Concor® / Concor® COR

Product information (abbreviated prescribing information shortened for visual)

Products: Concor 5, 10; Concor COR 1.25, 2.5, 3.75, 5, 7.5, 10 film-coated tablets for oral
use containing 1.25 mg, 2.5 mg, 3.75 mg, 5 mg, 7.5 mg, or 10 mg bisoprolol fumarate,
respectively. Different brand names are used for the products in some countries.
Indications: Concor: Treatment of hypertension; treatment of coronary heart disease
(angina pectoris, AP). Concor Cor: treatment of stable chronic moderate to severe heart
failure in addition to ACE inhibitors, and diuretics, and, optionally cardiac glycosides;
treatment of stable chronic heart failure (CHF).
Posology: Treatment of hypertension or AP: the dosage is 5 mg bisoprolol fumarate once
daily which may be increased to 10 mg once daily if necessary. The max. recommended
dose is 20 mg once daily. Treatment of stable CHF: requires a titration phase, starting with a
low dose (1.25 mg once daily) and with gradual up-titration (2.5, 3.75, 5, 7.5, 10 mg once
daily) according to tolerability It is recommended that the treating physician is experienced in
the management of CHF. The max. recommended dose for CHF is 10 mg bisoprolol
fumarate once daily. The treatment with bisoprolol must not be stopped abruptly, since this
might lead to a transitory worsening of condition, especially in patients with ischemic heart
disease or CHF. Special populations: In severe renal impairment (creatinine clearance <20
ml/min) or severe liver function disorders a daily dose of 10 mg bisoprolol fumarate should
not be exceeded and dose titration in patients with CHF and these functional impairments
should be made with particular caution. Use in children cannot be recommended (lack of
experience).
Contraindications: acute heart failure or during episodes of heart failure decompensation,
cardiogenic shock, second or third degree AV block, sick sinus syndrome, sinoatrial block,
symptomatic bradycardia or 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.
Warnings and precautions for use: Cessation of therapy with bisoprolol must not be done
abruptly unless clearly indicated, transitional worsening of heart condition possible.
AP/Hypertension: To be used with caution with accompanying heart failure. CHF: To be
initiated with a special titration phase. Initiation of treatment of stable chronic heart failure
with bisoprolol necessitates regular monitoring. No therapeutic experience in CHF in patients
with: insulin-dependent diabetes mellitus (type I), restrictive cardiomyopathy, congenital heart
disease, haemodynamically significant organic valvular disease, myocardial infarction within
3 months. CHF: No therap. experience in patients with: NYHA class II heart failure, impaired
renal (serum creatinine ≥ 300 micromol/l) and liver function, older than 80 years.
All indications: Must be used with caution in: Diabetes mellitus showing large fluctuations in
blood glucose values, symptoms of hypoglycemia can be masked; strict fasting; ongoing
desensitisation therapy; first degree AV block; Prinzmetal’s angina; peripheral arterial
occlusive disease. Patients with psoriasis or with a history of psoriasis should only be given
beta-blockers (e.g. bisoprolol) after a careful balancing of benefits and risks. Symptoms of
thyrotoxicosis may be masked. In patients with phaeochromocytoma bisoprolol must not be
administered until after alpha-receptor blockade. In patients undergoing general anesthesia,
the anesthesist must be aware of beta-blockade. If it is thought necessary to withdraw beta-
blocker therapy before surgery, this should be done gradually and completed about 48 hours
before anesthesia. 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 there are compelling clinical
reasons for their use. Where such reasons exist, Concor® / Concor® COR may be used with
caution. In bronchial asthma or other chronic obstructive airways diseases; concomitant
bronchodilating therapy is recommended. Increase of the airway resistance may occur in
patients with asthma, therefore the dose of beta2-stimulants may have to be increased. The
ability to drive a vehicle or to use machines may be impaired. This needs to be considered
particularly at start of treatment, upon change of medication, or in conjunction with alcohol.
Important Interactions: Class I antiarrhythmic drugs, Calcium antagonists of the verapamil
type and to a lesser extend of the diltiazem type, Centrally-acting antihypertensive drugs.
Pregnancy and lactation: Bisoprolol is not recommended during pregnancy and lactation.
Adverse reactions: Very common: bradycardia. Common: worsening of pre-existing heart
failure, dizziness, headache, gastrointestinal complaints such as nausea, vomiting,
diarrhoea, constipation; feeling of coldness or numbness in the extremities, hypotension,
asthenia, fatigue. Uncommon: AV-conduction disturbances, worsening of pre-existing heart
failure, bradycardia, bronchospasm in patients with bronchial asthma or a history of
obstructive airway disease, muscle weakness, muscle cramps, asthenia, depression, sleep
disorders. Rare: increased triglycerides, increased liver enzymes (ALAT, ASAT), reduced
tear flow, hearing disorders, allergic rhinitis, hypersensitivity reactions such as pruritus, flush,
rash; hepatitis, erectile dysfunction, nightmare, hallucination. Very rare: conjunctivitis,
alopecia; beta-blockers may provoke or worsen psoriasis or induce psoriasis-like rash.
Frequency not known: syncope.
Overdose: The most common signs expected with overdose of a beta-blocker are
bradycardia, hypotension, bronchospasm, acute cardiac insufficiency and hypoglycaemia.
There is a wide inter-individual variation in sensitivity to one single high dose of bisoprolol
and patients with heart failure are probably very sensitive. If overdose occurs, discontinuation
of bisoprolol treatment and supportive and symptomatic treatment is recommended.
Marketing Authorisation Holder: Merck Healthcare KGaA, Frankfurter Str. 250, 64293
Darmstadt, Germany; www.merckgroup.com)
Date of product information preparation: October 2020
Please refer to local prescribing information as this may vary between countries.