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CELECOXIB 200MG HARD CAPSULES

Active substance(s): CELECOXIB

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Celebrex® 200mg Capsules / Celecoxib 200mg hard Capsules
(celecoxib)
This product is available using any of the above names but will be referred to as
Celebrex throughout the following leaflet.
It is also available as the 100mg 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.

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 for the relief of signs and symptoms of rheumatoid arthritis,
osteoarthritis and ankylosing spondylitis.
Celebrex belongs to a group of medicinal products called nonsteroidal antiinflammatory 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 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.
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.

2. What you need to know before you take Celebrex

Breast-feeding

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.

Celebrex must not be used during breast-feeding.

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 painrelieving 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 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

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 contain lactose monohydrate (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 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 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 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.
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.
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 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 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.

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.

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.

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.

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:

Very rare: may affect up to 1 in 10,000 people

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













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

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

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.
5. How to store Celebrex
Do not store above 30°C. Store where children cannot see or reach them.
Don’t take the capsules after the ‘expiry date’ stated on the blister or carton. The
expiry date refers to the last day of that month.
If your capsules become discoloured or show signs of any deterioration, take them
back to your pharmacist.
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.
6. Contents of the pack and other information
What Celebrex contains
Each capsule contains 200mg of the active ingredient celecoxib.
Other ingredients of the capsules include: gelatin, lactose monohydrate, sodium lauryl
sulphate, povidone K-30, croscarmellose sodium type A, magnesium stearate and
titanium dioxide (E171) and gold ink SB-3002.
This medicine contains lactose. If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicinal product.
What Celebrex look like and contents of the pack
Celebrex are hard, opaque, white capsules with a gold band on the cap marked ‘7767
in white’ and a gold band on the body marked ‘200’ in white.
Celebrex are packed in blister strips and supplied in box of 10 or 30 capsules.
PL NO: 15814/0966

POM

This product is manufactured by Pfizer Manufacturing Deutschland GmbH, HeinrichMack-Strasse 35, Illertissen, Germany and procured from within the EU and
repackaged by the Product Licence Holder: OPD Laboratories Ltd., Unit 6 Colonial
Way, Watford, Herts WD24 4PR
Leaflet revision and issue date (Ref.) 08/09/2015.
Celebrex is a registered Trade Mark of G.D. Searle LLC, New Jersey, U.S.A.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332
796.

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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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