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Assessed against UK PIL grantedFRONT PAGE
May 2011
By AddisonF at 6:39 pm, Dec 15, 2011

Celebrex® 100 mg Hard capsules


The name of your product is Celebrex 100mg Hard capsules but will be referred to as
Celebrex throughout the leaflet.
Other strengths are also available.
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine
• Keep this leaflet. You may need to read it again
• If you have any further questions, please ask your doctor or pharmacist
• This medicine has been prescribed for you. Do not pass it on to others. It may
harm them, even if their symptoms are the same as yours
• If any of the side effects gets serious or if you notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist
In this leaflet:
1. What Celebrex is and what it is used for
2. Before you take Celebrex
3. How to take Celebrex
4. Possible side effects
5. How to store Celebrex
6. Further information

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).
Taking other medicines
Some medicines can affect the way other medicines work. Please tell your doctor or
pharmacist if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription:
• Dextromethorphan (used to treat coughs)
• ACE inhibitors or angiotensin II antagonists (used for high blood pressure and heart
• Diuretics (used to treat excess fluid in the body)
• Fluconazole and rifampicin (used to treat fungal and bacterial infections)
• Warfarin or other oral anticoagulants (“blood-thinning” agents that reduce blood
• 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
• Barbiturates (used to treat epilepsy/seizures and some sleep disorders)
• Ciclosporin and tacrolimus (used for immune system suppression e.g. after


Celebrex can be taken with low dose acetylsalicylic acid (75mg or less daily). Ask your
doctor for advice before taking both medicines together.

Celebrex is used for the relief of signs and symptoms of rheumatoid arthritis,
osteoarthritis and ankylosing spondylitis.

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.

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.

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.

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 (hypersensitive) to celecoxib or any of the other ingredients of
• 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
Take special care with Celebrex
Check with your doctor if any of the following applies to you:
• 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
• 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)
• 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 may 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 must not be used during breast-feeding.
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.
Important information about some of the ingredients of Celebrex
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

Always take Celebrex exactly as your doctor has told you. You should check with your
doctor or pharmacist if you are unsure. 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
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
• one 100 mg capsule twice a day
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
For ankylosing spondylitis the usual dose is 200 mg each day, increased by your
doctor to a maximum of 400mg, if needed.
The dose is usually:
• one 200 mg capsule once a day
• 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.
Children: Celebrex is for adults only; it is not for use in children.
You should not take more than 400 mg per day.
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 forgotten doses.
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 product, ask your doctor or

Like all medicines, Celebrex can have side-effects, although not everybody gets them.
If any of the side effects get serious, or if you notice any side effects not listed in this
leaflet, tell your doctor or pharmacist.
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
If you have:
• an allergic reaction such as skin rash, swelling of the face, wheezing or difficulty
• 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: affects more than 1 user in 10:
• High blood pressure*
Common : affects 1 to 10 users in 100:
• 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
• Dizziness, difficulty sleeping
• Vomiting*, stomach ache, diarrhoea, indigestion, wind
• Rash, itching
• Muscle stiffness
• Difficulty swallowing*
• Worsening of existing allergies
Uncommon: affects 1 to 10 users in 1,000:
• Stroke*
• Heart failure, palpitations (awareness of heart beat), fast heart rate
• Worsening of existing high blood pressure
• 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
• Constipation, burping, stomach inflammation (indigestion, stomach ache or
vomiting), worsening of inflammation of the stomach or intestine.
• Leg cramps
• Raised itchy rash (hives)
Rare: affects 1 to 10 users in 10,000:
• 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 gullet (can cause difficulty in swallowing), inflammation
of the pancreas (can lead to stomach pain)
• Reduced number of white blood cells (which help protect the body from infection)
and 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
Not known: frequency cannot be estimated from the available data:
• Bleeding within the brain causing death
• Serious allergic reactions (including potentially fatal anaphylactic shock) which can
cause skin rash, swelling of the face, lips, mouth, tongue or throat, wheezing or
difficulty breathing; difficulty swallowing
• Bleeding of the stomach or intestines (can lead to bloody stools or vomiting),
inflammation of the intestine or colon, nausea (feeling sick)
• 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 (red swollen area with numerous
small pustules)
• Liver failure, liver damage and severe liver inflammation (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
• Kidney problems (possible kidney failure, inflammation of the kidneys)

• Blood clot in the blood vessels in the lungs. Symptoms may include sudden
breathlessness, sharp pains when you breathe or collapse
• Irregular heartbeat
• Meningitis (inflammation of the membrane around the brain and spinal cord)
• Hallucinations
• Worsening of epilepsy (possible more frequent and/or severe seizures)
• Inflamed blood vessels (can cause fever, aches, purple blotches on the skin)
• Blockage of an artery or vein in the eye leading to partial or complete loss of vision,
inflammation of the conjunctiva, bleeding in the eye
• 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)
• Chest pain
• Impaired sense of smell
• Skin discolouration (bruising), muscle pain and weakness, painful joints
• Menstrual disturbances
• Headache, flushing
• Low levels of sodium in blood test results (can cause loss of appetite, headache,
nausea (feeling sick), muscle cramps and weakness)
In clinical studies not associated with Arthritis or other arthritic conditions, where
Celebrex was taken at doses of 400mg per day for up to 3 years, the following
additional side effects have been observed:
Common: affects 1 to 10 users in 100:
• 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: affects 1 to 10 users in 1,000:
• 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
• 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 any of the side effects get serious, or if you notice any side effects not listed in this
leaflet, tell your doctor or pharmacist.

Keep out of the reach and sight 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.

What Celebrex contains
Each Hard capsule contains 100mg of the active ingredient celecoxib.
The other ingredients are:
Lactose monohydrate, sodium lauryl sulphate, povidone K30, croscarmellose sodium,
magnesium stearate, gelatin, titanium dioxide (E171) and printing ink.
What Celebrex looks like and contents of the pack
Celebrex 100mg hard capsules are opaque, white with two blue bands marked 7767 and
Celebrex capsules are available in blister packs. Each pack contains either 20, 30 or 60
Manufacturer and Product Licence Holder:
This product is manufactured by Pharmacia Limited, Morpeth, United Kingdom. It is
procured from within the EU by the product licence holder: Swinghope Ltd, Brandon
House, Marlowe Way, Croydon CR0 4XS and repackaged by Interport Ltd, Brandon
House, Marlowe Way, Croydon CR0 4XS.

PL No: 10380/1478

Leaflet revision date: 14/12/11
Celebrex® is a registered Trademark of G.D. Searle LLC, New York, U.S.A.


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Further information

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