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Diclofenac Sandoz® diclofenac sodium enteric-coated tablets Consumer Medicine Information

WHAT IS IN THIS • relief of acute or chronic • any other similar medicines, such LEAFLET states in which there is an as , or other inflammatory component NSAIDs. This leaflet answers some common • symptoms of menstrual pain Some of the symptoms of an allergic questions about Diclofenac Sandoz. (period pain). reaction may include: It does not contain all the available It contains the active ingredient • shortness of breath information. It does not take the diclofenac sodium. • wheezing or difficulty breathing place of talking to your doctor or Diclofenac sodium belongs to a • swelling of the face, lips, tongue pharmacist. group of medicines called non- or other parts of the body The information in this leaflet was steroidal anti-inflammatory drugs • rash, itching or on the skin. last updated on the date listed on the (NSAIDs). final page. More recent information It works by reducing pain and Many medicines used to treat on the medicine may be available. (swelling and redness). headache, period pain and other aches and contain aspirin or You should ensure that you speak to It can relieve the symptoms of pain NSAID medicines. If you are allergic your pharmacist or doctor to obtain and inflammation but it will not cure to aspirin or NSAID medicines and the most up to date information on your condition. take Diclofenac Sandoz, these the medicine. You can also download Ask your doctor if you have any symptoms may be severe. the most up to date leaflet from questions about why this medicine www.sandoz.com.au. Do not take this medicine if you has been prescribed for you. have or have had any of the Those updates may contain important Your doctor may have prescribed it following medical conditions: information about the medicine and for another reason. its use of which you should be aware. • stomach or intestinal ulcer There is no evidence that this All medicines have risks and • bleeding from the stomach or medicine is addictive. benefits. Your doctor has weighed bowel (symptoms of which may the risks of you taking this medicine There is not enough information to include blood in your stools or against the benefits they expect it recommend the use of Diclofenac black stools) will have for you. Sandoz tablets in children. • severe kidney or liver problems If you have any concerns about • severe taking this medicine, ask your • heart bypass surgery. doctor or pharmacist. BEFORE YOU TAKE Do not take this medicine during Keep this leaflet with the medicine. DICLOFENAC the first 6 months of , You may need to read it again. SANDOZ except on doctor's advice. Do not use during the last three months of When you must not take it pregnancy. It may affect your developing baby if Do not take this medicine if you WHAT DICLOFENAC you take it during the last three have an allergy (hypersensitive) to: SANDOZ IS USED months of pregnancy. • diclofenac sodium, the active FOR Use of non-aspirin NSAIDs can ingredient, or to any of the other increase the risk of miscarriage, This medicine is used to treat: ingredients listed at the end of particularly when taken close to the this leaflet under Product • inflammatory and degenerative time of conception. forms of rheumatism, rheumatoid Description. and

DICLOFENAC SANDOZ® 1 Do not take this medicine after the tract (Crohn's disease) or colon Tell your doctor if you are lactose expiry date printed on the pack or (ulcerative or ischemic colitis) intolerant. if the packaging is torn or shows • past history of haemorrhoids Diclofenac Sandoz tablets contain signs of tampering. (piles) or irritation of the rectum lactose. If it has expired or is damaged, return (back passage) Tell your doctor if you currently it to your pharmacist for disposal. • liver or kidney problems have an infection. If you are not sure whether you • a rare liver condition called If you use Diclofenac Sandoz while should start taking this medicine, porphyria you have an infections, some of the talk to your doctor. • bleeding disorders or other blood signs of the infection such as pain, disorders (e.g. anaemia) fever, swelling and redness may be Before you start to take it hidden. You may think, mistakenly, • asthma or any other chronic lung Tell your doctor if you have that you are better or that the disease that causes difficulty in allergies to any other medicines, infection is not serious. breathing foods, preservatives or dyes. Tell your doctor if you are allergic • hay fever (seasonal allergic Your doctor will want to know if you to any other medicines, foods, dyes ) are prone to allergies, especially if or preservatives. • you get skin reaction with redness, repeated chest infections Your doctor will want to know if you itching or rash. • polyps in the nose are prone to allergies, especially if Tell your doctor if you have or • diabetes you get skin reactions with redness, itching or rash. have had any of the following • dehydration (e.g. by sickness, medical conditions: diarrhoea, before or after recent If you have not told your doctor • established disease of the heart or major surgery) about any of the above, tell blood vessels (also called him/her before you start taking • swollen feet. , including Diclofenac Sandoz. uncontrolled high blood pressure, Your doctor may want to take special congestive heart failure, precuations if you have any of the Taking other medicines above conditions. established ischemic heart Tell your doctor or pharmacist if disease, peripheral arterial disease It is generally important to take the you are taking any other or atherosclerotic cardiovascular lowest dose of diclofenac that medicines, including any that you disease), as treatment with relieves your pain and/ or swelling get without a prescription from diclofenac is generally not and for the shortest time possible in your pharmacy, supermarket or recommended order to keep your risk for health food shop. • established cardiovascular disease cardiovascular side effects as small as possible. Some medicines and Diclofenac (see above) or significant risk Sandoz may interfere with each factors such as high blood Tell your doctor if you are other. These include: pressure, abnormally high levels pregnant or trying to become • other anti-inflammatory of fat (cholesterol, triglycerides) pregnant. in your blood, diabetes, or if you medicines e.g.aspirin, salicylates, Do not use Diclofenac Sandoz during or ibuprofen smoke, and your doctor decides the first 6 months of pregnancy, • to prescribe diclofenac, you must except on doctor's advice and it must warfarin or other “blood thinner” not increase the dose above 100 not be used during the last 3 months. (medicines used to prevent blood mg per day if you are treated for Diclofenac Sandoz may also reduce clotting) more than 4 weeks. fertility and affect your chances of • digoxin, a medicine used to treat • a past history of ulcers (stomach becoming pregnant. Your doctor can heart problems or intestinal) discuss with you the risks and • lithium or selective serotonin- • gastrointestinal problems such as benefits involved. reuptake inhibitors (SSRIs), stomach ulcer, bleeding or black Tell your doctor if you are medicines used to treat some stools, or have experienced . types of depression stomach discomfort or heartburn Breastfeeding is not recommended • diuretics (medicines used to after taking anti-inflammatory while you are using this medicine. increase the amount of urine) medicines in the past The active ingredient in Diclofenac • ACE inhibitors or beta-blockers • diseases of the bowel or Sandoz passes into breast milk and (medicines used to treat high inflammation of the intestinal may affect your baby.

