CELEBREX 200MG CAPSULES

Active substance: CELECOXIB

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Read all of this leaflet carefully before
you start taking this medicine
1 Keep this leaflet. You may need to read
it again
1 If you have any further questions,
please ask your doctor or pharmacist
1 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
1 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. What Celebrex is and what it
is used for
2. Before you take Celebrex
3. How to take Celebrex
4. Possible side effects
5. How to store Celebrex
6. Further information

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.
1 if you are allergic (hypersensitive) to celecoxib or any
of the other ingredients of Celebrex
1 if you have had an allergic reaction to a group of
medicines called “sulphonamides” (e.g. some
antibiotics used to treat infections)
1 if you currently have an ulcer in your stomach or
intestines, or bleeding in your stomach or intestines
1 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

1 if you have fluid retention (such as swollen ankles

1 Warfarin or other oral anticoagulants (“blood-

during ongoing treatment you should discuss
methods of contraception with your doctor
1 if you are breast-feeding
1 if you have severe liver disease
1 if you have severe kidney disease
1 if you have an inflammatory disease of the intestines
such as ulcerative colitis or Crohn’s disease
1 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 “ministroke”), angina, or blockages of blood vessels to
the heart or brain
1 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

and feet)
1 if you are dehydrated, for instance due to sickness,
diarrhoea or the use of diuretics (used to treat
excess fluid in the body)
1 if you have had a serious allergic reaction or a
serious skin reaction to any medicines
1 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
1 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).

thinning” agents that reduce blood clotting)
1 Lithium (used to treat some types of depression)
1 Other medicines to treat depression, sleep
disorders, high blood pressure or an irregular
heartbeat
1 Neuroleptics (used to treat some mental
disorders)
1 Methotrexate (used to treat rheumatoid arthritis,
psoriasis and leukaemia)
1 Carbamazepine (used to treat epilepsy/seizures and
some forms of pain or depression)
1 Barbiturates (used to treat epilepsy/seizures
and some sleep disorders)
1 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.

Take special care with Celebrex
Check with your doctor if any of the following
applies to you:
1 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)
1 if you are taking acetylsalicylic acid (even at low
dose for heart protective purposes)
1 if you use medicines to reduce blood clotting
(e.g. warfarin)
1 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
1 if you smoke, have diabetes, raised blood pressure
or raised cholesterol
1 if your heart, liver or kidneys are not working well
your doctor may want to keep a regular check on
you

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:
1 Dextromethorphan (used to treat coughs)
1 ACE inhibitors or angiotensin II antagonists (used
for high blood pressure and heart failure)
1 Diuretics (used to treat excess fluid in the body)
1 Fluconazole and rifampicin (used to treat fungal and
bacterial infections)

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.

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 200 mg each
day, increased by your doctor to a maximum of
400 mg, if needed.
The dose is usually:
1 one 200 mg capsule once a day; or
1 one 100 mg capsule twice a day.
For rheumatoid arthritis the usual dose is 200 mg
each day, increased by your doctor to a maximum of
400 mg, if needed.
The dose is usually:
1 one 100 mg capsule twice a day.

For ankylosing spondylitis the usual dose is
200 mg each day, increased by your doctor to a
maximum of 400 mg, if needed.
The dose is usually:
1 one 200 mg capsule once a day; or
1 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.
Children: Celebrex is for adults only, it is not for use
in children.
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.

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.

543810M GI CBX 100/200 mg K GBR
Ersetzt: 516960
Schriftgröße: 8 pt
Maße: 148 x 580 mm (148x 290 mm)
Farbe 2/2: Pantone 072 C 100%, 20%, Pantone 354 C, 100%, 20%
Geprüft:

celecoxib

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.

1 if you are pregnant. If you can become pregnant

llIllIllII

Celebrex 100 mg hard capsule
Celebrex 200 mg hard capsule

1. What Celebrex is and
1.what it is used for

By signing this artwork copy the market confirms
that this document has been checked completely,
i.e. the correctness of all aspects (text, dosage
values, spelling, font size etc.) is certified. In case
of alterations the concerned parts must be marked
clearly. The market approval of this document
authorizes the plant to print the contents of this
proof. The market takes full responsibility for
correctness of this print proof

