Ethics Enalapril

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Enalapril maleate 5mg;  ;  

Available from:

Multichem NZ Limited

INN (International Name):

Enalapril maleate 5 mg

Dosage:

5 mg

Pharmaceutical form:

Tablet

Composition:

Active: Enalapril maleate 5mg     Excipient: Croscarmellose sodium Hypromellose Lactose monohydrate Maleic acid Sodium stearyl fumarate

Units in package:

Blister pack, PVDC coated PVC/aluminium, 30 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Zhejiang Huahai Pharmaceutical Co Ltd

Therapeutic indications:

All grades of essential hypertension.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVDC coated PVC/aluminium - 30 tablets - 24 months from date of manufacture stored at or below 25°C protect from light - Bottle, plastic, HDPE bottle and screw cap - 100 tablets - 24 months from date of manufacture stored at or below 25°C protect from light

Authorization date:

2013-08-06

Summary of Product characteristics

NEW ZEALAND DATA SHEET
ETHICS ENALAPRIL
Enalapril maleate 5 mg, 10 mg and 20 mg tablets
Page 1 of 13
1.
NAME OF THE MEDICINAL PRODUCT
Ethics Enalapril 5 mg, tablet
Ethics Enalapril 10 mg, tablet
Ethics Enalapril 20 mg, tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of enalapril maleate as the active
ingredient.
Each tablet contains 10 mg of enalapril maleate as the active
ingredient.
Each tablet contains 20 mg of enalapril maleate as the active
ingredient.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Ethics Enalapril Tablets 5 mg are white to off-white, round, flat
faced beveled edge tablets with
breakline on one side and ‘5’ debossed on the other side. Ethics
Enalapril 5mg tablets are not to be
divided.
Ethics Enalapril Tablets 10 mg are white to off white, round, flat
faced, beveled edge tablets with
breakline on one side and ‘10’ debossed on the other side.
Ethics Enalapril Tablets 20 mg are white to off white, round, flat
faced, beveled edge tablets with
breakline embossed on one side and ‘20’ debossed on the other
side.
Ethics Enalapril Tablets is the maleate salt of enalapril, a
derivative of two amino acids, L-alanine and
L-prolin.
Following
oral
administration,
enalapril
is
rapidly
absorbed
and
then
hydrolysed
to
enalaprilat, which is a highly specific, long acting, non-sulphydryl
angiotensin converting enzyme
inhibitor.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of:
•
All grades of essential hypertension
•
Renovascular hypertension
•
All degrees of heart failure
In patients with symptomatic heart failure, Ethics Enalapril is also
indicated to:
•
Improve survival
•
Retard the progression of heart failure
•
Reduce hospitalisation for heart failure
•
Prevention of symptomatic heart failure
In asymptomatic patients with left ventricular dysfunction, Ethics
Enalapril is indicated to:
•
Retard the development of symptomatic heart failure
•
Reduce hospitalisation for heart failure
•
Prevention of coronar