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CELECOXIB 100MG CAPSULES HARD

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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).

Package leaflet: Information for the user

Celecoxib 100 mg capsules, hard
Celecoxib 200 mg capsules, hard
Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.
Ÿ Keep this leaflet. You may need to read it again.
Ÿ If you have any further questions, ask your doctor
or pharmacist.
Ÿ 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.
Ÿ 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 Celecoxib capsules are and what they are
used for
2. What you need to know before you take
Celecoxib capsules
3. How to take Celecoxib capsules
4. Possible side effects
5. How to store Celecoxib capsules
6. Contents of the pack and other information
1. What Celecoxib capsules are and what they
are used for
Celecoxib capsules belong to a group of medicinal
products called nonsteroidal anti-inflammatory drugs
(NSAID), and specifically a sub-group known as
(COX-2) inhibitors. Your body makes prostaglandins
that may cause pain and inflammation. In conditions
such as rheumatoid arthritis and osteoarthritis your
body makes more of these. Celecoxib capsules act by
reducing the production of prostaglandins, thereby
reducing the pain and inflammation.
Celecoxib capsules are used in adults for the relief of
signs and symptoms of rheumatoid arthritis,
osteoarthritis and ankylosing spondylitis.
2. What you need to know before you take
Celecoxib capsules
You have been prescribed Celecoxib capsules by
your doctor. The following information will help you
get the best results with Celecoxib capsules. If you
have any further questions please ask your doctor or
pharmacist.
Do not take Celecoxib capsules
Tell your doctor if any of the following are true
for you as patients with these conditions should
not take Celecoxib capsules:

Warnings and precautions
Talk to your doctor before taking Celecoxib
capsules:
Ÿ if you have previously had an ulcer or bleeding
in your stomach or intestines.
(Do not take Celecoxib capsules if you currently
have an ulcer or bleeding in your stomach or
intestine);
Ÿ if you are taking acetylsalicylic acid (even at low
dose for heart protective purposes);
Ÿ if you use medicines to reduce blood clotting
(e.g. warfarin);
Ÿ if you are using Celecoxib capsules at the same
time as other non-acetylsalicylic NSAIDs such as
ibuprofen or diclofenac. The use of these
medicines together should be avoided;
Ÿ if you smoke, have diabetes, raised blood
pressure or raised cholesterol;
Ÿ if your heart, liver or kidneys are not working
well your doctor may want to keep a regular
check on you;
Ÿ if you have fluid retention (such as swollen
ankles and feet);
Ÿ if you are dehydrated, for instance due to
sickness, diarrhoea or the use of diuretics (used to
treat excess fluid in the body);
Ÿ if you have had a serious allergic reaction or a
serious skin reaction to any medicines;
Ÿ if you feel ill due to an infection or think you
have an infection, as Celecoxib capsules may
mask a fever or other signs of infection and
inflammation;
Ÿ if you are over 65 years of age your doctor may
want to keep a regular check on you.

Ÿ Dextromethorphan (used to treat coughs)
Ÿ ACE inhibitors or angiotensin II antagonists
(used for high blood pressure and heart failure)
Ÿ Diuretics (used to treat excess fluid in the body)
Ÿ Fluconazole and rifampicin (used to treat fungal
and bacterial infections)
Ÿ Warfarin or other oral anticoagulants (bloodthinning” agents that reduce blood clotting)
Ÿ Lithium (used to treat some types of depression)
Ÿ Other medicines to treat depression, sleep
disorders, high blood pressure or an irregular
heartbeat
Ÿ Neuroleptics (used to treat some mental
disorders)
Ÿ Methotrexate (used to treat rheumatoid arthritis,
psoriasis and leukaemia)
Ÿ Carbamazepine (used to treat epilepsy/seizures
and some forms of pain or depression)
Ÿ Barbiturates (used to treat epilepsy/seizures and
some sleep disorders)
Ÿ Ciclosporin and tacrolimus (used for immune
system suppression e.g. after transplants)
Celecoxib capsules 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
Celecoxib capsules 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
capsules you should discontinue the treatment and
contact your doctor for alternative treatment.
Breast-feeding
Celecoxib capsules must not be used during breastfeeding.
Fertility
NSAIDs, including Celecoxib capsules, 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 Celecoxib
capsules before you drive or operate machinery. If
you feel dizzy or drowsy after taking Celecoxib
capsules, do not drive or operate machinery until
these effects wear off.
Celecoxib capsules contain lactose
Celecoxib capsules contain 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 capsules
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 Celecoxib capsules 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 capsules for longer than necessary
to control symptoms.
Celecoxib capsules 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 capsules 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:
n one 200 mg capsule once a day; or
n one 100 mg capsule twice a day.
For rheumatoid arthritis: The initial recommended
daily dose is 200 mg taken in two divided doses. The
dose may, if needed, later be increased to 200 mg
twice daily.
The dose is usually:
n 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:
n one 200 mg capsule once a day; or
n 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: Celecoxib capsules are for adults
only, they are not for use in children.
If you take more Celecoxib capsules 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.

