DAPRIL Tablet Ref.[28163] Active ingredients: Lisinopril

Source: Υπουργείο Υγείας (CY)  Revision Year: 2020  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Product name and form

Dapril 5 mg tablets.

Dapril 10 mg tablets.

Dapril 20 mg tablets.

Pharmaceutical Form

Tablet.

Dapril 5 mg tablets are uncoated, peach, round, and convex.

Dapril 10 mg tablets are uncoated, peach, round, and convex.

Dapril 20 mg tablets are uncoated, peach, round, and convex.

Qualitative and quantitative composition

Each Dapril 5 mg tablet contains lisinopril dihydrate equivalent to 5 mg anhydrous lisinopril.

Each Dapril 10 mg tablet contains lisinopril dihydrate equivalent to 10 mg anhydrous lisinopril.

Each Dapril 20 mg tablet contains lisinopril dihydrate equivalent to 20 mg anhydrous lisinopril.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Lisinopril

Lisinopril is a peptidyl dipeptidase inhibitor. It inhibits the angiotensin-converting enzyme (ACE) that catalyses the conversion of angiotensin I to the vasoconstrictor peptide, angiotensin II. Angiotensin II also stimulates aldosterone secretion by the adrenal cortex. Inhibition of ACE results in decreased concentrations of angiotensin II which results in decreased vasopressor activity and reduced aldosterone secretion.

List of Excipients

Dapril tablets 5 mg, 10 mg, and 20 mg also contain mannitol (E421), dicalcium phosphate dihydrate, red iron oxide (E172), maize starch, pregelatinised maize starch, and magnesium stearate.

Pack sizes and marketing

PVC/PVDC-Aluminium blisters of ten tablets. Packs of ten (all strengths), thirty tablets (all stregths) and twenty tablets (20 mg), with a patient information leaflet are available.

Not all pack sizes may be marketed.

Marketing authorization holder

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Marketing authorization dates and numbers

Dapril 5 mg: 13083
Dapril 10 mg: 13084
Dapril 20 mg: 13085

Dapril 5m g: 26/11/1990
Dapril 10 mg: 26/11/1990
Dapril 20 mg: 26/11/1990

Drugs

Drug Countries
DAPRIL Cyprus, Hong Kong, Malta, Singapore

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