Metoprolol Sandoz® tartrate tablets Consumer Medicine Information WHAT IS IN THIS LEAFLET • asthma, difficulty breathing or other your baby, especially if you take it in the last lung problems, or have had them in the few days before your baby is born. Your This leaflet answers some common questions past doctor can discuss with you the risks and about Metoprolol Sandoz. • a history of allergic problems, e.g. hay benefits involved. It does not contain all the available fever Tell your doctor if you are breast-feeding information. It does not take the place of • low blood pressure or intend to breast-feed. talking to your doctor or pharmacist. • a very slow heart beat (less than 45-50 The active ingredient in Metoprolol Sandoz All medicines have risks and benefits. Your beats/minute) passes into breast milk and there is a doctor has weighed the risk of you taking possibility that your baby could be affected. this medicine against the benefits they expect • sudden and oppressive chest pain, sign of heart attack If you have not told your doctor about any it will have for you. of the above, tell him/her before you start If you have any concerns about taking this • irregular heart beat taking Metoprolol Sandoz. medicine, ask your doctor or pharmacist. • , heart disorders or other Taking other medicines heart conditions Keep this leaflet with the medicine. Tell your doctor if you are taking any • a severe blood vessel disorder causing You may need to read it again. other medicines, including any that you poor circulation in the arms and legs get without a prescription from your WHAT METOPROLOL SANDOZ IS • severe drop in blood pressure, dizziness, pharmacy, supermarket or health food USED FOR fast heart beat, rapid and shallow shop. breathing, cold clammy skin This medicine is used to treat: Some medicines and Metoprolol Sandoz may • sudden loss of consciousness sometimes • high blood pressure (hypertension). interfere with each other. These include: • phaeochromocytoma (a rare tumour of • heart attack (). • other beta-blocker medicines, including the adrenal gland) which is not already beta-blocker eye drops • prevent severe chest pain (angina being treated with other medicines pectoris). • calcium channel blockers or calcium • swollen ankles and/or tiredness due to antagonists, used to treat high blood • migraine. heart disease or certain other heart pressure and angina, for example It contains the active ingredient metoprolol conditions. verapamil, diltiazem and nifedipine tartrate. • poor blood circulation in your limbs (for • some medicines used to treat angina Metoprolol Sandoz belongs to a group of example, very cold, pale hands or feet, • adrenaline or similar substances, which medicines called beta-blockers. or pain in your leg muscles when you are often found in eye or nose drops, or walk) It works by affecting the body's response to in cough and cold medicines some nerve impulses, especially in the heart. • an operation where an anaesthetic is • certain medicines used to treat abnormal As a result, it decreases the heart's need for used during treatment or irregular heart beat, for example blood and oxygen and therefore reduces the • respiratory diseases such as asthma disopyramide and quinidine amount of work the heart has to do. It also • oculomucocutaneous syndrome (signs widens the blood vessels in the body, causing • clonidine, used to treat high blood include severe conjunctivitis and skin pressure blood pressure to fall. rash and ear infection). • insulin and tablets used to treat Ask your doctor if you have any questions Do not take this medicine after the expiry • quanethidine, a medicine used to treat about why this medicine has been date printed on the pack or if the certain heart conditions prescribed for you. packaging is torn or shows signs of Your doctor may have prescribed it for tampering. • monoamine-oxidase inhibitors (MAOIs), another reason. If it has expired or is damaged, return it to used to treat depression There is no evidence that Metoprolol Sandoz your pharmacist for disposal. • cimetidine, used to treat stomach ulcers is addictive. Do not give Metoprolol Sandoz to or reflux This medicine is available only with a children. • certain medicines, including non- doctor's prescription. The safety and effectiveness of Metoprolol steroidal anti-inflammatory drugs such There is not enough information to Sandoz has not been established. as COX-2 inhibitors, used to relieve recommend the use of this medicine for If you are not sure whether you should pain, swelling and other symptoms of children. start taking this medicine, talk to your inflammation and arthritis doctor. • warfarin, a medicine used to prevent