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EZETIMIBE/ GH ezetimibe and atorvastatin (as calcium trihydrate)) tablets

Consumer Medicine Information

What is in this leaflet block blood flow to vital organs such Ask your doctor if you have any as the heart and brain. This blocking questions about why This leaflet answers some common of blood flow can result in a heart Ezetimibe/Atorvastatin GH has been prescribed for you. questions about attack or . Ezetimibe/Atorvastatin GH. HDL cholesterol is often called Ezetimibe/Atorvastatin GH is not addictive. It does not contain all the available "good" cholesterol because it helps information. It does not take the keep the bad cholesterol from Ezetimibe/Atorvastatin GH does not place of talking to your doctor or building up in the arteries and help you lose weight. pharmacist. protects against heart disease. Ezetimibe/Atorvastatin GH is All medicines have risks and available only with a doctor's Triglycerides benefits. Your doctor has weighed prescription. the risks of you taking Triglycerides are another form of fat Ezetimibe/Atorvastatin GH against in your blood that may increase your Use in children the benefits they expect it will have risk for heart disease. Ezetimibe/Atorvastatin GH is not for you. recommended for use in children, as If you have any concerns about Heart Disease there have been no studies of its taking this medicine, ask your If you have heart disease and a effects in children. doctor or pharmacist. history of heart attack or Keep this leaflet with the medicine. hospitalisation for unstable angina You may need to read it again. (chest pain), Ezetimibe/Atorvastatin GH reduces the risk of heart attack, Before you take stroke, surgery to increase heart EZETIMIBE/ blood flow, or hospitalization for ATORVASTATIN GH What EZETIMIBE/ chest pain. ATORVASTATIN GH is When you must not take it used for How Ezetimibe/Atorvastatin Do not take GH works Ezetimibe/Atorvastatin GH helps to Ezetimibe/Atorvastatin GH if: lower cholesterol and triglyceride Ezetimibe/Atorvastatin GH contains • you have an allergy to levels. It is used in people whose two different medicines. One is Ezetimibe/Atorvastatin GH or cholesterol and triglyceride levels are Ezetrol (ezetimibe) and the other is any of the ingredients listed at too high and when diet alone cannot atorvastatin (atorvastatin calcium the end of this leaflet. lower these levels adequately. trihydrate). Ezetimibe/Atorvastatin Symptoms of an allergic reaction GH reduces elevated total may include: What is high cholesterol cholesterol, LDL ('bad') cholesterol - shortness of breath; and triglycerides and increases HDL - wheezing or difficulty Cholesterol is one of several fatty ('good') cholesterol. breathing; substances found in the bloodstream. Ezetimibe/Atorvastatin GH works by - swelling of the face, lips, Your total cholesterol is made up decreasing the absorption of tongue, throat or other parts of the mainly of LDL and HDL cholesterol. cholesterol in the and body; LDL cholesterol is often called "bad" by reducing the amount of - rash, itching or hives on the cholesterol because it can build up in cholesterol made in the . skin; the walls of your arteries forming Your doctor may have prescribed • you have had muscle pain, plaque. Eventually this plaque build Ezetimibe/Atorvastatin GH for tenderness or weakness from up can lead to a narrowing of the another reason. other medicines used to treat arteries. This narrowing can slow or

