CELEBREX 100MG CAPSULES

Active substance: CELECOXIB

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Package leaflet:
Information for the user

1.  hat Celebrex is and what it is
W
used for

Celebrex® 100 mg hard capsules
Celebrex® 200 mg hard capsules

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.

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
1 
it again.
If
1  you have any further questions, ask
your doctor or pharmacist.
This medicine has been prescribed for
1 
you only. Do not pass it on to others. It
may harm them, even if their signs of
illness are the same as yours.
1  you get any side effects, talk to your
If
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet. See section 4.

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.
1 f you are allergic to celecoxib or any of the other
i
ingredients of this medicine (listed in section 6)
i
1 f you have had an allergic reaction to a group of
medicines called “sulphonamides” (e.g. some
antibiotics used to treat infections)
1 if you currently have an ulcer in your stomach or
intestines, or bleeding in your stomach or
intestines

Warnings and precautions
Talk to your doctor before taking Celebrex:
1 f you have previously had an ulcer or bleeding
i
in your stomach or intestines.
(Do not take Celebrex if you currently have an
ulcer or bleeding in your stomach or intestine)
i
1 f you are taking acetylsalicylic acid (even at low
dose for heart protective purposes)
i
1 f you use medicines to reduce blood clotting
(e.g. warfarin)

1 f you are using Celebrex at the same time as
i
other non-acetylsalicylic NSAIDs such as
ibuprofen or diclofenac. The use of these
medicines together should be avoided
1 f you smoke, have diabetes, raised blood
i
pressure or raised cholesterol
1 f your heart, liver or kidneys are not working well
i
your doctor may want to keep a regular check on
you
1 f you have fluid retention (such as swollen ankles
i
and feet)
1 f you are dehydrated, for instance due to
i
sickness, diarrhoea or the use of diuretics (used
to treat excess fluid in the body)
1 f you have had a serious allergic reaction or a
i
serious skin reaction to any medicines
i
1 f 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
1 f you are over 65 years of age your doctor may
i
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). 

­­

What is in this leaflet:
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1.  hat Celebrex is and what it is used
for
W
2.  hat you need to know before you
take Celebrex
H
3.  ow to take Celebrex
P
4.  ossible side effects
H
5.  ow to store Celebrex
6.  ontents of the pack and other
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information

2.  hat you need to know before
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you take Celebrex

1 f as a result of taking acetylsalicylic acid or any
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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
i
1 f you are pregnant. If you can become pregnant
during ongoing treatment you should discuss
methods of contraception with your doctor
i
1 f you are breast-feeding
i
1 f you have severe liver disease
1 f you have severe kidney disease
i
i
1 f you have an inflammatory disease of the
intestines such as ulcerative colitis or Crohn’s
disease
1 f you have heart failure, established ischaemic
i
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
i
1 f 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

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Other medicines and Celebrex
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines:
1  extromethorphan (used to treat coughs)
D
1  CE inhibitors or angiotensin II antagonists (used
A
for high blood pressure and heart failure)
1  iuretics (used to treat excess fluid in the body)
D
1  luconazole and rifampicin (used to treat fungal
F
and bacterial infections)
1  arfarin or other oral anticoagulants (“bloodW
thinning” agents that reduce blood clotting)
1  ithium (used to treat some types of depression)
L
1  ther medicines to treat depression, sleep
O
disorders, high blood pressure or an irregular
heartbeat
1  euroleptics (used to treat some mental
N
disorders)
1  ethotrexate (used to treat rheumatoid arthritis,
M
psoriasis and leukaemia)
1  arbamazepine (used to treat epilepsy/seizures
C
and some forms of pain or depression)
1  arbiturates (used to treat epilepsy/seizures and
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some sleep disorders)
1  iclosporin and tacrolimus (used for immune
C
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

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.  ow to take Celebrex
H
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:
1  ne 200 mg capsule once a day; or
o
1  ne 100 mg capsule twice a day.
o
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:
1  ne 100 mg capsule twice a day.
o
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:
1  ne 200 mg capsule once a day; or
o
1  ne 100 mg capsule twice a day.
o
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.

­­

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.

