CHEMMART LISINOPRIL lisinopril 5mg (as dihydrate) tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
05-05-2016
Summary of Product characteristics
(SPC)
04-04-2017
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
lisinopril dihydrate
Available from:
Apotex Pty Ltd
INN (International Name):
Lisinopril dihydrate
Authorization status:
Registered
Patient Information leaflet
CHEMMART LISINOPRIL
TABLETS
_Contains the active ingredient lisinopril (as lisinopril dihydrate)_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about lisinopril. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.apotex.com.au.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is
Chemmart Lisinopril. It contains the
active ingredient lisinopril (as
lisinopril dihydrate).
It is used to treat the following:
•
People with mild or moderate
hypertension (high blood
pressure)
•
People with congestive heart
failure
•
People with acute myocardial
infarction (heart attack)
HIGH BLOOD PRESSURE
Everyone has blood pressure. This
pressure helps get your blood all
around your body.
Your blood pressure may be different
at different times of the day,
depending on how busy or worried
you are. You have hypertension (high
blood pressure) when your blood
pressure stays higher than is needed,
even when you are calm and relaxed.
People with high blood pressure
often feel fine and have no
symptoms. You can only tell if you
have high blood pressure by having
your blood pressure regularly
checked. If hi
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Summary of Product characteristics
Product Information – Australia
Chemmart Lisinopril Tablets
Page 1
CHEMMART LISINOPRIL TABLETS
NAME OF THE MEDICINE
Lisinopril dihydrate.
Chemical Name:
_N_-[_N_-[(1_S_)-1-carboxy-3-phenylpropyl]-L-lysyl]-L-proline
dehydrate.
Structural Formula:
_ _
_ _
_ _
Molecular Formula:
C
21
H
31
N
3
O
5
.2H
2
O
Molecular Weight:
441.53
CAS Registry Number:
83915-83-7
DESCRIPTION
Lisinopril dihydrate is a white to off-white crystalline powder that
is soluble in water, sparingly soluble
in methanol and practically insoluble in ethanol.
Each tablet contains lisinopril dihydrate as the active ingredient. In
addition, each tablet contains the
following inactive ingredients: calcium hydrogen phosphate, Mannitol,
maize starch, magnesium
stearate and iron oxide red (C177491).
PHARMACOLOGY
A synthetic peptide derivative, lisinopril dihydrate is an oral
long-acting angiotensin converting enzyme
inhibitor. It is a lysine analogue of enalaprilat (active metabolite
of enalapril).
MECHANISM OF ACTION
Lisinopril is a peptidyl dipeptidase inhibitor. It inhibits the
angiotensin converting enzyme (ACE) that
catalyses the conversion of angiotensin I to the vasoconstrictor
substance, angiotensin ll. Angiotensin
ll also stimulates aldosterone secretion by the adrenal cortex.
Inhibition of ACE results in decreased
concentrations of plasma angiotensin ll which results in decreased
vasopressor activity and to
decreased aldosterone secretion. The latter decrease may result in a
small increase of serum
potassium. In hypertensive patients with normal renal function treated
with lisinopril alone for up to
24
weeks,
the
mean
increase
in
serum
potassium
was
approximately
0.1
mmol/L;
however,
approximately 15% of patients had increases greater than 0.5 mmol/L
and approximately 6% had a
decrease
greater
than
0.5
mmol/L.
In
the
same
study,
patients
treated
with
lisinopril
and
hydrochlorothiazide for up to 24 weeks had a mean decrease in serum
potassium of 0.1 mmol/L;
approximately 4% of patients had increases greater than 0.5 mmol/L and
approximately 12
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