^{PACKAGE LEAFLET: I}N^FORMATION ^{FOR THE USER} work. Please tell your doctor or pharmacist if you are

taking or have recently taken any other medicines, Celecoxib 100 mg capsules, hard including medicines obtained without a prescription:

^CelecO^{xib 200} m^{g capsules}, ^hard • Dextromethorphan (used to treat coughs)

Celecoxib • ACE inhibitors or angiotensin II antagonists

(used for high blood pressure and heart failure)

Read all of this leaflet carefully before you start • Diuretics (used to treat excess fluid in the body) t^aking ^{this medicine because it contains} rnp°^rtant • Fluconazole and rifampicin (used to treat fungal ^{information for you}. and bacterial infections)

•    ^{Keep this leaflet}. ^{You may need to read it again}. • Warfarin or other oral anticoagulants (“blood-

•    If you have any further questions, ask your doctor or thinning” agents that reduce blood clotting) ^pharmacist. • Lithium (used to treat some types of depression)

•    ^{This medicine has been} p^{rescribed for} y^{ou onl}y. ^Do • other medicines to treat depression, sleep

^{not pass it on to others. It may harm them, even if their} disorders, high blood pressure or an irregular heartbeat

signs of illness are the same as yours.

•    Neuroleptics (used to treat some mental disorders)

•    If you get any side effects, talk to your doctor or

pharmacist. This includes any possible side effects not • ^{Methotrexate (used to treat rheumatoid art}hr^itis, listed in this leaflet. See section 4.4. p^{soriasis and leukaemia)}

•    Carbamazepine (used to treat epilepsy/seizures Wh_at i_s i_n this l_eafl_et and some forms ofpain or depression)

1.    What Celecoxib Capsules are and what they are • Barbiturates (used to treat epilepsy/seizures and used for some sleep disorders)

2.    What you need to know before you take Celecoxib • Ciclosporin and tacrolimus (used for immune Capsules system suppression e.g. after transplants)

3.    How to take Celecoxib Capsules

4.    Possible side effects Celecoxib can be taken with low dose acetylsalicylic

5.    How to store Celecoxib Capsules acid (75mg or less daily). Ask your doctor for advice

6.    Contents of the pack and other information ^{before taking both medicines together}.

1.    What Celecoxib Capsulesare and what they are Tell your doctor or pharmacist if you are taking, or _used fo_r have recently taken any of the medicines listed above or

Celecoxib Capsules are used for the relief of signs and ^{any other medicines}. symptoms of rheumatoid arthritis, osteoarthritis and

ankylosing spondylitis in adults. Celecoxib Capsules with food and drink

Food and drink do not influence the effect of Celecoxib Celecoxib belongs to a group of medicinal products ^Capsules. called nonsteroidal anti-inflammatory drugs (NSAID),

and specifically a sub-group known as (COX-2) Pregnancy and breast-feeding ^inhibitors. ^{Your body makes prostaglandins that may} Celecoxib must not be used by women who are pregnant cause pain and inflammation. In conditions such as or can become pregnant(i.e. women of child bearing ^{rheumatoid art}hr^{itis and} ofjtec^rthrite y^{our body makes} potential who are not using adequate contraception) ^{more of these}. ^{Celecoxib acts by reducing the} during ongoing treatment. If you become pregnant p^{roduction of prosta}g^{landins, thereb}y ^reducing ^the p^ain duringtreatment with celecoxib you should discontinue ^{and inflammation.} the treatment and contact your doctor for alternative

treatment.

2.    What you need to know before you take If you are pregnant or breast-feeding, think you may be Celecoxib Capsules pregnant or are planning to have a baby, ask your doctor You have been prescribed this medicine by your doctor. or pharmacist for advice before taking this medicine.

The following information will help you get the best

^{results with this medicine}. ^If y^{ou have an}y ^further Celecoxib must not be used during breast-feeding. questions please ask your doctor or pharmacist.

Driving and using machines

^{Do not take Celecoxib Capsules} You should be aware of how you react to celecoxib ^TeU ^{your doctor if any of the f}o^{llowing are true for} before you drive or operate machinery. If you feel dizzy ^{you as} p^{atients with these conditions should not take} or drowsy after taking celecoxib, do not drive or operate ^celecoxib. machinery until these effects wear off.

