INVORIL TABLET 5MG

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

ENALAPRIL MALEATE

Available from:

RANBAXY (MALAYSIA) SDN. BHD.

INN (International Name):

ENALAPRIL MALEATE

Units in package:

30 Tablets; 100 Tablets

Manufactured by:

RANBAXY (MALAYSIA) SDN. BHD.

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
INVORIL TABLET
Enalapril Maleate (5mg, 10mg and 20mg)
Page | 1
WHAT IS IN THIS LEAFLET
1.
What INVORIL TABLET is used
for
2.
How INVORIL TABLET works
3.
Before
you
use
INVORIL
TABLET
4.
How to use INVORIL TABLET
5.
While you are using INVORIL
TABLET
6.
Side effects
7.
Storage
and
Disposal
of
INVORIL TABLET
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10. Date of revision
What INVORIL TABLET is used for
INVORIL
TABLET
contain
the
active ingredient enalapril maleate. It
is used:
•
to
treat
high
blood
pressure
(hypertension)
•
to treat heart failure (weakening
of heart function). It can lower the
need to go to hospital and can help
some patients live longer
•
to
prevent
the
signs
of
heart
failure. The signs include: shortness
of
breath,
tiredness
after
light
physical activity such as walking, or
swelling of the ankles and feet.
•
to reduce the incidence of heart
attack and reduce hospitalisation for
unstable angina pectoris (a feeling of
tightness, pressure or heaviness in the
chest)
Follow all directions given to you by
your
doctor
carefully.
They
may
differ from the information contained
in this leaflet.
Ask your doctor if you want more
information.
This medicine is available only with
a doctor’s prescription.
HOW INVORIL TABLET WORKS
INVORIL
TABLET
(enalapril)
belongs
to
a
group
of
medicines
called
angiotensin
converting
enzyme (ACE) inhibitors.
One of the ways INVORIL TABLET
helps
to lower blood
pressure and
treat heart failure is that it widens
your
blood
vessels,
which
reduces
pressure
in
the
vessels,
making
it
easier for your heart to pump blood
around
your
body.
This
helps
increase the supply of oxygen to your
heart, so that when you place extra
demands
on
your
heart,
such
as
during exercise, your heart may cope
better and you may not get breathless
as easily.
BEFORE
YOU
USE
INVORIL
TABLET
-
_When you must not use it_
Do not take INVORIL TABLET:
•
If you are allergic to enalapril, or
any of the ingredients of the tablets

Summary of Product characteristics

_For the use of a Registered Medical Practitioner only _
PRESCRIBING INFORMATION
INVORIL TABLETS
(Enalapril Maleate Tablets 5 mg/ 10 mg/ 20 mg)
COMPOSITION
INVORIL TABLETS 5 MG
Each tablet contains
Enalapril Maleate USP 5 mg.
INVORIL TABLETS 10 MG
Each tablet contains
Enalapril Maleate USP 10 mg
INVORIL TABLETS 20 MG
Each tablet contains
Enalapril Maleate USP 20 mg
EXCIPIENTS: Colloidal Anhydrous Silica, Croscarmellose Sodium, Zinc
Stearate, Purified Talc,
Microcrystaline Cellulose, Lactose, Maleic acid, Sunset Yellow Lake,
Ferric Oxide (Yellow)
PRODUCT DESCRIPTION
INVORIL TABLETS 5 MG
White, barrel shaped uncoated tablets embossed with '5' on one side
and scored on other side.
INVORIL TABLETS 10 MG
Peach, barrel shaped uncoated tablets embossed with '10' on one side
and scored on other side.
INVORIL TABLETS 20 MG
Light yellow, barrel shaped uncoated tablets embossed with '20' on one
side and scored on other
side
DESCRIPTION
INVORIL TABLETS contain enalapril maleate. Enalapril maleate is
chemically described as (S)-1-
[_N_-[1-(ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline,
(_Z_)-2-butenedioate
salt
(1:1).
Its
empirical formula is C
20
H
28
N
2
O
5
•C
4
H
4
O
4
, and its structural formula is:
STRUCTURAL FORMULA
ENALAPRIL MALEATE
PHARMACODYNAMIC AND PHARMACOKINETIC PROPERTIES

PHARMACODYNAMICS
Enalapril, after hydrolysis to enalaprilat, inhibits
angiotensin-converting enzyme (ACE) in human
subjects and animals. ACE is a peptidyl dipeptidase that catalyzes the
conversion of angiotensin I
to
the
vasoconstrictor
substance,
angiotensin
II.
Angiotensin
II
also
stimulates
aldosterone
secretion by the adrenal cortex. The beneficial effects of enalapril
in hypertension and heart failure
appear to result primarily from suppression of the
renin-angiotensin-aldosterone system. Inhibition
of ACE results in decreased plasma angiotensin II, which leads to
decreased vasopressor activity
and to decreased aldosterone secretion. Although the latter decrease
is small, it results in small
increases of serum potassium. In h