ENALAPRIL GENERIC HEALTH enalapril maleate 20mg tablet blister pack

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

enalapril maleate, Quantity: 20 mg

זמין מ:

Generic Health Pty Ltd

INN (שם בינלאומי):

enalapril maleate

טופס פרצבטיות:

Tablet, uncoated

הרכב:

Excipient Ingredients: hypromellose; lactose monohydrate; iron oxide red; maleic acid; zinc stearate; iron oxide yellow; maize starch

מסלול נתינה (של תרופות):

Oral

יחידות באריזה:

30 tablets

סוג מרשם:

(S4) Prescription Only Medicine

סממני תרפויטית:

Hypertension. Enalapril Generic Health is indicated in the treatment of: All grades of essential hypertension; renovascular hypertension. Congestive heart failure. Enalapril Generic Health is indicated in the treatment of all degrees of symptomatic heart failure. In such patients it is recommended that enalapril be administered together with a diuretic. Left ventricular dysfunction. All degrees of left ventricular dysfunction where the left ventricular ejection fraction is less than 35%, irrespective of the presence or severity of obvious symptoms of heart failure.

leaflet_short:

Visual Identification: Peach, barrel shaped, embosed "20" on one side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

מצב אישור:

Registered

תאריך אישור:

2008-12-23

עלון מידע

CONSUMER MEDICINE INFORMATION
ENALAPRIL GENERIC HEALTH
(ENALAPRIL MALEATE) UNCOATED TABLET
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Enalapril 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
Enalapril 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 ENALAPRIL GENERIC
HEALTH IS USED FOR
Enalapril generic health lowers
high blood pressure, which
doctors call hypertension. It is
also used to treat heart failure.
_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.
Enalapril 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 patients may
wake up short of breath at night.
Fluid may c

מאפייני מוצר

AUSTRALIAN PRODUCT INFORMATION – ENALAPRIL GENERIC HEALTH
(ENALAPRIL MALEATE) UNCOATED TABLET
1
NAME OF THE MEDICINE
Enalapril maleate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg, 10 mg or 20 mg of enalapril maleate.
List of excipients with known effect: sugars as lactose.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Enalapril generic health 5 mg tablet: White, barrel shaped, embossed
with “5” on one side.
Enalapril generic health 10 mg tablet: Pink, barrel shaped, embossed
with “10” on one side.
Enalapril generic health 20 mg tablet: Peach, barrel shaped, embossed
with “20” on one side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
HYPERTENSION
Enalapril generic health is indicated in the treatment of:
•
all grades of essential hypertension;
•
renovascular hypertension.
CONGESTIVE HEART FAILURE
Enalapril generic health is indicated for the treatment of all degrees
of symptomatic heart failure. In
such patients it is recommended that enalapril be administered
together with a diuretic.
LEFT VENTRICULAR DYSFUNCTION
All degrees of left ventricular dysfunction where the left ventricular
ejection fraction is less than 35%,
irrespective of the presence or severity of obvious symptoms of heart
failure.
4.2 DOSE AND METHOD OF ADMINISTRATION
Since there is no lower dose (2.5 mg) of Enalapril generic health
available, if a 2.5 mg dose of enalapril
is required, an alternative product must be used. As the 5 mg
Enalapril generic health tablets do not
Enalapril generic health v4
Page 2 of 18
(enalapril maleate) uncoated tablet
have a breakline, alternative enalapril products should be used if a
2.5 mg dose is required. The 5 mg
Enalapril generic health tablets must not be broken in half to give a
2.5 mg dose.
ESSENTIAL HYPERTENSION
In patients who are currently being treated with a diuretic,
symptomatic hypotension occasionally may
occur following the initial dose of enalapril tablets. The diuretic
should, if possible, be discontinue