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CELEBREX 200MG CAPSULES

Active substance(s): CELECOXIB

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Package leaflet:
Information for the user

Celebrex® 100 mg hard capsules
Celebrex® 200 mg hard capsules
Celecoxib
Read all of this leaflet carefully before you
start taking this medicine because it
contains important information for you.
• Keep this leaflet. You may need to read it
again.
• If you have any further questions, ask
your doctor or pharmacist.
• This medicine has been prescribed for
you only. Do not pass it on to others. It
may harm them, even if their signs of
illness are the same as yours.
• If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet. See section 4.
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

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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.

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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

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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 lactose
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 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.
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.

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.
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.

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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

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• 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)

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• 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
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

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• 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

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.

Reporting of side effects

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).

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 (see details below). By reporting
side effects you can help provide more information
on the safety of this medicine.
United Kingdom
Yellow Card Scheme website:
www.mhra.gov.uk/yellowcard
Malta
ADR Reporting
www.medicinesauthority.gov.mt/adrportal

5. How to store Celebrex
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.

6. Contents of the pack and other
information
What Celebrex contains
The active substance is celecoxib.
1 capsule contains 100 mg or 200 mg celecoxib.

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
and Manufacturer
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
This medicinal product is authorized in the
Member States of the EEA under the following
names:
Name
Country
Celebra
Denmark, Finland, Iceland, Norway,
Sweden
Celebrex
Austria, Belgium, France, Germany,
Greece, Ireland, Italy, Luxembourg,
Netherlands, Portugal, Spain, UK
This leaflet was last revised in 03/2016.
Ref: CB 31_0

06.04.16 13:55

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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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