LERCANIDIPINE HYDROCHLORIDE Film-coated tablet Ref.[6938] Active ingredients:

Posology

Route of administration: For oral use.

The recommended dosage is 10 mg orally once a day at least 15 minutes before meals; the dose may be increased to 20 mg depending on the individual patient’s response.

Dose titration should be gradual, because it may take about 2 weeks before the maximal antihypertensive effect is apparent.

Some individuals, not adequately controlled on a single antihypertensive agent, may benefit from the addition of lercandipine to therapy with a beta-adrenoreceptor blocking drug, a diuretic (hydrochlorothiazide) or an angiotensin converting enzyme inhibitor.

Since the dose-response curve is steep with a plateau at doses between 20-30 mg, it is unlikely that efficacy will be improved by higher doses; whereas side effects may increase.

Elderly

Although the pharmacokinetic data and clinical experience suggest that no adjustment of the daily dosage is required, special care should be exercised when initiating treatment in the elderly.

Paediatric population

Lercanidipine is not recommended for use in children and adolescents below the age of 18 years as there is no clinical experience.

Renal or hepatic insufficiency

Special care should be exercised when treatment is commenced in patients with mild to moderate renal or hepatic dysfunction. Although the usually recommended dose schedule may be tolerated by these subgroups, an increase in dose to 20 mg daily must be approached with caution. The antihypertensive effect may be enhanced in patients with hepatic impairment and consequently an adjustment of the dosage should be considered.

Lercanidipine is not recommended for use in patients with severe hepatic impairment or with severe renal impairment (creatinine clearance <30 ml/min).

Method of administration

The tablets should be taken with some water at least 15 minutes before a meal.

In the post-marketing experience, three cases of overdose were reported (150 mg, 280 mg and 800 mg of lercanidipine, respectively, ingested in an attempt to commit suicide).

Overdosage might be expected to cause excessive peripheral vasodilatation with marked hypotension and reflex tachycardia. In case of severe hypotension, bradycardia and unconsciousness, cardiovascular support could be helpful, with intravenous atropine for bradycardia.

In view of the prolonged pharmacological effect of lercanidipine, it is essential that the cardiovascular status of patients who take an overdose is monitored for 24 hours at least. There is no information on the value of dialysis. Since the active substance is highly lipophilic, it is most probable that plasma levels are no guide to the duration of the period of risk and dialysis may not be effective.

Blister pack: 2 years.

Tablet container: 3 years.

AL/PVC/PVDC blister: Do not store above 30°C. Store in the original package in order to protect from moisture.

HDPE containers: Store in the original packaging. Keep the container tightly closed in order to protect from moisture.

Blister pack (Aluminium/PVC/PVDC) with push-through foil.

Tablet container (HDPE), closed with a sealed LDPE-cap.

Pack sizes

Blister (AL/PVC/PVDC):

Lercanidipine hydrochloride 10 mg film-coated tablets: 14, 20, 28, 30, 50, 56, 60, 90, 98, 100 film-coated tablets.

Tablet containers:

Lercanidipine hydrochloride 10 mg film-coated tablets: 100 film-coated tablets.

No special requirements.