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NEW ZEALAND CONSUMER MEDICINE INFORMATION IBUPROFEN Ibuprofen film-coated tablet 200 mg

IBUPROFEN also relieves • , wheezing or What is in this leaflet (high temperature). shortness of breath • swelling of the face, lips, Please read this leaflet carefully Although IBUPROFEN can relieve tongue which may cause before you start IBUPROFEN. the symptoms of and difficulty in swallowing or , it will not cure your breathing This leaflet answers some common condition. • , itching or skin . questions about IBUPROFEN. • stomach ache, fever, chills, IBUPROFEN contains the active and It does not contain all the available ingredient ibuprofen. Ibuprofen • fainting information. It does not take the belongs to a group of medicines place of talking to your doctor or called non-steroidal anti- If you are allergic to or pharmacist. inflammatory drugs (or NSAIDs). NSAID medicines and take IBUPROFEN, these symptoms All medicines have risks and Your doctor may have prescribed may be severe. benefits. Your doctor has weighed this medicine for another reason. the risks of you taking IBUPROFEN Do not take IBUPROFEN if you against the benefits they expect it Ask your doctor if you have any are in your third trimester of will have for you. questions about why this . medicine has been prescribed for It may affect your developing baby if If you have any concerns about you. you take it during this time. taking this medicine, ask your doctor or pharmacist. Many medicines used to treat Do not take IBUPROFEN if you , period pain and other have (or have previously) Keep this leaflet with the aches and contain aspirin or vomited blood or material that medicine. You may need to read it NSAID medicines. If you are not looks like coffee grounds. again. sure if you are taking any of these medicines, ask your doctor or Do not take IBUPROFEN if you pharmacist are (or have previously) bled What IBUPROFEN is from the rectum (back passage), This medicine is available only with have black sticky bowel motions used for a doctor’s prescription. (stools) or bloody diarrhoea.

IBUPROFEN provides temporary IBUPROFEN is not addictive. Do not take IBUPROFEN if you relief of pain and reduces have a condition resulting in an inflammation (swelling or redness) increased tendency to bleed. that may occur: Before you take Do not take IBUPROFEN if you • in different types of IBUPROFEN have a peptic ulcer (i.e. stomach including rheumatoid or duodenal ulcer), a recent arthritis, and When you must not take history of one, or have had peptic juvenile it ulcers before. • in muscle and bone injuries such as sprains, strains, Do not take IBUPROFEN if you Do not take IBUPROFEN if you low back pain (lumbago), have an allergy to: have, or have a history of, rheumatism, and tendonitis, ulcerative colitis or Crohn's • any medicine containing such as tennis elbow disease. ibuprofen • from swelling and pain after • any of the ingredients listed setting broken or dislocated Do not take IBUPROFEN if you at the end of this leaflet bones have severe , liver aspirin or any other NSAID • failure or kidney disease. • menstrual cramps (period medicine. pain) Do not give this medicine to a child • following Some of the symptoms of an under the age of 7 years. • due to dental pain. allergic reaction may include:

