Presentation: Bisoprolol fumarate 1mg/ml oral solution Indications: Treatment of stable chronic heart failure with reduced systolic left ventricular function in addition to ACE inhibitors, and diuretics, and optionally cardiac glycosides. Dosage, method and route of administration: Patients should be stable (without acute failure) when bisoprolol treatment is initiated. The treating physician should be experienced in the management of chronic heart failure. Transient worsening of heart failure, hypotension, or bradycardia may occur during the titration period and thereafter. Titration phase: The treatment of stable chronic heart failure with bisoprolol requires a titration phase, starting with gradual uptitration according to the following steps: 1.25 mg (1.25ml) once daily for 1 week; If well tolerated increase to 2.5 mg (2.5ml) once daily for a further week; If well tolerated increase to 3.75 mg (3.75ml) once daily for a further week; If well tolerated increase to 5 mg (5ml) once daily for the 4 following weeks; If well tolerated increase to 7.5 mg (7.5ml) once daily for the 4 following weeks; If well tolerated increase to 10mg (10ml) mg once daily for the maintenance therapy. The maximum recommended dose is 10 mg (10ml) once daily. Close monitoring of vital signs (heart rate, blood pressure) and symptoms of worsening heart failure is recommended during the titration phase. Symptoms may already occur within the first day after initiating the therapy. Treatment modification: If the maximum recommended dose is not well tolerated, gradual dose reduction may be considered. In case of transient worsening of heart failure, hypotension, or bradycardia reconsideration of the dosage of the concomitant medication is recommended. It may also be necessary to temporarily lower the dose of bisoprolol or to consider discontinuation. The reintroduction and/or uptitration of bisoprolol should always be considered when the patient becomes stable again. If discontinuation is considered, gradual dose decrease is recommended, since abrupt withdrawal may lead to acute deterioration of the patient’s condition. Treatment of stable chronic heart failure with bisoprolol is generally a long-term treatment. Take additional caution in dose uptitration in patients with hepatic or renal impairment. Bisoprolol use cannot be recommended in paediatric patients. Bisoprolol fumarate oral solution is for oral use only and should be taken in the morning and can be taken with food. Refer to the Summary of Product Characteristics for instructions for use. Contraindications: Bisoprolol is contraindicated in chronic heart failure patients with: acute heart failure or during episodes of heart failure decompensation requiring i.v. inotropic therapy, cardiogenic shock,  second or third degree AV block, sick sinus syndrome, sinoatrial block, symptomatic bradycardia, symptomatic hypotension, severe bronchial asthma, severe forms of peripheral arterial occlusive disease or severe forms of Raynaud’s syndrome, untreated phaeochromocytoma, metabolic acidosis, hypersensitivity to bisoprolol or to any of the excipients. Special warnings and precautions for use: The treatment of stable chronic heart failure with bisoprolol must be initiated with a special titration phase. Especially in patients with ischaemic heart disease the cessation of therapy with bisoprolol must not be done abruptly unless clearly indicated, because this may lead to transitional worsening of heart condition. Initiation and cessation of treatment with bisoprolol necessitates regular monitoring. There is no therapeutic experience of bisoprolol treatment of heart failure in patients with the following diseases and conditions: insulin dependent diabetes mellitus (type I), severely impaired renal function, severely impaired hepatic function, restrictive cardiomyopathy, congenital heart disease, haemodynamically significant organic valvular disease, myocardial infarction within 3 months. Bisoprolol must be used with caution in: bronchospasm (bronchial asthma, obstructive airways diseases), diabetes mellitus with large fluctuations in blood glucose values(Symptoms of hypoglycaemia can be masked), strict fasting, ongoing desensitisation therapy(Bisoprolol may increase sensitivity towards allergens and severity of anaphylactic reactions. Epinephrine treatment does not always yield the expected therapeutic effect), first degree AV block, Prinzmetal’s angina(Cases of coronary vasospasm have been observed and angina attacks cannot be completely excluded), peripheral arterial occlusive disease(Aggravation of symptoms may occur especially when starting therapy), general anaesthesia. In patients undergoing general anaesthesia beta-blockade reduces the incidence of arrhythmias and myocardial ischemia during induction and intubation, and the