NEW ZEALAND CONSUMER MEDICINE INFORMATION BISOPROLOL MYLAN Bisoprolol fumarate Film Coated Tablets 2.5, 5 & 10 mg

These medicines work by affecting caused by very low blood What is in this leaflet the body’s response to some nerve pressure) impulses, especially in the heart. As  irregular or abnormal Please read this leaflet carefully a result, bisoprolol slows down the heartbeat before you start taking heart rate and makes the heart  slow heart rate (less than BISOPROLOL MYLAN. more efficient at pumping blood 60 beats/min before the around the body. start of therapy) This leaflet answers some common  low blood pressure (systolic questions about BISOPROLOL Your doctor may have prescribed blood pressure less than MYLAN. this medicine for another reason. 100 mg Hg)

It does not contain all the available Ask your doctor if you have any Do not take BISOPROLOL information. It does not take the questions about why this MYLAN if you have: place of talking to your doctor or medicine has been prescribed for you.  severe asthma or severe pharmacist. chronic lung disease  severe blood circulation All medicines have risks and This medicine is available only with a doctor’s prescription. problems (such as benefits. Your doctor has weighed Raynaud’s syndrome, a the risks of you taking condition that may cause BISOPROLOL MYLAN against the your fingers and toes to benefits they expect it will have for Before you take tingle or turn pale or blue) you. BISOPROLOL  untreated phaeochromocytoma (a If you have any concerns about MYLAN rare tumour of the adrenal taking this medicine, ask your gland, which sits near the doctor or pharmacist. When you must not take kidney)  metabolic acidosis (too Keep this leaflet with the it much acid in the blood, medicine. You may need to read it Do not take BISOPROLOL which may cause rapid again. MYLAN if you have an allergy to: and/or shallow breathing)  any medicine containing Do not give this medicine to a bisoprolol fumarate What BISOPROLOL child.  any of the ingredients listed Safety and effectiveness in children MYLAN is used for at the end of this leaflet. have not been established. BISOPROLOL MYLAN is used: Some of the symptoms of an Do not take this medicine after allergic reaction may include: the expiry date printed on the  to treat stable chronic heart shortness of breath; wheezing pack or if the packaging is torn or failure (CHF) in combination or difficulty breathing; swelling shows signs of tampering. with other medicines of the face, lips, tongue or other If it has expired or is damaged, suitable for this condition. parts of the body; rash, itching return it to your pharmacist for  In treatment of coronary or hives on the skin. disposal. heart disease and chest pain (angina pectoris) Do not take BISOPROLOL If you are not sure whether you caused by shortage of MYLAN if you have one of the should start taking this medicine, oxygen in the heart muscle following heart problems: talk to your doctor.  to treat essential  acute heart failure hypertension (high blood  worsening heart failure pressure) Before you start to take requiring injection of medicines into a vein, that it BISOPROLOL MYLAN contains the adjusts the force of active ingredient bisoprolol Tell your doctor if you have contraction of the heart. fumarate. It belongs to a group of allergies to any other medicines, cardiogenic shock (a medicines called beta blockers.  foods, preservatives or dyes. serious heart condition

Page 1 of 5 Tell your doctor if you have or Taking other medicines cardiac arrest. and severe have had any of the following asthma attacks medical conditions: Tell your doctor or pharmacist if  any medicine, which can  asthma you are taking any other lower blood pressure as a  difficulty in breathing medicines, including medicines desired or undesired effect  wheezing or coughing that you buy without a such as medicines to treat  diabetes mellitus prescription from your pharmacy, high blood pressure and supermarket or health food shop.  strict fasting certain medicines for  prinzmetal’s angina (can depression (tricyclic cause pain or tightness in You should also tell any health antidepressants such as professional who is prescribing a the chest) imipramine or amitriptyline) new medication for you that you are  peripheral arterial occlusive  certain medicines used to taking BISOPROLOL MYLAN. disease (narrowing or treat epilepsy (such as blockage of an artery) phenytoin or barbiturates Some medicines may interfere with  psoriasis (skin disease with (such as phenobarbital) BISOPROLOL MYLAN. These thickened patches of red  certain medicines to treat include: skin, often with silvery mental illness characterized scales) by a loss of contact with  calcium antagonists used to  thyroid disorders reality (phenothiazines) treat high blood pressure,  allergies, bisoprolol may  moxisylate used to treat chest pain or irregular make it more likely that you Raynaud’s disease heartbeat such as experience an allergic  mefloquine used to treat verapamil, diltiazem, reaction, or such reaction malaria nifedipine, felodipine and may be more severe.  monoamineoxidase amlodipine  kidney or liver problems inhibitors (except MAO-B  medicines to treat changes inhibitors) such as in the rhythm or rate of the Tell your doctor if you are going moclobemide, used to treat heart beat such as to have: depression quinidine, disopyramide, flecainide, amiodarone and  desensitisation therapy (for These medicines may be affected propafenone by BISOPROLOL MYLAN or may example for the prevention  certain medicines used to of hay fever), because affect how well it works. You may treat high blood pressure need different amounts of your bisoprolol may make it such as clonidine, more likely that you medicines, or you may need to take methyldopa, moxonodine, different medicines. experience an allergic rilmenidine. However, do reaction, or not stop taking these such reaction may be more Your doctor and pharmacist have medicines without checking more information on medicines to severe. with your doctor first.  general anaesthesia be careful with or avoid while taking  locally applied beta- this medicine. blockers (e.g. eye drops for Tell your doctor if you are glaucoma treatment) pregnant or plan to become  parasympathomimetic How to take pregnant or are breast-feeding. medicines (such as Your doctor can discuss with you carbachol) BISOPROLOL the risks and benefits involved.  insulin or other medicines MYLAN used to treat diabetes. It may affect your developing baby if  anaesthetics including you take it during pregnancy. Follow all directions given to you lidocaine or barbiturates (for by your doctor or pharmacist example, during surgery) The active ingredient in carefully.  cardiac glycosides, used to BISOPROLOL MYLAN may pass They may differ from the information treat heart failure into breast milk and there is a contained in this leaflet.  NSAIDs (Non-steroidal anti- possibility that your baby may be inflammatory medicines) affected. If you do not understand the such as ibuprofen used to instructions on the box, ask your treat pain and inflammation Tell your doctor if you are lactose doctor or pharmacist for help. intolerant.  medicines that are used to This medicine contains lactose. treat acute heart problems such as isoprenaline and How much to take If you have not told your doctor dobutamine Treatment for stable chronic heart about any of the above, tell them  noradrenaline failure will normally be started at a before you start taking (norepinephrine) used to low dose and increased gradually. BISOPROLOL MYLAN. treat low blood pressure Your doctor will decide how to  adrenaline (epinephrine) increase the dose, and this may used to treat anaphylaxis,

