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CELECOXIB 200MG CAPSULES HARD

Active substance(s): CELECOXIB

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Package leaflet: Information for the patient
Celecoxib 100mg and 200mg 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 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 contains the active substance celecoxib. Celecoxib belongs to a group of
medicines 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 prostaglandins. Celecoxib
acts 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
Do not take Celecoxib capsules:
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 (aspirin) or any other anti-inflammatory and painrelieving medicine (NSAIDs) 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 Celecoxib capsules 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).
 you are taking acetylsalicylic acid (aspirin), even at low dose for heart protective purposes.
 you use medicines to reduce blood clotting (e.g. warfarin).
 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.
 you smoke, have diabetes, raised blood pressure or raised cholesterol.
 your heart, liver or kidneys are not working well your doctor may want to keep a regular
check on you.
 you have fluid retention (such as swollen ankles and feet).
 you are dehydrated, for instance due to sickness, diarrhoea or the use of diuretics (used to treat
excess fluid in the body).
 you have had a serious allergic reaction or a serious skin reaction to any medicines.
 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.
 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.
Taking Celecoxib capsules 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 capsules
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, especially the following medicines:
 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)
Ciclosporin and tacrolimus (used for immune system suppression e.g. after transplants)

Celecoxib capsules can be taken with low dose acetylsalicylic acid (aspirin), 75mg or less daily.
Ask your doctor for advice before taking both medicines together.
Pregnancy, breast-feeding and fertility
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, you should discontinue the treatment and
contact your doctor for alternative treatment.
Celecoxib capsules must not be used during breast-feeding.
Celecoxib capsules may make it more difficult to become pregnant (see section ‘Warnings and
precautions’).
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.
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 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 capsules
Always take this medicine exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.
For oral use.
Celecoxib capsules should be swallowed whole with a sufficient amount of water (e.g. one glass
[200 ml]). 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.
For osteoarthritis the recommended dose is 200mg each day, increased by your doctor to a
maximum of 400mg, if needed.

The dose is usually:
 one 200mg capsule once a day; or
 one 100mg capsule twice a day.
For rheumatoid arthritis the recommended dose is 200mg each day, increased by your doctor to
a maximum of 400mg, if needed.
The dose is usually:
 one 100mg capsule twice a day.
For ankylosing spondylitis the recommended dose is 200mg each day, increased by your doctor
to a maximum of 400mg, if needed.
The dose is usually:
 one 200mg capsule once a day; or
 one 100mg capsule twice a day.
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. If you think that the effect of Celecoxib capsules is too strong or too weak,
talk to your doctor or pharmacist.
Contact your doctor within two weeks of starting treatment if you do not experience any benefit.
Maximum daily dose:
You should not take more than 400mg of celecoxib per day (4 capsules of Celecoxib capsules
100mg or 2 capsules of Celecoxib capsules 200mg).
Kidney or liver problems
Make sure that 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 capsules is for adults only; it is 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.
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.
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.

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 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.
Stop taking Celecoxib capsules 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
 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 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
 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)
 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 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 the outer carton
after “EXP”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 contains
The active substance is celecoxib.
Each Celecoxib 100mg hard capsule contains 100mg celecoxib.
Each Celecoxib 200mg hard capsule contains 200mg celecoxib.
The other ingredients (excipients) are:
Sodium laurilsulfate, lactose monohydrate, crospovidone, povidone K29-32, magnesium stearate.
Capsule shells contain: titanium dioxide (E171), gelatin, sodium laurilsulfate.
Ink contains: shellac, indigo carmine (E132) (100mg capsule) or yellow iron oxide (E172) (200
mg capsule).
What Celecoxib capsules look like and contents of the pack
Celecoxib 100mg hard capsules are hard gelatin capsules comprised of white opaque cap with
blue band and white opaque body reverse printed on blue band with “100”, containing white
granular powder.
Celecoxib 200mg hard capsules are hard gelatin capsules comprised of white opaque cap with
yellow band and white opaque body reverse printed on yellow band with “200”, containing white
granular powder.
Celecoxib 100mg hard capsules are packaged in clear or white opaque PVC/Aluminium blisters
in packs of 10, 20, 25, 30, 40, 50, 60, 100 capsules.
Celecoxib 200mg hard capsules are packaged in clear or white opaque PVC/Aluminium blisters
in packs of 10, 20, 25, 30, 50, 60, 100 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Sigillata Limited
Suite 23 Park Royal House
23 Park Royal Road, London
NW10 7JH, United Kingdom
Manufacturer:
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.,
Dupnitza 260
Bulgaria
This leaflet was last revised in {03/2014}.

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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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