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EZALO COMPOSITE PACK and calcium

Consumer Medicine Information

What is in this leaflet plaque build-up can lead to a Use in children narrowing of the arteries. This EZALO COMPOSITE PACK is not This leaflet answers some common narrowing can slow or block blood recommended for use in children. questions about EZALO flow to vital organs such as the COMPOSITE PACK. It does not heart and brain. This blocking of contain all the available blood flow can result in a heart information. It does not take the attack or stroke. Before you take place of talking to your doctor or HDL is often called EZALO COMPOSITE pharmacist. "good" cholesterol because it helps PACK All medicines have risks and keep the bad cholesterol from building up in the arteries and benefits. Your doctor has weighed When you must not take it the risks of you taking EZALO protects against heart disease. COMPOSITE PACK against the Do not take EZALO benefits they expect it will have for How EZALO COMPOSITE COMPOSITE PACK if: you. PACK works • you have an allergy to EZALO If you have any concerns about EZALO COMPOSITE PACK is a COMPOSITE PACK or any taking this medicine, ask your combination pack, which contains of the ingredients listed at the doctor or pharmacist. two different medicines. One is end of this leaflet. Keep this leaflet with the Ezetrol (ezetimibe) and the other is Symptoms of an allergic medicine. rosuvastatin (rosuvastatin calcium). reaction may include: You may need to read it again. EZALO COMPOSITE PACK - shortness of breath reduces elevated total-cholesterol, - wheezing or difficulty LDL ('bad') cholesterol and breathing increases HDL ('good') cholesterol. - swelling of the face, lips, What EZALO tongue, throat or other parts of EZALO COMPOSITE PACK the body COMPOSITE PACK is works by decreasing the absorption used for - rash, itching or hives on the of cholesterol in the skin and by reducing the amount of EZALO COMPOSITE PACK helps • you have had muscle pain, cholesterol made in the . to lower cholesterol levels. It is tenderness or weakness from used in people whose cholesterol Your doctor may have prescribed other medicines used to treat levels are too high and when diet EZALO COMPOSITE PACK for high cholesterol or alone cannot lower these levels another reason. triglycerides. adequately. Ask your doctor if you have any • you are pregnant or intend to questions about why EZALO become pregnant. What is high cholesterol COMPOSITE PACK has been If you are a woman of child- prescribed for you. Cholesterol is one of several fatty bearing age and are taking substances found in the EZALO COMPOSITE PACK is not EZALO COMPOSITE addictive. bloodstream. Your total cholesterol PACK, use a proven method is made up mainly of LDL and EZALO COMPOSITE PACK is of birth control to avoid HDL cholesterol. available only with a doctor's pregnancy. prescription. The medicine may affect your LDL cholesterol is often called developing baby if you take it "bad" cholesterol because it can during pregnancy. build up in the walls of your arteries • you are breast-feeding. forming plaque. Eventually this This medicine may pass into

