CELECOXIB 100 MG CAPSULES HARD

Active substance: CELECOXIB

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Package leaflet:
Information for the user

Celecoxib 100 mg capsules, hard
Celecoxib 200 mg capsules, hard
Celecoxib
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 Celecoxib is and what it is used for
2. What you need to know before you take Celecoxib
3. How to take Celecoxib
4. Possible side effects
5. How to store Celecoxib
6. Contents of the pack and other information

• if

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.

intestines, or bleeding in your stomach or intestines
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

Do not take Celecoxib:
• if you are allergic to celeoxib 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

Warnings and precautions
Talk to your doctor or pharmacist before taking
Celecoxib:
• 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).

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.

1. What Celecoxib is and what it is
used for
Celecoxib is used in adults for the relief of signs and
symptoms of rheumatoid arthritis, osteoarthritis and
ankylosing spondylitis.
Celecoxib 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. Celecoxib acts by reducing the production
of prostaglandins, thereby reducing the pain and
inflammation.

2. What you need to know before you
take Celecoxib

• 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)
• 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

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).
Other medicines and Celecoxib
Some medicines can affect the way other medicines work.
Tell your doctor or pharmacist if you are taking, have
recently taken or might take 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)
• 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)
and tacrolimus (used for immune system
suppression e.g. after transplants)

• Ciclosporin

If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
taking this medicinal product.

Celecoxib can be taken with low dose acetylsalicylic acid
(75mg or less daily). Ask your doctor for advice before
taking both medicines together.

3. How to take Celecoxib

Pregnancy and 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.

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 Celecoxib is too strong or too weak, talk to your
doctor or pharmacist.

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.

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 must not be used during breast-feeding.

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.

Celecoxib may make it more difficult to become pregnant
(see section Warnings and precautions).
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.
Celecoxib contains lactose

Contact your doctor within two weeks of starting treatment
if you do not experience any benefit.
The recommended dose is:
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.
Use in children: Celecoxib is for adults only, it is not for
use in children.
Maximum daily dose:
You should not take more than 400 mg per day (4 capsules
of Celecoxib 100 mg or 2 capsules of Celecoxib 200 mg).

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.

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 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 a
forgotten capsule.

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

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)).

4. Possible side effects

Very common: may affect more than 1 in 10 people:
• High blood pressure*

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.

Like all medicines, this medicine can cause 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

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
swallowing*
• Worsening of existing allergies
• Difficulty

Uncommon: may affect up to 1 in 100 people:
• 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: 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 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 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 (eosinophilia,
a type of raised white blood cell count))
• 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

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)

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

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:

Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any side effects not listed in this
leaflet. You can also report side effects directly via Yellow

• Kidney

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

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 Celecoxib
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 box and blister after EXP. The expiry date
refers to the last day of that month.
Do not store above 25°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.

• The

other ingredients (excipients) of 200 mg hard
capsule are: lactose monohydrate, povidone K30,
croscarmellose sodium, sodium laurilsulfate and
magnesium stearate (E572) in the capsule core and
gelatin, titanium dioxide (E171) and iron oxide, yellow
(E172) in the capsule shell.

What Celecoxib looks like and contents of the pack
The body and the cap of 100 mg hard capsules are white,
of length 15.4 mm – 16.2 mm. The capsules contain white
or almost white granulate.
The body and the cap of 200 mg hard capsules are
brownish yellow, of length 18.9 mm – 19.7 mm. The
capsules contain white or almost white granulate.
The 100 mg and 200 mg capsules are available in boxes
of 10, 20, 30, 40, 50, 60, 90 and 100 capsules in blister
packs.
Not all pack sizes may be marketed.

6. Contents of the pack and other
information
What Celecoxib contains
• The active substance is celecoxib.
Each 100 mg hard capsule contains 100 mg celecoxib.
Each 200 mg hard capsule contains 200 mg celecoxib.
• The other ingredients (excipients) of 100 mg hard
capsule are: lactose monohydrate, povidone K30,
croscarmellose sodium, sodium laurilsulfate and
magnesium stearate (E572) in the capsule core and
gelatin and titanium dioxide (E171) in the capsule shell.

Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo
mesto, Slovenia
Distributor
Consilient Health (UK) Ltd, 500 Chiswick High Road,
London. W4 5RG.

This leaflet was last revised in November 2013
P0212

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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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