LERCARIL 20 mg/10 mg Film-coated tablet Ref.[51632] Active ingredients: Enalapril Enalapril and Lercanidipine Lercanidipine

Source: Health Products Regulatory Authority (IE)  Revision Year: 2021  Publisher: Recordati Ireland Limited, Raheens East, Ringaskiddy, Co. Cork, Ireland

Product name and form

Lercaril 20 mg/10 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Yellow, circular, biconvex tablets of 8.5 mm.

Qualitative and quantitative composition

Each film-coated tablet contains 20 mg enalapril maleate (equivalent to 15.29 mg enalapril) and 10 mg lercanidipine hydrochloride (equivalent to 9.44 mg lercanidipine).

Excipients with known effect: each tablet contains 92.0 mg lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Enalapril

Enalapril is hydrolysed via hepatic CES 1 to the active metabolite enalaprilat, which acts as an ACE inhibitor. ACE is a peptidyl dipeptidase which catalyses the conversion of angiotensin I to the vasoconstrictor substance angiotensin II and hence inhibition of ACE results in decreased plasma angiotensin II. This also leads to increased plasma renin activity and decreased aldosterone secretion. The mechanism of action of enalapril is therefore primarily via the suppression of the RAAS. However, ACE is identical to kininase II, and so enalapril may also exert its effects by blocking the degradation of bradykinin, a potent vasodepressor peptide.

Enalapril and Lercanidipine

Fixed combination of an ACE-inhibitor, enalapril, and a calcium channel blocker, lercanidipine, two antihypertensive compounds with complementary mechanism of action to control blood pressure in patients with essential hypertension. The combination of these substances has an additive antihypertensive effect, reducing blood pressure to a greater degree than either component alone.

Lercanidipine

Lercanidipine is a calcium antagonist of the dihydropyridine group and inhibits the transmembrane influx of calcium into cardiac and smooth muscle. The mechanism of its antihypertensive action is due to a direct relaxant effect on vascular smooth muscle thus lowering total peripheral resistance.

List of Excipients

Core:

Lactose monohydrate
Cellulose microcrystalline
Sodium starch glycolate type A
Povidone K30
Sodium hydrogen carbonate
Magnesium stearate

Film-Coating:

Hypromellose 5 cP
Titanium dioxide (E171)
Talc
Macrogol 6000
Quinoline yellow aluminium Lake (E104)
Iron oxide yellow (E172)

Pack sizes and marketing

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.

Marketing authorization holder

Recordati Ireland Limited, Raheens East, Ringaskiddy, Co. Cork, Ireland

Marketing authorization dates and numbers

PA1404/002/002

Date of first authorisation: 22nd August 2008
Date of last renewal: 25th July 2011

Drugs

Drug Countries
LERCARIL Estonia, Ireland, Romania

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