PREXUM Film-coated tablet Ref.[50301] Active ingredients: Perindopril

Hypertension

The usual starting dose is one PREXUM 5 tablet once daily, taken in the morning. Optimum control of blood pressure is achieved by increasing the dose, titrating it against the blood pressure to a maximum of one PREXUM 10 tablet once daily.

A starting dose of one PREXUM 2.5 tablet once daily is recommended in the following patients who may be at risk of ACE inhibitor-induced hypotension:

Combination with a Diuretic

The administration of PREXUM to patients under current treatment with a diuretic may induce hypotension and sometimes, but more rarely, acute renal failure, at the beginning of the treatment. Monitoring of plasma creatinine is recommended during the first month of treatment.

Elderly patients with hypertension

Elderly patients with hypertension should start treatment with one PREXUM 2.5 tablet once daily, with titration to one PREXUM 5 tablet once daily if necessary. It is recommended that renal function be assessed before starting treatment.

Other patients who may be at risk of ACE inhibitor-induced hypotension

Patients with renovascular hypertension, salt and/or volume depletion, or cardiac decompensation may have a strongly activated RAAS. These patients may experience an excessive drop in blood pressure following the first dose of an ACE inhibitor.

Congestive Heart Failure

Treatment of congestive heart failure with PREXUM should be initiated under close medical supervision.

The usual starting dose is one PREXUM 2.5 tablet once daily which should be given with a diuretic and/or digitalis. This is increased to one PREXUM 5 tablet once daily for maintenance.

Patients with severe hepatic or renal impairment and/or severe salt/volume depletion are particularly sensitive to ACE inhibitors. Doses in these patients should be carefully titrated as no pharmacokinetic and dose titration studies have been conducted.

Reduction of risk of cardiovascular events

For stable coronary artery disease, the starting dose is one PREXUM 5 tablet once daily for two weeks, and then increased to one PREXUM 10 tablet once daily, depending on tolerance and renal function.

Elderly patients should receive one PREXUM 2.5 tablet once daily for one week, then one PREXUM 5 tablet once daily the next week, before increasing the dose up to one PREXUM 10 tablet once daily depending on tolerance and renal function (see Table 1 under Patients with Renal impairment heading).

Elderly Patients

Renal insufficiency is commonly observed in elderly people. Care should therefore be taken when prescribing PREXUM to elderly patients. The initial dose of PREXUM should always be one PREXUM 2.5 tablet once daily and patients should be monitored closely during the initial stages of treatment (see section 4.4 – Special warnings and precautions for use).

Particular care should be taken in elderly patients with congestive heart failure who have renal and/or hepatic insufficiency.

Patients with renal impairment

In patients with renal failure, treatment should be initiated with one PREXUM 2.5 tablet once daily. The dose should be adjusted as indicated below (see Table 1) according to creatinine clearance. Creatinine and potassium levels should be closely monitored.

Table 1. Dose adjustment according to creatinine clearance:

Patients with hepatic impairment

The small changes in the kinetics of perindoprilat do not justify the need to change the usual dose in most patients with hepatic failure (see section 4.4 – Special warnings and precautions for use).

Food

Food intake may reduce hepatic biotransformation of perindopril to perindoprilat. Whilst this effect has not been shown to be clinically significant, it is recommended that PREXUM be taken before meals.

For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

Limited data are available for overdose in humans. Symptoms associated with overdose of ACE inhibitors may include hypotension, circulatory shock, electrolyte disturbances, renal failure, hyperventilation, tachycardia, palpitations, bradycardia, dizziness, anxiety, and cough. The recommended treatment of overdose is intravenous infusion of normal saline solution. If hypotension occurs, the patient should be placed in the shock position. If available, treatment with intravenous catecholamines may also be considered. Perindopril may be removed from the general circulation by haemodialysis (see section 4.4 – Special warnings and precautions for use). Vital signs, serum electrolytes and creatinine concentrations should be monitored continuously.

3 years.

Store in a dry place below 30°C.

Thirty (30) tablets supplied in a white HDPE bottle equipped with a white induction-sealed child resistant-closure and desiccant sachets. PREXUM 5 only, is also supplied in a 10-tablet bottle.

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.