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4.  ossible side effects
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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:
1  allergic reaction such as skin rash, swelling
an
of the face, wheezing or difficulty breathing
1 
heart problems such as pain in the chest
1 
severe stomach pain or any sign of bleeding in
the stomach or intestines, such as passing
black or bloodstained stools, or vomiting blood
1  skin reaction such as rash, blistering or
a
peeling of the skin
1 
liver failure (symptoms may include nausea
(feeling sick), diarrhoea, jaundice (your skin or
the whites of your eyes look yellow)).

blockage), dark or black stools, inflammation of
the pancreas (can lead to stomach pain),
inflammation of the gullet (oesophagus)
1  ow levels of sodium in the blood (a condition
L
known as hyponatraemia)
R
1  educed number of white blood cells (which help
protect the body from infection) or blood platelets
(increased chance of bleeding or bruising)
1  ifficulty coordinating muscular movements
D
F
1  eeling confused, changes in the way things taste
1  ncreased sensitivity to light
I
1  oss of hair
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1 Hallucinations
1  leeding in the eye
B
1 Irregular heartbeat
1 Flushing
1  lood clot in the blood vessels in the lungs.
B
Symptoms may include sudden breathlessness,
sharp pains when you breathe or collapse
1  leeding of the stomach or intestines (can lead to
B
bloody stools or vomiting), inflammation of the
intestine or colon
1  evere liver inflammation (hepatitis). Symptoms
S
may include nausea (feeling sick), diarrhoea,
jaundice (yellow discolouration of the skin or
eyes), dark urine, pale stools, bleeding easily,
itching or chills
1  cute kidney failure
A
1 Menstrual disturbances
1  welling of the face, lips, mouth, tongue or
S
throat, or difficulty swallowing
Very rare: may affect up to 1 in 10,000 people
1  erious allergic reactions (including potentially
S
fatal anaphylactic shock)
S
1  erious 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)

1  delayed allergic reaction with possible
A
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))
1  leeding within the brain causing death
B
1  eningitis (inflammation of the membrane
M
around the brain and spinal cord)
1  iver failure, liver damage and severe liver
L
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
L
1  iver 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)
1  nflammation of the kidneys and other kidney
I
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)
1  orsening of epilepsy (possible more frequent
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and/or severe seizures)
1  lockage of an artery or vein in the eye leading to
B
partial or complete loss of vision
1  nflamed blood vessels (can cause fever, aches,
I
purple blotches on the skin)
1  reduction in the number of red and white blood
A
cells and platelets (may cause tiredness, easy
bruising, frequent nose bleeds and increased
risk of infections)
1  uscle pain and weakness
M
1  mpaired sense of smell
I
Not known: frequency cannot be estimated
from the available data
1  ecreased fertility in females, which is usually
D
reversible on discontinuation of the medicine

­­

Very common: may affect more than 1 in
10 people
1  igh blood pressure, including worsening of
H
existing high blood pressure *
Common: may affect up to 1 in 10 people
1 Heart attack*
1  luid build up with swollen ankles, legs and/or
F
hands
1 Urinary infections
1  hortness of breath*, sinusitis (sinus
S
inflammation, sinus infection, blocked or painful
sinuses), blocked or runny nose, sore throat,
coughs, colds, flu-like symptoms

1  izziness, difficulty sleeping
D
1  omiting*, stomach ache, diarrhoea, indigestion,
V
wind
1 Rash, itching
1 Muscle stiffness
1 Difficulty swallowing*
1 Headache
1  ausea (feeling sick)
N
1 Painful joints
1  orsening of existing allergies
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1 Accidental injury
Uncommon: may affect up to 1 in 100 people
1 Stroke*
1  eart failure, palpitations (awareness of heart
H
beat), fast heart rate
1  bnormalities in liver-related blood tests
A
1  bnormalities in kidney-related blood tests
A
1  naemia (changes in red blood cells that can
A
cause fatigue and breathlessness)
1  nxiety, depression, tiredness, drowsiness,
A
tingling sensations (pins and needles)
1  igh levels of potassium in blood test results
H
(can cause nausea (feeling sick), fatigue, muscle
weakness or palpitations)
1  mpaired or blurred vision, ringing in the ears,
I
mouth pain and sores, difficulty hearing*
1  onstipation, burping, stomach inflammation
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(indigestion, stomach ache or vomiting),
worsening of inflammation of the stomach or
intestine
1 Leg cramps
1  aised itchy rash (hives)
R
1 Eye inflammation
1 Difficulty breathing
1  kin discolouration (bruising)
S
1  hest pain (generalised pain not related to the
C
heart)
Rare: may affect up to 1 in 1,000 people
1  lcers (bleeding) in the stomach, gullet or
U
intestines; or rupture of the intestine (can cause
stomach ache, fever, nausea, vomiting, intestinal

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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.  ow to store Celebrex
H
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date
which is stated on the blister and carton. The
expiry date refers to the last day of that month.
Do not store Celebrex above 30° C.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.