llIllIllII
PACKAGE LEAFLET:
INFORMATION FOR THE USER

Laetus-Code: 1170
Friends Satzmeister
PFI_K0_543810_GBR.qxd
Datum: 16.1.2013

PFI_K0_543810_GBR_GI CBX 100/200 mg K 16.01.13 15:12 Seite 1

PFI_K0_543810_GBR_GI CBX 100/200 mg K 16.01.13 15:12 Seite 2

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:
1 an allergic reaction such as skin rash, swelling of
the face, wheezing or difficulty breathing
1 heart problems such as pain in the chest
1 severe stomach pain or any sign of bleeding in the
stomach or intestines, such as passing black or
bloodstained stools, or vomiting blood
1 a skin reaction such as rash, blistering or
peeling of the skin
1 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:
1 High blood pressure*
Common: affects 1 to 10 users in 100:
1 Heart attack*
1 Fluid build up with swollen ankles, legs and/or
hands
1 Urinary infections
1 Shortness of breath*, sinusitis (sinus
inflammation, sinus infection, blocked or painful

sinuses), blocked or runny nose, sore throat,
coughs, colds, flu-like symptoms
1 Dizziness, difficulty sleeping
1 Vomiting*, stomach ache, diarrhoea,
indigestion, wind
1 Rash, itching
1 Muscle stiffness
1 Difficulty swallowing*
1 Worsening of existing allergies
Uncommon: affects 1 to 10 users in 1,000:
1 Stroke*
1 Heart failure, palpitations (awareness of heart
beat), fast heart rate
1 Worsening of existing high blood pressure
1 Abnormalities in liver-related blood tests
1 Abnormalities in kidney-related blood tests
1 Anaemia (changes in red blood cells that can
cause fatigue and breathlessness)
1 Anxiety, depression, tiredness, drowsiness,
tingling sensations (pins and needles)
1 High levels of potassium in blood test results
(can cause nausea (feeling sick), fatigue,
muscle weakness or palpitations)
1 Impaired or blurred vision, ringing in the ears,
mouth pain and sores, difficulty hearing*
1 Constipation, burping, stomach inflammation
(indigestion, stomach ache or vomiting), worsening
of inflammation of the stomach or intestine
1 Leg cramps
1 Raised itchy rash (hives)
Rare: affects 1 to 10 users in 10,000:
1 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)

1 Reduced number of white blood cells (which
help protect the body from infection) and blood
platelets (increased chance of bleeding or
bruising)
1 Difficulty coordinating muscular movements
1 Feeling confused, changes in the way things taste
1 Increased sensitivity to light
1 Loss of hair
Not known: frequency cannot be estimated from
the available data:
1 Bleeding within the brain causing death
1 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
1 Bleeding of the stomach or intestines (can lead
to bloody stools or vomiting), inflammation of the
intestine or colon, nausea (feeling sick)
1 Serious skin conditions such as StevensJohnson 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)
1 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))
1 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
1 Kidney problems (possible kidney failure,
inflammation of the kidneys)
1 Blood clot in the blood vessels in the lungs.

Symptoms may include sudden breathlessness,
sharp pains when you breathe or collapse
1 Irregular heartbeat
1 Meningitis (inflammation of the membrane around
the brain and spinal cord)
1 Hallucinations
1 Worsening of epilepsy (possible more frequent
and/or severe seizures)
1 Inflamed blood vessels (can cause fever, aches,
purple blotches on the skin)
1 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
1 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)
1 Chest pain
1 Impaired sense of smell
1 Skin discolouration (bruising), muscle pain and
weakness, painful joints
1 Menstrual disturbances
1 Headache, flushing
1 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 400 mg per day for up to
3 years, the following additional side effects
have been observed:
Common: affects 1 to 10 users in 100:

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

1 Weight gain
Uncommon: affects 1 to 10 users in 1,000:
1 Deep vein thrombosis (blood clot usually in the
leg, which may cause pain, swelling or redness
of the calf or breathing problems)
1 Stomach problems: stomach infection (which
can cause irritation and ulcers of the stomach
and intestines)
1 Lower limb fracture
1 Shingles, skin infection, eczema (dry itchy rash),
pneumonia (chest infection (possible cough,
fever, difficulty breathing))
1 Floaters in the eye causing blurred or impaired
vision, vertigo due to inner ear troubles, sore,
inflamed or bleeding gums, mouth sores
1 Excessive urination at night, bleeding from piles /
haemorrhoids, frequent bowel movements
1 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
1 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 reach and sight of children.
Do not use Celebrex after the expiry date stated on
the blister and carton. The expiry date refers to the
last day of that month.
Do not store Celebrex above 30°C.
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 substance is celecoxib.
1 capsule contains 100 mg or 200 mg celecoxib.
The other ingredients are:
Lactose monohydrate, sodium lauryl sulphate,
povidone K30, croscarmellose sodium, magnesium
stearate. Capsule shells contain gelatin, titanium
dioxide E171. Ink contains indigotine E132 (100 mg
capsule) or iron oxide E172 (200 mg capsule),
shellac, propylene glycol.

