Bisoprolol fumarate 10mg film-coated Tablets What Bisoprolol fumarate is used for Bisoprolol fumarate is used for to slow down the heart rate and make the heart more efficient at pumping blood around the body. Do not use Bisoprolol fumarate If you are allergic to the active substances or any of the other ingredients of this medicine. Warnings and precautions • You have severe asthma or severe chronic lung disease. • You have severe blood circulation problem in limbs (such as Raynaud’s syndrome), which may cause your fingers and toes to tingle or turn pale or blue. • You have untreated phaeochromocytoma, which is a rare tumor of the adrenal gland (medulla). • You have metabolic acidosis, which is a condition when there is too much acid in the blood. • Acute heart failure or heart failure that suddenly becomes worse and / or that may require hospital treatment. • Slow heart rate. • Very low blood pressure. • Certain heart condition 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. Possible side effects Stop using the product and seek immediate medical attention if you develop throat tightness or swelling of the eyes, face, lips or tongue, feel faint, or have difficulty breathing. Stop using the product if you develop hives or itching of the face or body. Other medicines and Bisoprolol fumarate Tell your doctor or pharmacist if you are taking • Water 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, phenytoin, propafenone, quinidine, rilmenidine, verapamil) • medicines for depression e.g. imipramine, amitriptyline, moclobemide • medicines to treat mental illness e.g. phenothiazines such as levomepromazine • medicines used for anesthesia during an operation • medicines used to treat epilepsy e.g. barbiturates such as phenobarbital • certain pain killers (for instance acetylsalicylic acid, diclofenac, indomethacin, ibuprofen, naproxen) • medicines for asthma or medicines used for a blocked nose • medicines used for certain eye disorders such as glaucoma (increased pressure in the eye) or used to widen the pupil of the eye • certain medicines to treat clinical shock (e. g. adrenaline, dobutamine, noradrenaline) • mefloquine, a medicine for malaria • all these drugs as well as bisoprolol may influence the blood pressure and/or heart function. • rifampicin for the treatment of infections • medicines to treat severe headaches or migraines (ergotamine derivatives). How to use Bisoprolol fumarate Treatment with Bisoprolol fumarate tablet 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: • 1.25 mg bisoprolol fumarate once daily for a week • 2.5 mg bisoprolol fumarate once daily for a week • 3.75 mg bisoprolol fumarate once daily for a week • 5 mg bisoprolol fumarate once daily for four weeks • 7.5 mg bisoprolol fumarate once daily for four weeks • 10 mg bisoprolol fumarate once daily for maintenance (on-going) therapy. The maximum recommended daily dose of bisoprolol fumarate is 10 mg. How to store Bisoprolol fumarate Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. Do not store above 30°C. Store in the original container. Keep the container tightly closed. Do not use Bisoprolol fumarate if you notice any deterioration or damage to the outer packaging. Do not throw away any medicines via wastewater or household waste. A valid prescription should be available upon delivery

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