BETALOC® TABLETS tartrate

Consumer Medicine Information

What is in this leaflet the heart has to do. It also widens the hives on the skin or you may feel blood vessels in the body, as well as faint. This leaflet answers some of the helping the heart to beat more • you have asthma, wheezing, common questions people ask about regularly. difficulty breathing or other BETALOC tablets. It does not Your doctor will have explained why lung problems, or have had contain all the information that is you are being treated with them in the past known about BETALOC. BETALOC and told you what dose • you have a history of allergic It does not take the place of talking to to take. problems, including hayfever your doctor or pharmacist. BETALOC may be used either alone • you have low blood pressure All medicines have risks and or in combination with other medicines to treat your condition. • you have a very slow heartbeat benefits. Your doctor will have (less than 45-50 beats/minute) weighed the risks of you taking Ask your doctor if you have any BETALOC against the benefits they questions about why BETALOC • you have certain other heart expect it will have for you. has been prescribed for you. conditions If you have any concerns about Your doctor may have prescribed this • you have phaeochromocytoma taking this medicine, ask your medicine for another reason. (a rare tumour of the adrenal doctor or pharmacist. gland) which is not being Follow all directions given to you treated already with other Keep this leaflet with the medicine. by your doctor carefully. medicines You may need to read it again. They may differ from the • you have a severe blood vessel information contained in this leaflet. disorder causing poor BETALOC is not addictive circulation in the arms and legs • you are receiving/having What BETALOC is emergency treatment for shock used for or severely low blood pressure. Before you take If you are not sure whether any of BETALOC belongs to a group of BETALOC medicines called beta-blockers. these apply to you, check with your doctor. BETALOC tablets are used to: When you must not take it Do not use BETALOC if the expiry • lower high blood pressure, also Do not take BETALOC tablets if: date (EXP) printed on the pack has called hypertension • You have any allergies to passed or if the packaging is torn • prevent angina metoprolol tartrate, the active or shows signs of tampering. • treat or prevent heart attacks, or ingredient in BETALOC If it has expired or is damaged, return reduce your risk of heart tablets, or any of the it to your pharmacist for disposal. complications following a heart ingredients listed at the end of Do not give BETALOC to children. attack this leaflet, or any other beta- The safety and effectiveness of • prevent migraine headaches. blocker medicine. BETALOC in children has not been It works by affecting the body's Some of the symptoms of an established. response to some nerve impulses, allergic reaction may include If you are not sure whether you especially in the heart. shortness of breath, wheezing or difficulty breathing; swelling of should start taking this medicine, As a result, it decreases the heart's the face, lips, tongue or other talk to your doctor. need for blood and oxygen and parts of the body; rash, itching or therefore reduces the amount of work

BETALOC® TABLETS - DOC ID-003734142 V1.0 1 Before you start to take it Some medicines and BETALOC may How to take BETALOC interfere with each other. These You must tell your doctor if you include: have any allergies to: Follow all directions given to you • other beta-blocker medicines, by your doctor or pharmacist • metoprolol tartrate or any of the including beta-blocker eye drops. carefully. ingredients listed at the end of this leaflet. • calcium channel blockers or They may differ from the calcium antagonists, medicines information contained in this leaflet. • any other medicine, including used to treat high blood pressure other beta-blocker medicines If you do not understand the and angina, for example instructions on the pack, ask your • any other substances, such as verapamil and diltiazem doctor or pharmacist for help. foods, preservatives or dyes. • medicines used to treat high Tell your doctor if you have, or blood pressure, for example How much to take have had, any medical conditions, clonidine, , and For high blood pressure: especially the following: prazosin The usual starting dose is one 50mg • asthma, wheezing, difficulty • medicines used to treat abnormal or 100mg tablet once a day for one breathing or other lung problems or irregular heartbeat, for week. • example amiodarone, disopyramide and quinidine The dose is then usually increased to • an overactive thyroid gland 50mg or 100mg once or twice daily. • medicines used to treat arthritis, • liver problems pain, or inflammation, for Your doctor may tell you to take a • kidney problems example indomethacin and different amount of BETALOC. • certain types of angina ibuprofen Follow your doctor's instructions • any other heart problems • warfarin, a medicine used to carefully. • phaeochromocytoma, a rare prevent blood clots If you are taking other prescription tumour of the adrenal gland • digoxin, a medicine used to treat medicines which lower blood pressure, your doctor may need to • any blood vessel disorder causing change the dose of them to obtain the poor circulation in the arms and • medicines used to treat diabetes best results for you. legs. • cimetidine, a medicine used to For angina pectoris: Tell your doctor if you are treat stomach ulcers The usual dose is 50mg or 100mg pregnant or intend to become • medicines used to treat bacterial taken two or three times a day. pregnant. infections, for example rifampicin After (heart Like most beta-blocker medicines, • medicines used to treat attack): BETALOC is not recommended for depression use during pregnancy. The usual dose is 100mg taken twice • monoamine-oxidase inhibitors a day, often starting with a lower Tell your doctor if you are breast- (MAOIs). feeding or plan to breast-feed. dose for 2 days. These medicines may be affected by For migraine prevention: The active ingredient in BETALOC BETALOC or may affect how well it passes into breast milk and therefore works. You may need to take The usual dose is 100-150 mg a day, there is a possibility that the breast- different amounts of your medicine, taken in divided doses morning and fed baby may be affected. or you may need to take different evening. If you have not told your doctor medicines. Your doctor will advise Ask your doctor or pharmacist if about any of these things, tell them you. you are unsure of the correct dose before you take BETALOC. Your doctor and pharmacist have for you. more information on medicines to be They will tell you exactly how much Taking other medicines careful with or avoid while taking to take. Tell your doctor or pharmacist if BETALOC. you are taking any other If you have not told your doctor How to take it medicines, including any that you about any of these things, tell them Swallow the tablet with a glass of get without a prescription from before you take any BETALOC. fluid. your pharmacy, supermarket or health food shop.

