Bisoprolol Fumarate 1 mg/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.

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

• allergy (hypersensitivity) to bisoprolol or to any of the other ingredients (see section 6 ‘What Bisoprolol fumarate oral solution contains’)
• 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.

• 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.

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

• diabetes
• strict fasting
• certain heart diseases such as disturbances in heart rhythm, or severe chest pain at rest (Prinzmetal’s angina)
• kidney or liver problems
• less severe blood circulation problems in your limbs
• chronic lung disease or less severe asthma
• history of a scaly skin rash (psoriasis)
• tumour of the adrenal gland (phaeochromocytoma)
• thyroid disorder.

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

• desensitisation therapy (for example for the prevention of hay fever), because this medicine may make it more likely that you experience an allergic reaction, or such reaction may be more severe
• anaesthesia (for example for surgery), because this medicine may influence how your body reacts to this situation.

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 this medicine.

Bisoprolol fumarate oral solution is not recommended for use in children or adolescents.

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 fumarate oral solution 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)
• certain medicines used to treat high blood pressure such as clonidine, methyldopa, moxonodine, rilmenidine. However, do not stop taking these medicines without checking with your doctor first.

Check with your doctor before taking the following medicines with Bisoprolol fumarate oral solution; 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 characterised 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.

Pregnancy

There is a risk that use of this medicine during pregnancy may harm the baby. If you are pregnant or planning to become pregnant, tell your doctor. He or she will decide whether you can take 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 this medicine.

Your ability to drive or use machinery may be affected depending on how well you tolerate the medicine. Please be especially cautious at the start of treatment, when the dose is increased or the medication is changed, as well as in combination with alcohol.

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

The maximum recommended daily dose is 10mg (10ml) of 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 (10ml) bisoprolol may be sufficient. Your doctor will tell you what to do.

If you have to stop treatment entirely, your doctor will usually advise you to reduce the dose gradually, as otherwise your condition may become worse.

• Open the bottle: turn the cap anti clockwise (figure 1)
• Separate the adaptor from the syringe (figure 2). Insert the adaptor into the bottle neck (figure 3). Ensure it is well fixed.
• Take the syringe and put it in the adaptor opening (figure 4). Turn the bottle upside down (figure 5).
• Fill the syringe with a small amount of solution by pulling the piston down (figure 5A), then push the piston upward in order to remove any possible bubble (figure 5B). Pull the piston down to the graduation mark corresponding to the quantity in millilitres (ml) prescribed by your doctor (figure 5C).
• Turn the bottle the right way up (figure 6A). Remove the syringe from the adaptor (figure 6B).
• Close the bottle with the plastic cap.
• Empty the contents of the syringe into your mouth.
• After dosing, wash the syringe with water only (figure 7).

If you have taken more of this medicine than you should, tell your doctor immediately. Your doctor will decide what measures are necessary.

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

Do not take a double dose to make up for a forgotten dose. Take your usual dose the next morning.

Never stop taking this medicine unless on your doctor’s advice. Otherwise your condition could become much worse.

If you get any side effects, talk to your doctor, pharmacist or nurse. 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.

Each ml of the oral solutions contains 1mg of Bisoprolol fumarate.

The other ingredients are: sucralose, methyl parahydroxybenzoate, ethyl parahydroxybenzoate and peppermint flavour.

Bisoprolol fumarate 1mg/ml oral solution is packaged in 185ml round white HDPE bottle with polypropylene 28mm white child resistant closures.

The package contains 10ml oral syringe with minor graduations printed at every 0.25ml together with an adaptor.