PERINACE TABLET 4MG [SIN13602P]

Product Info

PERINACE TABLET 4MG

[SIN13602P]

INDICATION(S)
Hypertension:
Treatment of hypertension.
Heart failure:
Treatment of symptomatic heart failure.
Stable coronary artery disease:
Reduction of risk of cardiac events in patients with a history of myocardial infarction and/or revascularisation.

DOSAGE AND ADMINISTRATION
It is recommended that PERINACE is taken once daily in the morning before a meal. The dose should be individualised according to the patient profile and blood pressure response.

Hypertension:
PERINACE may be used in monotherapy or in combination with other classes of antihypertensive therapy
The recommended starting dose is 4 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 mg is recommended in such patients and the initiation of treatment should take place under medical supervision.
The dose may be increased to 8 mg once daily after one month of treatment.
Symptomatic hypotension may occur following initiation of therapy with PERINACE; 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 PERINACE .
In hypertensive patients in whom the diuretic cannot be discontinued, therapy with PERINACE should be initiated with a 2 mg dose. Renal function and serum potassium should be monitored. The subsequent dosage of PERINACE 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 mg which may be progressively increased to 4 mg after one month then to 8 mg if necessary, depending on renal function (see table below).

Symptomatic heart failure:
It is recommended that PERINACE, 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 mg taken in the morning. This dose may be increased after 2 weeks to 4 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.
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 PERINACE. Blood pressure, renal function and serum potassium should be monitored closely, both before and during treatment with PERINACE.

Stable coronary artery disease:
Perinace should be introduced at a dose of 4 mg once daily for two weeks, then increased to 8 mg once daily, depending on renal function and provided that the 4 mg dose is well tolerated.
Elderly patients should receive 2 mg once daily for one week, then 4 mg once daily the next week, before increasing the dose up to 8 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 WARNING(s) AND PRECAUTION(s) and PHARMACOKINETICS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Paediatric population:
The safety and efficacy of perindopril in children and adolescents aged below 18 years have not been established.
Therefore, use in children and adolescents is not recommended.

METHOD OF ADMINISTRATION
Perinace is recommended to be taken once daily in the morning before a meal.

ROUTE OF ADMINISTRATION: Oral

CONTRAINDICATION

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

• History of angioedema associated with previous ACE inhibitor therapy (see WARNING(s) AND PRECAUTION(s) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information);

• Hereditary or idiopathic angioedema;

• Second and third trimesters of pregnancy (see WARNING(s) AND PRECAUTION(s) and USE IN PREGNANCY AND LACTATION – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information);

• Concomitant use of Perinace with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see DRUG INTERACTIONS and PHARMACODYNAMICS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information);

• Concomitant use with sacubitril/valsartan. Perinace must not be initiated earlier than 36 hours after the last dose of sacubitril/valsartan (see WARNING(s) AND PRECAUTION(s) and DRUG INTERACTIONS – 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 DRUG INTERACTIONS – 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 WARNING(s) AND PRECAUTION(s) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.