** Concor® COR 2.5mg (Bisoprolol fumarate) 30 film-coated tablets. Cardioselective beta-blocker. For treatment of stable chronic heart failure.
1 film-coated tablet contains:
Bisoprolol fumarate (2:1) 2.5 mg
Treatment of stable chronic, moderate to severe heart failure (myocardial insufficiency) with impaired systolic ventricularfunction (ejection fraction = 35%, determined by echocardiography) in addition to ACE inhibitors and diuretics, and optionally cardiac glycosides.
– Acute myocardial insufficiency (heart failure) or during deterioration (decompensation) of heart failure requiring I.V. therapy with substances increasing the contractility of the heart.
– Shock induced by disorders of cardiac function (cardiogenic shock).
– Severe disturbances of atrioventricular impulse conduction (2nd or 3rd degree AV block) without a pacemaker.
– Sick sinus syndrome.
– Sinoatrial block (disturbed impulse conduction between sinus node and atrium).
– Markedly slowed heart beat (pulse rate less than 50 beats/min) before the start of treatment.
– Markedly decreased blood pressure (systolic blood pressure below 100 mm Hg).
– Severe bronchial asthma or severe chronic obstructive lung disease.
– Late stages of peripheral arterial occlusive disease or vascular spasms in toes and fingers (Raynaud’s syndrome).
– Untreated tumors of the adrenal medulla (phaechromocytoma).
– Metabolic acidosis.
– Known hypersensitivity to bisoprolol.
** In the following cases you may take Concor COR 2.5mg only under certain conditions and with particular caution: Please ask your doctor about this. This is also applies if you have been affected by any of the following in the past:
– Bronchospasm (bronchial asthmas, obstructive airways diseases).
– Treatment with inhalation anaesthetics.
– Diabetes mellitus with extremely fluctuating blood glucose levels; symptoms of markedly reduced blood glucose (hypoglycemia) can be masked.
– Strict fasting.
– Ongoing desensitisation therapy.
– Mild disturbances of arterioventricular impulse conduction (first degree AV block).
– Disturbed cardiac blood flow due to vasospasms of the coronary vessels (Prinzmetal’s agina).
– Peripheral arterial occlusive disease (intensification of complaints may occur especially when starting therapy).
– In patients with a personal or family history of psoriasis, beta-receptor blocker (e.g. Concor COR 2.5mg) should not be used if the benefit-to-risk ratio has been carefully weighed.
– In patients with a tumor of the adrenal medulla (phaeochromocytoma) Concor COR 2.5mg may only be administered after previous alpha-receptor blockade.
* Dosage instructions, mode and duration of administration:
The following dosage instructions apply for Concor COR 2.5mg unless your doctor has prescribed otherwise.
Please follow these directions carefully, otherwise Concor COR 2.5mg cannot have the proper effect.
You should have stable chronic heart failure without any acute deterioration (decompensation) within the last 6 weeks. You should already be treated with an ACE inhibitor at optimal dosage (or, in the case of intolerance of ACE inhibitors, a different vasodilator), a diuretic and, if required, a digitalis preparation. This first-line medication should have remained largely unchanged for 2 weeks before starting therapy with Concor COR 2.5mg.
Treatment with bisoprolol should be initiated with slow, gradual dose increases. The attending physician should have experience in the therapy of chronic heart failure. Concor COR 2.5mg is intended for initial treatment. However, in some patients it may be sufficient for maintenance therapy.
The following dose increases are recommended:
– 1.25mg bisoprolol (equivalent to 0.5 tablet Concor COR 2.5mg) once daily for 1 week.
– If this dose is well tolerated increase to 2.5mg bisoprolol& (equivalent to 1 tablet Concor COR 2.5mg) once daily for 1 week.
– If this dose is well tolerated increase to 3.75mg bisoprolol& (equivalent to 1.5 tablet Concor COR 2.5mg) once daily for 1 week.
– If this dose is well tolerated increase to 5mg bisoprolol once daily for 4 weeks.
– If this dose is well tolerated increase to 7.5mg bisoprolol once daily for 4 weeks.
– If this dose is well tolerated increase to 10mg bisoprolol once daily as a maintenance dose.
At the start of treatment with 1.25mg bisoprolol& (equivalent to 0.5 tablet Concor COR 2.5mg), the patient should be monitored for 4 hours (blood pressure, heart rate, impulse conduction disorders as well as symptoms of heart failure). The recommended maximal dose of 10mg bisoprolol per day is reached at the earliest after a dose increase over 12 weeks and should not be exceeded. A result of adverse reactions (e.g. slowing of heart beat with symptoms or drop in blood pressure or symptoms of deteriorating heart failure) may be that not all patients can be treated with the highest recommended dosage. If necessary, the beta-blocker dosage can be gradually reduced again, or the treatment can be discontinued can resumed again at a later time. If deterioration of heart failure or intolerance occur during the titration phase the attending physician is advised to reduce or, in the presence of compelling reasons, immediately discontinue bisoprolol. Treatment of stable chronic heart failure generally means long-term therapy.
** For oral use. By prescription only.
** Do not store above 25 degrees C.
** Manufactured by: AMOUN PHARMACEUTICAL CO. S.A.E. – El-Obour City, Cairo, Egypt
Under licence from: Merck KGaA – Darmstadt – Germany (Merck Serono)
To be sold in Egypt only