CELECOXIB 200MG CAPSULES

Active substance: CELECOXIB

View full screen / Print PDF » Download PDF ⇩

Transcript
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

Keep this leaflet. You may need to read it again
If you have any further questions, please ask your doctor or
pharmacist
This medicine has been prescribed for you. Do not pass it on
to others. It may harm them, even if their symptoms are the
same as yours
If any of the side effects gets serious or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist

In this leaflet:
1.
2.
3.
4.
5.
6.

What Celebrex is and what it is used for
Before you take Celebrex
How to take Celebrex
Possible side effects
How to store Celebrex
Further 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. 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 (hypersensitive) to celecoxib or any of the
other ingredients of Celebrex
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

Take special care with Celebrex
Check with your doctor if any of the following
applies to you:

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).

Taking other medicines

Some medicines can affect the way other medicines work. Please
tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription:
Dextromethorphan (used to treat coughs)
ACE inhibitors or angiotensin II antagonists (used for high
blood pressure and heart 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)

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

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any
medicine.
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 must not be used during breast-feeding.

Driving and using machines

You should be aware of how you react to Celebrex before you
drive or operate machinery. If you feel dizzy or drowsy after
taking Celebrex, do not drive or operate machinery until these
effects wear off.

Important information about some of the
ingredients of Celebrex

Celebrex contains lactose (a type of sugar). If you have been
told by your doctor that you have an intolerance to some sugars,
contact your doctor before taking this medicinal product.

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)
Page 1 of 2

3. How to take Celebrex
Always take Celebrex exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are unsure. If
you think or feel that the effect of Celebrex is too strong or too
weak, talk to your doctor or pharmacist.
Your doctor will tell you what dose you should take. As the risk of
side effects associated with heart problems may increase with
dose and duration of use, it is important that you use the lowest
dose that controls your pain and you should not take Celebrex for
longer than necessary to control symptoms.
Celebrex should be swallowed whole with a drink of water.
The capsules can be taken at any time of the day, with or without
food. However, try to take each dose of Celebrex at the same
time each day.
Contact your doctor within two weeks of starting treatment if you
do not experience any 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.
Children: Celebrex is for adults only, it is not for use in children.
You should not take more than 400mg per day.

If you take more Celebrex than you should:

You should not take more capsules than your doctor tells you to.
If you take too many capsules contact your doctor, pharmacist or
hospital and take your medicine with you.

If you forget to take Celebrex:

If you forget to take a capsule, take it as soon as you remember.
Do not take a double dose to make up for forgotten doses.

If you stop taking Celebrex:

Suddenly stopping your treatment with Celebrex may lead to your
symptoms getting worse. Do not stop taking Celebrex unless your
doctor tells you to. Your doctor may tell you to reduce the dose
over a few days before stopping completely.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.

4. Possible side effects
Like all medicines, Celebrex can have side-effects, although not
everybody gets them.
If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, tell your doctor or pharmacist.
The side effects listed below were observed in arthritis
patients who took Celebrex.
Side effects marked with an asterisk (*) are listed below at
the higher frequencies that occurred in patients who took
Celebrex to prevent colon polyps. Patients in these studies
took Celebrex at high doses and for a long duration.

If any of the following happen, stop taking Celebrex
and tell your doctor 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: affects more than 1 user in 10:
High blood pressure*

Common: affects 1 to 10 users in 100:

Heart attack*
Fluid build up with swollen ankles, legs and/or hands
Urinary infections
Shortness of breath*, sinusitis (sinus inflammation, sinus
infection, blocked or painful sinuses), blocked or runny nose,
sore throat, coughs, colds, flu-like symptoms
Dizziness, difficulty sleeping
Vomiting*, stomach ache, diarrhoea, indigestion, wind
Rash, itching
Muscle stiffness
Difficulty swallowing*
Worsening of existing allergies

Uncommon: affects 1 to 10 users in 1,000:

