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CELEBREX (Sell-e-brecks) (sell-e-cox-ib) Consumer Medicine Information

What is in this leaflet Your doctor, however, may have • celecoxib prescribed Celebrex for another • any of the ingredients listed This leaflet answers some common purpose. at the end of this leaflet questions about Celebrex. It does not Ask your doctor if you have any • sulfonamides, a group of contain all the available information. questions about why Celebrex has medicines which include, for It does not take the place of talking to been prescribed for you. example, certain antibiotics (if you are not sure if you are your doctor or pharmacist. Celebrex is not approved for use in taking one of these medicines children or adolescents under 18 All medicines have risks and ask your Pharmacist). benefits. Your doctor has weighed years of age. the risks of you taking Celebrex This medicine is only available with Symptoms of an allergic reaction to against the benefits it is expected to a doctor's prescription. these medicines may include: have for you. • asthma, wheezing or shortness of If you have any concerns about breath taking this medicine, ask your • swelling of the face, lips or doctor or pharmacist. Before you take tongue which may cause difficulty in swallowing or Read this leaflet carefully before Celebrex breathing you start Celebrex and keep it with the medicine. • hives, itching or skin rash You may need to read it again. When you must not take it • fainting. If you are allergic to sulfonamides or Do not take Celebrex if: any of the capsule ingredients and • your doctor has told you that take Celebrex, these symptoms may What Celebrex is used you have severe heart or blood be severe. for vessel disease affecting the Ask your doctor or pharmacist if circulation in your brain or any of this applies to you: limbs Celebrex is used to treat joint , • you are already taking an tenderness, swelling and stiffness in: • you have severe problems NSAID Your doctor will decide if your • , • you have an ulcer or gastric condition is too severe to take this bleeding • and medicine. • , a chronic • you have Irritable Bowel • you have problems with your inflammatory rheumatic disorder Disease kidney function that primarily affects, but is not • you have heart failure limited to, the spine. • you have had an attack of • the expiry date printed on the asthma, hives, itching, skin rash Celebrex is also used to relieve short- packaging has passed, even or a runny nose after taking term pain, in cases such as: though the capsules may look or Non-steroidal Anti- alright • menstrual cramps (period pain) inflammatory Drugs (NSAIDs, If you take this medicine after the • following surgery medicines used to treat pain and ), including expiry date has passed, it may not • dental pain. other Coxib medicines work as well. Celebrex contains celecoxib and Many medicines used to treat • the packaging is torn or shows belongs to a group of medicines signs of tampering. called Coxibs which are used to headache, period pain and other relieve pain and inflammation in a aches and contain aspirin or If you are not sure if you should be number of conditions. an NSAID. taking Celebrex, talk to your doctor. Although Celebrex can relieve the If you are allergic to aspirin, symptoms of pain and inflammation, NSAIDs, or other Coxib Before you start to take it it will not cure your condition. medicines and use Celebrex, these symptoms may be severe. You must tell your doctor if: • you have an allergy to: CELEBREX® Page 1 of 4 • you currently have diabetes, • you are taking Celebrex • some medicines used to treat high blood pressure, high together with any medicines diabetes cholesterol levels, heart failure used to treat high blood • , a medicine used or have a history of heart pressure and some other heart to treat arthritis and some problems or , or problems such as ACE problems with the circulation in inhibitors, • cyclosporin, a medicine used to your limbs antagonists, beta blockers and suppress the • you have any allergies to: (also called fluid or water tablets) • certain medicines used to treat • any other medicines pain and inflammation called When taken together these • any other substances such as non-steroidal anti- medicines can cause kidney foods, dyes or preservatives. inflammatories (NSAIDs) or problems. • you are pregnant or intend to (cortico) steroids. become pregnant • you drink large amounts of Your doctor may need to adjust the Related medicines, NSAIDs, have dosage of these medicines, or provide been associated with reversible • you are a smoker additional advice if you are also infertility in some women. • you currently have an infection. taking Celebrex. Use of NSAIDs in early If you are given Celebrex while can increase the risk of you have an infection, it may hide spontaneous . some of the signs of an infection. There is no information on the If you have not told your doctor or How to take Celebrex use of Celebrex during pharmacist about these things, tell pregnancy. them before you start taking Follow all directions given to you Celebrex. by your doctor and pharmacist Celebrex may affect your carefully. developing baby if taken during They may differ from the pregnancy. Taking other medicines information in this leaflet. Celebrex use is not recommended Tell your doctor or your in pregnancy unless your doctor If you do not understand the pharmacist if you are taking any considers it essential. If you are instructions on the label, ask your other medicines, including taking Celecoxib while doctor or pharmacist for help. medicines you buy without a pregnant, you may need to be prescription from a pharmacy, closely monitored by your doctor. supermarket or health food shop. How much to take Discuss any questions you may have with your doctor. Some medicines and Celebrex may Osteoarthritis • you are breast-feeding or interfere with each other. These intend to breast-feed include: 200 mg once daily or 100 mg twice daily, or as directed by your doctor. Small amounts of celecoxib • any medicines used to treat high blood pressure and some other passes into breast milk, therefore, Rheumatoid arthritis taking Celebrex during breast- heart problems such as ACE feeding should be discussed with inhibitors, angiotensin 100 mg twice daily or 200 mg twice your doctor. receptor antagonists, beta daily. blockers or diuretics (also • you have any other health called fluid or water tablets) Ankylosing spondylitis problems including: • digoxin, a medicine used to treat 100 mg twice daily or 200 mg once • liver or kidney problems abnormal heart beats and some daily, or as directed by your doctor. • asthma, hives, itching, skin other heart problems rash or a runny nose • , an antifungal agent Management of short-term pain • high blood pressure or fluid • lithium, a medicine used to treat and menstrual cramps (period retention some types of depression pain) • peptic ulcer (i.e. stomach or • warfarin or similar medicines 400 mg as a single dose on the first duodenal ulcer), a recent including Eliquis (apixaban), day and 200 mg once daily on history of one, or have had Xarelto (rivaroxaban) or following days. You may take an peptic ulcers before Pradaxa (dabigatran), additional 200 mg on the following • vomiting blood or material medicines used to stop blood days if needed. You may take that looks like coffee clots Celebrex for up to 5 days. grounds • aspirin or salicylates, • bleeding from the rectum medicines used to treat pain (back passage), have black • antacids, medicines used to treat sticky bowel motions indigestion (stools) or bloody diarrhoea.

