RENITEC 20 Tablet

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

MSD (PTY) LTD

Pharmaceutical form:

Tablet

Composition:

Each tablet contains ENALAPRIL MALEATE 20 mg

Authorization date:

1987-07-09

Patient Information leaflet

1
PATIENT INFORMATION LEAFLET
INFORMATION FOR THE PATIENT ABOUT RENITEC
®
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING RENITEC

Keep this leaflet. You may need to read it again

If you have further questions, please ask your doctor or your
pharmacist.

RENITEC has been prescribed for you personally and you should not
share your medicine with
other people. It may harm them, even if their symptoms are the same as
yours.
SCHEDULING STATUS
S3
PROPRIETARY NAME AND DOSAGE FORM
RENITEC
®
2,5 Tablet
(2,5 mg enalapril maleate)
RENITEC
 5 Tablet
(5 mg enalapril maleate)
RENITEC

10 Tablet
(10 mg enalapril maleate)
RENITEC

20 Tablet
(20 mg enalapril maleate)
WHAT RENITEC CONTAINS
RENITEC (enalapril maleate, MSD) is a tablet.
RENITEC tablets contain either 2,5 mg; 5 mg; 10 mg or 20 mg of
enalapril maleate as the active ingredient.
Copyright © 2005 Merck Sharp & Dohme Corp., a subsidiary of Merck &
Co., Inc., Whitehouse Station, N.J, U.S.A.
2
In addition, RENITEC tablets contain the following inactive
ingredients:
Sodium hydrogen carbonate, maize starch, pregelatinised starch,
magnesium stearate, lactose monohydrate. In
addition the 10 mg and 20 mg tablet contains iron oxide red (E172) and
iron oxide yellow (E172) – 20 mg tablet
only.
RENITEC tablets contain sugar.
WHAT RENITEC IS USED FOR
RENITEC is a medication that belongs to the group of medicines called
angiotensin converting enzyme inhibitors,
(ACE inhibitors).
Your doctor has prescribed RENITEC to treat your hypertension (high
blood pressure) or heart failure (weakening
of heart function). RENITEC is also used for the prevention of
symptomatic heart failure in patients with decreased
heart function.
RENITEC works by widening your blood vessels to make it easier for the
heart to pump blood to all parts of your
body.
BEFORE YOU TAKE RENITEC
DO NOT TAKE RENITEC IF YOU:

Are allergic to enalapril maleate or any of the other ingredients of
RENITEC (see “WHAT RENITEC
CONTAINS”)

Have previously been treated with a medication in

Summary of Product characteristics

1
SCHEDULING STATUS
S3
PROPRIETARY NAME AND DOSAGE FORM
RENITEC
®
2,5 Tablet
RENITEC

5 Tablet
RENITEC

10 Tablet
RENITEC

20 Tablet
COMPOSITION
Each RENITEC 2,5 tablet contains 2,5 mg enalapril maleate, MSD.
Each RENITEC 5 tablet contains 5 mg enalapril maleate, MSD.
Each RENITEC 10 tablet contains 10 mg enalapril maleate, MSD.
Each RENITEC 20 tablet contains 20 mg enalapril maleate, MSD.
RENITEC tablets contain sugar.
EXCIPIENTS: sodium hydrogen carbonate, maize starch, pregelatinised
starch, magnesium stearate, lactose
monohydrate. In addition the 10 mg and 20 mg tablet contains iron
oxide red (E172) and iron oxide yellow
(E172) – 20 mg tablet only.
PHARMACOLOGICAL CLASSIFICATION
A 7.1.3 Vascular medicines - other hypotensives
PHARMACOLOGICAL ACTION
Enalapril maleate, is the maleate salt of enalapril, a derivative of
two amino acids, L-alanine and L-proline.
Following oral absorption, enalapril maleate, is hydrolysed to
enalaprilat, which is a specific, long-acting, non-
sulphydryl angiotensin converting enzyme inhibitor.
Copyright © 2005 Merck Sharp & Dohme Corp., a subsidiary of Merck &
Co., Inc., Whitehouse Station, N.J, U.S.A.
2
CLINICAL PHARMACOLOGY
Enalapril lowers blood pressure in patients with hypertension and
improves the signs and symptoms
associated with chronic heart failure.
PHARMACODYNAMICS
Mechanism of action
Angiotensin converting enzyme (ACE) is a peptidyl dipeptidase which
catalyzes the conversion of angiotensin
I
to the pressor substance angiotensin
II
. After absorption, enalapril is hydrolyzed to enalaprilat, which
inhibits ACE. Inhibition of ACE results in decreased plasma
angiotensin
II
, which leads to increased plasma
renin activity (due to removal of negative feedback of renin release),
and decreased aldosterone secretion.
In some patients the development of optimal blood pressure reduction
may require several weeks of therapy.
Effective inhibition of ACE activity usually occurs 2 to 4 hours after
oral administration of an individual dose of
enalapril. Onset of antihyper