ALAPREN Tablet Ref.[50543] Active ingredients: Enalapril

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2022  Publisher: Ranbaxy Pharmaceuticals (Pty) Ltd, 14 Lautre Road, Stormill, Ext. 1, Roodepoort, 1724, South Africa

Product name and form

ALAPREN 5 TABLETS.

ALAPREN 10 TABLETS.

ALAPREN 20 TABLETS.

Pharmaceutical Form

Tablet.

ALAPREN 5 TABLETS: White to off-white round, biconvex uncoated tablets debossed with ‘5’ on one side and plain on other side.

ALAPREN 10 TABLETS: Pink, round biconvex uncoated tablets debossed with ‘10 ’ on one side and plain on other side.

ALAPREN 20 TABLETS: Peach coloured round, biconvex, uncoated tablets debossed with ‘20 ’ on one side and plain on other side.

Qualitative and quantitative composition

ALAPREN 5 TABLETS

Each tablet contains:

Enalapril maleate 5 mg
Contains sugar: Lactose 40 mg per tablet
Contains sodium: 0,131 mg per tablet

ALAPREN 10 TABLETS

Each tablet contains:

Enalapril maleate 10 mg
Contains sugar: Lactose 80 mg per tablet
Contains sodium: 0,262 mg per tablet

ALAPREN 20 TABLETS

Each tablet contains:

Enalapril maleate 20 mg
Contains sugar: Lactose 80 mg per tablet
Contains sodium: 0,262 mg per tablet

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

ALAPREN 5 TABLETS:

Colloidal anhydrous silica
Croscarmellose sodium
Lactose
Maleic acid
Microcrystalline cellulose
Zinc stearate

ALAPREN 10 TABLETS:

Colloidal anhydrous silica
Croscarmellose sodium,
Ferric oxide red (CI No. 77491)
Lactose
Maleic acid
Microcrystalline cellulose
Zinc stearate

ALAPREN 20 TABLETS:

Colloidal anhydrous silica
Croscarmellose sodium
Ferric oxide red (CI No. 77491)
Ferric oxide yellow (CI No. 77492)
Lactose
Maleic acid
Microcrystalline cellulose
Zinc stearate

Pack sizes and marketing

ALAPREN 5 TABLETS: Carton containing 4 blister strips of 7 tablets in each blister.

ALAPREN 10 TABLETS: Carton containing 4 blister strips of 7 tablets in each blister.

ALAPREN 20 TABLETS: Carton containing 4 blister strips of 7 tablets in each blister.

Marketing authorization holder

Ranbaxy Pharmaceuticals (Pty) Ltd, 14 Lautre Road, Stormill, Ext. 1, Roodepoort, 1724, South Africa

Marketing authorization dates and numbers

ALAPREN 5 TABLETS: 34/7.1.3/0014
ALAPREN 1 S20 TABLETS: 34/7.1.3/0015
ALAPREN 20 TABLETS: 34/7.1.3/0016

27 September 2000

Drugs

Drug Countries
ALAPREN South Africa
 
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