LISINOPRIL AN lisinopril 2.5mg (as dihydrate) tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

lisinopril dihydrate (Equivalent: lisinopril, Qty 2.5 mg)

Available from:

Amneal Pharma Australia Pty Ltd

INN (International Name):

Lisinopril dihydrate

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: mannitol; calcium hydrogen phosphate dihydrate; magnesium stearate; maize starch

Administration route:

Oral

Units in package:

50, 10, 28 tablets, 14, 56 tablets, 84 tablets, 30 tablets, 100

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Hypertension: For treatment of hypertension, lisinopril may be used alone or concomitantly with other classes of antihypertensive agents. Sufficient data have not been provided to support the use of lisinopril in severe hypertension or renovascular hypertension. Congestive heart failure: For treatment of heart failure, it is recommended that lisinopril be administered together with a diuretic. Acute myocardial infarction: For treatment of acute myocardial infarction in haemodynamically stable patients, defined as patients who are not in cardiogenic shock and who have a systolic blood pressure greater than 100 mmHg, lisinopril may be initiated within 24 hours of an acute myocardial infarction.

Product summary:

Visual Identification: White to almost white, circular, biconvex, uncoated tablets with '2.5' embossing on one side and 'BL' embossing on the other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2009-01-30

Patient Information leaflet

_Lisinopril AN – Consumer Medicine Information _
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_Lisinopril AN CMI v2.0 _
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_Page 1 _
LISINOPRIL AN TABLETS
_Lisinopril dihydrate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
LISINOPRIL AN. It does not
contain all the available
information.
It does not take the place of
talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you taking
LISINOPRIL AN against the
benefits they expect it will have
for you.
.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again
WHAT LISINOPRIL AN IS
USED FOR
LISINOPRIL AN lowers high
blood pressure, called
hypertension. It is also used to
treat heart failure and patients
who have just had a heart
attack.
Lisinopril AN belongs to a group
of medicines called ACE
inhibitors.
BEFORE YOU TAKE
LISINOPRIL AN
_WHEN YOU MUST NOT TAKE _
_IT _
DO NOT TAKE LISINOPRIL AN IF:
• You have taken any medicines
called ‘ACE- inhibitor’ for high
blood pressure or heart failure
before, which caused your
face, lips, tongue, throat,
hands or feet to swell up, or
made it hard for you to breath.
• If you have had an allergic
reaction to an ACE inhibitor
before, you may be allergic to
LISINOPRIL AN.
• If you have an allergy to
Lisinopril or any of the
ingredients in LISINOPRIL AN
TABLETS listed at the end of
this leaflet.
• You are pregnant or breast-
feeding.
•You have a history of the
swelling of the face, lips,
tongue, throat, hands or feet,
for no apparent reason.
•The package is torn or shows
signs of tampering.
•The expiry date (EXP) printed
on the pack has passed. If you
take this medicine after the
expiry date has passed, it may
not work as well.
_BEFORE YOU START TO TAKE IT _
TELL YOUR DOCTOR:
1. IF YOU INTEND TO BECOME
PREGNANT OR INTEND TO
BREAST-FEED
2. IF YOU SUFFER FROM:
• Kidney disease or are
undergoing dialysis
• Low blood pressure
• Liver disea

Summary of Product characteristics

_Lisinopril AN tablets Product Information _
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_ Amneal Pharma Australia Pty Ltd _
Lisinopril AN PI v2.0
Page 1
LISINOPRIL AN
_ _
_(LISINOPRIL DIHYDRATE TABLETS) _
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PRODUCT INFORMATION
NAME OF THE MEDICINE
The name of the medicine is lisinopril dihydrate
CHEMICAL NAME: (S)-1-[N
2
-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate
MOLECULAR FORMULA: C
21
H
31
N
3
O
5
.2H
2
O
MW: 441.53
CAS NO: [83915-83-7]
DESCRIPTION
A
synthetic
peptide
derivative,
Lisinopril
dihydrate
is
an
oral,
long
acting
angiotension
converting
enzyme
inhibitor.
It
is
a
lysine
analogue
of enalaprilat
(active metabolite of
enalapril).
Lisinopril dihydrate is white to off-white crystalline powder that is
soluble in water,
sparingly
soluble in methanol and practically insoluble in ethanol.
LISINOPRIL AN TABLETS INCLUDE THE FOLLOWING INACTIVE INGREDIENTS:
Calcium Hydrogen Phosphate, Mannitol, Maize starch and, Magnesium
Stearate The 5mg,
10mg & 20mg tablets also include Iron Oxide Red
PHARMACOLOGY
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 II. Angiotensin II also stimulates aldosterone secretion
by the adrenal cortex.
Inhibition of ACE results in decreased concentrations of plasma
angiotensin II which results
in
decreased vasopressor activity and to decreased aldosterone secretion.
The latter decrease
_Lisinopril AN tablets Product Information _
_ _
_ Amneal Pharma Australia Pty Ltd _
Lisinopril AN PI v2.0
Page 2
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 p