APO-LISINOPRIL lisinopril 10mg (as dihydrate) tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Patient Information leaflet (PIL)

24-08-2020

Summary of Product characteristics (SPC)

24-08-2020

Public Assessment Report (PAR)

26-11-2017

Active ingredient:

lisinopril dihydrate (Equivalent: lisinopril, Qty 10 mg)

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Lisinopril dihydrate

Pharmaceutical form:

Tablet, uncoated

Composition:

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

Administration route:

Oral

Units in package:

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

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 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: Light pink circular, biconvex, uncoated tablets with '10' embossing on one side and 'BL' 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:

Licence status A

Authorization date:

2013-10-17

Patient Information leaflet

APO-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 APO-
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 high blood

Read the complete document

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION - APO- LISINOPRIL
(LISINOPRIL DIHYDRATE)
1
NAME OF THE MEDICINE
Lisinopril dihydrate
2
AND 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND
PHARMACEUTICAL FORM
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 dihydrate, mannitol,
maize starch, magnesium stearate and iron oxide red (C177491).
5 MG TABLETS
Light pink coloured, circular, biconvex, uncoated tablets with “5”
embossed and break line on
one side and “BL” embossing on other side.
10 MG TABLETS
Light pink, circular, biconvex, uncoated tablets with “10”
embossed and on one side and “BL”
embossing on other side.
20 MG TABLETS
Pink, circular, biconvex, uncoated tablets with “20” embossed and
on one side and “BL”
embossing on other side.
Alternative lisinopril products should be used if a 2.5 mg dose is
required. The 5 mg tablets
must not be broken in half to give a 2.5 mg dose.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
HYPERTENSION
Lisinopril is indicated in the treatment of mild to moderate essential
hypertension. It
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
Lisinopril is also indicated in the treatment of heart failure. In
such patients, it is
recommended that lisinopril be administered together with a diuretic.
•
ACUTE MYOCARDIAL INFARCTION
Lisinopril is indicated for the treatment of acute myocardial
infarction in
haemodynamically stable patients, defined as patients who are not in
cardiogenic
2
shock and who have a systolic blood pressure greater than 100 mmHg.
Lisinopril
may be initiated within 24 hours of an acute myocardia

Read the complete document