EXFORGE HCT TABLET 5MG/160MG/12.5MG [SIN13901P]

Product Info

EXFORGE HCT TABLET 5MG/160MG/12.5MG

[SIN13901P]

INDICATIONS

Treatment of essential hypertension as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of amlodipine, valsartan and hydrochlorothiazide (HCT), taken either as three single-component formulations or as a dual- component and a single-component formulation.

DOSAGE REGIMEN AND ADMINISTRATION

Dosage Regimen

The recommended dose of Exforge HCT is one tablet per day, to be taken preferably in the morning.

Before switching to Exforge HCT, patients should be controlled on stable doses of the monocomponents taken at the same time. The dose of Exforge HCT should be based on the doses of the individual components of the combination at the time of switching.

The maximum recommended dose of Exforge HCT is 10 mg/320 mg/25 mg.

Special populations

Geriatric patients (aged 65 years or above)

No dose adjustment of the starting dose is required for elderly patients aged 65 years or above. Starting with the lowest available dose of amlodipine should be considered. The lowest strength of Exforge HCT contains 5 mg of amlodipine. (See section CLINICAL PHARMACOLOGY – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) Caution, including more frequent monitoring of blood pressure, is recommended in elderly patients, particularly at the maximum dose of Exforge HCT, 10 mg/320 mg/25 mg, since availability data in this patient population are limited.

Paediatric patients (below 18 years)

There is no relevant use of Exforge HCT in the paediatric population (patients below age 18 years) for the indication of essential hypertension.

Renal impairment

Due to the hydrochlorothiazide component, Exforge HCT is contraindicated in patients with anuria (see section CONTRAINDICATIONS) and severe renal impairment (creatinine clearance <30 mL/min) (see section WARNINGS AND PRECAUTIONS and also section CLINICAL PHARMACOLOGY – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). No dosage adjustment is required for patients with mild to moderate renal impairment. Monitoring of potassium levels and creatinine is advised in patients with moderate renal impairment.

Hepatic impairment

Due to the valsartan, hydrochlorothiazide and amlodipine components, Exforge HCT is contraindicated in patients with severe hepatic impairment (see section CONTRAINDICATIONS). In patients with mild to moderate hepatic impairment without cholestasis, the maximum recommended dose is 80 mg valsartan and therefore Exforge HCT is not suitable in this group of patients. Starting with the lowest available dose of amlodipine should be considered. The lowest strength of Exforge HCT contains 5 mg of amlodipine. (See sections CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, CLINICAL PHARMACOLOGY and PHARMACOKINETICS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Heart failure and coronary artery disease

There is limited experience with the use of Exforge HCT, particularly at the maximum dose, in patients with heart failure and coronary artery disease. Caution is advised in patients with heart failure and coronary artery disease, particularly at the maximum dose of Exforge HCT, 10 mg/320mg/25 mg.

Method of administration

Exforge HCT can be taken with or without food. The tablets should be swallowed whole with some water, at the same time of the day and preferably in the morning.

CONTRAINDICATIONS

Known hypersensitivity to amlodipine, valsartan, HCTZ, other sulfonamide derived medicinal products or to any of the excipients.

Pregnancy (see section PREGNANCY, LACTATION, FEMALES AND MALES OF REPRODUCTIVE POTENTIAL – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Because of hydrochlorothiazide, Exforge HCT is contraindicated in patients with severe hepatic impairment, biliary cirrhosis, cholestasis, severe renal impairment (creatinine clearance <30 mL/min), anuria, patients undergoing dialysis, refractory hypokalaemia, hyponatraemia, hypercalcaemia, and symptomatic hyperuricaemia.

The concomitant use of Exforge HCT with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73m²) (see INTERACTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).