6.  ontents of the pack and other
C
information
What Celebrex contains
The active substance is celecoxib.
1 capsule contains 100 mg or 200 mg celecoxib.
The other ingredients are:
Lactose monohydrate, sodium laurilsulfate,
povidone, croscarmellose sodium, magnesium
stearate. Capsule shells contain gelatin, titanium
dioxide E171, sodium laurilsulfate and sorbitan
monolaurate. Printing ink contains shellac,
propylene glycol, indigotine E132 (100 mg capsule),
iron oxide E172 (200 mg capsule).

What Celebrex looks like and contents
of the pack
Celebrex is available as hard capsules.
Opaque, white with two blue bands marked 7767
and 100 (Celebrex 100 mg).
Opaque, white with two gold bands marked 7767
and 200 (Celebrex 200 mg).
The capsules are packaged in clear or opaque
PVC/aluminium blisters.
Celebrex is contained in packs of 2, 5, 6, 10, 20, 30,
40, 50, 60, 100, 10x10, 10x30, 10x50, 1x50 unit
dose, 1x100 unit dose, 5x(10x10).
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom

Manufacturer:
R-Pharm Germany GmbH
Heinrich-Mack-Str. 35, 89257 Illertissen
Germany
For any information about this medicine,
please contact:
Medical Information
Pfizer Ltd
Walton Oaks
Dorking Road
Tadworth
Surrey
KT20 7NS
Telephone: 01304 616161

566400M

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
1  eart problems: angina (chest pain)
H
1  tomach problems: irritable bowel syndrome
S
(can include stomach ache, diarrhoea,
indigestion, wind)
1  idney stones (which may lead to stomach or
K
back pain, blood in urine), difficulty passing urine
1 Weight gain
Uncommon: may affect up to 1 in 100 people
1  eep vein thrombosis (blood clot usually in the
D
leg, which may cause pain, swelling or redness of
the calf or breathing problems)
1  tomach problems: stomach infection (which
S
can cause irritation and ulcers of the stomach
and intestines)
1  ower limb fracture
L
1  hingles, skin infection, eczema (dry itchy rash),
S
pneumonia (chest infection (possible cough,
fever, difficulty breathing))
1  loaters in the eye causing blurred or impaired
F
vision, vertigo due to inner ear troubles, sore,
inflamed or bleeding gums, mouth sores
1  xcessive urination at night, bleeding from piles/
E
haemorrhoids, frequent bowel movements
1  atty lumps in skin or elsewhere, ganglion cyst
F
(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
1  igh levels of sodium in blood test results
H

This medicinal product is authorized in the
Member States of the EEA under the following
names:
Austria
Celebrex 100 mg/200 mg Hartkapseln
Belgium
Celebrex 100 mg/200 mg 
gélules/
harde capsules/
Hartkapseln
Denmark Celebra 100 mg/200 mg
Finland
Celebra 100 mg/200 mg Kapseli, kova
France
Celebrex 100 mg/200 mg gélules
Germany
Celebrex 100 mg/200 mg Hartkapseln
Greece
Celebrex 100 mg/200 mg Kαψάκιο, σκληρό
Iceland
Celebra 100 mg/200 mg
Ireland
Celebrex 100 mg/200 mg capsule, hard
Italy
Celebrex 100 mg/200 mg capslule rigide
Luxembourg Celebrex 100 mg/200 mg 
gélules/
harde capsules/
Hartkapseln
Netherlands Celebrex 100 mg/200 mg capsule, hard
Norway
Celebra 100 mg/200 mg kapsel, hard
Portugal
Celebrex 100 mg/200 mg cápsulas
Spain
Celebrex 100 mg/200 mg cápsulas duras
Sweden
Celebra 100 mg/200 mg hårda kapslar
UK
Celebrex 100 mg/200 mg capsule hard
This leaflet was last revised in 10/2014
Ref: CB 27_0

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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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