•    if you are allergic (hypersensitive) to celecoxib or

any _ of the other ingredients of this medicine (listed in Celecoxib Capsules contains lactose

^{section 6)}. Celecoxib Capsules contains lactose (a type of sugar). If

•    if you have had an allergic reaction to a group of you have been told by your doctor that you have an medicines called “sulphonamides” (e.g. some intolerance to some sugars, contact your doctor before antibiotics used to treat infections). taking this medicinal product.

•    if you currently have an ulcer in your stomach or

intestines, or bleeding in your stomach or intestines. 3. How to take Celecoxib Capsules

•    if as a result of taking acetylsalicylic acid or any Always take this medicine exactly as your doctor has

other anti-inflammatory and pain-relieving medicine ^{told you. Check with your doctor or pharmacist if you}

(NSAID) you have had asthma, nose polyps, severe ^{are not sure}. ^{If you think or feel that the effect of}

_{nose congestion, or an allergic reaction such as an} ^{celecoxib is too strong or too weak, talk to your doctor} itchy skin rash, swelling of the face, lips, tongue or ^{or pharmacist}.

throat, breathing difficulties or wheezing. Your doctor will tell you what dose you should take. As

•    if you are pregnant. If you can become pregnant ^{the risk of side} fte ^associ^{ated with hea}rt p^roblems during ongoing treatment you should discuss methods ^may “^creas<; ^{with dose}1 ^and ^^ati°ⁿ °^f f^e,, ^{it is} ofcontraclption with your doctor. uncart ^{that you use} tireb^t ^dose th^{at controls your}

pain and you should not take celecoxib for longer than

^{•    if you are breast-feeding.} necessary to control symptoms.

•    ifyou have severe liver disease.

•    ifyou have severe kidney disease. Celecoxib should be swallowed whole with a drink of

water. The capsules can be taken at any time of the day,

•    if you have an inflammatory disease ot the

with or without food. However, try to take each dose of

m^{testines such as ulcerative colitis or Crohn}'^s celecoxib at the same time each day disease.

•    i^{f y}o^{u have heart} f^ailure, ^establis^{hed ischaemic} Contact your doctor within two weeks of starting

h^{eart disease}, ^{or cerebr}o^vasc^ular dueaw, ^e.^g. y^ou treatment ifyou do not experience any benefit. 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”), ^{For oste}oa^{rthritis the usual dose is 200} m^{g each day}>. angina, or blockages of blood vessels to the heart or ^{increased b}y y^{our doctor to a maximum of 400 m}g^{, if} brain. needed.

•    if you have or have had problems with your blood ^{The dose is usually:}

circulation (peripheral arterial disease) or if you have ^{• one 200 mg capsule once a day; or}

had surgery on the arteries ofyour legs. • one 100 mg capsule twice a day.

Warnings and precautions

Talk to your doctor or pharmacist before taking For rheumatoid arthritis the usual dose is 200 mg ^{Celecoxib Capsules} each day (taken in two divided doses), increased by your Check with your doctor if any of the following doctor to a maximum of 400 mg (taken in two divided applies to you: doses), if needed.

•    if you have previously had an ulcer or bleeding in Celecoxib 100 mg Capsules: your stomach or intestines. (Do not take Celecoxib The dose is usually:

Capsules if you currently have an ulcer or bleeding in • one 100 mg capsule twice a day. y^{our stomach or intestine)}. Celecoxib 200 mg Capsules:

•    ⁱf y°^{u are takin}g. ^acety^{lsalicylic acid (even at low} • The dose of 200 mg (taken as one 100 mg capsule ^{dose for heart} p^rotective p^urp^oses). twice a day) cannot be achieved with Celecoxib 200 mg

•    ifyou use medicines to reduce blood clotting (e.g. Capsules, hard. Please consult your doctor. warfarin).

•    if you are using celecoxib at the same time as other For ankylosing spondylitis the usual dose is 200 mg non-acetylsalicylic NSAIDs such as ibuprofen or each day, increased by your doctor to a maximum of 400 diclofenac. The use of these medicines together should mg, ifneeded.

be avoided. The dose is usually:

•    if you smoke, have diabetes, raised blood • one 200 mg capsule once a day; or

^{pressure or raised cholester}<>^l. • one 100 mg capsule twice a day.

