CONCOR AMLO TABLET 5 MG/ 5 MG [SIN15033P]

Product Info

CONCOR AMLO TABLET 5 MG/ 5 MG

[SIN15033P]

4.1 Therapeutic indications

Concor® AMLO is indicated for treatment of hypertension as substitution therapy in patients adequately controlled with the individual products given concurrently at the same doses level as in the combination, but as separate tablets.

4.2 Posology and method of administration

Concor® AMLO is indicated in patients whose blood pressure is adequately controlled with separately administered monocomponent preparations of the same doses as the recommended fixed dose combination.

Recommended daily dose is one tablet of the given strength.

Treatment must not be abruptly discontinued, as it may lead to temporary deterioration of clinical condition. Treatment must not be abruptly discontinued especially in case of patients suffering from ischaemic heart disease. Gradual decrease of the dose is recommended.

Patients with hepatic impairment:
In case of hepatic impairment elimination of amlodipine may be elongated. Exact dosage recommendations concerning amlodipine have not been established, but the drug should therefore be administered with special caution in these patients (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

In case of severe hepatic impairment the daily dose of bisoprolol must not exceed 10mg.

Patients with renal impairment:
No dosage adjustment is required for patients with mild to moderate renal impairment.

Amlodipine is not dialyzable. Amlodipine should be administered with particular caution to patients undergoing dialysis (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

In case of severe renal impairment (creatinine clearance < 20ml/min) the daily dose of bisoprolol must not exceed 10mg.

Elderly patients:
The usual doses can be administered to elderly people; however, caution is advised when the dose is increased (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Paediatric population:
The safety and efficacy of Concor® AMLO in children and adolescents below the age of 18 years have not been established. No data are available.

Method of administration
Concor® AMLO should be taken in the morning with or without food, without chewing it.

4.3 Contraindications

In connection with amlodipine:

• Severe hypotension

• Shock (including cardiogenic shock)

• Obstruction of the outflow tract of the left ventricle (e.g. high grade aortic stenosis)

• Haemodynamically unstable heart failure after acute myocardial infarction

In connection with bisoprolol:

• Acute heart failure or during episodes of heart failure requiring i.v. inotropic therapy

• Cardiogenic shock

• Second or third degree AV block (without a pacemaker)

• Sick sinus syndrome

• Sinoatrial block

• Bradycardia (heart rate less than 60 beats/min) prior to start of therapy

• Hypotension (systolic blood pressure < 100mmHg)

• Severe bronchial asthma

• Severe forms of peripheral arterial occlusive disease and severe forms of Raynaud’s syndrome

• Untreated phaeochromocytoma (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

• Metabolic acidosis

In connection with Concor® AMLO:

• Hypersensitivity to amlodipine, dihydropyridine derivates, bisoprolol and/or any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.