CELEBREX 200MG CAPSULES

Active substance: CELECOXIB

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

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.
1 if you are allergic to celecoxib or any of the other
ingredients of this medicine (listed in section 6)
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

Warnings and precautions

Talk to your doctor before taking Celebrex:
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
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
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).

Other medicines and Celebrex

Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines:
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
(“blood-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)

Celebrex contains

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.

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.

Pregnancy, breast-feeding
and fertility

If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this
medicine.
Pregnancy
Celebrex must not be used by women who are
pregnant or can become pregnant (i.e. women of
child bearing potential who are not using adequate
contraception) during ongoing treatment. If you
become pregnant during treatment with Celebrex you
should discontinue the treatment and contact your
doctor for alternative treatment.
Breast-feeding
Celebrex must not be used during breast-feeding.
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.

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.

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.
You should not take more than 400 mg per day.
Use in children: Celebrex is for adults only, it is not for
use in children.

If you take more Celebrex than
you should:

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.

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.

Contact your doctor within two weeks of starting
treatment if you do not experience any benefit.

If you forget to take Celebrex:

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.

If you stop taking Celebrex:

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.

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.

554970M GI CBX 100/200 mg K GBR
Ersetzt: 543810
Schriftgröße: 7,5 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.

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 “mini-stroke”),
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

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Celebrex 100 mg hard capsules
Celebrex 200 mg hard capsules

1. What Celebrex is and
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

IlIIllIlI
Package leaflet:
Information for the user

Laetus-Code: 868
Friends Satzmeister
PFI_K1_554970_GBR.qxd
Datum: 28.1.2014

PFI_K1_554970_GBR_GI CBX 100/200 mg K 28.01.14 11:24 Seite 1

PFI_K1_554970_GBR_GI CBX 100/200 mg K 28.01.14 11:24 Seite 2

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:
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: may affect more than 1 in 10 people
1 High blood pressure*
Common: may affect up to 1 in 10 people
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: may affect up to 1 in 100 people

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: may affect up to 1 in 1,000 people
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

Very rare: may affect up to 1 in 10,000 people

1 Serious skin conditions such as acute generalised
exanthematous pustulosis (symptoms include the
skin becoming red with swollen areas covered in
numerous small pustules)
1 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)
1 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)
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 Stevens-Johnson
syndrome, exfoliative dermatitis and toxic epidermal
necrolysis (can cause rash, blistering or peeling of
the skin)
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 Decreased fertility in females, which is usually
reversible
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: may affect up to 1 in 10 people
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: may affect up to 1 in 100 people
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
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 this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is
stated on the blister and carton. The expiry date refers
to the last day of that month.
Do not store Celebrex above 30°C.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help protect the environment.

6. Contents of the pack
and other 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 laurilsulfate, povidone,
croscarmellose sodium, magnesium stearate.
Capsule shells contain gelatin, titanium dioxide E171,
sodium laurilsulfate and sorbitan monolaurate.
Printing ink contains shellac, propylene glycol,
indigotine E132 (100 mg capsule), iron oxide E172
(200 mg capsule).

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).
Opaque, white with two gold bands marked 7767
and 200 (Celebrex 200 mg).
The capsules are packaged in clear or opaque
PVC/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.

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

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 medicinal product is authorized in the Member
States of the EEA under the following names:
Austria
Celebrex 100 mg/200 mg Hartkapseln
Belgium
Celebrex 100 mg/200 mg gélules/
harde capsules/
Hartkapseln
Denmark
Celebra 100 mg/200 mg
Finland
Celebra 100 mg/200 mg Kapseli, kova
France
Celebrex 100 mg/200 mg gélules
Germany
Celebrex 100 mg/200 mg Hartkapseln
Greece
Celebrex 100 mg/200 mg Kαψάκιο,
σκληρό
Iceland
Celebra 100 mg/200 mg
Ireland
Celebrex 100 mg/200 mg capsule, hard
Italy
Celebrex 100 mg/200 mg capslule rigide
Luxembourg Celebrex 100 mg/200 mg gélules/
harde capsules/
Hartkapseln
Netherlands Celebrex 100 mg/200 mg capsule, hard
Norway
Celebra 100 mg/200 mg kapsel, hard
Portugal
Celebrex 100 mg/200 mg cápsulas
Spain
Celebrex 100 mg/200 mg cápsulas duras
Sweden
Celebra 100 mg/200 mg hårda kapslar
UK
Celebrex 100 mg/200 mg capsule hard
This leaflet was last revised in 01/2014.
Ref: CB 25_0

554970M

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

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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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