Stroke*
Heart failure, palpitations (awareness of heart beat), fast
heart rate
Worsening of existing high blood pressure
Abnormalities in liver-related blood tests
Abnormalities in kidney-related blood tests
Anaemia (changes in red blood cells that can cause fatigue
and breathlessness)
Anxiety, depression, tiredness, drowsiness, tingling
sensations (pins and needles)
High levels of potassium in blood test results (can cause
nausea (feeling sick), fatigue, muscle weakness or
palpitations)
Impaired or blurred vision, ringing in the ears, mouth pain
and sores, difficulty hearing*
Constipation, burping, stomach inflammation (indigestion,
stomach ache or vomiting), worsening of inflammation of
the stomach or intestine
Leg cramps
Raised itchy rash (hives)

Rare: affects 1 to 10 users in 10,000:

Ulcers (bleeding) in the stomach, gullet or intestines; or
rupture of the intestine (can cause stomach ache, fever,
nausea, vomiting, intestinal blockage), dark or black stools,
inflammation of the gullet (can cause difficulty in
swallowing), inflammation of the pancreas (can lead to
stomach pain)
Reduced number of white blood cells (which help protect the
body from infection) and blood platelets (increased chance
of bleeding or bruising)
Difficulty coordinating muscular movements
Feeling confused, changes in the way things taste
Increased sensitivity to light
Loss of hair

Not known: frequency cannot be estimated from the
available data:

Bleeding within the brain causing death
Serious allergic reactions (including potentially fatal
anaphylactic shock) which can cause skin rash, swelling of
the face, lips, mouth, tongue or throat, wheezing or difficulty
breathing; difficulty swallowing
Bleeding of the stomach or intestines (can lead to bloody
stools or vomiting), inflammation of the intestine or colon,
nausea (feeling sick)
Serious skin conditions such as Stevens-Johnson syndrome,
exfoliative dermatitis and toxic epidermal necrolysis (can
cause rash, blistering or peeling of the skin) and acute
generalised exanthematous pustulosis (red swollen area with
numerous small pustules)
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))
Liver failure, liver damage and severe liver inflammation
(sometimes fatal or requiring liver transplant). Symptoms
may include nausea (feeling sick), diarrhoea, jaundice
(yellow discolouration of the skin or eyes), dark urine, pale
stools, bleeding easily, itching or chills
Kidney problems (possible kidney failure, inflammation of
the kidneys)
Blood clot in the blood vessels in the lungs. Symptoms may
include sudden breathlessness, sharp pains when you
breathe or collapse
Irregular heartbeat
Meningitis (inflammation of the membrane around the brain
and spinal cord)
Hallucinations
Worsening of epilepsy (possible more frequent and/or severe
seizures)
Inflamed blood vessels (can cause fever, aches, purple
blotches on the skin)
Blockage of an artery or vein in the eye leading to partial or
complete loss of vision, inflammation of the conjunctiva,
bleeding in the eye
A reduction in the number of red and white blood cells and
platelets (may cause tiredness, easy bruising, frequent nose
bleeds and increased risk of infections)
Chest pain

Impaired sense of smell
Skin discolouration (bruising), muscle pain and weakness,
painful joints
Menstrual disturbances
Headache, flushing
Low levels of sodium in blood test results (can cause loss of
appetite, headache, nausea (feeling sick), muscle cramps
and weakness)

In clinical studies not associated with Arthritis or
other arthritic conditions, where Celebrex was
taken at doses of 400mg per day for up to 3 years,
the following additional side effects have been
observed:
Common: affects 1 to 10 users in 100:

Heart problems: angina (chest pain)
Stomach problems: irritable bowel syndrome (can include
stomach ache, diarrhoea, indigestion, wind)
Kidney stones (which may lead to stomach or back pain,
blood in urine), difficulty passing urine
Weight gain

Uncommon: affects 1 to 10 users in 1,000:

