MEZAVANT® Mesalazine 1.2 g, gastro-resistant, prolonged release tablets

Consumer Medicine Information

What is in this leaflet to treat the inflammation and reduce may be the result of an symptoms. MEZAVANT can also be in the heart) Please read this leaflet before you taken to help prevent re-occurrence • Have had a previous allergic start taking MEZAVANT. of ulcerative . reaction to MEZAVANT or other This leaflet answers some common medicines containing mesalazine questions about MEZAVANT. or sulphasalazine (other medicines taken for treatment of It does not contain all available Before you take ) information. It does not take the MEZAVANT place of talking to your doctor or • Have narrowing or blockage of the stomach or the gut pharmacist. MEZAVANT 1.2 g gastro-resistant, All medicines have risks and prolonged release tablets are not • Have skin conditions such as benefits. Your doctor has weighed suitable for everyone. atopic dermatitis or atopic the risk of you using MEZAVANT eczema against the benefit it is expected to When you must not take it • Are pregnant or intend to become have for you. pregnant Do not take MEZAVANT: If you have any concerns about • If you are allergic • Are or wish to taking MEZAVANT, talk to your (hypersensitive) to a family of breastfeed. doctor or pharmacist. drugs known as salicylates If you have not told your doctor or Keep this leaflet with the medicine. (which include ). pharmacist about any of the above, You may want to read it again. • If you are allergic tell them before you take any (hypersensitive) to mesalazine or MEZAVANT. any of the other ingredients of MEZAVANT listed in "Other Taking other medicines What MEZAVANT is ingredients" section of this Tell your doctor or pharmacist if you used for leaflet. are taking or have recently taken any • The expiry date printed on the other medicines that contain: The name of your medicine is carton is passed. If you use this MEZAVANT 1.2 g, gastro-resistant, • Mesalazine or sulphasalazine medication after the expiry date prolonged release tablets. It contains (taken for treatment of ulcerative has passed, it may not work as the active ingredient mesalazine (also colitis) well. called 5-aminosalicylic acid or 5- • Non-steroidal anti-inflammatory ASA), an anti-inflammatory drug for • The packaging is torn or shows drugs (for example medicines the treatment of ulcerative colitis. signs of tampering. containing aspirin, or Ulcerative colitis is a disease of the If you are not sure whether you ) large intestine (the colon and should start using MEZAVANT, • Azathioprine or 6-mercaptopurine ), where the lining of the contact your doctor. (known as 'immunosuppressant' intestine becomes red and swollen medicines). (inflamed) and ulcers develop. This Before you take it • Warfarin (taken to prevent blood can cause symptoms of frequent and Tell your doctor or pharmacist if you: clots) or other coumarin-type bloody stools together with stomach • Have any kidney problems anticoagulants cramps. • Have previously had Tell your doctor or pharmacist if you When MEZAVANT is taken for a inflammation of the heart (which are taking or have recently taken flare up of ulcerative colitis, it acts other medicines, including any that through the entire colon and rectum you buy without a prescription from

