TANATRIL Tablet Ref.[8910] Active ingredients: Imidapril

Posology

Adults

Treatment should be initiated with 5 mg once a day.

If optimum control of blood pressure has not been achieved after at least 3 weeks of treatment, the daily dose should be increased to 10 mg, which has been determined to be the most effective daily dose.

However, in a small number of patients it might be necessary to increase the daily dose to 20 mg (recommended maximum dose) or preferably, to consider combination therapy with a diuretic.

It has not been assessed whether hypertensive patients would benefit from a combination of imidapril with other antihypertensive therapies.

(See sections 4.3, 4.4, 4.5 and 5.1).

Older people (65 years or older)

The initial dose is 2.5 mg once a day. The dose should be titrated according to blood pressure response. The recommended maximum dose is 10 mg once a day.

Patients with renal impairment

Imidapril and its pharmacologically active metabolite, imidaprilat, are predominantly excreted via the kidney.

Renal function should be evaluated before commencing therapy with imidapril in patients suspected of renal impairment.

Creatinine clearance may be determined prior to treatment by using the formula of COCKROFT & GAULT (Nephron 1976; 16: 31-41):

Cl_Crea = (140 - ηλικία [έτη]) x σωματικό βάρος [kg] / 72 x κρεατινίνη ορού [mg/dl]

(for women the resulting value will be multiplied with 0.85; if the unit µmol/l is used instead of mg/dl, 72 will be replaced by 0.813)

Creatinine clearance between 30 ml/min and 80 ml/min (see section 4.4)

Reduced doses are required for these patients and therefore it is recommended that treatment be initiated with 2.5 mg.

Creatinine clearance between 10 ml/min and 29 ml/min (see section 4.4)

Because of limited experience which has shown an increase in the AUC of imidaprilat (see section 5.2), imidapril should not be administered to these patients.

Creatinine clearance below 10 ml/min (renal failure with or without haemodialysis)

The drug is contraindicated in these patients (see section 4.3).

Patients with hepatic impairment

The recommended starting dose in patients with hepatic impairment is 2.5 mg once a day. Imidapril should be used with caution in patients with hepatic impairment.

Patients at increased risk for first dose hypotension

First dose hypotension may occur in high risk patients (see section 4.4). Initiation of therapy requires, if possible, correction in salt and/or body fluids deficiencies, and discontinuation of an existing diuretic therapy for two to three days before ACE inhibition. If this is not possible, initial dose should be imidapril 2.5 mg. In hypertensive patients with concomitant cardiac failure symptomatic hypotension has been observed after treatment with ACE inhibitors.

In these patients the initial dose should be 2.5 mg imidapril once a day under close medical supervision. Patients at high risk for severe acute first dose hypotension should be monitored medically, preferably in hospital, for up to 6-8 hours after administration of the first dose of imidapril and whenever the dose of imidapril or a concomitant diuretic is increased. The initial dose should be 2.5 mg. This also applies to patients with angina pectoris and cerebrovascular disease. These patients are at increased risk to experience myocardial infarction or cerebrovascular accident following excessive hypotension.

Paediatric population

The safety and efficacy of Tanatril in children have not been established. No data are available.

Method of administration

It is recommended that the tablets be taken at about the same time of day about 15 minutes before meals, conditions under which efficacy has been demonstrated.

Symptoms of overdosage are severe hypotension, shock, stupor, bradycardia, electrolyte disturbances and renal failure.

After ingestion of an overdose, the patient should be kept under close supervision, preferably in an intensive care unit. Serum electrolytes and creatinine should be monitored frequently. Therapeutic measures depend on the nature and severity of the symptoms. Measurements to prevent absorption and hasten elimination such as gastric lavage, administration of adsorbents and sodium sulfate within 30 minutes after intake should be applied if ingestion is recent.

If hypotension occurs, the patient should be placed in the shock position and salt and volume supplementation should be given rapidly. Treatment with angiotensin II should be considered. Bradycardia or extensive vagal reactions should be treated by administering atropine. The use of a pacemaker may be considered. Imidapril and imidaprilat may be removed from the circulation by haemodialysis. The use of high-flux polyacrylonitrile membranes should be avoided.

3 years.

Aluminium/aluminium blister. Do not store above 30°C.

PVDC/aluminium blister. Do not store above 25°C.

Aluminium/aluminium or PVDC/aluminium – Blister with 5, 7 and 10 tablets.

Packs with 7, 10, 14, 15, 20, 28, 30, 50, 56, 84, 90, 100, and 1000 tablets

Not all packaging material or pack sizes may be marketed.

No special requirements.