Bisoprolol Fumarate 0.5mg/ml Oral Solution

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

The name of your medicine is Bisoprolol Fumarate 0.5mg/ml Oral Solution but it will be referred to as ‘Bisoprolol’ throughout this leaflet.

1. What Bisoprolol is and what it is used for
2. What you need to know before you take Bisoprolol
3. How to take Bisoprolol
4. Possible side effects
5. How to store Bisoprolol
6. Contents of the pack and other information

Do not take Bisoprolol if one of the following conditions applies to you:

• if you are allergic (hypersensitivity) to Bisoprolol or to any of the other ingredients of this medicine (listed in section 6).
• severe asthma
• severe blood circulation problems in your limbs (such as Raynaud’s syndrome), which may cause your fingers and toes to tingle or turn pale or blue
• untreated phaeochromocytoma, which is a rare tumour of the adrenal gland
• metabolic acidosis, which is a condition when there is too much acid in the blood.

Do not take Bisoprolol if you have one of the following heart problems:

• acute heart failure
• worsening heart failure requiring injection of medicines into a vein, that increase the force of contraction of the heart
• slow heart rate
• low blood pressure
• certain heart conditions causing a very slow heart rate or irregular heartbeat
• cardiogenic shock, which is an acute serious heart condition causing low blood pressure and circulatory failure.

Talk to your doctor or pharmacist before taking Bisoprolol.

If you have any of the following conditions; he or she may want to take special care (for example give additional treatment or perform more frequent checks):

• diabetes. Bisoprolol can hide the symptoms of low blood sugar
• strict fasting
• any certain heart diseases such as disturbances in heart rhythm, or severe chest pain at rest (Prinzmetal’s angina)
• kidney or liver problems
• have any problems with the circulation in your limbs, are taking verapamil or diltiazem, medicines used to treat heart conditions. Concomitant use is not recommended, see also “Other medicines and Bisoprolol”
• chronic lung disease or less severe asthma
• have (or have had) psoriasis (a recurring skin rash)
• have phaeochromocytoma (a rare tumour of the adrenal gland). Your doctor will need to treat this before prescribing Bisoprolol for you
• thyroid disorder. Bisoprolol can hide symptoms of an overactive thyroid.

In addition, tell your doctor if you are going to have:

• desensitization therapy (for example for the prevention of hay fever), because Bisoprolol may make it more likely that you experience an allergic reaction, or such reaction may be more severe
• are going to be given a general anaesthetic during an operation – tell your doctor that you are taking Bisoprolol
• worsening of symptoms of blockage of the main blood vessels to the legs, especially at the start of treatment.

If you have chronic lung disease or less severe asthma please inform your doctor immediately if you start to experience new difficulties in breathing, cough, wheezing after exercise, etc. when using Bisoprolol.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Do not take the following medicines with Bisoprolol without special advice from your doctor:

• certain medicines used to treat irregular or abnormal heartbeat (Class I antiarrhythmic medicines such as quinidine, disopyramide, lidocaine, phenytoin; flecainide, propafenone)
• certain medicines used to treat high blood pressure, angina pectoris or irregular heartbeat (calcium antagonists such as verapamil and diltiazem)
• medicines for controlling the blood pressure or medicines for heart problems (such as amiodarone, amlodipine, clonidine, digitalis glycosides, diltiazem, disopyramide, felodipine, flecainide, lidocaine, methyldopa, moxonidine, nifedipine, phenytoin, propafenone, quinidine, rilmenidine, verapamil). However, do not stop taking these medicines without checking with your doctor first.

Check with your doctor before taking the following medicines with Bisoprolol your doctor may need to check your condition more frequently:

• certain medicines used to treat high blood pressure or angina pectoris (dihydropyridine-type calcium antagonists such as felodipine and amlodipine)
• certain medicines used to treat irregular or abnormal heartbeat (Class III antiarrhythmic medicines such as amiodarone)
• beta-blockers applied locally (such as timolol eye drops for glaucoma treatment)
• certain medicines used to treat for example Alzheimer’s disease or glaucoma (parasympathomimetics such as tacrine or carbachol) or medicines that are used to treat acute heart problems (sympathomimetics such as isoprenaline and dobutamine)
• antidiabetic medicines including insulin
• anaesthetic agents (for example during surgery)
• digitalis, used to treat heart failure
• non-steroidal anti-inflammatory medicines (NSAIDs) used to treat arthritis, pain or inflammation (for example ibuprofen or diclofenac)
• any medicine, which can lower blood pressure as a desired or undesired effect such as antihypertensives, certain medicines for depression (tricyclic antidepressants such as imipramine or amitriptyline), certain medicines used to treat epilepsy or during anaesthesia (barbiturates such as phenobarbital), or certain medicines to treat mental illness characterized by a loss of contact with reality (phenothiazines such as levomepromazine)
• mefloquine, used for prevention or treatment of malaria
• depression treatment medicines called monoamine oxidase inhibitors (except MAO-B inhibitors) such as moclobemide
• medicines used for a blocked nose

Pregnancy

Bisoprolol can be harmful to the pregnancy and/or to the child (increased possibility of premature birth, miscarriage, retarded growth, low blood glucose level and reduced heart rate of the child). Therefore do not use this medicine during pregnancy.

