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CELECOXIB CAPSULES HARD 100MG

Active substance(s): CELECOXIB

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Package leaflet: Information for the patient

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.
- 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

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you maybe pregnant or are planning to have
a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
This medicine 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 this medicine you should discontinue
the treatment and contact your doctor for alternative treatment.

This medicine contains the active ingredient Celecoxib, which 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
Do not take this medicine:
• 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 “sulfonamides”
(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 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
• if you are pregnant. If you can become pregnant during on going 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, pharmacist or nurse before taking this medicine:
• if you have previously had an ulcer or bleeding in your stomach or intestines.
(Do not take this medicine 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 this medicine 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 this medicine 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

Breast-feeding
This medicine must not be used during breast-feeding.
Fertility
NSAIDs, including Celecoxib, 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 before you drive or operate machinery.
If you feel dizzy or drowsy after taking this medicine, do not drive or operate machinery
until these effects wear off.
This medicine contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact
your doctor before taking this medicine.

3. How to take Celecoxib
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 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 this medicine for
longer than necessary to control symptoms.
The 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
this medicine at the same time each day.
If you have difficulty swallowing capsules: The entire capsule contents can be sprinkled
onto a spoonful of semi-solid food (such as cool or room temperature apple sauce, 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.
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 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: This medicine is for adults only, it is not for use in children.
If you take more of this medicine 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 this medicine
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 this medicine
Suddenly stopping your treatment with this medicine maylead to your symptoms getting
worse. Do not stop taking this medicine unless your doctor tells you to. Your doctor may
tell you to reduce the dose over a few days before stopping completely.

This medicine 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, breast-feeding and fertility).

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

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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
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 fora long duration.
If any of the following happen, stop taking this medicine and tell your doctor
immediately:
IXXXX

Taking other medicines
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 warfarin like medicines (“blood-thinning” agents that reduce blood clotting)
including newer medicines like apixaban
• Lithium (used to treat some types of depression)

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1. What Celecoxib is and what it is used for
This medicine is used for the relief of signs and symptoms of rheumatoid arthritis,
osteoarthritis and ankylosing spondylitis.
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• 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)
This medicine can be taken with low dose acetylsalicylic acid (75 mg or less daily).
Ask your doctor for advice before taking both medicines together.

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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 gullet (can cause difficulty in swallowing), inflammation of
the pancreas (can lead to stomach pain)
• Low levels of sodium in the blood (a condition known as hyponatraemia)
• Reduced number of white blood cells (which help 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 exanthematouspustulosis (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

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• 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 Celecoxib 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, pharmacist or nurse. 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 Celecoxib
• Keep this medicine out of the sight and reach of children.
• This medicinal product does not require any special storage conditions.
Containers: Use within 60 days of first opening.
• Do not use this medicine after the expiry date which is stated on the label after EXP.
The expiry date refers to the last day of that month.
• 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 this medicine contains
• The active substance is Celecoxib. Each film-coated tablet contains 100 mg or 200 mg
of Celecoxib.
• The other ingredients are
Capsule content: Lactose monohydrate, Sodium lauryl sulfate, Povidone, Croscarmellose
sodium, Magnesium stearate. Capsule shell: Gelatin, Titanium dioxide E171, Sodium
lauryl sulfate. Printing ink: Shellac, Propylene glycol, Yellow Iron oxide E172.
Additionally, 100 mg contains Indigotine E132 in printing ink.
What this medicine looks like and contents of the pack
• 100 mg: Off white cap / Off white body size ‘2’ hard gelatin capsule reverse printed with
‘H’ on green band of cap and ‘C1’ on green band of body, filled with white to off white
granular powder.
• 200 mg: Off white cap / Off white body size ‘2’ hard gelatin capsule reverse printed with
‘H’ on golden yellow band of cap and ‘195’ on golden yellow band of body, filled with
white to off white granular powder.
• This medicine is available in blister packs of 2, 5, 6, 10, 20, 30, 40, 50, 60 or 100
capsules and HDPE containers of 60, 100 or 500 capsules. Not all pack sizes may be
marketed.
Marketing Authorisation Holder and Manufacturer
Name and address: Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road,
Berkhamsted, Hertfordshire, HP4 1EG, UK
Telephone:
0044 (0) 1442 200922
Fax:
0044 (0) 1442 873717
E-mail:
info@ bristol-labs.co.uk
Celecoxib 100 mg capsules, hard; PL 17907/0526
Celecoxib 200 mg capsules, hard; PL 17907/0527
This leaflet was last revised in January 2016
To request a copy of this leaflet in Braille, large print or audio format, please contact the
license holder at the address (or telephone, fax, email) above.

V3 04-01-16 D0

IXXXX

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 blood stained 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))

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V1 15-12-15 D0, V2 16-12-15 D1, V2 04-01-16 D0

PL 17907/0525 / 0526
Bristol Laboratories Ltd.

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IMPORTANT: Artwork, text and content must not be reset, remade, amended or altered.
The only exceptions to this are: bleeds, chokes, spreads or other print related adjustments
required for reproduction by the supplier. We must receive a copy of any 3rd Party Supplier’s
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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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