BISOPROLOL FUMARATE

Posology:

For the management of hypertension and angina pectoris: Adults The usual adult dose is 10mg once daily with a maximum recommended dose of 20mg per day. In some patients, 5mg per day may be adequate. Renal or hepatic impairment In patients with final stage impairment of renal function (creatinine clearance less than 20ml/min) or in patients with severe hepatic dysfunction, the dosage should not exceed 10mg bisoprolol once daily.

Experience of use of bisoprolol in renal dialysis patients is limited, however it is thought that bisoprolol fumarate cannot be dialysed. Elderly No dosage adjustment is normally required but 5mg per day may be adequate in some elderly patients; as for other adults, the dosage may have to be reduced in cases of severe renal or hepatic dysfunction.

Paediatric There is no paediatric experience with bisoprolol, therefore its use cannot be recommended for children.

Method of Administration:

Bisoprolol tablet should be taken in the morning and can be taken with food. They should be swallowed in liquid and should not be chewed.

The following definitions apply to the frequency terminology used hereafter:

Very common (> 1/10) Common (> 1/100, < 1/10) Uncommon (> 1/1,000, < 1/100) Rare (> 1/10,000, < 1/1,000) Very rare (< 1/10,000) Cardiac disorders: Uncommon: AV-conduction disturbances, worsening of pre-existing heart failure, bradycardia (decrease in pulse rate).

Very rare:

Chest pain Vascular disorders: Common: feeling of coldness or numbness in the extremities.

Uncommon:

Orthostatic hypotension.

Rare:

Cyanosis of extremities, paraesthesia, If you already have Raynaud’s disease or intermittent claudication (pain in the legs while walking) Bisoprolol may make these worse.

Metabolism and nutrition disorders:

Rare: Increased triglycerides. Beta-blockers may mask the symptoms of thyrotoxicosis or hypoglycaemia.

Psychiatric disorders:

Uncommon: sleep disorders (including vivid dreams), depression. Rare: nightmares, hallucinations, anxiety, psychosis, confusion.

Nervous system disorders:

Common: tiredness*, exhaustion*, dizziness*, headache*.

Rare: syncope Eye disorders:

Rare: dry eyes (to be considered if the patient uses lenses), impaired vision, reduced tear flow. Very rare: conjunctivitis, visual disturbances.

Ear and labyrinth disorders:

Rare: hearing impairment.

Respiratory, thoracic and mediastinal disorders:

Uncommon: bronchospasm in patients with bronchial asthma or a history of obstructive airways disease. Rare: allergic rhinitis.

Gastrointestinal disorders:

Common: gastrointestinal complaints such as nausea, vomiting, diarrhoea, constipation.

Hepatobiliary disorders:

Rare: increased liver enzymes (ALAT, ASAT), hepatitis.

Skin and subcutaneous tissue disorders:

Common: perspiration Rare: hypersensitivity reactions (such as itching, flush, rash and angioedema) Very rare: beta-blockers may provoke or worsen psoriasis or induce psoriasis- like rash, alopecia.

Musculoskeletal and connective tissue disorders:

Uncommon: muscular weakness, pain and cramps.

Rare: muscle and joint ache Reproductive system and breast disorders:

Rare: potency disorders.

General disorders:

Common: lassitude, fatigue*, oedema Uncommon: asthenia. *These symptoms especially occur at the beginning of the therapy. They are generally mild and often disappear within 1-2 weeks.

Reporting of suspected adverse reactions:

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. 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

Bisoprolol must be used with caution in: • heart failure:

The treatment of stable chronic heart failure with bisoprolol has to be initiated with a special titration phase (for details, see SPC for bisoprolol indicated for the treatment of stable chronic heart failure). • bronchospasm (bronchial asthma, obstructive airways diseases): In bronchial asthma or other chronic obstructive lung diseases, which may cause symptoms, 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. 2. • diabetes mellitus with large fluctuations in blood glucose values; symptoms of hypoglycaemia can be masked.

• strict fasting. • ongoing desensitisation therapy. • first degree AV block. • prinzmetal's angina. • peripheral arterial occlusive disease (intensification of complaints might happen especially during the start of 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 of beta-blockade 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. 5. • As with other beta-blockers, bisoprolol may increase both the sensitivity towards allergens and the severity of anaphylactic reactions.

Adrenaline treatment does not always give the expected therapeutic effect. 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 thyrotoxicosis may be masked. • Treatment with bisoprolol should not be stopped abruptly unless clearly indicated, especially in patients with ischaemic heart disease.

v. inotropic therapy • cardiogenic shock. • sinoatrial block. • second or third degree AV block (without pacemaker). • bradycardia (heart rate less than 60 beats/min prior to start of therapy). • severe bronchial asthma or severe chronic obstructive pulmonary disease • sick sinus syndrome.

• hypotension (systolic blood pressure <100mmHg). 1