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CELECOXIB 200MG CAPSULES

Active substance(s): CELECOXIB / CELECOXIB

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Celebrex® 200mg Capsules / Celecoxib 200mg Capsules

Ref: 0784/190816/1/F

(celecoxib)
Patient Information Leaflet
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.
Your medicine is known as Celebrex 200mg capsules/ Celecoxib 200mg
capsules but will be referred to as Celebrex throughout the leaflet. Please
note that the leaflet also contains information about other strength of the
medicine, Celebrex 100mg capsules/ Celecoxib 100mg capsules
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 in adults for the relief of signs and symptoms of
rheumatoid arthritis, osteoarthritis and ankylosing spondylitis.

* 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.
Breast-feeding
Celebrex must not be used during breast-feeding.

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.

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.

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.

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.

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.
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:

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.

Celebrex® 200mg Capsules / Celecoxib 200mg Capsules

Ref: 0784/190816/1/B

(celecoxib)
Patient Information Leaflet (continued)
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
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
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 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

5

How to store Celebrex

Expiry date
Do not use this medicine after the expiry date shown on the carton label or
blister strip.
If your doctor tells you to stop taking this medicine, return any unused
capsules to your pharmacist (chemist) for safe disposal. Only keep this
medicine, if your doctor tells you to. If your capsules become discoloured or
show any other signs of deterioration, consult your pharmacist (chemist) who
will tell you what to do.
Storing your medicine
OUT OF THE SIGHT AND REACH OF CHILDREN.
* KEEP
not store above 30°C.
* Do
not take your capsules out of the blister strip until it is time to take your
* Do
dose.
Important
Remember this medicine is for you. Only a doctor can prescribe it. Never
give your medicine to other people. It may harm them, even if their
symptoms are the same as yours.
This leaflet does not tell you everything about your medicine. If you have any
questions or are not sure about anything, ask your doctor or pharmacist
(chemist). He/she will have additional information about this medicine and
will be able to advise you.

6

Contents of the pack and other information

What Celebrex contains
The active substance is celecoxib. 1 capsule contains 200 mg celecoxib.
The other ingredients are: Lactose monohydrate, sodium lauryl sulphate,
povidone K30, croscarmellose sodium, magnesium stearate, gelatin, titanium
dioxide E171, yellow iron oxide E172, shellac and propylene glycol.
What Celebrex looks like and contents of the pack
Celebrex 200mg capsules are opaque white capsules with two gold bands
which have '7767' and '200' marked on them. Celebrex 200mg capsules are
available in blister strips in packs of 20 and 30.
Manufacturer and Licence Holder
This medicine is manufactured by R-Pharm Germany GmbH,
Heinrich-Mack-Strasse 35, D-89257 Illertissen, Germany and are procured
from within the EU and repackaged by the Product Licence Holder: Lexon
(UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL:15184/0784 Celebrex 200mg capsules /
Celecoxib 200mg capsules

Celebrex is a registered trademark of G.D.Searle LLC.
Revision date: 19/08/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

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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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