LERCARIL 10 mg/10 mg Film-coated tablet Ref.[51631] Active ingredients: Enalapril Enalapril and Lercanidipine Lercanidipine

Patients whose blood pressure is not adequately controlled by lercanidipine 10 mg alone could either be titrated up to lercanidipine 20 mg monotherapy or switched to fixed combination Lercaril 10 mg/10 mg.

Individual dose titration with the components can be recommended. When clinically appropriate, direct change from monotherapy to the fixed combination may be considered.

Posology

The recommended dose is one tablet once a day at least 15 minutes before meals.

Elderly

The dose should depend on the patient’s renal function (see “Use in renal impairment”).

Renal impairment

Lercaril is contraindicated in patients with severe renal dysfunction (creatinine clearance <30 ml/min) or in patients undergoing haemodialysis (see section 4.3 and 4.4). Particular caution is needed when initiating treatment in patients with mild to moderate renal dysfunction.

Hepatic impairment

Lercaril is contraindicated in severe hepatic dysfunction. Particular caution is needed when initiating treatment in patients with mild to moderate hepatic dysfunction.

Paediatric population

There is no relevant use of Lercaril in the paediatric population for the indication of hypertension.

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 be administered with grapefruit juice (see section 4.3 and 4.5).

In the post-marketing experience, some cases of intentional overdose requiring hospitalization were reported with administration of enalapril/lercanidipine at doses from 100 up to 1000 mg each. The reported symptoms (blood pressure systolic decreased, bradycardia, restlessness, somnolence and flank pain) could also be due to the concomitant administration of high doses of other drugs (e.g. beta-blockers).

Symptoms of overdose with enalapril and lercanidipine alone

The most prominent features of overdose reported with enalapril to date are marked hypotension (beginning some six hours after ingestion of the tablets), concomitant with blockade of the renin-angiotensin system, and stupor. Symptoms associated with overdose of ACE-inhibitors may include circulatory shock, electrolyte disturbances, renal failure, hyperventilation, tachycardia, palpitations, bradycardia, dizziness, anxiety and cough. Serum enalaprilat levels 100- and 200-fold higher than usually seen after therapeutic doses have been reported after ingestion of 300 mg and 440 mg of enalapril respectively.

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.

Treatment of cases of overdose with enalapril and lercanidipine alone

The recommended treatment of overdosage with enalapril is intravenous infusion of saline solution. If hypotension occurs, the patients should be placed in the shock position. If available, treatment with angiotensin II infusion and/or intravenous catecholamines may also be considered. If the tablets were ingested recently, measures to eliminate enalapril maleate should be taken (e.g. vomiting, gastric lavage, administration of absorbents or sodium sulfate). Enalaprilat can be removed from the circulation by haemodialysis (see section 4.4). Pacemaker therapy is indicated for therapy-resistant bradycardia. Vital signs, serum electrolytes and creatinine concentrations should be continuously monitored.

With lercanidipine, 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.

2 years.

Store in the original package in order to protect from light and moisture. Do not store above 25°C.

Polyamide-aluminium-PVC/aluminium blister.

Packs of 7, 14, 28, 30, 35, 42, 50, 56, 90, 98 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.