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.

If you forget to take Celecoxib capsules
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.

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.

If you stop taking Celecoxib capsules
Suddenly stopping your treatment with Celecoxib
capsules may lead to your symptoms getting worse.
Do not stop taking Celecoxib capsules unless your
doctor tells you to. Your doctor may tell you to
reduce the dose over a few days before
stopping completely.

Celecoxib capsules may make
it more difficult to become

If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist.

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Ÿ if you are allergic to celecoxib or any of the other
ingredients of this medicine (listed in section 6);
Ÿ if you have had an allergic reaction to a group of
medicines called “sulphonamides” (e.g. some
antibiotics used to treat infections);
Ÿ if you currently have an ulcer in your stomach or
intestines, or bleeding in your stomach or
intestines;
Ÿ if as a result of taking acetylsalicylic acid or
any other anti-inflammatory and painrelieving 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;
Ÿ if you are pregnant. If you can become
pregnant during ongoing treatment you
should discuss methods of contraception with
your doctor;
Ÿ if you are breast-feeding;
Ÿ if you have severe liver disease;
Ÿ if you have severe kidney disease;
Ÿ if you have an inflammatory disease of the
intestines such as ulcerative colitis or Crohn's
disease;
Ÿ 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
Ÿ 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.

Other medicines and Celecoxib capsules
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines:

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4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Ÿ

If any of the following happens, stop taking
Celecoxib capsules and tell your doctor
immediately:
If you have:

Ÿ

-

Ÿ

-

-

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
Ÿ High blood pressure, including worsening of
existing high blood pressure*
Common: may affect up to 1 in 10 people
Ÿ Heart attack*
Ÿ Fluid build up with swollen ankles, legs and/or
hands
Ÿ Urinary infections
Ÿ Shortness of breath*, sinusitis (sinus
inflammation, sinus infection, blocked or painful
sinuses), blocked or runny nose, sore throat,
coughs, colds, flu-like symptoms
Ÿ Dizziness, difficulty sleeping
Ÿ Vomiting*, stomach ache, diarrhoea, indigestion,
wind
Ÿ Rash, itching
Ÿ Muscle stiffness
Ÿ Difficulty swallowing*
Ÿ Headache
Ÿ Nausea (feeling sick)
Ÿ Painful joints
Ÿ Worsening of existing allergies
Ÿ Accidental injury
Uncommon: may affect up to 1 in 100 people

Rare: may affect up to 1 in 1,000 people
Ÿ 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)
Ÿ Low levels of sodium in the blood (a condition
known as hyponatraemia)
Ÿ Reduced number of white blood cells (which help
protect the body from infection) and blood
platelets (increased chance of bleeding or
bruising)
Ÿ Difficulty coordinating muscular movements
Ÿ Feeling confused, changes in the way things taste
Ÿ Increased sensitivity to light
Ÿ Loss of hair
Ÿ Hallucinations
Ÿ Bleeding in the eye
Ÿ Irregular heartbeat
Ÿ Flushing
Ÿ Blood clot in the blood vessels in the lungs.
Symptoms may include sudden breathlessness,
sharp pains when you breathe or collapse
Ÿ Bleeding of the stomach or intestines (can lead to
bloody stools or vomiting), inflammation of the
intestine or colon
Ÿ 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
Ÿ Acute kidney failure
Ÿ Menstrual disturbances
Ÿ Swelling of the face, lips, mouth, tongue or
throat, or difficulty swallowing
Very rare: may affect up to 1 in 10,000 people