BEFORE YOU TAKE Before you start to take it blood clots METOPROLOL SANDOZ • Tell your doctor if you have allergies to certain anaesthetics used during surgery When you must not take it any other medicines, foods, preservatives • rifampicin, used to treat tuberculosis Do not take this medicine if you have an or dyes. • ritonavir, an antiviral medicine allergy to: Your doctor will want to know if you are • diphenhydramine, an antihistamine prone to allergies. Beta-blocker medicines • metoprolol tartrate, the active ingredient, • terbinafine, used to treat fungal can make allergic reaction worse. or to any of the other ingredients listed infections at the end of this leaflet under Product Tell your doctor if you have or have had • SSRIs such as paroxetine, fluoxetine, Description any of the following medical conditions: bupropion and sertraline • • any other similar medicines such as any other heart problems • ergot alkaloids, a class of medicines other 'beta-blockers'. • chest pain when you are at rest, or used in the prevention and treatment of Some of the symptoms of an allergic reaction certain types of angina, such as migraine headaches may include: Prinzmetal angina or variant angina • dipyridamole, a medicine use to reduce • shortness of breath • diabetes the risk of blot clots • wheezing or difficulty breathing • kidney or liver problems • other medicines that may cause a • swelling of the face, lips, tongue or other • an overactive thyroid gland decrease in heart rate (e.g. fingolimod, a parts of the body Tell your doctor if you are pregnant or medicine used to treat multiple sclerosis) • rash, itching or hives on the skin. plan to become pregnant. • other medicines that may cause a Metoprolol Sandoz should not be used decrease in blood pressure (e.g. Do not take this medicine if you have or throughout pregnancy, especially during the aldesleukin, a medicine used to treat have had any of the following medical first 3 months of pregnancy, unless clearly kidney cancer). conditions: necessary. Metoprolol Sandoz may affect

Metoprolol Sandoz® Published by MIMS August 2020 1 These medicines may be affected by If you are not sure what to do, ask your If you become pregnant while taking this Metoprolol Sandoz, or may affect how well doctor or pharmacist. medicine, tell your doctor immediately. it works. You may need different amounts of If you have trouble remembering to take your If you are about to have any blood tests, your medicines, or you may need to take medicine, ask your pharmacist for some tell your doctor that you are taking this different medicines. hints. medicine. Your doctor and pharmacist have more If you take too much (overdose) It may interfere with the results of some information on medicines to be careful with tests. Immediately telephone your doctor or the or avoid while taking this medicine. Poisons Information Centre (telephone Things you must not do Australia 13 11 26 or New Zealand 0800 Do not take Metoprolol Sandoz to treat HOW TO TAKE METOPROLOL POISON or 0800 764 766) for advice, or any other complaints unless your doctor SANDOZ go to Accident and Emergency at your tells you to. Follow all directions given to you by your nearest hospital, if you think you or Do not give your medicine to anyone else, doctor or pharmacist carefully. anyone else may have taken too much even if they have the same condition as They may differ from the information Metoprolol Sandoz. you. contained in this leaflet. Do this even if there are no signs of Do not stop taking your medicine or lower If you do not understand the instructions, discomfort or poisoning. the dosage without checking with your ask your doctor or pharmacist for help. You may need urgent medical attention. doctor. How much to take Symptoms of an overdose may include Do not stop taking this medicine suddenly. feeling sick and vomiting, bluish skin and Hypertension (high blood pressure) By stopping suddenly, your angina may nails, very low blood pressure, slow heart The usual dosage is 50 mg to 100 mg either worsen or other heart complications may beat, difficulty breathing, fainting, once or twice daily. Your doctor may start occur. Your doctor may want you to convulsions (fits) or coma. you on a low dose and increase it over a gradually reduce the amount of Metoprolol period of time. Sandoz you are taking before stopping WHILE YOU ARE TAKING completely. Angina pectoris (chest pain) The usual dosage is 50 mg to 100 mg two to METOPROLOL SANDOZ Things to be careful of three times daily. Things you must do Be careful driving or operating machinery Myocardial infarction (heart attack) • If you are being treated for diabetes, until you know how Metoprolol Sandoz Your