What Celebrex looks like and
contents of the pack
Celebrex is available as hard capsules.
Opaque, white with two blue bands marked 7767
and 100 (Celebrex 100 mg).

Manufacturer:
Pfizer Manufacturing Deutschland GmbH
Heinrich-Mack-Strasse 35
D-89257 Illertissen
Germany
For any information about this medicine, please
contact:
Medical Information
Pfizer Ltd
Walton Oaks
Dorking Road
Tadworth
Surrey
KT20 7NS
Telephone: 01304 616161
This leaflet was last revised in 01/2013.
Ref: CB 24_0

Opaque, white with two gold bands marked 7767
and 200 (Celebrex 200 mg).
The capsules are packaged in clear and opaque PVC
blisters or aluminium blisters.
Celebrex is contained in packs of 2, 5, 6, 10, 20, 30,
40, 50, 60, 100, 10x10, 10x30, 10x50, 1x50 unit
dose, 1x100 unit dose, 5x(10x10).

By signing this artwork copy the market confirms
that this document has been checked completely,
i.e. the correctness of all aspects (text, dosage
values, spelling, font size etc.) is certified. In case
of alterations the concerned parts must be marked
clearly. The market approval of this document
authorizes the plant to print the contents of this
proof. The market takes full responsibility for
correctness of this print proof

4. Possible side effects

Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom.

543810M

Celebrex 100 mg hard capsule
Celebrex 200 mg hard capsule
celecoxib

Seite 1

Read all of this leaflet carefully before
you start taking this medicine
1 Keep this leaflet. You may need to read
it again
1 If you have any further questions,
please ask your doctor or pharmacist
1 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
1 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. What Celebrex is and what it
is used for
2. Before you take Celebrex
3. How to take Celebrex
4. Possible side effects
5. How to store Celebrex
6. Further information

1. What Celebrex is and
1. 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.
1 if you are allergic (hypersensitive) to celecoxib or any
of the other ingredients of Celebrex
1 if you have had an allergic reaction to a group of
medicines called “sulphonamides” (e.g. some
antibiotics used to treat infections)
1 if you currently have an ulcer in your stomach or
intestines, or bleeding in your stomach or intestines

1 if as a result of taking acetylsalicylic acid or any

1 if you use medicines to reduce blood clotting

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
1 if you are pregnant. If you can become pregnant
during ongoing treatment you should discuss
methods of contraception with your doctor
1 if you are breast-feeding
1 if you have severe liver disease
1 if you have severe kidney disease
1 if you have an inflammatory disease of the intestines
such as ulcerative colitis or Crohn’s disease
1 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 “ministroke”), angina, or blockages of blood vessels to
the heart or brain
1 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:
1 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)
1 if you are taking acetylsalicylic acid (even at low
dose for heart protective purposes)

(e.g. warfarin)

1 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
1
or raised cholesterol
1 if your heart, liver or kidneys are not working well
your doctor may want to keep a regular check on
you
1 if you have fluid retention (such as swollen ankles
and feet)
1 if you are dehydrated, for instance due to sickness,
diarrhoea or the use of diuretics (used to treat
excess fluid in the body)
1 if you have had a serious allergic reaction or a
serious skin reaction to any medicines
1 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
1
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.

llIllIllII
Uncommon: affects 1 to 10 users in 1,000:
1 Deep vein thrombosis (blood clot usually in the
leg, which may cause pain, swelling or redness
of the calf or breathing problems)
1 Stomach problems: stomach infection (which
can cause irritation and ulcers of the stomach
and intestines)

1 Weight gain
Common: affects 1 to 10 users in 100:
1 Heart problems: angina (chest pain)
1 Stomach problems: irritable bowel syndrome
(can include stomach ache, diarrhoea,
indigestion, wind)
1 Kidney stones (which may lead to stomach or
back pain, blood in urine), difficulty passing urine
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:

5. How to store Celebrex
1 Lower limb fracture
1 Shingles, skin infection, eczema (dry itchy rash),
pneumonia (chest infection (possible cough,
fever, difficulty breathing))
1 Floaters in the eye causing blurred or impaired
vision, vertigo due to inner ear troubles, sore,
inflamed or bleeding gums, mouth sores
1 Excessive urination at night, bleeding from piles/
haemorrhoids, frequent bowel movements
1 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
1 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.

