LISINOPRIL GENERIC HEALTH lisinopril 10mg tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

lisinopril dihydrate, Quantity: 10.89 mg (Equivalent: lisinopril, Qty 10 mg)

Available from:

Generic Health Pty Ltd

INN (International Name):

Lisinopril dihydrate

Pharmaceutical form:

Tablet, uncoated

Composition:

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

Administration route:

Oral

Units in package:

30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Hypertension. Lisinopril Generic Health Tablets are indicated in the treatment of 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 Generic Health Tablets are also indicated in the treatment of heart failure. In such patients, it is recommended that Lisinopril Generic Health Tablets be administered together with a diuretic. Acute Myocardial Infarction: Lisinopril Generic Health Tablets are indicated for the 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 100mmHg. Lisinopril may be initiated within 24 hours of an acute myocardial infarction.

Product summary:

Visual Identification: Pink coloured, round, biconvex uncoated tablets, with "10" debossed on one side and breakline on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2007-05-15

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
LISINOPRIL GENERIC HEALTH
(LISINOPRIL DIHYDRATE) UNCOATED TABLET
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Lisinopril generic health.
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 generic health 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 GENERIC
HEALTH IS USED FOR
Lisinopril generic health lowers
high blood pressure, which
doctors call hypertension. It is
also used to treat heart failure
and patients who have just had
a heart attack.
_HYPERTENSION _
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.
There are usually no symptoms
of hypertension. The only way
of knowing that you have
hypertension is to have your
blood pressure checked on a
regular basis.
If high blood pressure is not
treated it can lead to serious
health problems. You may feel
fine and have no symptoms, but
eventually hypertension can
cause stroke, heart disease and
kidney failure.
Lisinopril generic health helps to
lower your blood pressure.
_HEART FAILURE _
Heart failure means that the
heart muscle cannot pump blood
strongly enough to supply all the
blood needed throughout the
body. Heart failure is not the
same as heart attack and does
not mean that the heart stops
working.
Heart failure may start off with
no symptoms, but as the
condition progresses, patients
may feel short of breath or may
get tired easily after light
physical activity such as
walking. Some patient

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – LISINOPRIL GENERIC HEALTH
(LISINOPRIL DIHYDRATE) UNCOATED TABLET
1
NAME OF THE MEDICINE
Lisinopril dihydrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg, 10 mg or 20 mg lisinopril (as dihydrate).
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Lisinopril generic health 5 mg tablets are pink coloured, round,
biconvex uncoated tablets, with “5”
debossed on one side and breakline on the other side.
Lisinopril generic health 10 mg tablets are pink coloured, round,
biconvex uncoated tablets, with “10”
debossed on one side and breakline on the other side.
Lisinopril generic health 20 mg tablets are pink coloured, round,
biconvex uncoated tablets, with “20”
debossed on one side and breakline on the other side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
HYPERTENSION
Lisinopril generic health tablets are indicated in the treatment of
hypertension. They 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 generic health tablets are also indicated in the treatment
of heart failure. In such patients, it
is recommended that Lisinopril generic health tablets be administered
together with a diuretic.
ACUTE MYOCARDIAL INFARCTION_ _
_ _
Lisinopril generic health tablets are indicated for the 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.
Lisinopril generic health v8
Page 2 of 23
(lisinopril dihydrate) uncoated tablet
4.2 DOSE AND METHOD OF ADMINISTRATION
Since there is no clinically significant effect of food on the
absorption of lisinopril, the tablets may be
administered before, during or after meal