Deep vein thrombosis (blood clot usually in the leg, which
may cause pain, swelling or redness of the calf or breathing
problems)
Stomach problems: stomach infection (which can cause
irritation and ulcers of the stomach and intestines)
Lower limb fracture
Shingles, skin infection, eczema (dry itchy rash), pneumonia
(chest infection (possible cough, fever, difficulty breathing))
Floaters in the eye causing blurred or impaired vision,
vertigo due to inner ear troubles, sore, inflamed or bleeding
gums, mouth sores
Excessive urination at night, bleeding from
piles/haemorrhoids, frequent bowel 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

If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, tell your doctor or pharmacist.

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.

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.

Page 2 of 2

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): 11.07.14
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

Keep this leaflet. You may need to read it again
If you have any further questions, please ask your doctor or
pharmacist
This medicine has been prescribed for you. Do not pass it on
to others. It may harm them, even if their symptoms are the
same as yours
If any of the side effects gets serious or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist

In this leaflet:
1.
2.
3.
4.
5.
6.

What Celecoxib is and what it is used for
Before you take Celecoxib
How to take Celecoxib
Possible side effects
How to store Celecoxib
Further 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. 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 (hypersensitive) to celecoxib or any of the
other ingredients of Celecoxib
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

Take special care with Celecoxib
Check with your doctor if any of the following
applies to you:

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.
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.
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).

Taking other medicines

Some medicines can affect the way other medicines work. Please
tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription:
Dextromethorphan (used to treat coughs)
ACE inhibitors or angiotensin II antagonists (used for high
blood pressure and heart 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)

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

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any
medicine.
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.
Celecoxib must not be used during breast-feeding.

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.

Important information about some of the
ingredients of Celecoxib

Celecoxib 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.

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)
Page 1 of 2

3. How to take Celecoxib
Always take Celecoxib exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are unsure. If
you think or feel that the effect of 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, 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.
Children: Celecoxib is for adults only, it is not for use in children.
You should not take more than 400mg per day.

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.

If you forget to take Celecoxib:

If you forget to take a capsule, take it as soon as you remember.
Do not take a double dose to make up for forgotten doses.

If you stop taking Celecoxib:

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 product, ask
your doctor or pharmacist.

4. Possible side effects
Like all medicines, Celecoxib can have side-effects, although not
everybody gets them.
If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, tell your doctor or pharmacist.
The side effects listed below were observed in arthritis
patients who took Celecoxib.
Side effects marked with an asterisk (*) are listed below at
the higher frequencies that occurred in patients who took
Celecoxib 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
Celecoxib 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: affects more than 1 user in 10:
High blood pressure*

Common: affects 1 to 10 users in 100:

Heart attack*
Fluid build up with swollen ankles, legs and/or hands
Urinary infections
Shortness of breath*, sinusitis (sinus inflammation, sinus
infection, blocked or painful sinuses), blocked or runny nose,
sore throat, coughs, colds, flu-like symptoms
Dizziness, difficulty sleeping
Vomiting*, stomach ache, diarrhoea, indigestion, wind
Rash, itching
Muscle stiffness
Difficulty swallowing*
Worsening of existing allergies

Uncommon: affects 1 to 10 users in 1,000:

Stroke*
Heart failure, palpitations (awareness of heart beat), fast
heart rate
Worsening of existing high blood pressure
Abnormalities in liver-related blood tests
Abnormalities in kidney-related blood tests
Anaemia (changes in red blood cells that can cause fatigue
and breathlessness)
Anxiety, depression, tiredness, drowsiness, tingling
sensations (pins and needles)
High levels of potassium in blood test results (can cause
nausea (feeling sick), fatigue, muscle weakness or
palpitations)
Impaired or blurred vision, ringing in the ears, mouth pain
and sores, difficulty hearing*
Constipation, burping, stomach inflammation (indigestion,
stomach ache or vomiting), worsening of inflammation of
the stomach or intestine
Leg cramps
Raised itchy rash (hives)