doctor may start you on 50 mg twice make sure you check your blood sugar affects you. daily for two days and then continue with level regularly and report any changes to This medicine may cause dizziness, 100 mg twice daily. your doctor. Metoprolol Sandoz may headaches, and tiredness in some people. If Migraine change how well your diabetes is you have any of these symptoms, do not The usual dose is 100 mg to 150 mg each controlled. It may also cover up some of drive, operate machinery or do anything else day, divided into two doses (morning and the symptoms of low blood sugar that could be dangerous. evening) (hypoglycaemia). Metoprolol Sandoz Be careful when drinking alcohol while The daily dosage should not exceed 400 mg. may increase the time your body takes to you are taking this medicine. recover from low blood sugar. Your If you drink alcohol, dizziness or light Ask your doctor or pharmacist if you are doses of diabetic medicine, including headedness may be worse. unsure of the correct dose for you. insulin, may need to change. They will tell you exactly how much to take. Dress warmly during the cold weather. • Tell your doctor immediately if you You may feel colder, especially if you will Follow the instructions they give you. develop a severe allergic reaction to any be outside for a long time (for example when If you take the wrong dose, Metoprolol food, medicine or insect sting while playing winter sports). Metoprolol Sandoz, Sandoz may not work as well and your taking Metoprolol Sandoz. like other beta-blocker medicines, may make problem may not improve. • Make sure that you drink enough water you more sensitive to cold temperatures, How to take it during exercise and hot weather when especially if you have circulation problems. Swallow the tablet with a glass of fluid. you are taking Metoprolol Sandoz, When to take Metoprolol Sandoz especially if you sweat a lot. If you do SIDE EFFECTS Take your medicine at about the same not drink enough water while taking Tell your doctor or pharmacist as soon as time each day before or after food. Metoprolol Sandoz, you may feel faint possible if you do not feel well while you Taking it at the same time each day will have or light-headed or sick. This is because are taking Metoprolol Sandoz. your blood pressure is dropping the best effect. It will also help you All medicines can have side effects. suddenly. If you continue to feel unwell, remember when to take it. Sometimes they are serious, most of the time tell your doctor. If you need to break Metoprolol Sandoz, they are not. You may need urgent medical place it on a hard surface (e.g. table or • If you feel light-headed, get up slowly attention if you get some side effects. when getting out of bed or standing up. benchtop), and snap it along the break line Do not be alarmed by this list of possible You may feel light-headed or dizzy with two fingers. side effects. You may not experience any because your blood pressure is falling of them. How long to take Metoprolol Sandoz suddenly. Standing up slowly, especially Continue taking your medicine for as long when you get up from bed or chairs, will Ask your doctor or pharmacist to answer as your doctor tells you. help your body get used to the change in any questions you may have. This medicine helps to control your position and blood pressure. Tell your doctor if you notice any of the condition, but does not cure it. It is important • Elderly patients especially need to be following and they worry you: to keep taking your medicine even if you feel monitored to stop their blood pressure • tiredness, drowsiness, headache, well. falling too far. weakness, or lack of energy If you forget to take it If you are about to be started on any new • aches and pains, painful joints Take your dose as soon as you remember, medicine, remind your doctor and • nausea, vomiting and continue to take it as you would pharmacist that you are taking Metoprolol • muscle cramps and weakness normally. Sandoz. • stomach upset, diarrhoea or constipation, If it is almost time for your next dose, skip Tell any other doctors, dentists, and weight gain the dose you missed and take your next dose pharmacists who treat you that you are • dry mouth, changes in taste sensation when you are meant to. taking this medicine. • difficulty sleeping, nightmares Do not take a double dose to make up for If you are going to have surgery, tell the the dose you missed. surgeon or anaesthetist that you are • depression or mood changes This may increase the chance of you getting taking this medicine. • confusion, short-term memory loss, an unwanted side effect. It may affect other medicines used during inability to concentrate surgery.