CELEBREX® Page 2 of 4 How to take it also have difficulty breathing and • stomach pain, diarrhoea, feel faint. indigestion, wind Swallow the capsules whole with a • swollen hands, ankles and feet, glass of fluid. Celebrex can be unexplained weight gain taken with or without food. • dizziness While you are taking it • sore throat, runny nose, sinusitis, How long to take it upper respiratory tract infection. Depending on your condition, you Tell your doctor immediately if may need Celebrex for a few days or Things you must do you notice any of the following: for longer periods. If you become pregnant while • skin rash, including hives, raised Celebrex will not cure your condition taking Celebrex, tell your doctor red, itchy spots but should help control pain, swelling immediately. • blistering and bleeding in the and stiffness. lips, eyes, mouth, nose and If you are about to start any new genitals Keep taking Celebrex for as long medicines, tell your doctor and as your doctor advises. pharmacist that you are taking • swelling, blistering or peeling of Celebrex. the skin, which may be Do not exceed the dose accompanied by fever, chills, recommended by your doctor. Tell all doctors, dentists and headache, sore throat, diarrhoea, Your risk of developing heart or pharmacists who are treating you aching joints and muscles blood vessel diseases (e.g., heart that you are taking Celebrex. • muscles weakness attack) may increase with dose and If you develop any skin rash (e.g. • other signs of allergic reaction duration of use even if you don't have hives, spots) while being treated such as wheezing, swelling of a history of heart or blood vessel with Celebrex, contact your doctor the face, lips, mouth, tongue or disease. immediately. throat which may cause If you need to take Celebrex for a The onset of these events, if they difficulty in swallowing or long time see your doctor for occur, can occur at any time, but breathing most often occur in the first month of regular check-ups so your doctor • collapse or fainting, shortness of treatment. can monitor your condition and breath or tiredness, irregular heartbeat, chest pain, swollen or treatment. Things you must not do sore leg veins • severe stomach or throat pain, If you forget to take it Do not give Celebrex to anyone vomiting blood or black sticky else, even if they have the same bowel motions If it is almost time for your next symptoms or condition as you. • bleeding or bruising more than dose, skip the dose you missed and usual, reddish or purple blotches take your next dose when you are Do not take Celebrex to treat any under the skin meant to. Otherwise, take it as other complaints unless your soon as you remember, then go doctor tells you to. • nausea, lethargy, itchiness, flu- back to taking your capsules as you like symptoms or yellowing of would normally. the skin or eyes (jaundice) • signs of anaemia such as Do not take a double dose to make tiredness, being short of breath up for the dose you missed. Side effects and looking pale • loss or deterioration of hearing Check with your doctor as soon as If you take too much • confusion (overdose) possible if you have any problems while taking Celebrex, even if you • redness, irritation or watering of the eye(s) Immediately telephone your doctor do not think the problems are or Poisons Information Centre connected with the medicine or are • experience sensations with any (telephone 0800 POISON or 0800 not listed in this leaflet. of the senses (sight, sound, touch, taste or feel) which may 764 766) for advice, or go to Like other medicines, Celebrex can not be real Accident and Emergency at your cause some side effects. If they nearest hospital if you think you or occur, most are likely to be minor • severe or persistent headache, anyone else may have taken too and temporary. fever, stiff neck, sensitivity to much Celebrex. Do this even if light and vomiting. Ask your doctor or pharmacist any there are no signs of discomfort or • sudden severe headache, loss of questions you may have. poisoning. You may need urgent consciousness, sudden tingling, medical attention. Tell your doctor if you notice any numbness or paralysis on one If you take too much Celebrex, you of the following: side the face, arm, leg or body, may feel tired, drowsy, sick, vomit, difficulty speaking, and have stomach pain. You may understanding, reading or