MEZAVANT® CMI V1.0 1 your pharmacy, supermarket or If you forget to take it · Do not give to children under health food shop. 18 years of age. If you forget to take your tablets then take them as usual the next MEZAVANT is not suitable for day. Do not take a double dose to children under 18 years of age as make up for a forgotten tablet. there is not enough information How to take on its effects in children. MEZAVANT If you take too much · Do not give MEZAVANT to anyone else, even if they have Follow all directions given to you Immediately telephone your doctor the same condition as you. It by your pharmacist or doctor or the Poisons Information Centre may not be safe for another carefully as this may differ from (telephone 13 11 26) for advice, or person to take MEZAVANT the information contained in this go to Accident and Emergency at leaflet. the nearest hospital, if you think · Do not take MEZAVANT to that you or anyone else may have treat any other complaints If you do not understand the used too much MEZAVANT. Do unless your doctor tells you to. instructions in this leaflet, ask your this even if there are no signs of It may not be safe to use doctor or pharmacist for help. discomfort or poisoning. MEZAVANT for another complaint. How much to take If you take too much MEZAVANT you may have one or more of the Adults and the elderly following symptoms: ringing in ears Driving or operating The usual daily dose for adults and (tinnitus), dizziness, headache, machinery the elderly is 2.4g to 4.8g (two to confusion, drowsiness, shortness of MEZAVANT is unlikely to have any four tablets) taken once a day for an breath, excess loss of water effect on your ability to drive or use acute episode of ulcerative colitis. (associated with sweating, diarrhoea machines. • If you are taking the highest daily and vomiting), low blood sugar dose of 4.8g/day, you should be (which can cause light-headedness), evaluated after 8 weeks of rapid breathing, and increased body treatment temperature. Blood tests may show Side effects changes in your blood chemistry • Once your symptoms have (electrolyte balance). cleared and to help prevent re- Tell your doctor or pharmacist as occurrence of another episode, soon as possible if you do not feel your doctor may direct you to well while you are taking take 2.4g (two tablets) once a MEZAVANT. day. While you are taking Like all medicines, MEZAVANT MEZAVANT Children and Adolescents can cause some side effects. Sometimes they are serious, most of MEZAVANT is not recommended to Things you must do the time they are mild and temporary. be given to children under 18 years of age due to lack of data on safety • MEZAVANT should be taken Do not be alarmed by this list of and efficacy. with or without food at the same possible side effects. You may not time each day. The tablets should experience any of them. How to take it be swallowed whole and must not Ask your doctor or pharmacist to be crushed or chewed answer any questions you may Take your tablets with or without • Ensure adequate fluid intake have. food at the same time each day. during treatment. The tablets must be swallowed Tell your doctor or pharmacist if whole and must not be crushed or • Make sure that all of your doctors you notice any of the following and chewed. and pharmacists know you are they worry you: taking MEZAVANT. Remind • Headache How long to take it them if any new medicines are • Mild stomach pains about to be started. It is important to take your • Bloating or passing wind MEZAVANT tablets every day for Things you must not do • Excessive gas in the stomach or as long as your doctor tells you to, bowel even when you don©t have any · Do not stop taking your tablets symptoms of ulcerative colitis. or change the dosage without • Increased number of bowel checking with your doctor motions

MEZAVANT® CMI V1.0 2 • Nausea (feeling sick) Other rare events which have been MEZAVANT is supplied as a 60 • Vomiting (being sick) reported with mesalazine include: tablets pack size. • Rash or itchy skin • Changes in kidney function and inflammation of the kidney, Ingredients • Fever including Active substance • Loss of strength • Changes in blood test results such The active substance is 1.2 g • Muscle, joint or back pain as low white blood cell and/or mesalazine platelet counts • Increased blood pressure Other ingredients • Changes in liver function tests • Indigestion Carmellose sodium, carnauba wax, • Tiredness • Liver disease with nausea, stearic acid, silicon dioxide, sodium vomiting, loss of appetite, feeling starch glycollate, talc-purified, Tell your doctor immediately or go generally unwell, fever, itching, magnesium stearate, methacrylic acid to Accident and Emergency at yellowing of the skin and eyes, copolymer, triethyl citrate, titanium your nearest hospital if you notice and dark coloured urine dioxide (E171), iron oxide red any of the following: • Changes relating to your heart (CI77491), Macrogol 6000. • If you experience symptoms such • Inflammation of the lung, causing as cramping, severe stomach Sponsor pain, bloody and excessive stools difficulty in breathing or (diarrhoea), fever, headache or wheezing Shire Australia Pty Ltd rash. These symptoms could be a Tell your doctor or pharmacist if Shire is now part of Takeda sign of Acute Intolerance you notice anything that is making Level 39 Syndrome which can happen you feel unwell. during an acute episode of 225 George Street Other side effects not listed above ulcerative colitis. This is a serious Sydney, NSW 2000 may also occur in some people. condition which occurs rarely, but Australia means your treatment would have to be stopped immediately Phone: 1800 012 612

• If you develop unexplained After taking bruising (without injury), rash, MEZAVANT This leaflet was prepared in Aug anaemia (feeling tired, weak and 2020. looking pale, especially on lips, Storage nails and inside of eyelids), fever Australian Registration Number: (high temperature), sore throat or • Keep out of the reach and sight of AUST R 155172 unusual bleeding (e.g. nose children bleeds) • Store below 25°C • If you develop allergic swelling • Store in the original package of face, eyes, lips, mouth, tongue • Do not use MEZAVANT after or throat which may cause difficulty in swallowing or the expiry date which is stated on breathing. the box. • Widespread rash with blistering Disposal of the skin, particularly around the mouth, eyes and genitals Return any unused or out of date medicine to your pharmacist. • Allergic skin rash with fever • Severe pain in the back, side or stomach. Trouble urinating, pain or burning during urination. Product description These could be symptoms of kidney stones What MEZAVANT looks like These are very serious side effects. You may need urgent medical MEZAVANT are oval shaped red- attention or hospitalisation. All of brown tablets which are stamped these side effects are very rare. with S476.

MEZAVANT® CMI V1.0 3