Metoprolol Sandoz® Published by MIMS August 2020 2 • increased sweating, runny or blocked AFTER TAKING METOPROLOL nose SANDOZ • numbness, tingling in the extremities • hair loss. Storage These are mild side effects of the medicine. Keep Metoprolol Sandoz in the original container. Tell your doctor immediately if you notice any of the following: If you take it out of its original container it may not keep well. • dizziness, light headedness (sometimes with fainting) especially on standing up, Keep your medicine in a cool dry place where the temperature stays below 25°C and which may be due to low blood pressure away from direct sunlight. • skin reactions (e.g. rash, itching, worsening of psoriasis) Do not store Metoprolol Sandoz or any other medicine in the bathroom or near a sink. Do • irritated eyes (red, runny, itchy or dry), not leave it on a window sill or in the car. visual disturbances (e.g. blurred vision) Heat and dampness can destroy some • numbness in the arms and legs medicines. • buzzing and ringing in the ears, Keep it where children cannot reach it. difficulty hearing A locked cupboard at least one-and-a-half • tingling or "pins and needles" metres above the ground is a good place to • sunburn happening more quickly than store medicines. usual Disposal • abnormal thinking or hallucinations If your doctor tells you to stop taking this • constant "flu-like" symptoms with medicine or the expiry date has passed, ask tiredness or lack of energy your pharmacist what to do with any • sexual problems medicine that is left over. • breathlessness, difficulty breathing when lying down. PRODUCT DESCRIPTION • abnormal triglycerides or What it looks like values, or liver function tests Metoprolol Sandoz 50 mg: white, round • sleepiness during the day or troubled tablets, scored on one side. Available in sleep blisters of 100 tablets. • coldness, burning, numbness or pain in Metoprolol Sandoz 100 mg: white, round arms and legs tablets, scored on one side. Available in • pain behind the breastbone (different blisters of 60 tablets. from angina) Ingredients • constant "flu-like" symptoms (chills, Active ingredients: fever, sore throat, aching joints, swollen • Metoprolol Sandoz 50 mg - 50 mg glands, tiredness or lack of energy) metoprolol tartrate • increased sweating • Metoprolol Sandoz 100 mg - 100 mg • hair thinning metoprolol tartrate • confusion or loss of memory Inactive ingredients: • unusual bleeding or bruising • lactose The above list includes serious side effects • maize starch that may require medical attention. Serious • microcrystalline cellulose side effects are rare. • magnesium stearate If any of the following happen, stop taking • colloidal anhydrous silica Metoprolol Sandoz, and tell your doctor immediately, or go to Accident and • hydroxypropylcellulose Emergency at your nearest hospital: • calcium hydrogen phosphate • swelling of the face, lips, mouth or • crospovidone. throat, which may cause difficulty in Contains sugar as lactose. swallowing or breathing Supplier • shortness of breath, sometimes with Sandoz Pty Ltd tiredness and reduced ability to exercise, ABN 60 075 449 553 and swelling of the feet or legs due to 54 Waterloo Road fluid build up Macquarie Park, NSW 2113 • chest pain, chest tightness, changes in Australia heart rate or palpitations Tel: 1800 726 369 • yellowing of the skin or eyes (jaundice), Novartis New Zealand Ltd generally feeling unwell. PO Box 99102 The above list includes very serious side Newmarket effects. You may need urgent medical Auckland 1149 attention or hospitalisation. All of these side New Zealand effects are very rare. Tel: 0800 354 335 Tell your doctor or pharmacist if you This leaflet was revised in June 2020. notice anything else that is making you Australian Register Numbers feel unwell. 50 mg tablets: AUST R 62560 Other side effects not listed above may also occur in some people. 100 mg tablets: AUST R 62561

Metoprolol Sandoz® Published by MIMS August 2020 3