BETALOC® TABLETS - DOC ID-003734142 V1.0 2 When to take BETALOC poisoning. You may need urgent feel faint or light headed or sick. This medical attention. is because your blood pressure is Take your medicine at about the dropping too much. If you continue same time each day before or after If you take too many BETALOC to feel unwell, tell your doctor. food. tablets your blood pressure may drop too far. You will feel faint or faint, If you are being treated for Taking it at the same time each day and your heart rate will also slow diabetes, make sure you check will have the best effect. It will also down. You may also have nausea, your blood sugar level regularly help you remember when to take it. vomiting, and convulsions. In and report any changes to your extreme cases, serious heart and lung doctor. How long to take BETALOC problems may occur. BETALOC may change how well Continue taking your medicine for as your diabetes is controlled. It may long as your doctor tells you. This also cover up some of the symptoms medicine helps to control your of low blood sugar (hypoglycaemia). condition, but does not cure it. While you are using BETALOC may increase the time It is important to keep taking your BETALOC your body takes to recover from low medicine even if you feel well. blood sugar. Your doses of diabetic DO NOT STOP TAKING Things you must do medicines, including insulin, may need to change. BETALOC TABLETS Be sure to keep all of your doctor's SUDDENLY. appointments so that your progress If you are about to be started on The dose needs to be reduced slowly can be checked. any new medicine, remind your doctor and pharmacist that you over 7 to 14 days to make sure that Elderly patients especially need to be are taking BETALOC. your condition does not get worse. monitored to stop their blood Your doctor will tell you how to pressure falling too far. Tell any doctors, dentists, and gradually reduce the dose before pharmacists who are treating you If you become pregnant while stopping completely. that you are taking BETALOC. taking BETALOC, tell your doctor immediately. If you plan to have surgery (even If you forget to take it at the dentist) that needs an If you have a severe allergic If it is almost time for your next anaesthetic, tell your doctor or reaction to foods, medicines or dose, skip the dose you missed and dentist that you are taking insect stings, tell your doctor take your next dose when you are BETALOC. immediately. meant to. If you have to have any medical If you have a history of allergies, Otherwise, take it as soon as you tests while you are taking there is a chance that BETALOC remember, and then go back to BETALOC, tell your doctor. may cause allergic reactions to be taking your tablets as you would worse and harder to treat. BETALOC may affect the results of normally. some tests. If you feel light-headed, dizzy or Do not take a double dose to make faint when getting out of bed or up for the dose that you missed. Things you must not do standing up, get up slowly. If you are not sure what to do, ask Do not stop taking BETALOC You may feel light-headed or dizzy your doctor or pharmacist. without checking with your doctor. when you begin to take BETALOC. If you have trouble remembering This is because your blood pressure Your doctor may want you to when to take your medicine, ask your has fallen suddenly. gradually reduce the amount of pharmacist for some hints. BETALOC you are taking before Standing up slowly, especially when stopping completely. This may help you get up from bed or chairs, will Overdose reduce the possibility of your help your body get used to the condition getting worse. Telephone your doctor, the Poisons change in position and blood Information Centre (13 11 26) or pressure. If this problem gets worse Do not give BETALOC to anyone go to Accident and Emergency at or continues, talk to your doctor. else even if they have the same condition as you. your nearest hospital immediately Make sure you drink enough water if you think that you or anyone else during exercise and hot weather Do not use BETALOC to treat any may have taken too much when you are taking BETALOC, other complaints unless your BETALOC. Do this even if there especially if you sweat a lot. doctor tells you to. are no signs of discomfort or If you do not drink enough water while taking BETALOC, you may

