COSYREL FILM-COATED TABLET 5 mg/ 5 mg

Les Laboratoires Servier Industrie [LSI] (FRANCE)🇸🇬 Health Sciences Authority

Approval Date: Dec 28, 2017
Approval ID: bb24c592b0d3f284
Company: Les Laboratoires Servier Industrie [LSI] (FRANCE)
Type: Therapeutic

Approval Details

Approval Id: bb24c592b0d3f284
Drug Name: COSYREL FILM-COATED TABLET 5 mg/ 5 mg
Product Name: COSYREL FILM-COATED TABLET 5 mg/ 5 mg
Approval Number: SIN15398P
Approval Date: 2017-12-28
Registrant: SERVIER (S) PTE LTD
Licence Holder: SERVIER (S) PTE LTD
Drug Type: Therapeutic
Forensic Classification: Prescription Only
Dosage Form: TABLET, FILM COATED
Dosage: 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: <img src="/TGIF/Cosyrel-Table1.png" alt="Cosyrel Dosage Table 1" /> 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.
Route Of Administration: ORAL
Indication Info: 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.
Contraindications: 4.3 Contraindications <ul> <li>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</li> <li>Acute heart failure or during episodes of heart failure decompensation requiring i.v. inotropic therapy</li> <li>Cardiogenic shock</li> <li>Second or third degree AV block (without pacemaker)</li> <li>Sick sinus syndrome</li> <li>Sinoatrial block</li> <li>Symptomatic bradycardia</li> <li>Symptomatic hypotension</li> <li>Severe bronchial asthma or severe chronic obstructive pulmonary disease</li> <li>Severe forms of peripheral arterial occlusive disease or severe forms of Raynaud's syndrome</li> <li>Untreated phaeochromocytoma (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)</li> <li>Metabolic acidosis</li> <li>History of angioedema associated with previous ACE inhibitor therapy</li> <li>Hereditary or idiopathic angioedema</li> <li>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)</li> <li>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).</li> <li>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),</li> <li>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),</li> <li>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).</li> </ul>
Atc Code: C09BX02
Atc Item Name: perindopril and bisoprolol
Pharma Manufacturer Name: SERVIER (S) PTE LTD

Active Ingredients

Bisoprolol 4.24 mg eqv bisoprolol fumarate

5 mg

Perindopril 3.395 mg eqv perindopril arginine

5 mg

BISOPROLOL 4.24 MG EQV BISOPROLOL FUMARATE

5 MG

PERINDOPRIL 3.395 MG EQV PERINDOPRIL ARGININE

5 MG

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Dec 28, 2017

Approval ID

bb24c592b0d3f284

Type

Therapeutic

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