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Diclofenac Sandoz® Diclofenac Sodium Enteric-Coated Tablets Consumer Medicine Information

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Diclofenac Sandoz® Diclofenac Sodium Enteric-Coated Tablets Consumer Medicine Information Diclofenac Sandoz® diclofenac sodium enteric-coated tablets Consumer Medicine Information WHAT IS IN THIS • relief of acute or chronic pain • any other similar medicines, such LEAFLET states in which there is an as aspirin, ibuprofen 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 hives 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. inflammation (swelling and redness). headache, period pain and other aches and pains 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 heart failure 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 pregnancy, 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. arthritis and osteoarthritis 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 rhinitis) 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. cardiovascular disease, 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 breastfeeding. 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 migraine) 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 • sulfinpyrazone (a medicine used dose. to treat gout) you feel the full effects of the Ask your doctor or pharmacist if medicine.
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