post- operative period. It is currently recommended that maintenance betablockade be continued peri-operatively. The anaesthetist must be aware of beta- blockade because of the potential for interactions with other drugs, resulting in bradyarrhythmias, attenuation of the reflex tachycardia and the decreased reflex ability to compensate for blood loss. If it is thought necessary to withdraw beta- blocker therapy before surgery, this should be done gradually and completed about 48 hours before anaesthesia. Combination of bisoprolol with calcium antagonists of the verapamil ordiltiazem type, with Class I antiarrhythmic drugs and with centrally acting antihypertensive drugs is generally not recommended. Although cardioselective (beta1) beta-blockers may have less effect on lung function than non-selective beta-blockers, as with all beta-blockers, these should be avoided in patients with obstructive airways diseases, unless compelling clinical reasons for their use. Where such reasons exist, Bisoprolol fumarate may be used with caution and should be started at the lowest possible dose and patients should be carefully monitored for new symptoms (e.g. dyspnea, exercise intolerance, cough). In bronchial asthma or other chronic obstructive lung diseases, bronchodilating therapy should be given concomitantly. Occasionally an increase of the airway resistance may occur in patients with asthma, therefore the dose of beta2- stimulants may have to be increased. Patients with psoriasis or psoriasis history should only be given betablockers (e.g. bisoprolol) after carefully balancing the benefits against the risks. In patients with phaeochromocytoma bisoprolol must not be administered until after alpha- receptor blockade. Under treatment with bisoprolol the symptoms of a thyreotoxicosis may be masked. Interactions: Not recommended: Calcium antagonists of the verapamil type and to a lesser extent of the diltiazem type, Class I antiarrhythmic drugs (e.g. quinidine, disopyramide; lidocaine, phenytoin; flecainide, propafenone), Centrally acting antihypertensive drugs such as clonidine and others (e.g. methyldopa, moxonodine, rilmenidine). Use with caution: Calcium antagonists of the dihydropyridine type such as felodipine and Amlodipine, Class-III antiarrhythmic drugs (e.g. amiodarone), Topical beta-blockers (e.g. eye drops for glaucoma treatment), Parasympathomimetic drugs, Insulin and oral antidiabetic drugs, Anaesthetic agents, Digitalis glycosides, non-steroidal anti-inflammatory drugs (NSAIDs), β-Sympathomimetic agents (e.g. isoprenaline, dobutamine), Sympathomimetics that activate both β- and α-adrenoceptors (e.g. noradrenaline, adrenaline), concomitant use of antihypertensive agents and  drugs with blood pressure lowering potential (e.g. tricyclic antidepressants, barbiturates, phenothiazines) may increase the risk of hypotension. Considerations: Mefloquine, Monoamine oxidase inhibitors (except MAO-B inhibitors). Ability to drive/use machines:  Due to individual variations in reactions to the drug, the ability to drive a vehicle or to operate machinery may be impaired. This should be considered particularly at start of treatment and upon change of medication as well as in conjunction with alcohol.  Pregnancy and breastfeeding: Pregnancy: Bisoprolol may cause harmful effects on pregnancy and/or the fetus/newborn. In general, beta-adrenoceptor blockers reduce placental perfusion, which has been associated with growth retardation, intrauterine death, abortion or early labour. Adverse effects(eg hypoglycaemia, bradycardia) may occur in the fetus and newborn infant. Bisoprolol should not be used during pregnancy unless clearly necessary. If bisoprolol is considered necessary, the uteroplacental blood flow, fetal growth and the newborn infant should be monitored. Breast-feeding It is not known whether this drug is excreted in human milk. Therefore, breastfeeding is not recommended during administration of bisoprolol. Side effects: For full list of side effects consult SmPC. ‘Very Common’ (≥1/10) and ‘Common’ (≥1/100 to <1/10) included in the prescribing information: Very common: bradycardia. Common: worsening of heart failure, dizziness, headache, gastrointestinal complaints (nausea, vomiting, diarrhoea, constipation), coldness or numbness in the extremities, hypotension, asthenia, fatigue. Rare: increased triglycerides, increased liver enzymes (ALAT, ASAT), syncope, reduced tear flow, hearing disorders, allergic rhinitis, hypersensitivity reactions (pruritus, flush, rash and angioedema), hepatitis, erectile dysfunction, nightmare, hallucination MA number: PL 35533/0227 MAH: Aspire Pharma Limited, Unit 4 Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, United Kingdom Cost: 155ml 1mg/ml £190.40 Legal Category: POM Date last reviewed: June 2025 Version number: 10106162798 v 1.0