Page 1 of 5 Do not take this medicine after • If you are a current smoker • ciclosporin or tacrolimus, the expiry date printed on the • high . medicines used to treat pack or if the packaging is torn or certain problems with the shows signs of tampering. Tell your doctor if you currently immune system or to help If it has expired or is damaged, have an infection. prevent organ transplant return it to your pharmacist for If you take IBUPROFEN while you rejection disposal. have an infection, it may hide some • aminoglycosides, medicines of the signs and symptoms of an used to treat certain If you are not sure whether you infection. This may make you think, infections should start taking this medicine, mistakenly, that you are better or • gingko biloba, a herbal talk to your doctor. that it is not serious. medicine used to improve memory Before you start to take Tell your doctor if you plan to • quinolone , it have surgery. medicines used to treat certain infections Tell your doctor if you have If you have not told your doctor • zidovudine, a medicine allergies to any other medicines, about any of the above, tell them used to treat HIV including aspirin or other NSAID before you start taking • cholestyramine, a medicine medicines, foods, preservatives IBUPROFEN. used to treat high or dyes. cholesterol Taking other medicines • sulfonylureas, medicines to Tell your doctor if you are treat diabetes pregnant or plan to become Tell your doctor or pharmacist if • medicines used to treat pregnant or are breast-feeding or you are taking any other certain fungal infections plan to breast-feed. medicines, including medicines such as voriconazole or Like most NSAID medicines, that you buy without a fluconazole IBUPROFEN is not recommended prescription from your pharmacy, • mifepristone, a medicine while you are pregnant or breast- supermarket or health food shop. used to terminate a feeding. pregnancy. You should also tell any health Tell your doctor if you have or professional who is prescribing a These medicines may be affected have had any of the following new medication for you that you are by IBUPROFEN or may affect how medical conditions: taking IBUPROFEN. well it works. You may need different amounts of your • heart disease or high blood Some medicines may interfere with medicines, or you may need to take pressure IBUPROFEN. These include: different medicines. • diabetes • heart failure • aspirin, salicylates or other Your doctor and pharmacist have • swelling of ankles or feet NSAID medicines more information on medicines to • , , • warfarin or clopidogrel be careful with or avoid while taking stomach ulcer or any other medicines used to this medicine. stomach problems prevent/stop blood clots • bowel or intestinal problems • , a medicine used to • vomiting blood or bleeding treat changes in mood and How to take from the rectum (back some types of depression passage) • medicines used to treat IBUPROFEN • severe skin reactions such depression (SSRIs) such as as Stevens-Johnson fluoxetine Follow all directions given to you syndrome • medicines used to treat by your doctor or pharmacist • chicken pox high blood pressure or carefully. other heart conditions They may differ from the information • asthma or hay fever • diuretics, also called fluid contained in this leaflet. • other difficulties with tablets, medicines that breathing increase the production of If you do not understand the • runny or blocked nose, urine instructions on the pack, ask sneezing, facial pressure or methotrexate, a medicine your doctor or pharmacist for pain • used to treat arthritis and help. • nasal polyps some types of cancer • visual disturbances • corticosteroids used for liver or kidney disease How much to take • inflammatory conditions, • tendency to bleed or other such as prednisone or Your doctor will tell you how blood problems cortisone many IBUPROFEN tablets to take • aseptic meningitis • medicines used to treat each day and when to take them. • if you drink heart failure or irregular • If you feel dehydrated heart beats such as digoxin