DICLOFENAC SANDOZ® 2 blood pressure, heart conditions, They may differ from the When to take Diclofenac glaucoma and ) information contained in this leaflet. Sandoz • prednisone, cortisone, or other If you do not understand the It is recommended to take the tablets corticosterioids (medicines used instructions, ask your doctor or before meals. You may take them to provide relief for inflamed pharmacist for help. with, or immediately after food in areas of the body) order to reduce the chance of • medicines (such as metformin) How much to take stomach upset. used to treat diabetes, except The usual starting dose is 75 mg to insulin 150 mg per day. After the early How long to take Diclofenac • methotrexate (a medicine used to stages of treatment, it is usually Sandoz possible to reduce the dose to 75 treat arthritis and some cancers) Continue taking your medicine for mg to 100 mg each day. • ciclosporin, tacrolimus (a as long as your doctor tells you. In period pain, the usual starting dose medicines used in patients who This medicine helps to control your have received organ transplants) is 50 mg to 100 mg per day, condition but does not cure it. beginning as soon as cramps begin • trimethoprim used to treat urinary and continuing until the pain goes Do not use Diclofenac Sandoz for tract infections away, but for no longer than 3 days. longer than your doctor says. • some medicines used to treat If necessary, the dose can be If you are using Diclofenac Sandoz infection (quinolone increased over several menstrual for arthritis, it will not cure your antibacterials) cycles up to a maximum of 200 mg disease but it should help to control • glucocorticoid medicines, used to per day. pain and inflammation. It usually treat arthritis begins to work within a few hours Do not exceed the recommended but several weeks may pass before • (a medicine used dose. to treat ) you feel the full effects of the Ask your doctor or pharmacist if medicine. • voriconazole (a medicine used to you are unsure of the correct dose treat fungal infections) for you. If you forget to take it • phenytoin (a medicine used to They will tell you exactly how much Take your dose as soon as you treat seizures) to take. remember, and continue to take it as • rifampicin (an antibiotic medicine Follow the instructions they give you would normally. used to treat bacterial infections). you. If it is almost time for your next dose You may need to take different If you take the wrong dose, (e.g. within 2 or 3 hours), skip the amounts of your medicines, or take Diclofenac Sandoz may not work as dose you missed and take your next different medicines while you are well and your problem may not dose when you are meant to. using Diclofenac Sandoz. improve. Do not take a double dose to make Your doctor and pharmacist have up for the dose that you missed. more information on medicines to be How to take it This may increase the chance of you careful with or avoid while taking Diclofenac Sandoz are usually taken getting an unwanted side effect. this medicine. in 2 or 3 doses during the day. If you are not sure what to do, ask If you have not told your doctor Swallow the tablets whole with a full your doctor or pharmacist. about any of these things, tell him/ glass of water or other liquid. her before you start using this If you have trouble remembering to medicine. Do not chew them. take your medicine, ask your These tablets have a special coating pharmacist for some hints. to stop them dissolving until they have gone through the stomach and If you take too much HOW TO TAKE into the intestines, where they can (overdose) DICLOFENAC start to work. If you chew them, the Immediately telephone your doctor SANDOZ coating is destroyed. or the Poisons Information Centre (telephone 13 11 26 or New Follow all directions given to you Zealand 0800 POISON or 0800 by your doctor or pharmacist 764766) for advice, or go to carefully. Accident and Emergency at the

