Do not take Bisoprolol fumarate if you:

• are allergic to bisoprolol fumarate or to any of the other ingredients of this medicine (listed in section 6)
• have severe asthma
• have a late-stage vascular condition causing impaired perfusion of the arms and legs (peripheral arterial occlusive disease)
• have 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
• have untreated phaeochromocytoma (a rare tumour of the adrenal gland)
• have metabolic acidosis (a condition when there is too much acid in the blood).

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

• acute heart failure
• worsening heart failure requiring the injection of medicines into a vein, that increase the force of contraction of the heart
• slow heart rate (less than 50 bpm)
• low blood pressure (systolic less than 90 mmHg)
• certain heart diseases causing a very slow heart rate or irregular heartbeat
• cardiogenic shock (an acute serious heart condition causing low blood pressure and circulatory failure).

Talk to your doctor about taking this medicine if you think that one of the conditions listed above applies to you.

Warnings and precautions

Talk to your doctor or pharmacist before taking Bisoprolol fumarate if one of the following conditions applies to you. 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 scaly skin rash (psoriasis)
• tumour of the adrenal gland (phaeochromocytoma)
• thyroid disorders.

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

• desensitization therapy (for example for the prevention of hay fever), because Bisoprolol fumarate may make it more likely that you experience an allergic reaction, or the reaction may be more severe
• anaesthesia (for example for surgery), because Bisoprolol fumarate 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 with breathing, coughing, wheezing after exercise, etc. when taking Bisoprolol fumarate.

Children and adolescents

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

Other medicines and Bisoprolol fumarate

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 without special advice from your doctor:

• certain medicines used to treat an 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 an 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; 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 an 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, dobutamine and orciprenaline)
• 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 the prevention or treatment of malaria
• medicines to treat depression called monoamine oxidase inhibitors (except MAO-B inhibitors) such as moclobemide.

Pregnancy and breast-feeding

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

Pregnancy

There is a risk that use of Bisoprolol fumarate 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 Bisoprolol fumarate 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 fumarate.

Driving and using machines

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.

Doping tests

The use of Bisoprolol fumarate may cause positive results in doping tests. The use of Bisoprolol fumarate as a doping substance may constitute a health hazard.