, a type of raised white blood cell
count))

 Bleeding within the brain causing death
 Meningitis (inflammation of the membrane around
the brain and spinal cord)
 Liver failure, liver damage and severe liver
inflammation (fulminant hepatitis) (sometimes fatal
or requiring liver transplant). Symptoms may include
nausea (feeling sick), diarrhoea, jaundice (yellow
discolouration of the skin or eyes), dark urine, pale
stools, bleeding easily, itching or chills
 Liver problems (such as cholestasis and cholestatic
hepatitis, which may be accompanied by symptoms
such as discoloured stools, nausea and yellowing of
the skin or eyes)
 Inflammation of the kidneys and other kidney
problems (such as nephrotic syndrome and minimal
change disease, which may be accompanied by
symptoms such as water retention (oedema), foamy
urine, fatigue and a loss of appetite)
 Worsening of epilepsy (possible more frequent
and/or severe seizures)
 Blockage of an artery or vein in the eye leading to
partial or complete loss of vision
 Inflamed blood vessels (can cause fever, aches,
purple blotches on the skin)
 A reduction in the number of red and white blood
cells and platelets (may cause tiredness, easy
bruising, frequent nose bleeds and increased risk of
infections)
 Muscle pain and weakness
 Impaired sense of smell
 Loss of taste

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.

Not known: frequency cannot be estimated from
the available data
 Decreased fertility in females, which is usually
reversible on discontinuation of the medicine

The other ingredients are:
lactose monohydrate, sodium lauryl sulphate,
povidone K30, croscarmellose sodium, magnesium
stearate. Capsule shells contain gelatin, titanium
dioxide E171. Ink contains indigotine.

In clinical studies not associated with arthritis or
other arthritic conditions, where Celecoxib
Capsules were 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

5. How to store Celecoxib Capsules
Keep out of the sight and reach of children.
Do not use Celecoxib Capsules 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 Capsules 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 your medicine gets discoloured or shows any other
signs of deterioration, seek the advice of your
pharmacist.

6. Contents of the pack and other
information
What Celecoxib Capsules contain
The active substance is celecoxib.
Each hard capsule contains 100 mg celecoxib

What Celecoxib Capsules look like and
contents of the pack
Celecoxib is available as hard capsules.
Celecoxib 100 mg hard capsules are opaque, white
with two blue bands marked 7767 and 100.
The capsules are packaged in clear and opaque PVC
blisters or aluminium blisters.
Celecoxib Capsules are contained in blister packs of
30.
Manufactured by:
Pfizer Manufacturing Deutschland GmbH, HeinrichMack-Strasse 35, 89257 Illertissen, Germany.
Procured from within the EU & repackaged by PL
holder: Kosei Pharma UK Ltd., 956 Buckingham
Avenue, Slough Trading Estate, SL1 4NL, United
Kingdom

Celecoxib 100 mg hard capsules,
PL 39352/0112
Leaflet date: 03/11/2016

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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