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CELECOXIB 100 mg and 200 mg CAPSULES, HARD

Package leaflet: Information for the patient

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

OWhat Celecoxib is and what it is used for

Celecoxib Capsules is used for the relief of signs and symptoms of rheumatoid arthritis, osteoarthritis and ankylosing spondylitis in adults.

Celecoxib Capsules, with the active substance celecoxib, belong to a group of medicin al products called nonsteroidal anti-inflammatory drugs (NSAIDs) and specifically a sub-group known as COX-2 inhibitors.

Your body produces substances, so-called 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 these substances, thereby reducing the pain and inflammation.

^2    What you need to know before you

take Celecoxib

Do not take Celecoxib:

• 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 pain-relieving 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 • if you have 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 pectoris, 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

•    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

•    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 smoke

•    if you have diabetes (diabetes mellitus)

•    if you have high blood pressure

•    if you have 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 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.

Children

Celcoxib is not for use in children.

Other medicines and Celecoxib

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

•    some medicines to treat coughs (dextrometorphan)

•    medicines used for high blood pressure and heart failure (e.g. ACE inhibitors, angiotensin II antagonists, beta blockers and diuretics)

•    some medicines used to treat fungal and bacterial infections (fluconazole and rifampicin)

•    "blood-thinning" agents that reduce blood clotting (warfarin or other warfarin like medicines including newer medicines like apixaban);

•    medicines to treat depression (e.g. lithium)

•    medicines to treat sleep disorders or an irregular heartbeat

•    medicines to treat some mental disorders (neuroleptics)

•    some medicines to treat rheumatoid arthritis, psoriasis and leukaemia (methotrexate)

•    some medicines to treat epilepsy/seizures and some forms of pain or depression (carbamazepine)

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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

•    skin reactions such as rash, blistering or peeling of the skin

•    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

•    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 (inflammation of the joints) 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 pectoris (chest pain);