COSYREL FILM-COATED TABLET 10 MG/ 10 MG [SIN15401P]

Product Info

COSYREL FILM-COATED TABLET 10 MG/ 10 MG

[SIN15401P]

4.1 Therapeutic indications

Cosyrel 5 mg/5 mg and Cosyrel 10 mg/5 mg

Cosyrel 5 mg/5 mg and Cosyrel 10 mg/5 mg are indicated as substitution therapy for treatment of hypertension and/or stable coronary artery disease (in patients with a history of myocardial infarction and/or revascularisation) and/or stable chronic heart failure with reduced systolic left ventricular function in adult patients adequately controlled with bisoprolol and perindopril given concurrently at the same dose level.

Cosyrel 5 mg/10 mg and Cosyrel 10 mg/10 mg

Cosyrel 5 mg/10 mg and Cosyrel 10 mg/10 mg are indicated as substitution therapy for treatment of hypertension and/or stable coronary artery disease (in patients with a history of myocardial infarction and/or revascularisation) in adult patients adequately controlled with bisoprolol and perindopril given concurrently at the same dose level.

4.2 Posology and method of administration

Posology

The usual posology is one tablet once daily.
Patients should be stabilized with bisoprolol and perindopril at the same dose level for at least 4 weeks. The fixed-dose combination is not suitable for initial therapy.

For patients stabilized with bisoprolol 2.5 mg and perindopril 2.5 mg: one half 5 mg/5 mg tablet once daily.

If a change of posology is required, titration should be done with the individual components.

Special population

Renal impairment (see section 4.4 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)
In patients with renal impairment, the recommended dose of Cosyrel 5 mg/5 mg should be based on creatinine clearance as outlined in table 1 below:

Hepatic impairment (see section 4.4 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)
No dosage adjustment is necessary in patients with hepatic impairment.

Elderly
Cosyrel should be administered according to the renal function.

Paediatric population
The safety and efficacy of Cosyrel in children and adolescents have not been established. No data are available. Therefore, use in children and adolescents is not recommended.

Method of administration

Cosyrel tablet should be taken as a single dose once daily in the morning before a meal.

4.3 Contraindications

• Hypersensitivity to the active substances, or to any of the excipients listed in section 6.1, or to any other angiotensin converting enzyme (ACE) inhibitor – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information

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

• Cardiogenic shock

• Second or third degree AV block (without pacemaker)

• Sick sinus syndrome

• Sinoatrial block

• Symptomatic bradycardia

• Symptomatic hypotension

• Severe bronchial asthma or severe chronic obstructive pulmonary disease

• Severe forms of peripheral arterial occlusive disease or 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

• History of angioedema associated with previous ACE inhibitor therapy

• Hereditary or idiopathic angioedema

• Second and third trimesters of pregnancy (see sections 4.4 and 4.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

• Concomitant use of Cosyrel with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73m²) (see sections 4.4, 4.5 and 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Concomitant use with sacubitril/valsartan therapy, Cosyrel must not be initiated earlier than 36 hours after the last dose of sacubitril/valsartan (see sections 4.4 and 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information),

• Extracorporeal treatments leading to contact of blood with negatively charged surfaces (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information),

• Significant bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).