Page 2 of 5 normally be done in the following It does not matter if you take this If you are about to have any way: medicine before or after food. blood tests, tell your doctor that you are taking this medicine.  1.25 mg once daily for 1 How long to take it It may interfere with the results of week, if well tolerated some tests. increase to Continue taking your medicine  2.5 mg once daily for a for as long as your doctor tells Keep all of your doctor’s further week, if well you. appointments so that your tolerated increase to This medicine helps to control your progress can be checked.  3.75 mg once daily for a condition, but does not cure it. It is further week, if well important to keep taking your tolerated increase to medicine even if you feel well. Things you must not do  5 mg once daily for the 4 following weeks, if well If you forget to take it Do not take BISOPROLOL tolerated increase to MYLAN to treat any other If it is almost time for your next  7.5 mg once daily for the 4 complaints unless your doctor dose, skip the dose you missed following weeks, if well tells you to. and take your next dose when tolerated increase to you are meant to.  10 mg once daily for the Do not give your medicine to maintenance therapy. anyone else, even if they have Otherwise, take it as soon as you the same condition as you. remember, and then go back to The maxim recommended dose is taking your medicine as you 10 mg once daily. Do not stop taking your medicine would normally. or lower the dosage without checking with your doctor. For patients with Hypertension Do not take a double dose to If you stop taking it suddenly, your and/or angina pectoris the usual make up for the dose that you condition may worsen or you may dose is 10 mg once daily with a missed. have unwanted side effects. maximum recommended dose of 20 This may increase the chance of mg per day. you getting an unwanted side effect. If possible, your doctor will gradually reduce the amount you take each If you are not sure what to do, Depending on how well you tolerate day before stopping the medicine ask your doctor or pharmacist. the medicine, your doctor may also decide to lengthen the time between Things to be careful of dose increases. If you have trouble remembering to take your medicine, ask your Be careful driving or operating pharmacist for some hints. machinery until you know how If your condition gets worse or you BISOPROLOL MYLAN affects no longer tolerate the drug, it may you. be necessary to reduce the dose While you are taking This medicine may cause dizziness, again or to interrupt treatment. light-headedness or tiredness in BISOPROLOL some people. If you have any of these symptoms, do not drive, In some patients a maintenance MYLAN operate machinery or do anything dose lower than 10 mg bisoprolol else that could be dangerous. may be sufficient. Your doctor will Things you must do tell you what to do. If you are about to be started on Be careful when drinking alcohol any new medicine, tell your while you are taking this If you have to stop treatment doctor and pharmacist that you medicine. entirely, your doctor will usually are taking BISOPROLOL MYLAN. If you drink alcohol, dizziness or advise you to reduce the dose light-headedness and tiredness may gradually, as otherwise your Tell any other doctors, dentists, be worse. condition may become worse. and pharmacists who treat you that you are taking this medicine. If you feel light-headed, dizzy or faint when getting out of bed or How to take it If you are going to have surgery, standing up, get up slowly. Swallow the tablets whole with a tell the surgeon or anaesthetist Standing up slowly, especially when full glass of water. The tablets that you are taking this medicine. you get up from bed or chairs, will should not be chewed. It may affect other medicines used help your body get used to the during surgery. change in position and blood pressure. If this problem continues When to take it or gets worse, talk to your doctor. If you become pregnant while Take your medicine in the taking this medicine, tell your morning. doctor immediately.

