CONCOR 5 TABLET 5 mg

MERCK PTE. LTD.

MERCK PTE. LTD.

Therapeutic

Prescription Only

TABLET, FILM COATED

**Posology and method of administration** For all indications Treatment with bisoprolol 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 condition. Especially in patients with ischaemic heart disease, treatment must not be discontinued suddenly. If discontinuation is necessary, the daily dose is gradually decreased. Concor tablets are taken in the morning with or without food. They are swallowed with some liquid and not to be chewed. Treatment of hypertension or angina pectoris For both indications the dosage is 5 mg bisoprolol once daily. If necessary, the dose may be increased to 10 mg bisoprolol once daily. In all cases the dosage is adjusted individually, in particular according to the pulse rate and therapeutic success. 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 Concor 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 treatment of stable chronic heart failure with bisoprolol is initiated according to the following titration scheme, individual adaptation may be necessary depending on how well the patient tolerates each dose, i.e. the dose is to be increased only, if the previous dose is well tolerated. - 1.25 mg once daily for 1 week, if well tolerated increase to - 2.5 mg once daily for a further week, if well tolerated increase to - 3.75 mg once daily for a further week, if well tolerated increase to - 5 mg once daily for the 4 following weeks, if well tolerated increase to - 7.5 mg once daily for the 4 following weeks, if well tolerated increase to - 10 mg once daily for the maintenance therapy. Close monitoring of vital signs (blood pressure, heart rate) and symptoms of worsening heart failure is recommended during the titration phase. The maximum recommended dose is 10 mg once daily. Occurrence of adverse events may exclude some patients from being treated with the maximum recommended dose. If necessary, the dose reached can also be decreased step by step and the maintenance treatment will be the maximum dose well tolerated by the patient. The treatment may be interrupted if necessary and reintroduced as appropriate. 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. **Special populations** Renal or liver insufficiency _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 insufficiency (creatinine clearance < 20 ml/min) and in patients with severe liver function disorders it is recommended that a daily dose of 10 mg bisoprolol is not exceeded. Experience with the use of bisoprolol in renal dialysis patients is limited; however, there is no evidence that the dosage regimen needs to be altered. _Treatment of stable chronic heart failure:_ There is no information regarding pharmacokinetics of bisoprolol in patients with chronic heart failure and with concomitant impaired liver or renal function. Uptitration of the dose in these populations should therefore be made with particular caution. Elderly No dosage adjustment is required. Children There is no experience with bisoprolol in children, therefore its use cannot be recommended for children.