Betacor 2.5 tablet: Each film-coated tablet contains 2.5 mg Bisoprolol Fumarate as active ingredient. Betacor 5 tablet: Each film-coated tablet contains 5 mg Bisoprolol Fumarate as active ingredient.
Dosage and administration:
Treatment of hypertension or angina pectoris In all cases the dose regimen is adjusted individually by your doctor, in particular according to the pulse rate and therapeutic success. The usual initial dose is 5 mg bisoprolol fumarate (1 tablet of BetacorTM 5) once daily. If necessary, the dose may be increased to 10 mg bisoprolol fumarate (2 tablets of BetacorTM 5) once daily. The maximum recommended dose is 20 mg bisoprolol fumarate once daily. BetacorTM must be used with caution in patients with hypertension or angina pectoris and accompanying heart failure. Treatment of stable chronic heart failure Standard treatment of CHF consists of an ACE inhibitor (or an angiotensin receptor blocker in case of intolerance to ACE inhibitors), a beta-blocker, diuretics, and when appropriate cardiac glycosides. The initiation of treatment of stable chronic heart failure with Betacor necessitates a special titration phase. Precondition for treatment with bisoprolol is stable chronic heart failure without acute failure. It is recommended that the treating physician be experienced in the management of chronic heart failure. The recommended starting dose is 1.25 mg bisoprolol fumarate once daily (Half a tablet of BetacorTM 2.5). Depending on individual tolerance the dose is stepwise increased to 2.5 mg, 3.75 mg, 5 mg, 7.5 mg, and 10 mg bisoprolol fumarate once daily in intervals of two weeks or longer. If a dose increase is not well tolerated treatment may be maintained at a lower dose. The maximum recommended dose is 10 mg bisoprolol fumarate once daily. Close monitoring of vital signs (blood pressure, heart rate) and symptoms of worsening heart failure is recommended during the titration phase. Treatment modification If during the titration phase or thereafter, transient worsening of heart failure, hypotension or bradycardia occurs, reconsideration of the dosage of 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. Duration of treatment for all indications Treatment with BetacorTM is generally a long-term therapy. Do not stop treatment abruptly or change the recommended dose without talking to your doctor first since this might lead to a transitory worsening of heart condition. Especially in patients with ischaemic heart disease, treatment must not be discontinued suddenly. If discontinuation is necessary, the daily dose is gradually decreased. Special populations Renal or hepatic impairment:
- Treatment of hypertension or angina pectoris: In patients with liver or kidney function disorders of mild to moderate severity no dosage adjustment is normally required. In patients with severe renal impairment (creatinine clearance < 20 ml/min) and in patients with severe hepatic impairment a daily dose of 10 mg bisoprolol fumarate must not be exceeded.
- Treatment of stable chronic heart failure: There is no information regarding pharmacokinetics of bisoprolol in patients with chronic heart failure and concomitant hepatic or renal impairment. Titration of the dose in these populations must therefore be made with particular caution.
Side effect:
Elderly: No dosage adjustment is required. Administration Betacor tablets are taken in the morning with or without food. They are swallowed with some liquid and not to be chewed.
The adverse effects described below are sorted according to system organ classes. Frequencies are classified as follows: Very common (affects more than 1 person in 10) Common (affects less than 1 person in 10) Uncommon (affects less than 1 person in 100) Rare (affects less than 1 person in 1,000) Very rare (affects less than 1 person in 10,000) • Investigations Rare: increased triglycerides, increased liver enzymes (ALAT, ASAT)
- Cardiac disorders Very common: bradycardia (in patients with chronic heart failure) Common: worsening of pre-existing heart failure (in patients with chronic heart failure) Uncommon: AV-conduction disturbances; bradycardia (in patients with hypertension or angina pectoris); worsening of pre-existing heart failure (in patients with hypertension or angina pectoris)
- Nervous system disorders
Common: dizziness*, headache*
- Eye disorders
Rare: reduced tear flow (to be considered if the patient uses contact lenses) Very rare: conjunctivitis
- Ear and labyrinth disorders
Rare: hearing disorders
- 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 as nausea, vomiting, diarrhoea, constipation Skin and subcutaneous tissue disorders Rare: hypersensitivity reactions such as itching, flush, rash Very rare: alopecia. Beta-blockers may provoke or worsen psoriasis or induce psoriasis- like rash.
- Musculoskeletal and connective tissue disorders
Uncommon: muscle weakness, muscle cramps
- Vascular disorders
Common: feeling of coldness or numbness in the extremities, hypotension especially in patients with heart failure
- General disorders
Common: asthenia (in patients with chronic heart failure), fatigue* Uncommon: asthenia (in patients with hypertension or angina pectoris)
- Hepatobilary disorders
Rare: hepatitis
- Reproductive system and breast disorders
Rare: potency disorders
- Psychiatric disorders
Uncommon: depression, sleep disorders Rare: nightmares, hallucinations Applies only to patients with hypertension or angina pectoris: *These symptoms especially occur at the beginning of the therapy. They are generally mild and usually disappear within 1-2 weeks. Tell your doctor if you notice any of the side effects listed above or any other unwanted or unexpected effects. To prevent serious reactions, speak to a doctor immediately if a side effect is severe, occurred suddenly, or gets worse rapidly.
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