Page 3 of 5  dizziness when standing up or changes in function of the liver) In case of overdose  fainting can only be found when your doctor  reduced tear flow does tests from time to time to If you take too much  hearing problems check your progress.  runny nose or hay fever (overdose)  impaired erection Other side effects not listed above may also occur in some people. Tell Immediately telephone your  nightmares your doctor if you notice any other doctor or the National Poisons  psoriasis (red or scaly skin) effects. Centre (telephone 0800 POISON  hair loss or 0800 764 766), or go to Do not be alarmed by this list of accident and emergency at your The above list includes the more possible side effects. You may nearest hospital, if you think that common side effects of your not experience any of them. you or anyone else may have medicine. They are usually mild. taken too much BISOPROLOL MYLAN. Do this even if there are Tell your doctor as soon as no signs of discomfort or possible if you notice any of the After taking poisoning. You may need urgent following: BISOPROLOL medical attention.  changes in mood such as MYLAN Symptoms of an overdose may feeling low. include slowed/irregular heart rate,  breathing difficulties in Storage low blood pressure, severe difficulty patients with bronchial in breathing, feeling dizzy or asthma or a history of Keep your tablets in the pack trembling (due to decreased blood obstructive airways until it is time to take them. sugar).  slowing of heart rate If you take the tablets out of the  irregular heart beat pack they may not keep well.  feeling dizzy or weak Side effects  low blood pressure Keep your tablets in a cool dry  yellowing of the skin and/or place where the temperature Tell your doctor or pharmacist as eyes, sometimes stays below 25°C. soon as possible if you do not accompanied by feeling feel well while you are taking sick and loss of appetite, Do not store BISOPROLOL MYLAN BISOPROLOL MYLAN. nausea, fever, itching, light or any other medicine in the This medicine helps most people, coloured bowel motions or bathroom or near a sink. Do not but it may have unwanted side dark urine. leave it on a window sill or in the effects in a few people.  hallucinations car.  irritation and redness of the Heat and dampness can destroy All medicines can have side eye (conjunctivitis) some medicines. effects. Sometimes they are serious, most of the time they are The above list includes serious side Keep it where children cannot not. You may need medical effects that may require medical reach it. treatment if you get some of the attention. A locked cupboard at least one-and- side effects. a half metres above the ground is a If any of the following happen, good place to store medicines. Ask your doctor or pharmacist to tell your doctor immediately or answer any questions you may go to Accident and Emergency at Disposal have. your nearest hospital: If your doctor tells you to stop  worsening of heart failure taking this medicine or the expiry Tell your doctor or pharmacist if (can include shortness of date has passed, ask your you notice any of the following breath and/or swelling of pharmacist what to do with any and they worry you: the feet or legs) medicine that is left over.  headache  allergic like reactions such  stomach or intestine as itching, flush or rash problems such as nausea, Product description vomiting, diarrhoea and/or The above list includes very serious side effects. You may need urgent constipation What it looks like  feeling of coldness or medical attention or hospitalisation. numbness in the hands or BISOPROLOL MYLAN 2.5 mg – feet Tell your doctor or pharmacist if Grey, oval, biconvex film coated  tiredness you notice anything that is tablets with side notches and  unusual weakness making you feel unwell. debossed with ‘BL & M’ on either  muscle weakness or side of the scoreline on one side cramps Some side effects (for and ‘2.5’ on the other side example, changes in cholesterol  sleep disturbances

Page 4 of 5 BISOPROLOL MYLAN 5 mg – Pale NEW ZEALAND yellow, oval, biconvex film coated tablets with side notches and Telephone: 0800 579 811 debossed with ‘BL & M’ on either side of the scoreline on one side and ‘5’ on the other side Date of Preparation

BISOPROLOL MYLAN 10 mg – 04 August 2020. Pale orange to light orange, oval, (Based on datasheet dated 27 April biconvex film coated tablets with 2020) side notches and debossed with ‘BL & M’ on either side of the scoreline on one side and ‘10’ on the other side

Ingredients Active ingredient(s): BISOPROLOL MYLAN contains 2.5, 5 or 10 mg of bisoprolol fumarate as the active ingredient.

Inactive ingredient(s): BISOPROLOL MYLAN also contains:

 Microcrystalline cellulose  Lactose anhydrous  Silica (colloidal anhydrous)  Magnesium stearate  Sodium lauryl sulphate  Croscarmellose sodium  Titanium dioxide  Polydextrose  Hypromellose  macrogol  Iron oxide yellow  Iron oxide red (2.5 mg & 10 mg only)  Iron oxide black (2.5 mg & 5 mg only)  Sunset yellow (10 mg only)

BISOPROLOL MYLAN is gluten- free.

If you want to know more

Should you have any questions regarding this product, please contact your pharmacist or doctor. Who supplies this medicine BISOPROLOL MYLAN is supplied in New Zealand by:

Mylan New Zealand Ltd, PO Box 11183, Ellerslie, Auckland

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