LERCANIDIPINE HYDROCHLORIDE

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 Lercanidipine Hydrochloride to therapy with a beta- adrenoreceptor 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 people:

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 lercanidipine in children up to 18 years have not been established.

No data are available. Patients with renal and hepatic impairment 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 contraindicatedin patients with severe hepatic impairment or severe renal impairment (Glomerular Filtration Rate (GFR) < 30 ml/min).

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Method of administration:

For oral use.

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. 5).

Summary of safety profile The safety of lercanidipine at a dose of 10-20 mg once daily has been evaluated in double- blind, placebo-controlled clinical trials (with 1200 patients receiving lercanidipine and 603 patients receiving placebo) and in active-controlled and uncontrolled long term clinical trials on a total of 3676 hypertensive patients receiving lercanidipine.

The most commonly reported adverse reactions in clinical trials and in the post- marketing experience are: peripheral oedema, headache, flushing, tachycardia and palpitations. Tabulated list of adverse reactions In the table below, adverse reactions reported in clinical trials and in the worldwide post- marketing experience for which a reasonable causal relationship exists are listed by MedDRA system organ class and frequency: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from available data).

Within each frequency grouping the observed adverse reactions are presented in order of decreasing seriousness. 83% with placebo. This frequency reached 2% in the overall study population including long term clinical trials. Lercanidipine does not appear to influence adversely blood sugar or serum lipid levels.

Some dihydropyridines may rarely lead to precordial pain or angina pectoris. Very rarely patients with pre-existing angina pectoris may experience increased frequency, duration or severity of these attacks. Isolated cases of myocardial infarction may be observed.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Sick-sinus syndrome Lercanidipine should be administered with caution in patients with sick sinus syndrome (without a pacemaker). Left ventricular dysfunction and ischaemic heart disease Although hemodynamic controlled studies revealed no impairment of ventricular function, care is also required in patients with left ventricular dysfunction.

It has been suggested that some short-acting dihydropyridines may be associated with increased cardiovascular risk in patients with ischaemic heart disease. Although Lercanidipine Hydrochloride is long-acting caution is required in such patients.

Some dihydropyridines (like for example amlodipine, felodipine, nifedipine, etc) may rarely lead to precordial pain or angina pectoris. Very rarely patients with pre-existing angina pectoris may experience increased frequency, duration or severity of these attacks.

8). Use in renal or hepatic impairment Special care should be exercised when treatment is commenced in patients with mild to moderate renal or impairment. Although the usual recommended dose of 10mg dailymay be tolerated by, an increase to 20 mg daily must be approached with caution.

The antihypertensive effect may be enhanced in patients with moderate hepatic impairment and consequently an adjustment of the dosage should be considered. 3). Peritoneal Dialysis Lercanidipine has been associated with the development of cloudy peritoneal effluent in patients on peritoneal dialysis.

The turbidity is due to an increased triglyceride concentration in the peritoneal effluent. Whilst the mechanism is unknown, the turbidity tends to resolve soon after withdrawal of lercanidipine. This is an important association to recognise as cloudy peritoneal effluent can be mistaken for infective peritonitis with consequential unnecessary hospitalisation and empiric antibiotic administration.

5). g. 5). Paediatric population The safety and efficacy of lercanidipine has not been demonstrated in children. Excipient This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

1. • Left ventricular outflow tract obstruction. • Untreated congestive cardiac failure. • Unstable angina pectoris or recent (within 1 month) myocardial infarction. • Severe hepatic impairment. 5).