ZINOPRIL 10 lisinopril 10mg (as dihydrate) tablet blister pack

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

lisinopril dihydrate (Equivalent: lisinopril, Qty 10 mg)

Saatavilla:

Alphapharm Pty Ltd

INN (Kansainvälinen yleisnimi):

Lisinopril dihydrate

Lääkemuoto:

Tablet, uncoated

Koostumus:

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

Antoreitti:

Oral

Kpl paketissa:

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

Prescription tyyppi:

(S4) Prescription Only Medicine

Käyttöaiheet:

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.

Tuoteyhteenveto:

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

Valtuutuksen tilan:

Licence status A

Valtuutus päivämäärä:

2009-01-30

Pakkausseloste

ZINOPRIL
_lisinopril (as dihydrate)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ZINOPRIL.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking ZINOPRIL
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT ZINOPRIL IS
USED FOR
ZINOPRIL lowers high blood
pressure, called 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.
ZINOPRIL 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 patients may wake up
short of breath at night. Fluid may
collect in different parts of the body,
often first noticed as swollen ank

Valmisteyhteenveto

AUSTRALIAN PRODUCT INFORMATION
ZINOPRIL 2.5/5/10/20
_Lisinopril (as dihydrate) tablets _
1
NAME OF THE MEDICINE
Lisinopril (as dihydrate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lisinopril (as dihydrate), a synthetic peptide derivative, is an oral,
long acting angiotensin converting
enzyme inhibitor. It is a lysine analogue of enalaprilat (active
metabolite of enalapril).
ZINOPRIL 2.5mg, 5 mg, 10 mg and 20 mg tablets contain lisinopril
dihydrate equivalent to 2.5 mg, 5
mg, 10 mg or 20 mg of lisinopril active ingredient respectively.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
_ _
3
PHARMACEUTICAL FORM
ZINOPRIL 2.5 mg
: white, circular, biconvex, uncoated tablets with “2.5” embossing
on one
side and “BL” embossing on other side.
ZINOPRIL 5 mg
: light pink coloured, circular, biconvex, uncoated tablets with
“5”
embossed and break line on one side and “BL” embossing on other
side.
ZINOPRIL 10 mg
: light pink coloured, circular, biconvex, uncoated tablets with
“10”
embossing on one side and “BL” embossing on the other side.
ZINOPRIL 20 mg
: pink coloured, circular, biconvex, uncoated tablets with “20”
embossing
on one side and “BL” embossing on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
HYPERTENSION
ZINOPRIL is 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
ZINOPRIL is also indicated in the treatment of heart failure. In such
patients, it is recommended that
ZINOPRIL be administered together with a diuretic.
ACUTE MYOCARDIAL INFARCTION
ZINOPRIL 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, ZINOPRIL may be initiated within 24 hours of an
acute