EZETIMIBE/ATORVASTATIN GH Published by MIMS February 2020 1

high cholesterol or • you have any allergies to any Tell your doctor if... triglycerides. other medicines or any other Tell your doctor if you are taking substances, such as foods, • you are pregnant or intend to any of the following: become pregnant or you are preservatives or dyes. • bile acid sequestrants, such as . If you are a you have, or have had, any medical cholestyramine, used to lower woman of childbearing age and condition, including: cholesterol levels; are taking • liver problems • other medicines to lower Ezetimibe/Atorvastatin GH use Your doctor will do blood tests cholesterol or triglyceride levels, a proven method of birth sometimes to make sure you have for example, , control to avoid . no problems with your liver; Ezetimibe/Atorvastatin GH is , other , • kidney problems; contraindicated (i.e. should not be Vitamin B3 (); • you have unexplained muscle used) during pregnancy and • warfarin or fluindione, used to pain, tenderness or weakness breastfeeding. If you take this prevent blood clots; not caused by exercise. This is medicine during pregnancy and • erythromycin, clarithromycin, because on rare occasions, breastfeeding your baby may rifampicin or fusidic acid, muscle problems can be serious, absorb this medicine and it may antibiotics used to treat infection; including muscle breakdown affect your baby's normal • some medicine used to treat resulting in kidney damage that development causing fetal can lead to death; certain fungal infections, such as malformations (birth defects) or Your doctor may do a blood test ketoconazole or itraconazole; irreversible damage. to check for certain muscle • efavirenz and protease inhibitors • you have active or problems. such as fosamprenevir and repeated blood tests indicating • type of stroke called a combinations of lopinavir/ possible liver problems. haemorrhagic stroke, or a type ritonavir, darunavir/ritonavir and • the expiry date on the pack has saquinavir/ritonavir for the of stroke called a lacunar passed or if the packaging is stroke; treatment of HIV infections; torn or shows signs of If you have had one of these • hepatitis C antiviral agents, such tampering. before, this medicine may as, telaprevir, boceprevir, elbasvir If you take increase the risk of you having a or grazoprevir; Ezetimibe/Atorvastatin GH after haemorrhagic stroke; • phenytoin, used to treat epilepsy the expiry date has passed, it may • breathing problems; (seizures); not work. Return any expired or • , used to suppress the damaged • you drink alcohol regularly. immune system; Ezetimibe/Atorvastatin GH to If you have not told your doctor your pharmacist for disposal about any of the above, tell him/ • colchicine, used for gout her before you start taking • spironolactone, used to treat high Do not take Ezetimibe/Atorvastatin GH. Ezetimibe/Atorvastatin GH blood pressure and certain types together with fenofibrate if you of swelling; have gall bladder disease. Taking other medicines • diltiazem used to treat angina Do not take Tell your doctor or pharmacist if • digoxin, used to treat heart Ezetimibe/Atorvastatin GH you are taking any other failure; together with fusidic acid (an medicines, including any that you • oral contraceptives for birth buy without a prescription from antibiotic). control; your pharmacy, supermarket or If you are not sure whether you health food shop. • antacids and cimetidine, used to should start taking treat reflux or ulcers; Ezetimibe/Atorvastatin GH, talk to Some medicines may be affected by • St. John’s Wort (hypericum your doctor. Ezetimibe/Atorvastatin GH, or may perforatum) (a medicine to treat affect how well it works, or may depression). Before you start to take it increase the risk of side effects with Ezetimibe/Atorvastatin GH. You Your doctor or pharmacist has more Your doctor will ask you to have may need different amounts of your information on medicines to be your liver function tested before you medicines, or you may need to take careful with or avoid while taking start to take Ezetimibe/Atorvastatin different medicines or take your Ezetimibe/Atorvastatin GH. GH. medicines at different times. Your If you have not told your doctor Tell your doctor if: doctor will advise you. about any of the above, tell them

EZETIMIBE/ATORVASTATIN GH Published by MIMS February 2020 2 before you start taking help you remember when to take it. the nearest hospital, if you think Ezetimibe/Atorvastatin GH. Take Ezetimibe/Atorvastatin GH that you or anyone else may have with or without food. taken too much Ezetimibe/Atorvastatin. Do this Taking Ezetimibe/Atorvastatin even if there are no signs of discomfort or poisoning. How to take GH with other cholesterol- You or anyone else may need urgent EZETIMIBE/ lowering agents ATORVASTATIN GH medical attention. Your doctor may ask you to take Take Ezetimibe/Atorvastatin GH Ezetimibe/Atorvastatin GH with only when prescribed by your other cholesterollowering agents doctor. such as bile acid sequestrants. While you are taking it Follow all directions given to you If you are taking a bile acid Things you must doIf you become by your doctor or pharmacist sequestrant, such as pregnant while you are taking carefully. cholestyramine, take your Ezetimibe/Atorvastatin GH, stop Ezetimibe/Atorvastatin GH either They may differ from the taking it and tell your doctor at least two hours before or four information contained in this leaflet. immediately hours after taking the bile acid If you do not understand these sequestrant. Keep all your doctor's instructions, ask your doctor or appointments. pharmacist for help. How long to take it Even if you are taking medicines to If you are currently taking a treat high cholesterol, it is important medicine that contains ezetimibe Take Ezetimibe/Atorvastatin GH and/or atorvastatin which are every day and continue taking it to have your cholesterol measured contained in for as long as your doctor tells you. regularly. You should also know your cholesterol levels and goals. Ezetimibe/Atorvastatin GH: Ezetimibe/Atorvastatin GH helps to • Stop taking your current medicine lower your cholesterol levels but Your doctor will ask you to have (s) that contain ezetimibe and/or does not cure your condition. If you your liver function tested from time atorvastatin as this may result in stop taking Ezetimibe/Atorvastatin to time while you are taking you taking more medicine than GH your cholesterol levels may rise Ezetimibe/Atorvastatin GH to make you need; again. sure the medicine is working and to • take the remaining medicine(s) to prevent unwanted side effects. your pharmacist for safe disposal. If you forget to take it If you are about to be started on any new medicine, tell your doctor Check with your doctor if you are not If it is almost time for your next and pharmacist that you are taking sure about the medicines you are dose, skip the dose you missed and Ezetimibe/Atorvastatin GH. taking. take your next dose when you are meant to. Otherwise, take it as Tell any other doctors, dentists, How much to take soon as you remember, and then go and pharmacists who treat you back to taking your as you that you are taking The recommended dose in adults (18 would normally. Ezetimibe/Atorvastatin GH. years and over) is one Do not take a double dose to make Ezetimibe/Atorvasatin GH 10/10 mg, up for the dose that you missed. Things you must not do 10/20 mg, 10/40 mg or 10/80 mg This may increase the chance of you Do not take tablet once a day. getting a side effect. Ezetimibe/Atorvastatin GH to If you are not sure what to do, talk treat any other conditions unless How to take it to your doctor or pharmacist. your doctor tells you to. Swallow the tablet whole with a If you have trouble remembering Do not give Ezetimibe/Atorvastatin full glass of water. to take your medicine, ask your GH to anyone else, even if they pharmacist for some hints. have the same condition as you. When to take it Things to be careful of Ezetimibe/Atorvastatin GH can be If you take too much taken at any time of the day. (overdose) Avoid drinking large quantities of However, Ezetimibe/Atorvastatin Immediately telephone your doctor alcohol. GH should be taken at about the or the Poisons Information Centre Drinking large quantities of alcohol same time each day. (telephone 13 11 26) for advice, or while taking Ezetimibe/Atorvastatin Taking it at the same time each day go to Accident and Emergency at will have the best effect. It will also