Marketing Authorisation Holder:
Celebrex is available as hard capsules.
Opaque, white with two blue bands marked 7767
and 100 (Celebrex 100 mg).
Opaque, white with two gold bands marked 7767
and 200 (Celebrex 200 mg).
The capsules are packaged in clear and opaque PVC
blisters or aluminium blisters.
Celebrex is contained in packs of 2, 5, 6, 10, 20, 30,
40, 50, 60, 100, 10x10, 10x30, 10x50, 1x50 unit
dose, 1x100 unit dose, 5x(10x10).
Not all pack sizes may be marketed.

What Celebrex looks like and
contents of the pack
The active substance is celecoxib.
1 capsule contains 100 mg or 200 mg celecoxib.
The other ingredients are:
Lactose monohydrate, sodium lauryl sulphate,
povidone K30, croscarmellose sodium, magnesium
stearate. Capsule shells contain gelatin, titanium
dioxide E171. Ink contains indigotine E132 (100 mg
capsule) or iron oxide E172 (200 mg capsule),
shellac, propylene glycol.

What Celebrex contains

6. Further information

This leaflet was last revised in 01/2013.
Ref: CB 24_0
For any information about this medicine,
please contact:
Medical Information
Pfizer Ltd
Walton Oaks
Dorking Road
Tadworth
Surrey
KT20 7NS
Telephone: 01304 616161
Pfizer Manufacturing Deutschland GmbH
Heinrich-Mack-Strasse 35
D-89257 Illertissen
Germany

Manufacturer:

543820M

1 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)
1 Chest pain
1 Impaired sense of smell
1 Skin discolouration (bruising), muscle pain and
weakness, painful joints
1 Menstrual disturbances
1 Headache, flushing
1 Low levels of sodium in blood test results (can
cause loss of appetite, headache, nausea
(feeling sick), muscle cramps and weakness)

Keep out of the reach and sight of children.
Do not use Celebrex after the expiry date stated on
the blister and carton. The expiry date refers to the
last day of that month.
Do not store Celebrex above 30°C.
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.

Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom.
Seite 4

By signing this artwork copy the market confirms
that this document has been checked completely,
i.e. the correctness of all aspects (text, dosage
values, spelling, font size etc.) is certified. In case
of alterations the concerned parts must be marked
clearly. The market approval of this document
authorizes the plant to print the contents of this
proof. The market takes full responsibility for
correctness of this print proof

543820M GI CBX 100/200 mg K GBR ROKL
Ersetzt: 516970
Schriftgröße: 8 pt
Maße: 148 x 297 mm (Rolle Kleb)
Farbe 2/2: Pantone 072 C 100%, 20%, Pantone 354 C, 100%, 20%
Geprüft:

Laetus-Code: 1170
Friends Satzmeister
PFI_K0_543820_GBR.qxd
Datum: 16.1. 2013

PFI_K0_543820_GBR_GI CBX 100/200 mg K ROKL 16.01.13 15:15 Seite 1

PACKAGE LEAFLET:
INFORMATION FOR THE USER

If you have:
1 an allergic reaction such as skin rash, swelling of
the face, wheezing or difficulty breathing
1 heart problems such as pain in the chest
1 severe stomach pain or any sign of bleeding in the
stomach or intestines, such as passing black or
bloodstained stools, or vomiting blood
1 a skin reaction such as rash, blistering or
peeling of the skin
1 liver failure (symptoms may include nausea
(feeling sick), diarrhoea, jaundice (your skin or the
whites of your eyes look yellow))

If any of the following happen, stop taking
Celebrex and tell your doctor immediately:

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

Uncommon: affects 1 to 10 users in 1,000:
1 Stroke*
1 Heart failure, palpitations (awareness of heart
beat), fast heart rate
1 Worsening of existing high blood pressure
1 Abnormalities in liver-related blood tests
1 Abnormalities in kidney-related blood tests
1 Anaemia (changes in red blood cells that can
cause fatigue and breathlessness)
1 Anxiety, depression, tiredness, drowsiness,
tingling sensations (pins and needles)
1 High levels of potassium in blood test results
(can cause nausea (feeling sick), fatigue,
muscle weakness or palpitations)