DICLOFENAC SANDOZ® 3 nearest hospital, if you think you Keep all of your doctor's Do not stop any other forms of or anyone else may have taken too appointments so that your progress treatment for arthritis that your much Diclofenac Sandoz. Do this can be checked. doctor has told you to follow. even if there are no signs of Your doctor will periodically re- This medicine does not replace discomfort or poisoning. evaluate whether you should exercise or rest programs or the use You may need urgent medical continue treatment, if you have of heat/cold treatments. attention. established heart disease or Do not take Diclofenac Sandoz to Symptoms of an overdose may significant risks for heart disease, treat any other complaints unless include: especially in case you are treated for your doctor tells you to. more than 4 weeks. • vomiting Do not give your medicine to Your doctor may do some tests • bleeding from the stomach or anyone else, even if they have the (check your kidneys, liver and blood) same condition as you. bowel from time to time to prevent • diarrhoea unwanted side effects. Things to be careful of • dizziness If, at any time while taking Be careful driving or operating Diclofenac Sandoz you experience • ringing in the ears machinery until you know how any signs or symptoms of problems • convulsions (fits). Diclofenac Sandoz affects you. with your heart or blood vessels such as chest pain, shortness of breath, This medicine may cause dizziness weakness, or slurring of speech, or light-headedness in some people. contact your doctor immediately. If you have any of these symptoms, WHILE YOU ARE do not drive, operate machinery or do If you get an infection while using TAKING DICLOFENAC anything else that could be Diclofenac Sandoz, tell your dangerous. SANDOZ doctor. Elderly patients should take the This medicine may hide some of the Things you must do minimum number of tablets that signs of an infection (pain, fever, provides relief of symptoms. If you are about to be started on swelling, redness). You may think, any new medicine, remind your mistakenly, that you are better or that Elderly patients may be more doctor and pharmacist that you the infection is not serious. sensitive to the effects of Diclofenac are taking Diclofenac Sandoz. Sandoz than other adults. Tell any other doctors, dentists, Things you must not do and pharmacists who treat you Do not take any of the following that you are taking this medicine. medicines while you are taking SIDE EFFECTS If you are going to have surgery, Diclofenac Sandoz without first telling your doctor: tell the surgeon or anaesthetist that Tell your doctor or pharmacist as you are taking this medicine. • aspirin (also called ASA or soon as possible if you do not feel It can slow down blood clotting and acetylsalicylic acid) well while you are taking affect kidney function. • other salicylates Diclofenac Sandoz. If you become pregnant whilst • other medicines containing All medicines can have side effects. taking this medicine, tell your diclofenac Sometimes they are serious, most of doctor immediately. the time they are not. You may need • ibuprofen Your doctor can discuss with you the medical attention if you get some of • any other NSAID medicine. risk of using it while you are the side effects. pregnant. If you take these medicines together If you are over 65 years old, you with Diclofenac Sandoz, they may Tell your doctor if you get an should be especially careful while cause unwanted side effects. infection while taking this taking this medicine. Report any medicine. If you need to take something for side effects promptly to your headache or fever, it is usually okay doctor. This medicine may hide some of the to take . If you are not signs of an infection (pain, fever, As people grow older, they are more sure, your doctor or pharmacist can swelling, redness). You may think, likely to get side effects from advise you. mistakenly, that you are better or that medicines. the infection is not serious.

