COVERSYL 5MG TABLET [SIN13494P]

Product Info

COVERSYL 5MG TABLET

[SIN13494P]

4.1 Therapeutic indications

Coversyl 5 mg and 10 mg

Hypertension
Treatment of hypertension

Stable coronary artery disease
Reduction of risk of cardiac events in patients with a history of myocardial infarction and/or revascularisation.

Coversyl 5 mg

Heart failure
Treatment of symptomatic heart failure

4.2 Posology and method of administration

Method of administration

For oral use.
COVERSYL is recommended to be taken once daily in the morning before a meal.

Posology
The dose should be individualised according to the patient profile (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) and blood pressure response.

Hypertension
COVERSYL may be used in monotherapy or in combination with other classes of antihypertensive therapy (see sections 4.3, 4.4, 4.5 and 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

The recommended starting dose is 5 mg given once daily in the morning.

Patients with a strongly activated renin-angiotensin-aldosterone system (in particular, renovascular hypertension, salt and/or volume depletion, cardiac decompensation or severe hypertension) may experience an excessive drop in blood pressure following the initial dose. A starting dose of 2.5 mg is recommended in such patients and the initiation of treatment should take place under medical supervision.

The dose may be increased to 10 mg once daily after one month of treatment.

Symptomatic hypotension may occur following initiation of therapy with COVERSYL; this is more likely in patients who are being treated concurrently with diuretics. Caution is therefore recommended since these patients may be volume and/or salt depleted.

If possible, the diuretic should be discontinued 2 to 3 days before beginning therapy with COVERSYL (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

In hypertensive patients in whom the diuretic cannot be discontinued, therapy with COVERSYL should be initiated with a 2.5 mg dose. Renal function and serum potassium should be monitored. The subsequent dosage of COVERSYL should be adjusted according to blood pressure response. If required, diuretic therapy may be resumed.

In elderly patients treatment should be initiated at a dose of 2.5 mg which may be progressively increased to 5 mg after one month then to 10 mg if necessary depending on renal function (see table below).

Symptomatic heart failure:
It is recommended that COVERSYL, generally associated with a non-potassium-sparing diuretic and/or digoxin and/or a beta blocker, be introduced under close medical supervision with a recommended starting dose of 2.5 mg taken in the morning. This dose may be increased after 2 weeks to 5 mg once daily if tolerated. The dose adjustment should be based on the clinical response of the individual patient.

In severe heart failure and in other patients considered to be at high risk (patients with impaired renal function and a tendency to have electrolyte disturbances, patients receiving simultaneous treatment with diuretics and/or treatment with vasodilating agents), treatment should be initiated under careful supervision (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Patients at high risk of symptomatic hypotension e.g. patients with salt depletion with or without hyponatraemia, patients with hypovolaemia or patients who have been receiving vigorous diuretic therapy should have these conditions corrected, if possible, prior to therapy with COVERSYL. Blood pressure, renal function and serum potassium should be monitored closely, both before and during treatment with COVERSYL (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Stable coronary artery disease:
COVERSYL should be introduced at a dose of 5 mg once daily for two weeks, then increased to 10 mg once daily, depending on renal function and provided that the 5 mg dose is well tolerated.

Elderly patients should receive 2.5 mg once daily for one week, then 5 mg once daily the next week, before increasing the dose up to 10 mg once daily depending on renal function (see Table 1 “Dosage adjustment in renal impairment”). The dose should be increased only if the previous lower dose is well tolerated.

Special population

Patients with renal impairment
Dosage in patients with renal impairment should be based on creatinine clearance as outlined in Table 1 below:

Patients with hepatic impairment
No dosage adjustment is necessary in patients with 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)

Paediatric population
The efficacy and safety of use in children and adolescents (less than 18 years) have not been established. Therefore, use in children and adolescents is not recommended.

4.3 Contraindications

• Hypersensitivity to the active substance, 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 or to any other ACE inhibitor;

• History of angioedema associated with previous ACE inhibitor therapy;

• Hereditary or 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);

• Concomitant use of COVERSYL 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. COVERSYL 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).