Page 2 of 5 Adults As with other NSAID medicines, if If you are going to have surgery, you are taking IBUPROFEN for tell the surgeon or anaesthetist The usual dose of IBUPROFEN is arthritis, it will not cure your that you are taking this medicine. 1200 mg to 1800 mg daily. This condition but it should help to It may affect other medicines used dose may be increased for short control pain, swelling and stiffness. during surgery. NSAID medicines periods of time, in severe can slow down blood clotting. conditions, up to a maximum dose It usually begins to work within a of 2400 mg daily. few hours but several weeks may If you become pregnant while pass before you feel the full effects taking this medicine, tell your It is usual for elderly patients to be of the medicine. If you have arthritis, doctor immediately. prescribed a smaller dose of IBUPROFEN should be taken every IBUPROFEN than younger adult day for as long as your doctor If you are about to have any patients. prescribes. blood tests, tell your doctor that you are taking this medicine. Period pain For menstrual cramps (period pain), It may interfere with the results of IBUPROFEN is usually taken at the some tests. The usual dose of IBUPROFEN first sign of pain or menstrual tablets is 400 mg to 800 mg at the bleeding (whichever comes first). first sign of menstrual bleeding. If you get an infection while Treatment should be continued for a Then, 400 mg every 4 to 6 hours as taking IBUPROFEN, tell your few days until the pain goes away. necessary. Do not take more than doctor. 1600 mg in one day. IBUPROFEN may hide some of the If you are not sure how long to signs of an infection and may make take your IBUPROFEN, talk to you think mistakenly, that you are Children your doctor or pharmacist. better or that it is not serious. Signs The dose of IBUPROFEN will of an infection may include fever, depend on the age and weight of If you forget to take it pain, swelling and redness. your child, and their illness. Your doctor will tell you how much If it is almost time for your next Tell your doctor if, for any IBUPROFEN to give your child. dose, skip the dose you missed reason, you have not taken your and take your next dose when medicine exactly as prescribed. IBUPROFEN film coated tablets are you are meant to. Otherwise your doctor may think not recommended for children that it was not effective and change under 7 years of age. Otherwise, take it as soon as you your treatment unnecessarily. remember, and then go back to How to take it taking your medicine as you Tell your doctor if you feel the would normally. medicine is not helping your Swallow the tablets whole with a condition. full glass of water with or without Do not take a double dose to This will help your doctor to food. make up for the dose that you determine the best treatment for missed. you. It does not matter if you take this This may increase the chance of medicine before or after food. you getting an unwanted side effect. Keep all your doctor’s Taking with food may help reduce appointments so that your the possibility of an upset stomach. If you are not sure what to do, progress can be checked. ask your doctor or pharmacist. When to take it Things you must not do If you have trouble remembering Take your medicine at about the when to take your medicine, ask Do not take any other medicines same time(s) each day. your pharmacist for some hints. to relieve pain and reduce Taking it at the same time(s) each inflammation while you are taking day will have the best effect. It will IBUPROFEN without first telling also help you remember when to While you are using your doctor. These include: take it. IBUPROFEN • aspirin (also called How long to take it acetylsalicylic ) Things you must do • other medicines containing Do not take IBUPROFEN for ibuprofen, the active longer than your doctor says. If you are about to be started on ingredient in IBUPROFEN any new medicine, remind your • any other NSAID medicine. Depending on your condition, you doctor and pharmacist that you may need IBUPROFEN for a few are taking IBUPROFEN. Do not take IBUPROFEN to treat days, a few weeks or for longer any other complaints unless your periods. Tell any other doctors, dentists, doctor tells you to. and pharmacists who treat you that you are taking this medicine.

Page 3 of 5 Do not give your medicine to • have a headache and/or • changes in mood, for anyone else, even if they have experience rapid, example depression, the same condition as you. uncontrollable movements confusion, nervousness of the eyes. • severe pain or tenderness Do not stop taking your medicine in the stomach or lower the dosage without • eye problems such as checking with your doctor. blurred vision, loss of vision Side effects or sore red eyes or itching Things to be careful of • signs of frequent or Be careful driving or operating Tell your doctor or pharmacist as worrying infections such as machinery until you know how soon as possible if you do not fever, severe chills, sore IBUPROFEN affects you. feel well while you are taking throat or mouth ulcers This medicine may cause , IBUPROFEN. • bleeding or bruising more drowsiness, fatigue and visual This medicine helps most people easily than normal, reddish disturbance in some people. If you with pain and inflammation, but it or purplish blotches under have any of these symptoms, do not may have unwanted side effects in the skin drive, operate machinery or do a few people. • signs of anaemia, such as anything else that could be tiredness, , dangerous. Children should be If you are over 65 years of age you being short of breath, and careful when riding bicycles or may have an increased chance of looking pale climbing trees getting side effects. • yellowing of the skin and/or eyes, also called jaundice Be careful when drinking alcohol All medicines can have side • dark coloured urine while you are taking this effects. Sometimes they are • unusual weight gain, medicine. serious, most of the time they are swelling of ankles or legs If you drink alcohol, certain side not. You may need medical • tingling of the hands and effects may be worse. treatment if you get some of the feet side effects. • symptoms of (such as redness, itching, In case of overdose Do not be alarmed by this list of swelling, blistering) which possible side effects. You may may occur more quickly If you take too much not experience any of them. than normal. • severe or persistent (overdose) Ask your doctor or pharmacist to headache answer any questions you may Immediately telephone your • fast or irregular heartbeats, have. doctor or the National Poisons also called palpitations Centre (telephone 0800 POISON • hallucinations. or 0800 764 766) for advice, or go Tell your doctor or pharmacist if to Accident and Emergency at you notice any of the following The above list includes serious side your nearest hospital, if you think and they worry you: effects that may require medical that you or anyone else may have • nausea or vomiting attention. taken too much IBUPROFEN. Do • loss of appetite this even if there are no signs of • heartburn or pain in the If any of the following happen, discomfort or poisoning. You may upper part of your stomach stop taking IBUPROFEN and tell your doctor immediately or go to need urgent medical attention. • cramps, wind, Accident and Emergency at your or diarrhoea nearest hospital: If you take too much IBUPROFEN • headache you may: • sleepiness or drowsiness • vomiting blood or material

