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CELEBREX 200MG HARD CAPSULES

Active substance(s): CELECOXIB / CELECOXIB / CELECOXIB

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Celebrex® 200mg Hard Capsules
celecoxib
This product will be referred to as Celebrex throughout this leaflet.
This product is available in multiple strengths and all strengths will
be referred to throughout this leaflet
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor or pharmacist.
 This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
 If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See section
4.
What is in this leaflet:
1. 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
1.

What Celebrex is and what it is used for

Celebrex is used in adults 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.
You should expect your medicine to start working within hours of taking
the first dose, but you may not experience a full effect for several days.
2.

What you need to know before you take Celebrex

You have been prescribed Celebrex by your doctor.
The following information will help you get the best results with Celebrex.
If you have any further questions please ask your doctor or pharmacist.
Do not take Celebrex
Tell your doctor if any of the following are true for you as patients
with these conditions should not take Celebrex.
 if you are allergic to celecoxib or any of the other ingredients of this
medicine (listed in section 6)
 if you have had an allergic reaction to a group of medicines called
“sulphonamides” (e.g. some antibiotics used to treat infections)
 if you currently have an ulcer in your stomach or intestines, or
bleeding in your stomach or intestines
 if as a result of taking acetylsalicylic acid or any other
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
Warnings and precautions
Talk to your doctor or pharmacist before taking Celebrex:
 if you have previously had an ulcer or bleeding in your stomach or
intestines. (Do not take Celebrex if you currently have an ulcer or
bleeding in your stomach or intestine)
 if you are taking acetylsalicylic acid (even at low dose for heart
protective purposes)
 if you use medicines to reduce blood clotting (e.g. warfarin/warfarin
like anticoagulants or novel oral anti-clotting medicines, e.g. apixaban)
 if you use medicines called corticosteroids (e.g. prednisone)
 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 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 will want to monitor you
regularly
 the consumption of alcohol and NSAIDs may increase the risk of
gastrointestinal problems
As with other NSAIDs (e.g. ibuprofen or diclofenac) this medicine may
lead to an increase in blood pressure, and so your doctor may ask to
monitor your blood pressure on a regular basis.
Some cases of severe liver reactions, including severe liver inflammation,
liver damage, liver failure (some with fatal outcome or requiring liver
transplant), have been reported with celecoxib.
Of the cases that reported time to onset, most severe liver reactions
occurred within one month of start of treatment.