EZALO COMPOSITE PACK Published by MIMS August 2020 1 breast milk and affect your you start to take EZALO Some medicines may be affected by baby. COMPOSITE PACK. EZALO COMPOSITE PACK, or • you have active liver disease. Tell your doctor if: may affect how well it works, or may increase the risk of side effects • you are taking any medicine • you have any allergies to any with EZALO COMPOSITE PACK. containing fusidic acid (for other medicines or any other You may need different amounts of bacterial infections) substances, such as foods, your medicines, or you may need to • the expiry date on the pack preservatives or dyes. take different medicines or take has passed or if the packaging you have, or have had, any your medicines at different times. is torn or shows signs of medical condition, including: Your doctor will advise you. tampering. • liver problems If you take EZALO Your doctor will do a blood test Tell your doctor if… COMPOSITE PACK after the to make sure you have no expiry date has passed, it may Tell your doctor if you are taking problems with your liver. not work. any of the following: • kidney problems Return any expired or • acid sequestrants, such as • damaged EZALO personal or family history of colestyramine, used to lower COMPOSITE PACK to your muscle problems cholesterol levels • pharmacist for disposal muscle pain, tenderness or • other medicines to lower Do not take EZALO weakness from other cholesterol or triglyceride levels, COMPOSITE PACK together medicines used to treat high for example, , other with if: cholesterol or triglycerides , Vitamin B3 • • you have gall bladder disease. unexplained muscle aches or • or fluindione, used to pains in your muscle Do not use EZALO COMPOSITE prevent blood clots • PACK 10mg+40mg if you: breathing problems • HIV protease inhibitors, used to • • have low hormone levels low thyroid hormone levels treat HIV infection () (hypothyroidism) • hepatitis C antiviral agents, such • • have a personal or family or risk factors for as elbasvir or grazoprevir, used history of hereditary muscular diabetes to treat the hepatitis C virus disorders • you drink alcohol regularly. infection • have a previous history of Excessive alcohol consumption • colchicine, used to treat gout muscular problems from using may not be safe in patients • ciclosporin, used to suppress the other medicines used to treat taking EZALO COMPOSITE immune system PACK. high cholesterol or triglycerides • antacids, used to treat reflux or • have a history of very heavy If you have not told your doctor ulcers. EZALO COMPOSITE about any of the above, tell alcohol consumption PACK should be taken 2 hours him/her before you start taking before or 2 hours after taking • have severe kidney impairment EZALO COMPOSITE PACK. • are of Asian descent antacid. • are taking another type of lipid- Taking other medicines • daptomycin, a medicine used to lowering medicine called a treat complicated skin and skin Tell your doctor or pharmacist if structure infections and you are taking any other bacteraemia Before taking EZALO medicines, including any that you COMPOSITE PACK buy without a prescription from Your doctor or pharmacist has more 10mg+40mg, talk to your doctor your pharmacy, supermarket or information on medicines to be about situations that can increase health food shop. careful with or avoid while taking rosuvastatin blood levels. Some medicines should not be EZALO COMPOSITE PACK. Also talk to your doctor if you are taken with EZALO If you have not told your doctor not sure whether you should start COMPOSITE PACK, including: about any of the above, tell them taking EZALO COMPOSITE • fusidic acid, antibiotic used to before you start taking EZALO PACK. COMPOSITE PACK. treat infection Before you start to take it • fenofibrate (a medicine to lower triglyceride levels) if you Your doctor will ask you to have have gall bladder disease your liver function tested before

EZALO COMPOSITE PACK Published by MIMS August 2020 2 How to take EZALO How to take it Do not take a double dose to make up for the dose that you COMPOSITE PACK Swallow the tablets whole with a missed. full glass of water. This may increase the chance of you Take EZALO COMPOSITE Do not chew or crush the tablets. PACK only when prescribed by getting a side effect. your doctor. If you are not sure what to do, When to take it Follow all directions given to you talk to your doctor or pharmacist. by your doctor or pharmacist EZALO COMPOSITE PACK If you have trouble remembering carefully. can be taken at any time of the to take your medicine, ask your They may differ from the day. However, EZALO pharmacist for some hints. information contained in this leaflet. COMPOSITE PACK should be taken at about the same time each If you do not understand these If you take too much day. (overdose) instructions, ask your doctor or Taking it at the same time each day pharmacist for help. will have the best effect. It will also Immediately telephone your If you are currently taking a help you remember when to take it. doctor or the Poisons Information medicine that contains ezetimibe Centre (telephone 13 11 26) for and/or rosuvastatin which are Take EZALO COMPOSITE PACK advice, or go to Accident and contained in EZALO with or without food. Emergency at the nearest COMPOSITE PACK: hospital, if you think that you or Taking EZALO COMPOSITE anyone else may have taken too • stop taking your current PACK with other cholesterol- much EZALO COMPOSITE medicine(s) that contain lowering agents PACK. Do this even if there are ezetimibe and/or rosuvastatin as no signs of discomfort or this may result in you taking Your doctor may ask you to take poisoning. more medicine than you need EZALO COMPOSITE PACK with You or anyone else may need • take the remaining medicine(s) other cholesterol-lowering agents urgent medical attention. to your pharmacist for safe such as sequestrants. disposal If you are taking a bile acid Check with your doctor if you are sequestrant, such as not sure about the medicines you colestyramine, take EZALO While you are taking are taking. COMPOSITE PACK either at EZALO COMPOSITE least two hours before or four PACK How much to take hours after taking the . There are two different medicines in Things you must do EZALO COMPOSITE PACK. How long to take it If you become pregnant while you Your doctor will prescribe a are taking EZALO COMPOSITE strength that is appropriate for you. Take EZALO COMPOSITE PACK every day and continue PACK, stop taking it and tell It is very important that you take taking it for as long as your your doctor immediately. EZALO COMPOSITE PACK doctor tells you. Keep all your doctor's exactly as follows: appointments. EZALO COMPOSITE PACK helps Take one Ezetrol (ezetimibe) tablet to lower your cholesterol levels but Even if you are taking medicines to and one MSD Rosuvastatin does not cure your condition. If you treat high cholesterol, it is important (rosuvastatin) tablet at the same stop taking EZALO COMPOSITE to have your cholesterol measured time once a day. PACK your cholesterol levels may regularly. You should also know If your doctor has increased the rise again. your cholesterol levels and goals. strength of EZALO COMPOSITE Your doctor will ask you to have PACK tablets you take, do not take If you forget to take it your liver function tested from time multiple doses of any remaining If it is almost time for your next to time while you are taking supplies of lower strength EZALO dose, skip the dose you missed EZALO COMPOSITE PACK. This COMPOSITE PACK tablets instead and take your next dose when you may help prevent unwanted side of the new higher strength tablets as are meant to. Otherwise, take it effects. this will result in you taking more as soon as you remember, and Your doctor may adjust your medicine (ezetimibe) than you need. then go back to taking your dose depending on the result of tablets as you would normally. the test. If you are about to be started on any new medicine, tell

