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CELECOXIB 100MG CAPSULES

Active substance(s): CELECOXIB

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Ref: 0286/050916/1/F

Celebrex 100mg Capsules / Celecoxib 100mg Capsules
®

(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 100mg capsules/ Celecoxib 100mg
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 200mg capsules/ Celecoxib 200mg 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.

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.

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.

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

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

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.

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.

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

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.

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.

Use in children
Celebrex is for adults only, it is not for use in children.

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).

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.

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.

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.

Ref: 0286/050916/1/B

Celebrex 100mg Capsules / Celecoxib 100mg Capsules
®

(celecoxib)
Patient Information Leaflet (continued)
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
problems such as pain in the chest
* heart
stomach pain or any sign of bleeding in the stomach or intestines,
* severe
such as passing black or bloodstained stools, or vomiting blood
skin reaction such as rash, blistering or peeling of the skin
* aliver
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
attack*
* Heart
build up with swollen ankles, legs and/or hands
* Fluid
infections
* Urinary
of breath*, sinusitis (sinus inflammation, sinus infection, blocked
* Shortness
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
liver-related blood tests
* Abnormalities in
in kidney-related blood tests
* Anaemia (changes
* breathlessness) in red blood cells that can cause fatigue and
depression, tiredness, drowsiness, tingling sensations (pins and
* Anxiety,
needles)
levels of potassium in blood test results (can cause nausea (feeling
* High
sick), fatigue, muscle weakness or palpitations)
or blurred vision, ringing in the ears, mouth pain and sores,
* Impaired
difficulty hearing*
burping, stomach inflammation (indigestion, stomach ache or
* Constipation,
vomiting), worsening of inflammation of the stomach or intestine
cramps
* Leg
itchy rash (hives)
* Raised
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
(bleeding) in the stomach, gullet or intestines; or rupture of the
* Ulcers
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)
levels of sodium in the blood (a condition known as hyponatraemia)
* Low
Reduced number of white blood cells (which help to protect the body from
* infection) or blood platelets (increased chance of bleeding or bruising)
coordinating muscular movements
* Difficulty
confused, changes in the way things taste
* Feeling
sensitivity to light
* Increased
of hair
* Loss
* Hallucinations
Bleeding in the eye
* Acute
reaction that may lead to lung inflammation
* Irregular
* Flushing heartbeat
* Blood clot in the blood vessels in the lungs. Symptoms may include
* sudden breathlessness, sharp pains when you breathe or collapse
of the stomach or intestines (can lead to bloody stools or
* Bleeding
vomiting), inflammation of the intestine or colon
liver inflammation (hepatitis). Symptoms may include nausea
* Severe
(feeling sick), diarrhoea, jaundice (yellow discolouration of the skin or
eyes), dark urine, pale stools, bleeding easily, itching or chills
kidney failure
* Acute
disturbances
* Menstrual
Swelling of the face, lips, mouth, tongue or throat, or difficulty swallowing

*

Very rare: may affect up to 1 in 10,000 people
allergic reactions (including potentially fatal anaphylactic shock)
* Serious
skin conditions such as Stevens-Johnson syndrome, exfoliative
* Serious
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))
within the brain causing death
* Bleeding
Meningitis (inflammation of the membrane around the brain and spinal
* cord)
failure, liver damage and severe liver inflammation (fulminant
* Liver
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)
of the kidneys and other kidney problems (such as nephrotic
* Inflammation
syndrome and minimal change disease, which may be accompanied by
symptoms such as water retention (oedema), foamy urine, fatigue and a
loss of appetite)
of epilepsy (possible more frequent and/or severe seizures)
* Worsening
Blockage of an artery or vein in the eye leading to partial or complete loss
* of vision
blood vessels (can cause fever, aches, purple blotches on the
* Inflamed
skin)
reduction in the number of red and white blood cells and platelets (may
* Acause
tiredness, easy bruising, frequent nose bleeds and increased risk
of infections)
pain and weakness
* Muscle
Impaired sense of smell
* Loss of taste

*

Not known: frequency cannot be estimated from the available data
fertility in females, which is usually reversible on
* Decreased
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
problems: angina (chest pain)
* Heart
problems: irritable bowel syndrome (can include stomach ache,
* Stomach
diarrhoea, indigestion, wind)
stones (which may lead to stomach or back pain, blood in urine),
* Kidney
difficulty passing urine
Weight gain

*

Uncommon: may affect up to 1 in 100 people
vein thrombosis (blood clot usually in the leg, which may cause pain,
* Deep
swelling or redness of the calf or breathing problems)
problems: stomach infection (which can cause irritation and
* Stomach
ulcers of the stomach and intestines)
limb fracture
* Lower
skin infection, eczema (dry itchy rash), pneumonia (chest
* Shingles,
infection (possible cough, fever, difficulty breathing))
in the eye causing blurred or impaired vision, vertigo due to inner
* Floaters
ear troubles, sore, inflamed or bleeding gums, mouth sores
urination at night, bleeding from piles/haemorrhoids, frequent
* Excessive
bowel movements
lumps in skin or elsewhere, ganglion cyst (harmless swellings on or
* Fatty
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 100 mg celecoxib.
The other ingredients are: Lactose monohydrate, sodium lauryl sulphate,
povidone K30, croscarmellose sodium, magnesium stearate. Capsules shells
contain gelatin, titanium dioxide E171, sodium lauryl sulphate and sorbitan
monolaurate. Printing ink contains shellac, propylene glycol and indigotine
E132.
What Celebrex looks like and contents of the pack
Celebrex are opaque, white hard capsules with two blue bands which have
'7767' and ‘100’ marked on them.
Celebrex are available in blister strips in packs of 20 & 60.
Manufacturer and Licence Holder
This medicine is manufactured by R-Pharm Germany GmbH, 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:15184/0286 Celebrex 100mg capsules /
Celecoxib 100mg capsules

Celebrex is a registered trademark of G.D. Searle & Co.
Revision date: 05/09/16

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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