Celebrex may make it more difficult to become pregnant. You should
inform your doctor if you are planning to become pregnant or if you have
problems to become pregnant (see section on Pregnancy and
breast-feeding).
Other medicines and Celebrex
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines:
 Dextromethorphan (used to treat coughs)
 ACE inhibitors, angiotensin II antagonists, beta blockers and diuretics
(used for high blood pressure and heart failure)
 Fluconazole and rifampicin (used to treat fungal and bacterial
infections)
 Warfarin or other warfarin like medicines (“blood-thinning” agents that
reduce blood clotting) including newer medicines like apixaban
 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 (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.
Celebrex contains lactose
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 this medicine exactly as your doctor or pharmacist 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.
Method of administration:
Celebrex is for oral use. 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.
If you have difficulty swallowing capsules: The entire capsule contents
can be sprinkled onto a level teaspoon of semi-solid food (such as cool or
room temperature applesauce, rice gruel, yogurt or mashed banana) and
swallowed immediately with a drink approximately 240 ml of water.
To open the capsule, hold upright to contain the granules at the bottom
then gently squeeze the top and twist to remove, taking care not to spill
the contents. Do not chew or crush the granules.
Contact your doctor within two weeks of starting treatment if you do not
experience any benefit.
The recommended dose is:
For osteoarthritis the recommended 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 recommended 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 recommended 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.
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
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 a forgotten dose.
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 medicine, ask your
doctor or pharmacist.
4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not
everybody gets them.
The side effects listed below were observed in arthritis patients who
took Celebrex. Side effects marked with an asterisk (*) are listed
below at the higher frequencies that occurred in patients who took
Celebrex to prevent colon polyps. Patients in these studies took
Celebrex at high doses and for a long duration.
If any of the following happen, stop taking Celebrex and tell your
doctor immediately:
If you have:
 an allergic reaction such as skin rash, swelling of the face, wheezing
or difficulty breathing
 heart problems such as pain in the chest
 severe stomach pain or any sign of bleeding in the stomach or
intestines, such as passing black or bloodstained stools, or vomiting
blood
 a skin reaction such as rash, blistering or peeling of the skin
 liver failure (symptoms may include nausea (feeling sick), diarrhoea,
jaundice (your skin or the whites of your eyes look yellow)).
Very common: may affect more than 1 in 10 people
 High blood pressure, including worsening of existing high blood
pressure *
Common: may affect up to 1 in 10 people
 Heart attack*
 Fluid build up with swollen ankles, legs and/or hands
 Urinary infections
 Shortness of breath*, sinusitis (sinus inflammation, sinus infection,
blocked or painful sinuses), blocked or runny nose, sore throat,
coughs, colds, flu-like symptoms
 Dizziness, difficulty sleeping
 Vomiting*, stomach ache, diarrhoea, indigestion, wind
 Rash, itching
 Muscle stiffness
 Difficulty swallowing*
 Headache
 Nausea (feeling sick)
 Painful joints
 Worsening of existing allergies
 Accidental injury
Uncommon: may affect up to 1 in 100 people
 Stroke*
 Heart failure, palpitations (awareness of heart beat), fast heart rate
 Abnormalities in liver-related blood tests
 Abnormalities in kidney-related blood tests
 Anaemia (changes in red blood cells that can cause fatigue and
breathlessness)
 Anxiety, depression, tiredness, drowsiness, tingling sensations (pins
and needles)
 High levels of potassium in blood test results (can cause nausea
(feeling sick), fatigue, muscle weakness or palpitations)
 Impaired or blurred vision, ringing in the ears, mouth pain and sores,
difficulty hearing*
 Constipation, burping, stomach inflammation (indigestion, stomach
ache or vomiting), worsening of inflammation of the stomach or
intestine
 Leg cramps
 Raised itchy rash (hives)
 Eye inflammation
 Difficulty breathing
 Skin discolouration (bruising)
 Chest pain (generalised pain not related to the heart)
 Face swelling
Rare: may affect up to 1 in 1,000 people
 Ulcers (bleeding) in the stomach, gullet or intestines; or rupture of the
intestine (can cause stomach ache, fever, nausea, vomiting, intestinal
blockage), dark or black stools, inflammation of the pancreas (can
lead to stomach pain), inflammation of the gullet (oesophagus)
 Low levels of sodium in the blood (a condition known as
hyponatraemia)
 Reduced number of white blood cells (which help to protect the body
from infection) or blood platelets (increased chance of bleeding or
bruising)
 Difficulty coordinating muscular movements
 Feeling confused, changes in the way things taste
 Increased sensitivity to light
 Loss of hair
 Hallucinations
 Bleeding in the eye
 Acute reaction that may lead to lung inflammation
 Irregular heartbeat
 Flushing
 Blood clot in the blood vessels in the lungs. Symptoms may include
sudden breathlessness, sharp pains when you breathe or collapse
 Bleeding of the stomach or intestines (can lead to bloody stools or
vomiting), inflammation of the intestine or colon
 Severe liver inflammation (hepatitis). Symptoms may include nausea
(feeling sick), diarrhoea, jaundice (yellow discolouration of the skin or
eyes), dark urine, pale stools, bleeding easily, itching or chills
 Acute kidney failure
 Menstrual disturbances
 Swelling of the face, lips, mouth, tongue or throat, or difficulty
swallowing