•    if your heart, liver or kidneys are not working well

^{your doctor may want to keep a regular check on you}. Kidney or liver problems: make sure your doctor

^{•    if you have fluid retention (such as swollen ankles} knows if you have liver or kidney problems as you may

^{and feet)} need a lower dose.

•    if you are dehydrated, for instance due to sickness,

diarrhoea or the use of diuretics (used to treat excess The elderly, especially those with a weight less than fluid in the body). 50 kg: if you are over 65 years of age and especially if

•    if you have had a serious allergic reaction or a you weigh less than 50 kg, your doctor may want to serious skin reaction to any medicines. ^{monitor you more closely}.

•    if you feel ill due to an infection or think you have

an infection, as celecoxib may mask a fever or other ^{Use in children: celecoxib is for adults only}, ^{it is not for} signs of infection and inflammation ^{use in children}.

•    if you are over 65 years of age your doctor may ^{You should not take more than 400 m}g p^{er da}y. want to keep a regular check on you.

If you take more Celecoxib Capsulesthan you should

As with other NSAIDs (e.g. ibuprofen or diclofenac) ^{You shou}T^{ld not take more ca}p^{sules than} y^{our doctor tells} this medicine may lead to an increase in blood pressure, y^{ou ta If you take t}o^{o ma}n^{y c}a^psu^{les contac}t ^your and so your doctor may ask to monitor your blood doctor, pharmacist or hospital and take your medicine pressure on a regular basis. ^{with you.}

Some cases of severe liver reactions, including severe ^{If you forget to take Celecoxib Capsules}

liver inflammation, liver damage, liver failure (some If you forget to take a capsule, take it as soon as you with fatal outcome or requiring liver transplant), have remember. Do not take a double dose to make up for been reported with celecoxib. Of the cases that ^{forgotten doses}. reported time to onset, most severe liver reactions

occurred within one month of start of treatment. If you stop taking Celecoxib Capsules

Celecoxib may make it more difficult to become Suddenly stopping your treatment with celecoxib may pregnant. You should inform your doctor if you are lead to your symptoms getting worse. Do not stop planning to become pregnant or ifyou have problems to taking celecoxib unless your doctor tells you to. Your become pregnant (see section on Pregnancy and breast- doctor may tell you to reduce the dose over a few days feeding). before stopping completely.

Other medicines and Celecoxib Capsules If you have any further questions on the use of this Some medicines can affect the way other medicines medicine, ask your doctor or pharmacist.

4. Possible side effects • Ch_est p_ai_n

Lik^e aUm^ed^{icines this med}ic^{ine can cause side effects}, • Impaired sense of smell although not everybody gets them.

If you get any side effects, talk to your doctor or • Skin discolouration (bruising), muscle pain and pharmacist. This includes any possible side effects not ^weakness, ^{painful joints} listed in this leaflet. • Menstrual disturbances

•    Headache, flushing

^{The side effects listed below were observed in} • Low levels of sodium in blood test results (can

arthritis patients who took Celecoxib Capsules. Side

effects marked with an asterisk (*) are listed below at ^cause, ^{loss of appetite}, h.^eadache, ^{nausea (feeling sick)}, the higher frequencies that occurred in patients who ^{musc e cramps an wea ness)} took celecoxib to prevent colon polyps. Patients in • ^{Ageusia (loss oftaste)} these studies took celecoxib at high doses and for a

long duration. In clinical studies not associated with arthritis or

other arthritic conditions, where Celecoxib Capsules If any of the following happen, stop taking Celecoxib was taken at doses of400mg per day for up to 3 years, Capsules and tell your doctor immediately if you the following additional side effects have been have: observed:

•    an allergic reaction such as skin rash, swelling ofthe ^{Common side effects (may affect up} to ^{1 in 10 people)} face, wheezing or difficulty breathing • Heart problems: angina (chest pain)

•    heart problems such as pain in the chest • Stomach problems: irritable bowel syndrome (can

_{•    severe stomach pain or any sign of bleeding in the} ^{include stomach ache, diarrhoea, indigestion, wind)} stomach or • Kidney stones (which may lead to stomach or back

•    intestines, such as passing black or bloodstained p^ain ^{blood in difficult}y p^assing unne ^elevated st_ool_{s or vom}iti_ng bl_ood levels of blood creatinine (indicates kidney failure)

•    a skin reaction such as rash, blistering or peeling of • ^{Weight gain}

the skin • Benign prostatic hyperplasia (enlargement of the

•    liver failure (symptoms may include nausea ^prostate)