DICLOFENAC SANDOZ® 4 Do not be alarmed by the following • hypertension (high blood aching muscles and generally list of side effects. You may not pressure) feeling unwell (possible serious experience any of them. • hair loss or thinning. skin reaction) • Ask your doctor or pharmacist to *If symptoms of vision disorders signs of a possible effect on the answer any questions you may occur during treatment with brain, such as sudden and severe have. Diclofenac Sandoz, contact your headache, stiff neck (signs of Tell your doctor or pharmacist if doctor as an eye examination may viral meningitis), severe nausea, you notice any of the following and be considered to exclude other dizziness, numbness, difficulty in they worry you: causes. speaking, paralysis, fainting, convulsions/seizures (fits) • stomach upset including nausea If any of the following happen, tell • (feeling sick), vomiting, your doctor immediately, or go to change in the colour or amount of indigestion, cramps, loss of Accident and Emergency at your urine passed, frequent need to appetite, wind nearest hospital: urinate, burning feeling when passing urine, blood or excess of • • heartburn or pain behind or below red or purple skin (possible sings protein in the urine (possible the breastbone (possible of blood vessel inflammation) kidney disorders) symptoms of an ulcer in the tube • severe pain or tenderness in the • sudden and oppressive chest that carries food from the throat stomach, vomiting blood or to the stomach) pains (which may be a sign of material that looks like coffee or a heart • stomach or grounds, bleeding from the back attack) passage, black sticky bowel • constipation, diarrhoea • motions (stools) or bloody breathlessness, difficulty • sore mouth or tongue diarrhoea (possible stomach breathing when lying down, • altered taste sensation problems) swelling of the feet or legs (signs of cardiac failure) • headache • rash, skin rash with blisters, • coincidental occurrence of chest • dizziness, spinning sensation itching or hives on the skin, swelling of the face, lips, mouth, pain and allergic reactions (signs • drowsiness, disorientation, tongue, throat or other part of the of Kounis syndrome). forgetfulness body which may cause difficulty The above list includes very serious • feeling depressed, anxious or to swallow, low blood pressure side effects. You may need urgent irritable (hypotension), fainting, shortness medical attention or hospitalisation. • strange or disturbing thoughts or of breath (possible allergic These side effects are rare. moods reaction) Tell your doctor or pharmacist if • shakiness, sleeplessness, • wheezing, troubled breathing or you notice anything else that is nightmares feelings of tightness in the chest making you feel unwell. (signs of asthma) • tingling or numbness of the hands Other side effects not listed above or feet • yellowing of the skin or eyes may also occur in some people. (signs of /liver failure) • feeling fast or irregular heart beat • persistent nausea, loss of appetite, • unusual weight gain or swelling unusual tiredness, vomiting, pain of ankles or legs due to fluid in the upper right abdomen, dark AFTER TAKING build up urine or pale bowel motions DICLOFENAC • symptoms of (such as (possible liver problems) SANDOZ redness, itching, swelling, • constant "flu-like" symptoms like blistering of the lips, eyes, mouth chills, fever, sore throat, aching Storage and/or skin) that happen more joints, swollen glands, tiredness quickly than normal Keep your medicine in the original or lack of energy, bleeding or container. • skin inflammation with flaking or bruising more easily than normal peeling (possible blood problem) If you take it out of its original container it may not keep well. • vision disorders* (e.g. blurred or • painful red areas, large blisters, double vision) peeling of layers of skin, bleeding Keep your medicine in a cool dry place where the temperature stays • buzzing or ringing of the ears, in the lips, eyes, mouth, nose or difficulty hearing genitals which may be below 25°C. accompanied by fever and chills,

DICLOFENAC SANDOZ® 5 Do not store Diclofenac Sandoz or • microcrystalline cellulose any other medicine in the bathroom • maize starch or near a sink. Do not leave it on a • window sill or in the car. sodium starch glycollate • Heat and dampness can destroy some magnesium stearate medicines. • colloidal silicon dioxide Keep it where children cannot • methacrylic acid copolymer reach it. • triethyl citrate A locked cupboard at least one-and- • purified talc a-half metres above the ground is a • titanium dioxide good place to store medicines. • yellow ferric oxide. Disposal This medicine does not contain If your doctor tells you to stop taking sucrose, gluten, tartrazine or any this medicine or the expiry date has other azo dyes. passed, ask your pharmacist what to do with any medicine that is left Supplier over. Sandoz Pty Ltd ABN 60 075 449 553 54 Waterloo Road PRODUCT Macquarie Park, NSW 2113 DESCRIPTION Australia Tel: 1800 726 369 What it looks like

Diclofenac Sandoz tablets come in New Zealand Ltd two strengths: PO Box 99102 Diclofenac Sandoz 25 mg - Brown yellow, biconvex with an intact Newmarket, Auckland 1149 surface and uniform colour enteric- New Zealand coated tablets. Tel: 0800 354 335 Diclofenac Sandoz 50 mg - Brown yellow, biconvex with facet on both sides, intact surface and uniform This leaflet was revised in September colour enteric-coated tablets. 2019. Available in blisters or bottles of 50 tablets. Australian Register Numbers: Not all strengths or presentations Diclofenac Sandoz 25 mg - AUST R may be available 63664 (blisters) Diclofenac Sandoz 25 mg - AUST R Ingredients 61297 (bottles)* Active ingredients: Diclofenac Sandoz 50 mg - AUST R • Diclofenac Sandoz 25 mg – 25 63661 (blisters) mg diclofenac sodium Diclofenac Sandoz 50 mg - AUST R • Diclofenac Sandoz 50 mg – 50 61298 (bottles)* mg diclofenac sodium Inactive ingredients: * Not registered in New Zealand • Lactose monohydrate • calcium hydrogen phosphate dihydrate

DICLOFENAC SANDOZ® 6