Very rare: may affect up to 1 in 10,000 people
Serious allergic reactions (including potentially fatal anaphylactic
shock)
 Serious skin conditions such as Stevens-Johnson syndrome,
exfoliative dermatitis and toxic epidermal necrolysis (can cause rash,
blistering or peeling of the skin) and acute generalised exanthematous
pustulosis (symptoms include the skin becoming red with swollen
areas covered in numerous small pustules)
 A delayed allergic reaction with possible symptoms such as rash,
swelling of the face, fever, swollen glands, and abnormal test results
(e.g., liver, blood cell (eosinophilia, a type of raised white blood cell
count))
 Bleeding within the brain causing death
 Meningitis (inflammation of the membrane around the brain and spinal
cord)
 Liver failure, liver damage and severe liver inflammation (fulminant
hepatitis) (sometimes fatal or requiring liver transplant). Symptoms
may include nausea (feeling sick), diarrhoea, jaundice (yellow
discolouration of the skin or eyes), dark urine, pale stools, bleeding
easily, itching or chills
 Liver problems (such as cholestasis and cholestatic hepatitis, which
may be accompanied by symptoms such as discoloured stools,
nausea and yellowing of the skin or eyes)
 Inflammation of the kidneys and other kidney problems (such as
nephrotic syndrome and minimal change disease, which may be
accompanied by symptoms such as water retention (oedema), foamy
urine, fatigue and a loss of appetite)
 Worsening of epilepsy (possible more frequent and/or severe seizures)
 Blockage of an artery or vein in the eye leading to partial or complete
loss of vision
 Inflamed blood vessels (can cause fever, aches, purple blotches on
the skin)
 A reduction in the number of red and white blood cells and platelets
(may cause tiredness, easy bruising, frequent nose bleeds and
increased risk of infections)
 Muscle pain and weakness
 Impaired sense of smell
 Loss of taste


Not known: frequency cannot be estimated from the available data
 Decreased fertility in females, which is usually reversible on
discontinuation of the medicine
In clinical studies not associated with arthritis or other arthritic
conditions, where Celebrex was taken at doses of 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
 Heart problems: angina (chest pain)
 Stomach problems: irritable bowel syndrome (can include stomach
ache, diarrhoea, indigestion, wind)
 Kidney stones (which may lead to stomach or back pain, blood in
urine), difficulty passing urine
 Weight gain
Uncommon: may affect up to 1 in 100 people
 Deep vein thrombosis (blood clot usually in the leg, which may cause
pain, swelling or redness of the calf or breathing problems)
 Stomach problems: stomach infection (which can cause irritation and
ulcers of the stomach and intestines)
 Lower limb fracture
 Shingles, skin infection, eczema (dry itchy rash), pneumonia (chest
infection (possible cough, fever, difficulty breathing))
 Floaters in the eye causing blurred or impaired vision, vertigo due to
inner ear troubles, sore, inflamed or bleeding gums, mouth sores
 Excessive urination at night, bleeding from piles/ haemorrhoids,
frequent bowel movements
 Fatty lumps in skin or elsewhere, ganglion cyst (harmless swellings on
or around joints and tendons in the hand or foot), difficulty speaking,
abnormal or very heavy bleeding from the vagina, breast pain
 High levels of sodium in blood test results
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme website: www.mhra.gov.uk/
yellowcard. By reporting side effects you can help provide more
information on the safety of this medicine.
5.

How to store Celebrex

 Keep out of the sight and reach of children.
 Do not store Celebrex above 30°C.
 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.

 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.

Content of the pack and other information

What Celebrex contains
 The active substance is celecoxib.
 Each hard capsule contains 200mg of the active ingredient celecoxib.
 Each capsule also contains the following ingredients: gelatine, lactose
monohydrate, sodium lauryl sulphate, povidone K-30, croscarmellose
sodium, sorbitan monolaurate, shellac, propylene glycol, magnesium
stearate, titanium dioxide (E171) and yellow ferric oxide (E172).
This product contains lactose. If you have been told by your doctor that
you have an intolerance to some sugars, contact your doctor before
taking this medicinal product.
What Celebrex looks like and contents of the pack
Celebrex are opaque, white hard capsules with two gold bands marked
‘7767’ and ‘200’. They are available in blister packs of 20 or 30 capsules.
Manufacturer:
This product is manufactured by R-Pharm Germany GmbH, HeinrichMack-Str. 35, 89257 Illertissen, Germany. Procured from within the EU.
Repackaged by the Parallel Import Product Licence holder: G Pharma
Ltd, Dakota Avenue, Salford M50 2PU.
POM

PL 16369/1076

Celebrex 200mg Hard Capsules
10/10/2016
Celebrex® is a trade mark of Pfizer.

Expand Transcript

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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