(feeling sick),

•    diarrhoea, jaundice (your skin or the whites of your ^Uncom^{mon side effects (may affect up} to ^{1 in 100}

eyes look yellow). ^people)

•    Deep vein thrombosis (blood clot usually in the leg,

Very common side effects (may affect more than 1 in 10 ^which ^may ^ p^ ^swelling ^{or redness of the calf or} people) breathing problems)

•    High bl_ood p_ressure* • Stomach problems: stomach infection (which can

cause irritation and ulcers of the stomach and intestines)

•    Lower limb fracture Shingles, skin infection, eczema

Common side effects (may affect up to 1 in 10 people)

(dry itchy rash), pneumonia (chest infection (possible

•    ^{Heart attack}* cough, fever, difficulty breathing)

•    ^{Fluid build up with swollen ankles}, ^{legs and/or} • Floaters in the eye causing blurred or impaired vision, ^hands vertigo due to inner ear troubles, sore, inflamed or

•    Urinary infections bleeding gums, mouth sores

•    Shortness of breath*, sinusitis (sinus inflammation, • Excessive urination at night, bleeding from piles/ sinus infection, blocked or painful sinuses), blocked or haemorrhoids, frequent bowel movements.

runny nose, sore throat, coughs, colds, flu-like • Fatty lumps in skin or elsewhere, ganglion cyst ^symptoms (harmless swellings on or around joints and tendons in

•    Dizziness, difficulty sleeping the hand or foot), difficulty speaking, abnormal or very

•    Vomiting*, stomach ache, diarrhoea, indigestion, ^{heavy bleeding from the vagina breast pain} wi_nd • High levels of sodium in blood test results

•    Rash, itching • Allergic dermatitis (allergic skin reaction)

•    Muscle stiffness

•    Difficulty swallowing* ^Jfj^ou g^et ^ ^side f^fects, ^talk .t^o yo^{u d}°^ct°^r

pharmacist. This includes any possible side effects not

^{•    Worsening of existing allergies} listed in this leaflet. You can also report side effects

directly via the Yellow Card Scheme Website: Uncommon side effects (may affect up to 1 in 100 www.mhra.gov.uk/yellowcard. people)

•    Stroke* By reporting side effects you can help provide more

•    Heart failure, palpitations (awareness ofheart beat), ^{information on the safet}y ^{ofthis medicine}. fast heart rate

•    Worsening of existing high blood pressure

5. How to store Celecoxib Capsules

•    Abnormalities in liver-related blood tests

•    ^{Abnormalities in kidne}y^{-related blood tests} Keep this medicine out of the sight and reach of

•    Anaemia (changes in red blood cells that can cause ^children. fatigue and breathlessness)

•    Anxiety, depression, tiredness, drowsiness, tingling Do not use this medicine after the expiry date which is _sensati_ons (pi_{ns an}d _needl_es) stated on the blister and carton after 'EXP'. The first two

•    High levels of potassium in blood test results (can ^{digits indic}f^{te the} ^ ^{and the last}tf^ou[ ^ ^ate

the year. The expiry date refers to the last day of that

cause nausea (feeling sick), fatigue, muscle weakness or palpitations)

•    paired ^or Mimed wot, ^{ringing in the ears}, This medicinal product medicine does not require any ^mouth p^{ain and sores}, ^difficulty ^hearing* special storage conditions.

•    Constipation, burping, stomach inflammation

(indigestion, stomach ache or vomiting), worsening of Do not throw away any medicines via wastewater or ^{inflammation ofthe stomach or intestine}. household waste. Ask your pharmacist how to throw

•    Leg cramps away medicines you no longer use. These measures will

•    Raised itchy rash (hives) ^help p^{rotect the environment}.

Rare side effects (may affect up to 1 in 1,000 people)

•    Ulcers (bleeding) in the stomach, gullet or ⁶. ^{Contents of the pack and other information}

intestines; or rupture of the intestine (can cause stomach

ache, fever, nausea, vomiting, intestinal blockage), dark ^{What Celecoxib Capsules contain}

or black stools, inflammation of the gullet (can cause The active substance is celecoxib. Each capsule

difficulty in swallowing), inflammation of the pancreas contains 100 mg celecoxib.

