LISINOPRIL SANDOZ lisinopril dihydrate 10mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

lisinopril dihydrate, Quantity: 10.89 mg

Available from:

Sandoz Pty Ltd

INN (International Name):

Lisinopril dihydrate

Pharmaceutical form:

Tablet

Composition:

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

Administration route:

Oral

Units in package:

30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

1.Hypertension: Lisinopril is indicated for 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. 2. Congestive heart failure: Lisinopril is also indicated for the treatment of heart failure. In such patients, it is recommended that lisinopril be administered together with a diuretic. 3. 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 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: Round, biconvex and a score notch on one side. The tablets are uniformly red, mottled, the surface must be smooth.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2010-03-31

Patient Information leaflet

LISINOPRIL SANDOZ
®
1
LISINOPRIL SANDOZ
_lisinopril dihydrate tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Lisinopril Sandoz.
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 this medicine
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
SANDOZ IS USED FOR
This medicine is used to treat:
•
high blood pressure
(hypertension)
•
heart failure
•
patients who have just had a heart
attack.
It contains the active ingredient
lisinopril dihydrate.
Lisinopril belongs to a group of
medicines called angiotensin
converting enzyme (ACE) inhibitors.
It works by widening your blood
vessels, which reduces pressure in
the vessels. This makes it easier for
your heart to pump blood around
your body.
This also helps to increase the supply
of oxygen to your heart, so that when
you place extra demands on your
heart, such as exercise, your heart
may cope better and you may not get
short of breath as easily.
By making it easier for your heart to
pump blood around your body and by
increasing the supply of oxygen to
your heart, Lisinopril Sandoz may
reduce the risk of further damage to
your heart after you have had a heart
attack.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
LISINOPRIL SANDOZ
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE OR HAVE HAD AN ALLERGY TO:
•
lisinopril dihydrate, the active
ingredient, or to any of the other
ingredients listed at the end of
this leaflet under Product
description
•

Summary of Product characteristics

190605-lisinopril-sandoz-pi
Page 1 of 24
AUSTRALIAN PRODUCT INFORMATION
LISINOPRIL SANDOZ
® (LISINOPRIL DIHYDRATE) TABLETS
1
NAME OF THE MEDICINE
Lisinopril dihydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Lisinopril Sandoz 5 mg tablet contains 5.44 mg lisinopril
dihydrate equivalent to 5 mg
lisinopril.
Each Lisinopril Sandoz 10 mg tablet contains 10.89 mg lisinopril
dihydrate equivalent to 10 mg
lisinopril.
Each Lisinopril Sandoz 20 mg tablet contains 21.78 mg lisinopril
dihydrate equivalent to 20 mg
lisinopril.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Lisinopril Sandoz 5 mg tablets are round, biconvex and a score notch
on one side. The tablets
are uniformly red, mottled, the surface must be smooth.
Lisinopril Sandoz 10 mg tablets are round, biconvex and a score notch
on one side. The tablets
are uniformly red, mottled, the surface must be smooth.
Lisinopril Sandoz 20 mg tablets are round, biconvex and a score notch
on one side. The tablets
are uniformly red, mottled, the surface must be smooth
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
_HYPERTENSION _
Lisinopril Sandoz is indicated for 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 Sandoz is also indicated for the treatment of heart
failure. In such patients, it is
recommended that lisinopril be administered together with a diuretic.
_ACUTE MYOCARDIAL INFARCTION _
Lisinopril
Sandoz
is
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.
190605-lisinopril-sandoz-pi
Page 2 of 24
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
Lisinopril