BETALOC® TABLETS - DOC ID-003734142 V1.0 3 Things to be careful of • stomach upset, diarrhoea or • swelling of the face, lips, tongue constipation, weight gain or throat which may cause Be careful driving or operating difficulty swallowing or breathing machinery until you know how • dry mouth, changes in taste BETALOC affects you. sensation • yellowing of the skin or eyes (jaundice), generally feeling As with other beta-blocker • difficulty sleeping, nightmares unwell. medicines, BETALOC may cause • mood changes dizziness, light-headedness, These are very serious side effects. • confusion, short-term memory You may need urgent medical tiredness, or drowsiness in some loss, inability to concentrate people. Make sure you know how attention or hospitalisation. These you react to BETALOC before you • increased sweating, runny or side effects are rare. blocked nose drive a car, operate machinery, or do Other side effects not listed here anything else that could be dangerous • hair loss may occur in some patients. Tell if you are dizzy or light-headed. These side effects are usually mild. your doctor or pharmacist if you notice anything that is making you Be careful drinking alcohol while Tell your doctor immediately if feel unwell. you are taking BETALOC. you notice any of the following: Do not be alarmed by this list of If you drink alcohol, dizziness or • dizziness, lightheadedness or possible side effects. light-headedness may be worse. fainting especially on standing Dress warmly during cold weather, up, which may be due to low You may not experience any of them. especially if you will be outside for blood pressure. a long time (for example when • tingling or "pins and needles" playing winter sports). • coldness, burning, numbness or After using it BETALOC, like other beta-blocker pain in the arms and/or legs medicines, may make you more sensitive to cold temperatures, • skin rash or worsening of Storage psoriasis especially if you have circulation Keep your tablets in the blister • sunburn happening more quickly problems. pack until it is time to take them. than usual If you take BETALOC out of the • abnormal thinking or blister pack it will not keep well. hallucinations Keep the tablets in a cool dry place Side effects • buzzing or ringing in the ears, where the temperature stays below deafness Tell your doctor or pharmacist as 30°C. • irritated eyes or blurred vision soon as possible if you do not feel Do not store it or any other well while you are taking • sexual problems medicine in the bathroom or near a BETALOC. • constant "flu-like" symptoms sink. Do not leave it in the car or All medicines can have side effects. with tiredness or lack of energy on a window sill. Sometimes they are serious, most of • unusual bleeding or bruising. Heat and dampness can destroy some the time they are not. You may need medicines. medical treatment if you get some of These are serious side effects. You Keep it where young children the side effects. may need urgent medical attention. Serious side effects are rare. cannot reach it. If you are over 65 years of age you A locked cupboard at least one-and- may have an increased chance of If any of the following happen, tell a-half metres above the ground is a getting side effects. your doctor immediately or go to Accident and Emergency at your good place to store medicines. Ask your doctor to answer any nearest hospital: questions you may have. • shortness of breath, being less Tell your doctor if you notice any able to exercise of the following and they worry Disposal you: • swelling of the ankles, feet or legs • headache, tiredness, drowsiness, • chest tightness, wheezing, noisy If your doctor tells you to stop weakness, or lack of energy breathing, difficulty breathing taking them, or you find that the expiry date has passed, ask your • aches and pains, painful joints • chest pain, changes in heart rate or palpitations pharmacist what to do with any • nausea (feeling sick), vomiting tablets you have left over.

BETALOC® TABLETS - DOC ID-003734142 V1.0 4 Product description This leaflet was prepared in November 2017. What BETALOC looks like BETALOC® is a trade mark of the BETALOC 50 mg tablets are white AstraZeneca group of companies. to off-white, circular with a diameter of 8 mm, scored and marked A/BB on one side. The score line is only © AstraZeneca 2017 there to help you break the tablet if you have difficulty swallowing it whole. BETALOC 100 mg tablets are white to off-white, circular with a diameter of 10 mm, scored and marked A/ME on one side. The tablet can be divided into equal halves by breaking along the score line.

Ingredients Each BETALOC tablet contains: Metoprolol tartrate 50mg or 100mg as the active ingredient, plus • Lactose monohydrate • Microcrystalline cellulose • Colloidal anhydrous silica • Sodium starch glycollate • Povidone • Magnesium stearate (E 572)

Sponsor

AstraZeneca Pty Ltd ABN 54 009 682 311 66 Talavera Road MACQUARIE PARK NSW 2113

Telephone: 1800 805 342

Australian Registration Number Betaloc 50mg - Aust R 12065 Blister pack of 100 tablets

Betaloc 100mg - Aust R 12384 Blister pack of 60 tablets

BETALOC® TABLETS - DOC ID-003734142 V1.0 5