(can lead to stomach pain) The active substance is celecoxib. Each capsule

•    Reduced number of white blood cells (which help ^{contains 200 mg celecoxib.}

protect the body from infection) and blood platelets ^{The other ingredients are lactose monohydrate,}

(increased chance ofbleeding or bruising) povidone, croscarmellose sodium, sodium lauryl

•    Difficulty coordinating muscular movements ^h^/⁽Et572? ^{x (}g^ranulate)^;

gelatin (E441), titanium dioxide (E171), iron oxide

•    ^Feeling ^{confused, chan}g^{es in the wa}y ^thing^{s taste} yellow (E172) (capsule), The printing ink components

•    Increased sensitivity to light are Shellac (E904), Propylene glycol (E1520) and FD &

•    C Blue #2 Aluminum Lake (E132) for Celecoxib 100

mg.

•    Elevation of liver enzymes

The printing ink components are Shellac (E904,) Not known side effects (frequency cannot be Propylene glycol (E1520) and Iron oxide yellow (E172) estimatedfrom the available data) f_or C_el_ecoxib 200 _mg.

•    Bleeding within the brain causing death

•    Serious allergic reactions (including potentially ^{What Celecoxib Capsules looks like and contents of} fatal anaphylactic shock) which can cause skin rash, ^{the pack}

swelling of the face, lips, mouth, tongue or throat, Opaque, white, hard gelatin capsule. The body contains wheezing or difficulty breathing; difficulty swallowing a blue band and white text “C9OX-100”.

•    Bleeding of the stomach or intestines (can lead to Opaque, white, hard gelatin capsule. The body contains bloody stools or vomiting), inflammation of the ^{a yellow band and white text} “^C9°^X-2°°”. intestine or colon, nausea (feeling sick)

•    Serious skin conditions such as Stevens-Johnson ^{Celecoxib 100 mg Capsules are available in} syndrome, exfoliative dermatitis and toxic epidermal blister packs of 1,

necrolysis (can cause rash, blistering or peeling of the 10, 20, 30, 40, 50, 60, or 100 capsules.

skin) and acute generalised exenthematous pustulosis Celecoxib 200 mg Capsules, hard, are available in

(red swollen area with numerous small pustules) bliste_r p_ack_{s o}f 1,

•    A delayed allergic reaction with possible symptoms 10, 20, 30, 40, 50, 60, or 100 capsules. such as rash, swelling of the face, fever, swollen glands,

^and ^boOTmal ^test resiulte (^e.g., ^liver, b^{lood ced} Not all pack sizes may be marketed (eosinophilia, a type of raised white blood cell count).

•    ^{Liver failure} , ^{liver dama}g^{e and severe liver} Marketing Authorisation Holder inflammation (sometimes fatal or requiring liver

^transp^lant). ^Sy^mp^{toms ma}y ^{include nausea (feelin}g _{Tupin (F},,_rope) T_imited

sick), diarrhoea, jaundice (yellow discolouration of the

skin or eyes), dark urine, pale stools, bleeding easily, ^{Vic oria Court}

itching or chills ^{Bexton Road}

•    Kidney problems (possible kidney failure, ^Knutsford

inflammation ofthe kidneys) ^Cheshire ^{WA16 0PF}

•    Blood clot in the blood vessels in the lungs. ^{United Kingdom} Symptoms may include sudden breathlessness, sharp

pains when you breathe or collapse ^Manufacturer

•    Irregular heartbeat ^Sy^{nthon His}p^{ania SL}.

Castello 1, Pohgono Las Salinas

•    Meningitis (inflammation of the membrane around the brain and spinal cord)

Spain

•    Hallucinations

•    ^Worsening ^{of e}p^ilep^sy ⁽p^{ossible more fre}q^uent This medicinal product is authorised in the Member ^{and/or severe seizures)} states of the EEA under the following names:

•    Inflamed blood vessels (can cause fever, aches,

p^urp^{le blotches on the skin)} United Kingdom Celecoxib 100 mg Capsules, hard

•    Blockage of an artery or vein in the eye leading to United Kingdom Celecoxib 200 mg Capsules, hard partial or complete loss of vision, inflammation of the

^{conjunctiva, bleedin}g ^{in the e}y^e This leaflet was last revised in:

•    A reduction in the number of red and white blood April 2014 cells and platelets (may cause tiredness, easy bruising,

frequent nose bleeds and increased risk of infections)

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