CELECOXIB 100 MG CAPSULES HARD

Active substance: CELECOXIB

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Celecoxib 100 mg hard capsule
Celecoxib 200 mg hard capsule

celecoxib

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.
What Celecoxib is and what it is used for
2.
Before you take Celecoxib
3.
How to take Celecoxib
4.
Possible side effects
5.
How to store Celecoxib
6.
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 antiinflammatory 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.

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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 anti-inflammatory and
pain-relieving medicine (NSAID) you have had asthma, nose polyps, severe
nose congestion, or an allergic reaction such as an itchy skin rash, swelling of
the face, lips, tongue or throat, breathing difficulties or wheezing
if you are pregnant. If you can become pregnant during ongoing treatment you
should discuss methods of contraception with your doctor
if you are breast-feeding
if you have severe liver disease
if you have severe kidney disease
if you have an inflammatory disease of the intestines such as ulcerative colitis or
Crohn’s disease
if you have heart failure, established ischaemic heart disease, or cerebrovascular
disease, e.g. you have been diagnosed with a heart attack, stroke, or transient
ischaemic attack (temporary reduction of blood flow to the brain; also known as
“mini-stroke”), angina, or blockages of blood vessels to the heart or brain
if you have or have had problems with your blood circulation (peripheral
arterial disease) or if you have had surgery on the arteries of your legs

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





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)

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if you are using Celecoxib at the same time as other non-acetylsalicylic NSAIDs
such as ibuprofen or diclofenac. The use of these medicines together should be
avoided
if you smoke, have diabetes, raised blood pressure or raised cholesterol
if your heart, liver or kidneys are not working well your doctor may want to
keep a regular check on you
if you have fluid retention (such as swollen ankles and feet)
if you are dehydrated, for instance due to sickness, diarrhoea or the use of
diuretics (used to treat excess fluid in the body)
if you have had a serious allergic reaction or a serious skin reaction to any
medicines
if you feel ill due to an infection or think you have an infection, as 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)

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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.

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.

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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:
 one 200 mg capsule once a day; or
 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:
 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 400mg, if needed.
The dose is usually:
 one 200 mg capsule once a day; or
 one 100 mg capsule twice a day.
Kidney or liver problems: make sure your doctor knows if you have liver or kidney
problems as you may need a lower dose.
The elderly, especially those with a weight less than 50 kg: if you are over 65 years of
age and especially if you weigh less than 50 kg, your doctor may want to monitor you
more closely.
Children: Celecoxib 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 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.

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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

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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

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generalised exenthematous 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)
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)

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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 reach and sight of children.
Do not use Celecoxib after the expiry date stated on the blister and carton. The expiry
date refers to the last day of that month.
Do not store Celecoxib above 30o 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 Celecoxib 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).

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What Celecoxib looks like and contents of the pack
Celecoxib is available as hard capsules.
Opaque, white with two blue bands marked 7767 and 100.
Opaque, white with two gold bands marked 7767 and 200.
The capsules are packaged in clear or opaque PVC/aluminium blisters.
Celecoxib 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 and Manufacturer:
Marketing Authorisation Holder:
Pfizer Healthcare Ireland
9 Riverwalk
National Digital Park
Citywest Business Campus
Dublin 24
Ireland
Manufacturer:
Pfizer Manufacturing Deutschland GmbH
Heinrich-Mack-Str. 35
D-89257 Illertissen
Germany

This medicinal product is authorized in the Member States of the EEA under the
following names:
Austria
Belgium
Denmark
Finland
France
Germany

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Celecoxib
Pfizer
Celecoxib
Pfizer
Celecoxib
Pfizer
Celecoxib
Pfizer
Celecoxib
Pfizer
Celecoxib

100 mg/200 mg

Hartkapseln

100 mg/200 mg

gélules/harde
capsules/Hartkapseln

100 mg/200 mg

gélules

100 mg/200 mg

Hartkapseln

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Greece
Iceland
Ireland
Italy
Luxembourg
Netherlands
Norway
Portugal
Spain
Sweden
UK

Pfizer
Celecoxib
Pfizer
Celecoxib
Pfizer
Celecoxib
Pfizer
Celecoxib
Pfizer
Celecoxib
Pfizer
Celecoxib
Pfizer
Celecoxib
Pfizer
Celecoxib
Parke-Davis
Celecoxib
Pharmacia
Celecoxib
Pfizer
Celecoxib

100 mg/200 mg

Kαψάκιο, σκληρό

100 mg/200 mg

capsule, hard

100 mg/200 mg

capslule rigide

100 mg/200 mg

gélules/harde
capsules/Hartkapseln

100 mg/200 mg
100 mg/200 mg

kapsel, hard

100 mg/200 mg
100 mg/200 mg

cápsulas duras

100 mg/200 mg
100 mg/200 mg

capsule hard

This leaflet was last revised in 04/2013.
Ref: dCB 3_0

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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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