EZETIMIBE/ATORVASTATIN GH Published by MIMS February 2020 3

GH may increase your chance of Do not be alarmed by the following and have high blood pressure. getting liver problems. lists of side effects. Your doctor will monitor you Avoid drinking large quantities of You may not experience any of them. while taking this medicines). grapefruit juice. Ask your doctor or pharmacist to The above list includes the more Grapefruit juice contains one or more answer any questions you may common and uncommon side effects components that alter the metabolism have. of your medicine. They are usually of some medicines, including mild and short-lived. Ezetimibe/Atorvastatin GH. Drinking Tell your doctor if... very large quantities (over 1.2 litres) Tell your doctor or pharmacist if Tell your doctor immediately of grapefruit juice each day while you notice any of the following and if... taking Ezetimibe/Atorvastatin GH they worry you: Tell your doctor immediately if increases your chance of getting side • diarrhoea; you notice any of the following: effects. • muscle aches, spasms, tiredness • skin rash and hives; Be careful driving or operating or weakness; machinery until you know how • raised red rash, sometimes with • constipation; Ezetimibe/Atorvastatin GH affects circle-shaped lesions; you. • frequent bowel movements; • steady with There have been side effects reported • nausea; nausea and vomiting; with Ezetimibe/Atorvastatin GH that • stomach or belly pain; • joint pain; may affect your ability to drive or • heartburn, indigestion or wind; • tendon injury; operate machinery. Individual • aches and pain; • bleeding or bruising more easily responses to Ezetimibe/Atorvastatin • stiffness; than normal; GH may vary. • leg cramps; • yellowing of the skin and eyes; Things that may help your • taste disturbance; • dark coloured urine; condition • depression; • light coloured bowel motions • trouble sleeping; • problems with breathing Lifestyle Changes - including shortness of breath, This includes a cholesterol-lowering • influenza; persistent cough and fever that diet, increasing physical activity, and • dizziness; may also occur with or weight management. Ask your doctor • headache; unexplained weight loss. for advice before increasing physical • tingling or numbness of the hands These may be serious side effects. activity. or feet; You may need urgent medical Medicines - • slow heart beat; attention. Cholesterol-lowering medicines are • hot flush; used together with lifestyle changes • shortness of breath; Go to hospital if... to help lower cholesterol. • unusual tiredness or weakness; If any of the following happen, tell • generally feeling unwell; your doctor immediately or go to • elevation in some laboratory Accident and Emergency at your Side effects blood tests of liver or muscle nearest hospital: function; • swelling of the face, lips, mouth, Tell your doctor or pharmacist as • weight gain; throat or tongue which may cause soon as possible if you do not feel • acne; difficulty in swallowing or well while you are taking breathing. • pain in arms and legs; Ezetimibe/Atorvastatin GH. These may be serious side effects. • swelling; Ezetimibe/Atorvastatin GH helps If you have them, you may have most people with high cholesterol • poor memory; had a serious allergic reaction to levels or triglyceride levels, but it • confusion; Atozet. You may need urgent may have unwanted side effects in a • hearing loss; medical attention or few people. All medicines can have • visual disturbance; hospitalisation. These side effects are very rare. side effects. Sometimes they are • sexual difficulties; serious, most of the time they are not. • diabetes (this is more likely if you • chest pain You may need medical attention if have high levels of sugars and • unexpected muscle pain, you get some of the side effects. fats in your blood, are overweight tenderness, or weakness not caused by exercise and