CELEBREX® Page 3 of 4 writing, loss of coordination or Product description balance. These are serious side effects. You may need urgent medical attention. What it looks like Not all of these side effects have • Celebrex 100 mg - opaque, white been reported with Celebrex but have capsules with two blue bands been seen with similar medicines. marked 7767 and 100. Other side effects not listed above The 100 mg capsules come in may occur in some people. blister packs of 60. Do not be alarmed by this list of • Celebrex 200 mg - opaque, white possible side effects. capsules with two gold bands You may not get any of them. marked 7767 and 200. The 200 mg capsules come in Tell your doctor if you notice blister packs of 30. anything else that is making you feel unwell, even if it is not on this list. Ingredients

Active Ingredient The active ingredient in Celebrex is After taking Celebrex celecoxib. • Celebrex 100 mg – 100 mg celecoxib/capsule Storage • Celebrex 200 mg – 200 mg celecoxib/capsule. Keep your capsules where young children cannot reach them. Other ingredients A locked cupboard at least 1½ metres above the ground is a good place to • lactose monohydrate store medicines. • sodium lauryl sulphate Keep Celebrex in a cool, dry place • povidone where the temperature stays at or • croscarmellose sodium below 25°C. Do not store it, or any • stearate other medicine, in the bathroom or • gelatin near a sink. Do not leave it in the car or on windowsills. • titanium dioxide Heat and dampness can destroy some • iron oxide yellow CI 77492 medicines. (200 mg capsules) Keep your capsules in their blister • indigo carmine CI 73015 pack until it is time to take them. (100 mg capsule). If you take the capsules out of their Celebrex does not contain sucrose, container they may not keep well. gluten, tartrazine or other azo dyes.

Disposal Supplier

If your doctor tells you to stop Celebrex is supplied in New Zealand taking Celebrex, or the capsules by: have passed their expiry date, ask Pfizer New Zealand Limited your pharmacist what to do with PO Box 3998 any left over. Auckland, New Zealand Toll Free number: 0800 736 363. This document was prepared in January 2020.  Registered Trademark © Pfizer Australia Pty Ltd 2020

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