Rare: affects 1 to 10 users in 10,000:

Ulcers (bleeding) in the stomach, gullet or intestines; or
rupture of the intestine (can cause stomach ache, fever,
nausea, vomiting, intestinal blockage), dark or black stools,
inflammation of the gullet (can cause difficulty in
swallowing), inflammation of the pancreas (can lead to
stomach pain)
Reduced number of white blood cells (which help protect the
body from infection) and blood platelets (increased chance
of bleeding or bruising)
Difficulty coordinating muscular movements
Feeling confused, changes in the way things taste
Increased sensitivity to light
Loss of hair

Not known: frequency cannot be estimated from the
available data:

Bleeding within the brain causing death
Serious allergic reactions (including potentially fatal
anaphylactic shock) which can cause skin rash, swelling of
the face, lips, mouth, tongue or throat, wheezing or difficulty
breathing; difficulty swallowing
Bleeding of the stomach or intestines (can lead to bloody
stools or vomiting), inflammation of the intestine or colon,
nausea (feeling sick)
Serious skin conditions such as Stevens-Johnson syndrome,
exfoliative dermatitis and toxic epidermal necrolysis (can
cause rash, blistering or peeling of the skin) and acute
generalised exanthematous pustulosis (red swollen area with
numerous small pustules)
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))
Liver failure, liver damage and severe liver inflammation
(sometimes fatal or requiring liver transplant). Symptoms
may include nausea (feeling sick), diarrhoea, jaundice
(yellow discolouration of the skin or eyes), dark urine, pale
stools, bleeding easily, itching or chills
Kidney problems (possible kidney failure, inflammation of
the kidneys)
Blood clot in the blood vessels in the lungs. Symptoms may
include sudden breathlessness, sharp pains when you
breathe or collapse
Irregular heartbeat
Meningitis (inflammation of the membrane around the brain
and spinal cord)
Hallucinations
Worsening of epilepsy (possible more frequent and/or severe
seizures)
Inflamed blood vessels (can cause fever, aches, purple
blotches on the skin)
Blockage of an artery or vein in the eye leading to partial or
complete loss of vision, inflammation of the conjunctiva,
bleeding in the eye
A reduction in the number of red and white blood cells and
platelets (may cause tiredness, easy bruising, frequent nose
bleeds and increased risk of infections)
Chest pain

Impaired sense of smell
Skin discolouration (bruising), muscle pain and weakness,
painful joints
Menstrual disturbances
Headache, flushing
Low levels of sodium in blood test results (can cause loss of
appetite, headache, nausea (feeling sick), muscle cramps
and weakness)

In clinical studies not associated with Arthritis or
other arthritic conditions, where Celecoxib was
taken at doses of 400mg per day for up to 3 years,
the following additional side effects have been
observed:
Common: affects 1 to 10 users in 100:

Heart problems: angina (chest pain)
Stomach problems: irritable bowel syndrome (can include
stomach ache, diarrhoea, indigestion, wind)
Kidney stones (which may lead to stomach or back pain,
blood in urine), difficulty passing urine
Weight gain

Uncommon: affects 1 to 10 users in 1,000:

Deep vein thrombosis (blood clot usually in the leg, which
may cause pain, swelling or redness of the calf or breathing
problems)
Stomach problems: stomach infection (which can cause
irritation and ulcers of the stomach and intestines)
Lower limb fracture
Shingles, skin infection, eczema (dry itchy rash), pneumonia
(chest infection (possible cough, fever, difficulty breathing))
Floaters in the eye causing blurred or impaired vision,
vertigo due to inner ear troubles, sore, inflamed or bleeding
gums, mouth sores
Excessive urination at night, bleeding from
piles/haemorrhoids, frequent bowel 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

If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, tell your doctor or pharmacist.

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.

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.

Page 2 of 2

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): 11.07.14

Expand view ⇕

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.

Hide
(web1)