KORANDIL Tablet Ref.[28209] Active ingredients: Enalapril

Source: Υπουργείο Υγείας (CY)  Revision Year: 2021  Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Product name and form

Korandil 5 mg tablets.

Korandil 10 mg tablets.

Korandil 20 mg tablets.

Pharmaceutical Form

Tablet.

Korandil 5 mg tablets: White, scored, normal convex, barrel shaped tablets with Remedica’s logo on one side.

Korandil 10 mg tablets: Light red, scored, normal convex, barrel shaped tablets with Remedica’s logo on one side.

Korandil 20 mg tablets: Peach, mottled, normal convex, barrel shaped tablets scored on one side with Remedica’s logo on the other side

The tablet can be divided into equal doses.

Qualitative and quantitative composition

Korandil 5 mg tablets: Each tablet contains 5 mg of enalapril maleate.

Korandil 10 mg tablets: Each tablet contains 10 mg of enalapril maleate.

Korandil 20 mg tablets: Each tablet contains 20 mg of enalapril maleate.

Excipient(s) with known effect:

Korandil 5 mg tablets: This product contains 190.5 mg lactose.

Korandil 10 mg tablets: This product contains 184.9 mg lactose and 0.4 mg Ponceau 4R E124.

Korandil 20 mg tablets: This product contains 174.5 mg lactose.

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.

List of Excipients

Korandil 5 mg tablets:

Lactose
Maleic acid
Zinc Stearate

Korandil 10 mg tablets:

Lactose
Maleic acid
Zinc Stearate
Quinoline Yellow aluminium lake E104
Ponceau 4R aluminium lake E124

Korandil 20 mg tablets:

Lactose
Maleic acid
Zinc Stearate
Yellow Iron Oxide E172
Red Iron Oxide E172

Pack sizes and marketing

Korandil 5 mg tablets: PVC/PVDC-Aluminium blisters. Pack sizes of 30, 50 and 100 tablets.

Korandil 10 mg tablets: PVC/PVDC-Aluminium blisters. Pack sizes of 30, 50 and 100 tablets.

Korandil 20 mg tablets: PVC/PVDC-Aluminium blisters. Pack sizes of 10, 30 and 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Marketing authorization dates and numbers

Korandil 5 mg tablets: 12841
Korandil 10 mg tablets: 12842
Korandil 20 mg tablets: 12843

Korandil 5 mg tablets:

Date of first authorization: 25 July 1990
Date of latest renewal: 12 July 2012

Korandil 10 mg tablets:

Date of first authorization: 25 July 1990
Date of latest renewal: 05 June 2013

Korandil 20 mg tablets:

Date of first authorization: 25 July 1990
Date of latest renewal: 12 July 2012

Drugs

Drug Countries
KORANDIL Cyprus, Malta, Singapore

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