Regulatory Information
SERVIER (S) PTE LTD
SERVIER (S) PTE LTD
Therapeutic
Prescription Only
Formulation Information
TABLET
**4.2 Posology and method of administration** _Posology_ Oral route. One tablet per day as a single dose, preferably to be taken in the morning and before a meal. The fixed dose combination is not suitable for initial therapy. If a change of posology is required, the dose of Coveram could be modified or individual titration with free combination may be considered. _Special populations_ _Renal impairment and elderly (see sections 4.4 and 5.2_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _)_ Elimination of perindoprilat is decreased in the elderly and in patients with renal failure. Therefore, the usual medical follow-up will include frequent monitoring of creatinine and potassium. Coveram can be administered in patients with Clcr ≥ 60ml/min, and is not suitable for patients with Clcr < 60ml/min. In these patients, an individual dose titration with the monocomponents is recommended. Amlodipine used at similar doses in elderly or younger patients is equally well tolerated. Normal dosage regimens are recommended in the elderly, but increase of the dosage should take place with care. Changes in amlodipine plasma concentrations are not correlated with degree of renal impairment. Amlodipine is not dialysable. _Hepatic impairment (see sections 4.4 and 5.2_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _)_ Dosage recommendations have not been established in patients with mild to moderate hepatic impairment; therefore dose selection should be cautious and should start at the lower end of the dosing range (see sections 4.4 and 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). To find the optimal starting dose and maintenance dose of patients with hepatic impairment, the patients should be individually titrated using the free combination of amlodipine and perindopril. The pharmacokinetics of amlodipine have not been studied in severe hepatic impairment. Amlodipine should be initiated at the lowest dose and titrated slowly in patients with severe hepatic impairment. _Children and adolescents_ Coveram should not be used in children and adolescents as the efficacy and tolerability of perindopril and amlodipine, alone or in combination, have not been established in children and adolescents.
ORAL
Medical Information
**4.1 Therapeutic indications** Coveram is indicated as substitution therapy for treatment of essential hypertension and/or stable coronary artery disease, in patients already controlled with perindopril and amlodipine given concurrently at the same dose level.
**4.3 Contraindications** _**Linked to perindopril**_ - Hypersensitivity to the active substance or to any other ACE inhibitor - History of angioedema associated with previous ACE inhibitor therapy, - Hereditary or idiopathic angioedema, - 2nd and 3rd 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 Coveram with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73m2) (see sections 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. Coveram 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_). **_Linked to amlodipine_** - Severe hypotension, - Hypersensitivity to the active substance or to dihydropyridines derivatives, - 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 (during the first 28 days). **_Linked to Coveram_** All contraindications related to each monocomponent, as listed above, should also apply to the fixed combination of Coveram. - Hypersensitivity to 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_.
C09BB04
perindopril and amlodipine
Manufacturer Information
SERVIER (S) PTE LTD
LES LABORATOIRES SERVIER INDUSTRIE [LSI]
SERVIER (IRELAND) INDUSTRIES LTD. [SII]
Active Ingredients
Documents
Package Inserts
COVERAM PI.pdf
Approved: April 18, 2023