EZALO COMPOSITE PACK Published by MIMS August 2020 3 your doctor and pharmacist that Side effects Tell your doctor if you have been you are taking EZALO diagnosed with: COMPOSITE PACK. Tell your doctor or pharmacist as • inflammation of the pancreas Tell any other doctors, dentists, soon as possible if you do not feel • gallstones and pharmacists who treat you well while you are taking EZALO • inflammation of the gallbladder that you are taking EZALO COMPOSITE PACK. • elevation in some laboratory COMPOSITE PACK. EZALO COMPOSITE PACK helps blood tests of liver or muscle most people with high cholesterol function Things you must not do levels, but it may have unwanted • depression Do not take EZALO side effects in a few people. All COMPOSITE PACK to treat any medicines can have side effects. • elevation in blood glucose levels other conditions unless your Sometimes they are serious, most of • diabetes doctor tells you to. the time they are not. You may need • high blood pressure Do not give EZALO medical attention if you get some of • thyroid function abnormalities COMPOSITE PACK to anyone the side effects. The above list includes the more else, even if they have the same Do not be alarmed by the condition as you. common and uncommon side following lists of side effects. effects of your medicine. They are You may not experience any of usually mild and short-lived. Things to be careful of them. Tell your doctor if you notice a Avoid drinking large quantities of Ask your doctor or pharmacist to significant increase in your need alcohol. answer any questions you may to urinate or if you are Drinking large quantities of alcohol have. significantly more hungry or while taking EZALO COMPOSITE thirsty than usual. PACK may increase your chance of Tell your doctor if… getting liver problems. Tell your doctor or pharmacist if Tell your doctor immediately Be careful driving or operating you notice any of the following if… machinery until you know how and they worry you: EZALO COMPOSITE PACK Tell your doctor immediately if affects you. • diarrhoea you notice any of the following: There have been side effects • muscle aches, spasms, tiredness • skin rash and hives reported with EZALO or weakness • raised red rash, sometimes with COMPOSITE PACK that may • circular-shaped lesions affect your ability to drive or • nausea • steady abdominal pain with operate machinery. Individual • stomach or belly pain nausea and vomiting responses to EZALO COMPOSITE • heartburn, indigestion or wind • joint pain PACK may vary. • aches and pain • bleeding or bruising more easily than normal Things that may help your • pain in arms and legs condition • trouble sleeping • yellowing of the skin and eyes • dizziness • dark coloured urine Lifestyle Changes - • light coloured bowel motions This includes a cholesterol-lowering • headache • problems with breathing diet, increasing physical activity, • tingling or numbness of the including shortness of breath, and weight management. Ask your hands or feet persistent cough and fever doctor for advice before increasing • hot flush physical activity. • shortness of breath These may be serious side effects. You may need urgent medical Medicines - • unusual tiredness or weakness attention. Cholesterol-lowering medicines are • generally feeling unwell used together with lifestyle changes • memory loss Go to hospital if… to help lower cholesterol. • itchy skin If any of the following happen, • decreased appetite tell your doctor immediately or go • dry mouth to Accident and Emergency at • swelling, especially in the hands your nearest hospital: and feet • swelling of the face, lips, mouth, • cough throat or tongue which may

