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CELEBREX 200 MG HARD CAPSULES

Active substance(s): CELECOXIB

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Page 4

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

T05714

(celecoxib)

Patient Information Leaflet
The name of your medicine is Celebrex
200 mg Hard Capsules but will be referred
to as Celebrex throughout the leaflet.
This product is also available as the 100
mg strength.
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.

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.

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

5. How to store Celebrex
Keep out of the sight and reach of
children.
Do not store above 30°C.
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.
If the medicine become discoloured or
show any other signs of deterioration, you
should seek the advice of your doctor or
pharmacist who will tell you what to do.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines
no longer required. These measures will
help to protect the environment.

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.

6. Contents of the pack and other
information
What Celebrex contains
Each hard capsule contains 200 mg of the
active ingredient celecoxib.

2. What you need to know before
you take Celebrex

The other ingredients are:
Lactose monohydrate, sodium lauryl
sulphate, povidone K30, croscarmellose
sodium, magnesium stearate.

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.

Capsule shell for Celebrex 200 mg Hard
Capsules contains:
Gelatin, titanium dioxide E171 and
printing ink contains yellow iron oxide
E172.

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

What Celebrex looks like and contents
of the pack
Celebrex 200 mg hard capsules are
opaque, white with two yellow bands
marked 7767 and 200.
Celebrex capsules are available in blister
packs. The capsules are available in the
packs of 20 and 30 packs.
Manufacturer and Product Licence
Holder:
This product is manufactured by Pfizer
Manufacturing
Deutschland
GmbH,
Heinrich-Mach-Strasse 35, D-89257
llertissen, Germany. It is procured from
within the EU by the Product Licence
Holder: Swinghope Ltd, Brandon House,
Marlowe Way, Croydon CR0 4XS UK and
repackaged
by
Interport
Ltd,
Brandon
House,
Marlowe
Way,
Croydon CR0 4XS UK.
POM
PL No: 10380/1484

Celebrex® 200 mg Hard Capsules

Celebrex 200 mg
Hard Capsules

Leaflet revision date: 25/09/2015

Fold

Celebrex® is a registered Trademark of
G.D. Searle LLC, New York, U.S.A.

• 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 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

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• Methotrexate
(used
to
treat
rheumatoid arthritis, psoriasis and
leukaemia)
• Carbamazepine (used to treat
epilepsy/seizures and some forms of
pain or depression)
• Barbiturates
(used
to
treat
epilepsy/seizures and some sleep
disorders)
• Ciclosporin and tacrolimus (used for
immune system suppression e.g. after
transplants)
Celebrex can be taken with low dose
acetylsalicylic acid (75 mg or less daily).
Ask your doctor for advice before taking
both medicines together.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding,
think you may be pregnant or are planning
to have a baby, ask your doctor or
pharmacist for advice before taking this
medicine.
Pregnancy
Celebrex must not be used by women
who are pregnant or can become
pregnant (i.e. women of child bearing
potential who are not using adequate
contraception) during ongoing treatment.
If you become pregnant during treatment
with Celebrex you should discontinue the
treatment and contact your doctor for
alternative treatment.
Breast-feeding
Celebrex must not be used during
breast-feeding.
Fertility
NSAIDs, including Celebrex, may make it
more difficult to become pregnant. You
should tell your doctor if you are planning
to become pregnant or if you have
problems becoming pregnant.
Driving and using machines
You should be aware of how you react to
Celebrex before you drive or operate
machinery. If you feel dizzy or drowsy
after taking Celebrex, do not drive or
operate machinery until these effects wear
off.
Celebrex contains
Celebrex contains lactose (a type of
sugar). If you have been told by your
doctor that you have an intolerance to
some sugars, contact your doctor before
taking this medicinal product.

For osteoarthritis the usual dose is 200
mg each day, increased by your doctor to
a maximum of 400 mg, if needed.
The dose is usually:
• one 200 mg capsule once a day or
• one 100 mg capsule twice a day

For ankylosing spondylitis the usual
dose is 200 mg each day, increased by
your doctor to a maximum of 400 mg, if
needed.
The dose is usually:
• one 200 mg capsule once a day or
• one 100 mg capsule twice a day
Kidney or liver problems: make sure
your doctor knows if you have liver or
kidney problems as you may need a lower
dose.

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.

Like all medicines, this medicine can
cause side effects, although not
everybody gets them.

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.

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

If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist.

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.

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 240 ml of water.

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

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.

4. Possible side effects

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.

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

For rheumatoid arthritis the usual dose
is 200 mg each day, increased by your
doctor to a maximum of 400 mg, if
needed.
The dose is usually:
• one 100 mg capsule twice a day

3. How to take Celebrex

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.

Very common: may affect more than 1
in 10 people
• High blood pressure, including
worsening of existing high blood
pressure *

Contact your doctor within two weeks of
starting treatment if you do not experience
any benefit.

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)).

Fold

• 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)

• 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
Not known: frequency cannot be
estimated from the available data
• Decreased fertility in females, which is
usually reversible on discontinuation
of the medicine
In clinical studies not associated with
arthritis or other arthritic conditions,
where Celebrex was taken at doses of
400 mg per day for up to 3 years, the
following additional side effects have
been observed:
Common: may affect up to 1 in 10
people
• Heart problems: angina (chest pain)
• Stomach problems: irritable bowel
syndrome (can include stomach ache,
diarrhoea, indigestion, wind)
• Kidney stones (which may lead to
stomach or back pain, blood in urine),
difficulty passing urine
• Weight gain

T05714

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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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