Ÿ
Ÿ

Not known: frequency cannot be estimated from
the available data
Ÿ 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 Celecoxib
capsules 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
Ÿ Heart problems: angina (chest pain)
Ÿ Stomach problems: irritable bowel syndrome
(can include stomach ache, diarrhoea,
indigestion, wind)
Ÿ Kidney stones (which may lead to stomach or
back pain, blood in urine), difficulty passing
urine
Ÿ Weight gain
Uncommon: may affect up to 1 in 100 people
Ÿ Deep vein thrombosis (blood clot usually in the
leg, which may cause pain, swelling or redness of
the calf or breathing problems)
Ÿ Stomach problems: stomach infection (which can
cause irritation and ulcers of the stomach and
intestines),
Ÿ Lower limb fracture
Ÿ Shingles, skin infection, eczema (dry itchy rash),
pneumonia (chest infection (possible cough,
fever, difficulty breathing))
Ÿ Floaters in the eye causing blurred or impaired
vision, vertigo due to inner ear troubles, sore,
inflamed or bleeding gums, mouth sores
Ÿ Excessive urination at night, bleeding from piles/
haemorrhoids, frequent bowel movements
Ÿ 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
Ÿ 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
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 Celecoxib capsules
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 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 Celecoxib capsules contain
The active substance is celecoxib.
Each capsule contains 100 mg or 200 mg celecoxib.
The other ingredients are:
Lactose anhydrous, Hydroxypropyl cellulose,
Crospovidone, Povidone, Sodium lauril sulfate,
Magnesium stearate. Capsule shells contain:
Titanium dioxide E171, Gelatin, Sodium lauril
sulfate. Printing ink contains Shellac, Propylene
glycol, Strong ammonia solution, FD & C blue 2
Aluminum lake E132 (100mg capsules) and Yellow
iron oxide E172 (200mg capsules).
What Celecoxib capsules look like and contents of
the pack
Celecoxib 100mg Capsules: Size '4'capsules,
containing white to off white powder, having white
opaque cap, white opaque body with 'C5' imprinted
on a blue band on the cap and '100mg' imprinted on a
blue band on the body.
Celecoxib 200mg Capsules: Size '2' capsules,
containing white to off white powder, having white
opaque cap, white opaque body with 'C6' imprinted
on a yellow band on the cap and '200mg' imprinted
on a yellow band on the body.
“The capsules are packaged in clear PVC/PVdC/
aluminium blisters and are presented in packs of 20,
30, 40, 50, 60, 100 capsules (100mg dosage strength)
and 10, 20, 30, 50, 100 capsules (200mg dosage
strength)”.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Macleods Pharma UK Limited
Wynyard Park House,
Wynyard Avenue,
Wynyard, Billingham,
TS22 5TB, United Kingdom
Manufacturer
Mawdsleys Brooks and Co Ltd
Unit 22, Quest Park,
Wheatley Hall Road,
Doncaster,
DN2 4LT, United Kingdom.
PL 34771/0166-0167
This leaflet was last
revised in {05/2016}

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Ÿ Serious allergic reactions (including potentially
fatal anaphylactic shock)
Ÿ 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
exanthematouspustulosis (symptoms include the
skin becoming red with swollen areas covered in
numerous small pustules)
Ÿ 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))
Ÿ Bleeding within the brain causing death
Ÿ Meningitis (inflammation of the membrane
around the brain and spinal cord)
Ÿ 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
Ÿ Liver problems (such as cholestasis
and cholestatic hepatitis, which

Ÿ

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Ÿ Stroke*
Ÿ Heart failure, palpitations (awareness of heart
beat), fast heart rate
Ÿ Abnormalities in liver-related blood tests
Ÿ Abnormalities in kidney-related blood tests
Ÿ Anaemia (changes in red blood cells that can
cause fatigue and breathlessness)
Ÿ Anxiety, depression, tiredness, drowsiness,
tingling sensations (pins and needles)
Ÿ High levels of potassium in blood test results
(can cause nausea (feeling sick), fatigue, muscle
weakness or palpitations)
Ÿ Impaired or blurred vision, ringing in the
ears, mouth pain and sores, difficulty
hearing*
Ÿ Constipation, burping, stomach inflammation
(indigestion, stomach ache or vomiting),
worsening of inflammation of the stomach or
intestine.
Ÿ Leg cramps
Ÿ Raised itchy rash (hives)
Ÿ Eye inflammation
Ÿ Difficulty breathing
Ÿ Skin discolouration (bruising)
Ÿ Chest pain (generalised pain not related to the
heart)

Ÿ

PM01889503

The side effects listed below were observed in
arthritis patients who took Celecoxib capsules. Side
effects marked with an asterisk (*) are listed below at
the higher frequencies that occurred in patients who
took Celecoxib capsules to prevent colon polyps.
Patients in these studies took Celecoxib capsules at
high doses and for a long duration.

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

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