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CELECOXIB 200MG CAPSULES

Active substance: CELECOXIB

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PACKAGE LEAFLET: INFORMATION FOR THE USER

CELEBREX® 200MG CAPSULES
(celecoxib)
Your medicine is available using the name Celebrex 200mg
Capsules but will be referred to as Celebrex throughout this
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.

What is in this leaflet:

1.
2.
3.
4.
5.
6.

What Celebrex is and what it is used for
What you need to know before you take Celebrex
How to take Celebrex
Possible side effects
How to store Celebrex
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 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.

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 antiinflammatory 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 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)













if you are using Celebrex at the same time as other nonacetylsalicylic 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 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 or angiotensin II antagonists (used for high
blood pressure and heart failure)

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 clotting)

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)

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 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 benefit.

For osteoarthritis the usual dose is 200mg each day,

increased by your doctor to a maximum of 400mg, if needed.
The dose is usually:

one 200mg capsule once a day; or

one 100mg capsule twice a day.

For rheumatoid arthritis the usual dose is 200mg each day,
increased by your doctor to a maximum of 400mg, if needed.
The dose is usually:

one 100mg capsule twice a day.

For ankylosing spondylitis the usual dose is 200mg each

day, increased by your doctor to a maximum of 400mg, if needed.
The dose is usually:

one 200mg capsule once a day; or

one 100mg 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
50kg: if you are over 65 years of age and especially if you weigh
less than 50kg, your doctor may want to monitor you more
closely.
You should not take more than 400mg 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.

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

If you forget to take Celebrex:

Pregnancy, breast-feeding and fertility

If you stop taking Celebrex:

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.

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 contains 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.

Page 1 of 2

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.

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 (brushing)
Chest pain (generalised pain not related to the heart)

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 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
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

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 400mg 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 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
Keep out of the sight and reach of children.
Do not store above 30°C.
Don't take the capsules after the 'expiry date' shown on the
carton label. The expiry date refers to the last day of that month.
If your capsules are out of date, take them to your pharmacist
who will get rid of them safely.
If your capsules become discoloured or deformed, take them back
to your pharmacist.
If your doctor decides to stop treatment, return any leftover
capsules to your pharmacist. Only keep them if your doctor tells
you to.
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.
Page 2 of 2

6. Further information
What Celebrex contains

The active ingredient is celecoxib. Each hard gelatin capsule
contains 200mg of celecoxib.
The other ingredients are:
Capsule contents: lactose monohydrate, sodium laurilsulfate,
povidone, croscarmellose sodium and magnesium stearate.
Capsule shells contain gelatin, titanium dioxide E171,
sodium laurilsulfate and sorbitan monolaurate.
Printing ink contains shellac, propylene glycol and
iron oxide E172.

What Celebrex looks like and contents of the pack

Each hard gelatin capsule has a white opaque cap and body
with ‘7767’ printed on the cap in a yellow band and ‘200’ printed
on the body in a yellow band. Each capsule contains a white to
off-white fine powder.
Celebrex is available in blister packs containing 30 hard gelatin
capsules.

Manufacturer:

Celebrex is manufactured by:
Pfizer Manufacturing Deutschland GmbH, Illertissen, Germany.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Doncaster Pharmaceuticals Group Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
PL: 04423/0588

POM

Leaflet revision and issue date (Ref):29.01.15
CELEBREX® is a registered trademark of G.D. Searle LLC.

PACKAGE LEAFLET: INFORMATION FOR THE USER

CELECOXIB 200MG CAPSULES
Your medicine is available using the name Celecoxib 200mg
Capsules but will be referred to as Celecoxib throughout this
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.

What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Celecoxib is and what it is used for
What you need to know before you take Celecoxib
How to take Celecoxib
Possible side effects
How to store Celecoxib
Contents of the pack and other information

1. What Celecoxib is and what it is used for
Celecoxib is used for the relief of signs and symptoms of
rheumatoid arthritis, osteoarthritis and ankylosing
spondylitis.
Celecoxib 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. Celecoxib acts by reducing the
production of prostaglandins, thereby reducing the pain and
inflammation.

2. What you need to know before you take
Celecoxib
You have been prescribed Celecoxib by your doctor. The following
information will help you get the best results with Celecoxib. If
you have any further questions please ask your doctor or
pharmacist.