• dizziness that looks like coffee • feel sick or vomit; • buzzing or ringing in the grounds • have stomach pain; ears or other trouble • bleeding from the back • have convulsions; hearing passage, black sticky bowel • have a slow or fast • runny or stuffy nose motions (stools) or bloody heartbeat; • sleeplessness (insomnia) diarrhoea • have ringing in your ears; • feeling tired (fatigue) • swelling of the face, lips or • feel drowsy; tongue which may cause • feel dizzy or even become The above list includes side effects difficulty in swallowing or unconscious. that are usually mild. breathing • vomit blood or material that • asthma, wheezing, looks like coffee grounds; Tell your doctor immediately if shortness of breath, • bleed from the rectum (back you notice any of the following: • chest pain/tightness passage), black sticky • sudden or severe itching, bowel motions (stools) or skin rash, hives bloody diarrhoea.

Page 4 of 5 • severe blisters and bleeding Disposal Date of Information in the lips, eyes, mouth, nose and genitals (Stevens If your doctor tells you to stop 10 August 2020 Johnson Syndrome) taking this medicine or the expiry (based on datasheet dated 10 • fever, generally feeling date has passed, ask your August 2020). unwell, nausea, stomach pharmacist what to do with any ache, headache and stiff medicine that is left over. neck, extreme sensitivity to bright light • severe skin rash with fever Product description • pustules (boils and abscesses) on the skin What it looks like • convulsions. IBUPROFEN 200 mg tablets are IBUPROFEN may be associated white, circular tablets with "IBU 200" with an increased risk of heart embossed on one side and plain on attack () or the other side. . Ingredients Blood disorders and kidney problems may occur with Active ingredient: IBUPROFEN. IBUPROFEN tablets contain 200 mg of ibuprofen as the active The above list includes very serious ingredient. side effects. You may need urgent medical attention or hospitalisation. Inactive ingredient(s): IBUPROFEN also contains: Other side effects not listed above may occur in some people. • colloidal silica anhydrous Tell your doctor or pharmacist if • maize starch you notice anything that is • stearic acid. making you feel unwell. • hypromellose • titanium dioxide • polyethylene glycol. After using This medicine does not contain IBUPROFEN lactose, sucrose, gluten, tartrazine or any other azo dyes. Storage Keep your tablets in the pack If you want to know until it is time to take them. If you take the tablets out of the more pack they may not keep well. Should you have any questions Keep your tablets in a cool dry regarding this product, please place where the temperature contact your pharmacist or doctor. stays below 30°C. Who supplies this Do not store IBUPROFEN or any other medicine in the bathroom medicine or near a sink. Do not leave it on IBUPROFEN is supplied in New a window sill or in the car. Zealand by: Heat and dampness can destroy some medicines. Mylan New Zealand Ltd, PO Box 11183, Keep it where children cannot Ellerslie, reach it. Auckland A locked cupboard at least one-and- NEW ZEALAND a half metres above the ground is a good place to store medicines. Telephone: 0800 579 811

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