Regulatory Information
SERVIER (S) PTE LTD
SERVIER (S) PTE LTD
Therapeutic
Prescription Only
Formulation Information
TABLET, FILM COATED
**4.2 Posology and method of administration** Posology One Triplixam film-coated 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 the posology is required, titration should be done with the individual components. Special population _Renal impairment (see section 4.3 and 4.4_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _)_ In severe renal impairment (creatinine clearance below 30 mL/min), treatment is contraindicated. In patients with moderate renal impairment (creatinine clearance 30–60 mL/min), Triplixam at the doses 10mg/2.5mg /5mg and 10mg/2.5mg/10mg is contraindicated. It is recommended to start treatment with the adequate dosage of the free combination. Usual medical follow-up will include frequent monitoring of creatinine and potassium. Concomitant use of perindopril with aliskiren-containing products is contraindicated in patients with renal impairment (GFR < 60 ml/min/1.73 m2) (see section 4.3). _Hepatic impairment (see sections 4.3, 4.4 and 5.2_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _)_ In severe hepatic impairment, Triplixam is contraindicated. In patients with mild to moderate hepatic impairment, Triplixam should be administrated with caution, as dosage recommendations for amlodipine in these patients have not been established. _Elderly (see section 4.4_ – _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 (see section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Elderly can be treated with Triplixam according to renal function (see section 4.3). _Paediatric population_ The safety and efficacy of Triplixam in children and adolescents have not been established. No data are available. Method of administration Oral use.
ORAL
Medical Information
**4.1 Therapeutic indications** Triplixam is indicated as substitution therapy for treatment of essential hypertension, in patients already controlled with perindopril/indapamide fixed dose combination and amlodipine, taken at the same dose level.
**4.3 Contraindications** - Dialysis patients - Patients with untreated decompensated heart failure - Severe renal impairment (creatinine clearance below 30 mL/min) - Moderate renal impairment (creatinine clearance below 60 mL/min) for Triplixam doses containing 10mg/2.5mg of perindopril/indapamide combination (i.e., Triplixam 10mg/2.5mg/5mg and 10mg/2.5mg/10mg) - Hypersensitivity to the active substances, to other sulfonamides, to dihydropyridine derivatives, any other ACE-inhibitor or 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_ - History of angioedema (Quincke’s oedema) associated with previous ACE inhibitor therapy (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_) - Hereditary/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_) - Hepatic encephalopathy - Severe hepatic impairment - Hypokalaemia - 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 - Concomitant use of Triplixam with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR < 60mL/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, Triplixam 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_)
C09BX01
perindopril, amlodipine and indapamide
Manufacturer Information
SERVIER (S) PTE LTD
Servier (Ireland) Industries Ltd. [SII]
Active Ingredients
Documents
Package Inserts
Triplixam Film Coated Tablet PI.pdf
Approved: March 21, 2023