ZANIDIP Film-coated tablet Ref.[50868] Active ingredients: Lercanidipine

Posology

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 ZANIDIP to therapy with a beta-adrenoceptor blocking drug (atenolol), a diuretic (hydrochlorothiazide) or an angiotensin converting enzyme inhibitor (captopril or enalapril).

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 patients

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

The safety and efficacy of ZANIDIP in children aged up to 18 years have not been established. No data are available.

Patients with renal or hepatic impairment

Special care should be exercised when treatment is commenced in patients with mild to moderaterenal 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.

ZANIDIP is contraindicated in patients with severe hepatic impairment or in patients with severe renal impairment (GFR <30 ml/min), including patients undergoing dialysis (see sections 4.3 and 4.4).

Method of administration

Precautions to be taken before handling or administering the medicinal product:

• Treatment should be preferably administered in the morning at least 15 minutes before breakfast.
• This product should not been administered with grapefruit juice (see section 4.3 and 4.5).

In the post-marketing experience of lercanidipine, some cases of overdose have been reported ranging from 30-40 mg up to 800 mg, including reports of suicide attempt.

Symptoms

As with other dihydropyridines, lercanidipine overdosage results in excessive peripheral vasodilation with marked hypotension and reflex tachycardia. However, at very high doses, the peripheral selectivity may be lost, causing bradycardia and a negative inotropic effect. The most common ADRs associated to cases of overdose have been hypotension, dizziness, headache and palpitations.

Management

Clinically significant hypotension requires active cardiovascular support including frequent monitoring of cardiac and respiratory function, elevation of extremities and attention to circulating fluid volume and urine output. In view of the prolonged pharmacological effect of lercanidipine, it is essential that the cardiovascular status of the patient is monitored for 24 hours at least. Since the product has a high protein binding, dialysis is not likely to be effective. Patients in whom a moderate to severe intoxication is anticipated should be observed in a high-care setting.

3 years.

Store in the original package in order to protect from light.

Aluminium/opaque PVC blister.

Packs of 14, 28, 35, 50 and 100 tablets.*

^* Not all pack sizes may be marketed

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.