EZETIMIBE/ATORVASTATIN GH Published by MIMS February 2020 4

particularly, if at the same time, leave it on a window sill or in the you feel unwell or have a high car. Ingredients temperature while taking or after Heat and dampness can destroy some your doctor has advised you to medicines. Active ingredients: stop taking Keep it where children cannot Ezetimibe/Atorvastatin GH 10/10 mg Ezetimibe/Atorvastatin GH. reach it. – Ezetimibe 10 mg / Atorvastatin (as This may be a serious side effect. A locked cupboard at least one-and- calcium trihydrate) 10 mg per tablet. This is because on rare occasions, a-half metres above the ground is a muscle problems can be serious Ezetimibe/Atorvastatin GH 10/20 mg good place to store medicines. including muscle breakdown – Ezetimibe 10 mg / Atorvastatin (as calcium trihydrate) 20 mg per tablet. resulting in kidney damage. You Disposal may need urgent medical Ezetimibe/Atorvastatin GH 10/14 mg attention. If your doctor tells you to stop – Ezetimibe 10 mg / Atorvastatin (as • sudden severe headache, which taking Ezetimibe/Atorvastatin GH calcium trihydrate) 40 mg per tablet. or the expiry date has passed, ask may be accompanied by nausea, Ezetimibe/Atorvastatin GH 10/10 mg your pharmacist what to do with vomiting, loss of sensation, – Ezetimibe 10 mg / Atorvastatin (as any medicine that is left over. tingling in any part of ringing in calcium trihydrate) 80 mg per tablet. the ears. Inactive ingredients: • serious illness with severe peeling and swelling of the skin, severe • Povidone; blisters and bleeding of the lips, Product description • Sodium lauryl sulfate; eyes, mouth, nose or genitals and • Lactose monohydrate; What it looks like skin rash with pink-red blotches • Crospovidone, especially on the palms of hands Ezetimibe/Atorvastatin GH comes in • Colloidal anhydrous silica; or soles of feet, which may four different strengths: • Sodium stearylfumarate; blister. • Ezetimibe/Atorvastatin GH 10/10 • Microcrystalline cellulose; The above list includes very serious mg; side effects. You may need urgent • Lactose; • Ezetimibe/Atorvastatin GH 10/20 medical attention or hospitalisation. • Calcium carbonate; mg; Tell your doctor or pharmacist if • Hyprolose; • Ezetimibe/Atorvastatin GH 10/40 you notice anything that is making • Opadry White AMB complete you feel unwell. mg; film coating system OY-B-28920 • Ezetimibe/Atorvastatin GH 10/80 Other side effects not listed above White (4271) mg; may also occur in some people. The film coating contains: Ezetimibe/Atorvastatin GH 10/10 mg • Polyvinyl alcohol; If you are prescribed is a white to off-white capsule- Ezetimibe/Atorvastatin GH your shaped, biconvex, film-coated tablet • Titanium dioxide; healthcare professional may want to debossed with ‘AE’ on one side and • Talc; conduct routine blood tests to check ‘1’ on the other. • Lecithin; your liver function before and after • Xanthan gum. starting treatment. Ezetimibe/Atorvastatin GH 10/20 mg is a white to off-white, capsule- shaped, biconvex, film-coated tablet Australian Registration debossed with ‘AE; on one side and Numbers After taking ‘2’ on the other side. Ezetimibe/Atorvastatin GH 10/10 Ezetimibe/Atorvastatin Ezetimibe/Atorvastatin GH 10/40 mg mg: AUST R 306961 GH is a white to off-white, capsule- Ezetimibe/Atorvastatin GH 10/20 shaped, biconvex, film-coated tablet mg: AUST R 306957 Storage debossed with ‘AE’ on one side and ‘3’ on the other. Ezetimibe/Atorvastatin GH 10/40 Keep your tablets in a cool dry mg: AUST R 306955 Ezetimibe/Atorvastatin GH 10/80 mg place where the temperature stays Ezetimibe/Atorvastatin GH 10/80 below 25°C. is a white to off-white, capsule- shaped, biconvex, film-coated tablet mg: AUST R 306965 Do not store Ezetimibe/Atorvastatin debossed with ‘AE” on one side and GH or any other medicine in the on the other. bathroom or near a sink. Do not

EZETIMIBE/ATORVASTATIN GH Published by MIMS February 2020 5

Supplier Generic Health Pty Ltd Suite 2, Level 2 19-23 Prospect Street Box Hill, VIC, 3128 Email: [email protected] Telephone: +61 3 9809 7900 Website: www.generichealth.com.au This leaflet was prepared in November 2019.

EZETIMIBE/ATORVASTATIN GH Published by MIMS February 2020 6