Breast-feeding

It is not known whether Bisoprolol passes into human breast milk.

Therefore, breast-feeding is not recommended during therapy with Bisoprolol.

No information is available on the effects of Bisoprolol on fertility.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

The use of Bisoprolol may sometimes result in dizziness or fatigue (see ‘Possible side effects’). If you suffer from these side effects, do not operate vehicles and/or machines. These side-effects are likely to happen at the start of treatment, or with a change in the amount of Bisoprolol you take.

Methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216): May cause allergic reactions (possibly delayed).

Sodium: This medicine contains less than 1 mmol sodium (23mg) per 20ml, that is to say essentially ‘sodium-free’.

Chest pain and high blood pressure (angina and hypertension)

Your doctor will start the treatment with the lowest possible dose (5mg (10ml)). Your doctor will monitor you closely at the start of treatment. Your doctor will increase your dose to obtain the best possible dosage for you.

The maximum recommended dose is 20mg (40ml) once per day.

Patients with severe kidney disease should not exceed 10mg (20ml) of Bisoprolol once daily. Please consult your doctor before starting to use this medicine.

Patients with severe liver disease should not exceed 10mg (20ml) of Bisoprolol once daily. Please consult your doctor before starting to use this medicine.

Heart failure

Before you start using Bisoprolol oral solution, you should already be taking other medicines for heart failure including an ACE-inhibitor, a diuretic and (as an added option) a cardiac glycoside.

Treatment with Bisoprolol must be started at a low dose and increased gradually. Your doctor will decide how to increase the dose, and this will normally be done in the following way:

• 1.25mg (2.5ml) Bisoprolol once daily for one week
• 2.5mg (5ml) Bisoprolol once daily for one week
• 3.75mg (7.5ml) Bisoprolol once daily for one week
• 5mg (10ml) Bisoprolol once daily for four weeks
• 7.5mg (15ml) Bisoprolol once daily for four weeks
• 10mg (20ml) Bisoprolol once daily for maintenance (on-going) therapy.

The maximum recommended daily dose is 10mg (20ml) Bisoprolol.

Depending on how well you tolerate the medicine, your doctor may also decide to lengthen the time between dose increases. If your condition gets worse or you no longer tolerate the drug, it may be necessary to reduce the dose again or to interrupt treatment. In some patients a maintenance dose lower than 10mg (20ml) Bisoprolol may be sufficient.

Your doctor will tell you what to do.

The use of Bisoprolol is not recommended as there is insufficient experience with the use of this medicine in children and adolescents.

In general an adjustment of the dose is not needed. It is recommended to start with the lowest possible dose.

If you notice that the Bisoprolol dose is too strong or does not work well enough, please consult your doctor or pharmacist.

• Bisoprolol should be taken in the morning.
• This medicinal product must be taken orally.
• Use the measuring syringe provided in the pack to deliver the required dose.
• Take Bisoprolol with or without food.

a) Open the bottle: press the cap and turn it anticlockwise (figure 1).

b) Separate the adaptor from the syringe (figure 2). Insert the adaptor into the bottle neck (figure 3). Ensure it is properly fixed. Take the syringe and put it in the adaptor opening (figure 4).

c) Turn the bottle upside down. Fill the syringe with a small amount of solution by pulling the piston down (figure 5A) and then push the piston up in order to remove any possible air bubbles (figure 5B). Pull the piston down to the graduation mark corresponding to the quantity in millilitres (ml) prescribed by your doctor (figure 5C).

d) Turn the bottle the right way up (figure 6A). Remove the syringe from the adaptor (figure 6B). Once again check that pulled-up millilitres (ml) corresponds with the prescribed dose.

e) Empty the contents of the syringe into the mouth by pushing the piston to the bottom of the syringe (figure 7). The contents of the syringe should be emptied into the side cheek of the patient's mouth to avoid a choking hazard. Close the bottle with the plastic screw cap. Wash the syringe with water (figure 8).

If you have taken more Bisoprolol than you should contact your doctor or casualty department immediately. Take the bottle of Bisoprolol with you.

Do not take a double dose to make up for a forgotten dose. Take the next dose on time. If you miss several doses, contact your doctor.

Symptoms of an overdose may include slowed heart rate, severe difficulty in breathing, feeling dizzy, or trembling (due to decreased blood sugar).

If you suddenly stop taking Bisoprolol you are likely to suffer from side effects. Your doctor will reduce your dose slowly over 2 weeks.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is bisoprolol fumarate.

Each ml of oral solution contains 0.5mg of bisoprolol fumarate.

The other ingredients are methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium dihydrogen phosphate monohydrate (E339), disodium phosphate and purified water.

Bisoprolol is a clear, colourless oral solution supplied in 150ml amber glass bottle with tamper-evident child-resistant white (polyethylene/polypropylene) plastic cap with EPE liner.

The pack also contains a 20ml oral syringe with 5ml graduation, 1ml intermediate graduation and 0.5ml sub graduation marks with an adaptor.