TRIVERAM FILM-COATED TABLET 40 MG/10 MG/10 MG [SIN15430P]

Product Info

TRIVERAM FILM-COATED TABLET 40 MG/10 MG/10 MG

[SIN15430P]

4.1 Therapeutic indications

Triveram is indicated for the treatment of essential hypertension and/or stable coronary artery disease, in association with primary hypercholesterolaemia or mixed hyperlipidaemia, as substitution therapy in adult patients adequately controlled with atorvastatin, perindopril and amlodipine given concurrently at the same dose level as in the combination, but as separate products.

4.2 Posology and method of administration

Posology

The usual posology is one tablet once daily.

The fixed dose combination is not suitable for initial therapy.
If a change of posology is required, titration should be done with the individual components.

Co-administration with other medicines (see sections 4.4 and 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)
In patients taking hepatitis C antiviral agents elbasvir/grazoprevir or letermovir for cytomegalovirus infection prophylaxis concomitantly with Triveram the dose of atorvastatin in Triveram should not exceed 20 mg/day.

Use of Triveram is not recommended in patients taking letermovir coadministered with ciclosporin.

Renal impairment (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)
Triveram can be administered in patients with creatinine clearance ≥ 60mL/min, and is not suitable for patients with creatinine clearance < 60mL/min. In these patients, an individual dose titration with the monocomponents is recommended.

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)
Elderly can be treated with Triveram according to the renal function.

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)
Triveram should be used with caution in patients with hepatic impairment. Triveram is contraindicated in patients with active liver disease.

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

Method of administration
Oral use.
Triveram 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 other ACE inhibitor or dihydropyridine derivatives or statin or to any of the excipients of this medicinal product listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information;

• Active liver disease or unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal;

• During pregnancy, while breast-feeding and in women of child-bearing potential not using appropriate contraceptive measures (see section 4.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information);

• Concomitant use with the hepatitis C antivirals glecaprevir/pibrentasvir;

• Severe hypotension;

• Shock (including cardiogenic shock);

• Obstruction of the outflow tract of the left ventricle (e.g., hypertrophic obstructive cardiomyopathy and high grade aortic stenosis);

• Haemodynamically unstable heart failure after acute myocardial infarction;

• History of angioedema (Quincke’s oedema) associated with previous ACE inhibitor therapy;

• Hereditary or idiopathic angioedema;

• Concomitant use 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. Triveram 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).