Common: affects 1 to 10 users in 100:
1 Heart attack*
1 Fluid build up with swollen ankles, legs and/or
hands
1 Urinary infections
1 Shortness of breath*, sinusitis (sinus
inflammation, sinus infection, blocked or painful
sinuses), blocked or runny nose, sore throat,
coughs, colds, flu-like symptoms
1 Dizziness, difficulty sleeping
1 Vomiting*, stomach ache, diarrhoea,
indigestion, wind
1 Rash, itching
1 Muscle stiffness
1 Difficulty swallowing*
1 Worsening of existing allergies

3. How to take Celebrex

Like all medicines, Celebrex can have side-effects,
although not everybody gets them.

1 Bleeding of the stomach or intestines (can lead

mouth pain and sores, difficulty hearing*
1 Constipation, burping, stomach inflammation
(indigestion, stomach ache or vomiting), worsening
of inflammation of the stomach or intestine
1 Leg cramps
1 Raised itchy rash (hives)

Not known: frequency cannot be estimated from
the available data:
1 Bleeding within the brain causing death
1 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

Rare: affects 1 to 10 users in 10,000:
1 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)
1 Reduced number of white blood cells (which
help protect the body from infection) and blood
platelets (increased chance of bleeding or
bruising)
1 Difficulty coordinating muscular movements
1 Feeling confused, changes in the way things taste
1 Increased sensitivity to light
1 Loss of hair

to bloody stools or vomiting), inflammation of the
intestine or colon, nausea (feeling sick)
1 Serious skin conditions such as StevensJohnson 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)
1 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))
1 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
1 Kidney problems (possible kidney failure,
inflammation of the kidneys)
1 Blood clot in the blood vessels in the lungs.
Symptoms may include sudden breathlessness,
sharp pains when you breathe or collapse
1 Irregular heartbeat
1 Meningitis (inflammation of the membrane around
the brain and spinal cord)
1 Hallucinations
1 Worsening of epilepsy (possible more frequent
and/or severe seizures)
1 Inflamed blood vessels (can cause fever, aches,
purple blotches on the skin)
1 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

1 Impaired or blurred vision, ringing in the ears,

By signing this artwork copy the market confirms
that this document has been checked completely,
i.e. the correctness of all aspects (text, dosage
values, spelling, font size etc.) is certified. In case
of alterations the concerned parts must be marked
clearly. The market approval of this document
authorizes the plant to print the contents of this
proof. The market takes full responsibility for
correctness of this print proof

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 and breast-feeding

Very common: affects more than 1 user in 10:
1 High blood pressure*

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

The dose is usually:
1 one 200 mg capsule once a day; or
1 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.
Children: Celebrex is for adults only, it is not for use
in children.
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.

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.
Seite 2

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.

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 200 mg each
day, increased by your doctor to a maximum of
400 mg, if needed.
The dose is usually:
1 one 200 mg capsule once a day; or
1 one 100 mg capsule twice a day.
For rheumatoid arthritis the usual dose is 200 mg
each day, increased by your doctor to a maximum of
400 mg, if needed.
The dose is usually:
1 one 100 mg capsule twice a day.
For ankylosing spondylitis the usual dose is
200 mg each day, increased by your doctor to a
maximum of 400 mg, if needed.

Seite 3

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:
1 Dextromethorphan (used to treat coughs)
1 ACE inhibitors or angiotensin II antagonists (used
for high blood pressure and heart failure)
1 Diuretics (used to treat excess fluid in the body)
1 Fluconazole and rifampicin (used to treat fungal and
bacterial infections)
1 Warfarin or other oral anticoagulants (“bloodthinning” agents that reduce blood clotting)
1 Lithium (used to treat some types of depression)
1 Other medicines to treat depression, sleep
disorders, high blood pressure or an irregular
heartbeat
1 Neuroleptics (used to treat some mental
disorders)
1 Methotrexate (used to treat rheumatoid arthritis,
psoriasis and leukaemia)
1 Carbamazepine (used to treat epilepsy/seizures and
some forms of pain or depression)
1 Barbiturates (used to treat epilepsy/seizures
and some sleep disorders)
1 Ciclosporin and tacrolimus (used for immune
system suppression e.g. after transplants)

4. Possible side effects

PFI_K0_543820_GBR_GI CBX 100/200 mg K ROKL 16.01.13 15:15 Seite 2

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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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