EZALO COMPOSITE PACK Published by MIMS August 2020 4 cause difficulty in swallowing or Keep it where children cannot Ingredients breathing. reach it. Ezetrol These may be serious side A locked cupboard at least one-and- effects. If you have them, you a-half metres above the ground is a Active ingredient: may have had a serious allergic good place to store medicines. • Ezetimibe 10 mg per tablet. reaction to EZALO Inactive ingredients: COMPOSITE PACK. You may Disposal • Croscarmellose sodium need urgent medical attention or If your doctor tells you to stop • Magnesium stearate hospitalisation. These side taking EZALO COMPOSITE effects are very rare. PACK or the expiry date has • Lactose monohydrate • chest pain passed, ask your pharmacist what • Microcrystalline cellulose • unexpected muscle pain, to do with any medicine that is • Povidone left over. tenderness, or weakness not • Sodium lauryl sulfate caused by exercise, particularly MSD Rosuvastatin if you also have a fever or Active ingredient: generally feel unwell. • This may be a serious side Product description Rosuvastatin (as rosuvastatin effect. This is because on rare calcium) 5 mg per tablet. occasions, muscle problems can What it looks like • Rosuvastatin (as rosuvastatin calcium) 10 mg per tablet. be serious including muscle EZALO COMPOSITE PACK breakdown resulting in kidney comes in four different strengths: • Rosuvastatin (as rosuvastatin damage. You may need urgent calcium) 20 mg per tablet. • EZALO COMPOSITE PACK medical attention. • Rosuvastatin (as rosuvastatin 10 mg + 5 mg • severe blisters and bleeding of calcium) 40 mg per tablet. • EZALO COMPOSITE PACK the lips, eyes, mouth, nose or Inactive ingredients: 10 mg + 10 mg genitals. • EZALO COMPOSITE PACK • Purified talc The above list includes very serious 10 mg + 20 mg • Microcrystalline cellulose side effects. You may need urgent • Silicon dioxide medical attention or hospitalisation. • EZALO COMPOSITE PACK 10 mg + 40 mg • Colloidal anhydrous silica Tell your doctor or pharmacist if you notice anything that is Ezetrol 10 mg tablet is a white to • Maize starch making you feel unwell. off-white, capsule-shaped tablet • Sodium stearylfumarate with "414" marked on one side. Other side effects not listed above • Hypromellose may also occur in some people. MSD Rosuvastatin 5 mg is a brown, • Mannitol round, film coated tablet. • Lactose MSD Rosuvastatin 10 mg is a • Macrogol 6000 brown, round, film coated tablet • Titanium dioxide After taking EZALO with "RSV 10" marked on one side. COMPOSITE PACK • Iron oxide yellow MSD Rosuvastatin 20 mg is a • Iron oxide red brown, round, film coated tablet Storage with "RSV 20" marked on one side. Date of Preparation Keep your tablets in a cool dry MSD Rosuvastatin 40 mg is a This Consumer Medicine place where the temperature brown, round, film coated tablet Information was prepared in June stays below 25°C. with "RSV 40" marked on one side. 2020. Do not store EZALO Ezetrol 10mg and MSD Ask your pharmacist about any COMPOSITE PACK or any Rosuvastatin (5, 10, 20, 40 mg) are other medicine in the bathroom updates. supplied in 10-day calendar packs or near a sink. Do not leave it on of 10 Ezetrol and 10 MSD a window sill or in the car. Supplier Rosuvastatin tablets. Heat and dampness can destroy EZALO COMPOSITE PACK is some medicines. A trade pack contains 3 x 10-day calendar packs. supplied in Australia by: A starter pack contains 1 x 10-day Merck Sharp & Dohme (Australia) calendar pack. Pty Limited ABN 14 000 173 508

EZALO COMPOSITE PACK Published by MIMS August 2020 5 Level 1, Building A 26 Talavera Road Macquarie Park NSW 2113 Australia

Australian Registration Numbers EZALO COMPOSITE PACK 10 mg + 5 mg - Aust R 203693 EZALO COMPOSITE PACK 10 mg + 10 mg - Aust R 203689 EZALO COMPOSITE PACK 10 mg + 20 mg - Aust R 203691 EZALO COMPOSITE PACK 10 mg + 40 mg - Aust R 203688

EZALO COMPOSITE PACK Published by MIMS August 2020 6