Do not take Celecoxib

Tell your doctor if any of the following are true for you as
patients with these conditions should not take Celecoxib.

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 antiinflammatory 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 before taking Celecoxib:

if you have previously had an ulcer or bleeding in your
stomach or intestines.
(Do not take Celecoxib 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)













if you are using Celecoxib at the same time as other nonacetylsalicylic 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 Celecoxib 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.

3. How to take Celecoxib
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 Celecoxib 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 Celecoxib for
longer than necessary to control symptoms.

Celecoxib 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 Celecoxib
at the same time each day.
Contact your doctor within two weeks of starting treatment if you
do not experience any benefit.

For osteoarthritis the usual dose is 200mg each day,

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.

increased by your doctor to a maximum of 400mg, if needed.
The dose is usually:

one 200mg capsule once a day; or

one 100mg capsule twice a day.

Celecoxib 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).

increased by your doctor to a maximum of 400mg, if needed.
The dose is usually:

one 100mg capsule twice a day.

Other medicines and Celecoxib

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 or angiotensin II antagonists (used for high
blood pressure and heart failure)

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 clotting)

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)

For rheumatoid arthritis the usual dose is 200mg each day,

For ankylosing spondylitis the usual dose is 200mg each

day, increased by your doctor to a maximum of 400mg, if needed.
The dose is usually:

one 200mg capsule once a day; or

one 100mg 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
50kg: if you are over 65 years of age and especially if you weigh
less than 50kg, your doctor may want to monitor you more
closely.
You should not take more than 400mg per day.

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

If you take more Celecoxib 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.

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

If you forget to take Celecoxib:

Pregnancy, breast-feeding and fertility

If you stop taking Celecoxib:

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

Celecoxib 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 Celecoxib you should
discontinue the treatment and contact your doctor for alternative
treatment.

Breast-feeding

Celecoxib must not be used during breast-feeding.

Fertility

NSAIDs, including Celecoxib, 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 Celecoxib before you
drive or operate machinery. If you feel dizzy or drowsy after
taking Celecoxib, do not drive or operate machinery until these
effects wear off.

Celecoxib contains

Celecoxib contains 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.

Page 1 of 2

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.

Suddenly stopping your treatment with Celecoxib may lead to
your symptoms getting worse. Do not stop taking Celecoxib
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 Celeoxib. Side effects
marked with an asterisk (*) are listed below at the
higher frequencies that occurred in patients who
took Celeoxib to prevent colon polyps. Patients in
these studies took Celecoxib at high doses and for a
long duration.
If any of the following happen, stop taking Celeoxib
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 (brushing)
Chest pain (generalised pain not related to the heart)

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 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
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

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 Celeoxib was
taken at doses of 400mg 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 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 Celecoxib
Keep out of the sight and reach of children.
Do not store above 30°C.
Don't take the capsules after the 'expiry date' shown on the
carton label. The expiry date refers to the last day of that month.
If your capsules are out of date, take them to your pharmacist
who will get rid of them safely.
If your capsules become discoloured or deformed, take them back
to your pharmacist.
If your doctor decides to stop treatment, return any leftover
capsules to your pharmacist. Only keep them if your doctor tells
you to.
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.
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6. Further information
What Celecoxib contains

The active ingredient is celecoxib. Each hard gelatin capsule
contains 200mg of celecoxib.
The other ingredients are:
Capsule contents: lactose monohydrate, sodium laurilsulfate,
povidone, croscarmellose sodium and magnesium stearate.
Capsule shells contain gelatin, titanium dioxide E171,
sodium laurilsulfate and sorbitan monolaurate.
Printing ink contains shellac, propylene glycol and
iron oxide E172.

What Celecoxib looks like and contents of the pack
Each hard gelatin capsule has a white opaque cap and body
with ‘7767’ printed on the cap in a yellow band and ‘200’ printed
on the body in a yellow band. Each capsule contains a white to
off-white fine powder.
Celecoxib is available in blister packs containing 30 hard gelatin
capsules.

Manufacturer:

Celecoxib is manufactured by:
Pfizer Manufacturing Deutschland GmbH, Illertissen, Germany.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Doncaster Pharmaceuticals Group Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
PL: 04423/0588

POM

Leaflet revision and issue date (Ref): 29.01.15

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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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