ENALAPRIL AN enalapril maleate 10mg tablet blister pack

Страна: Австралия

Язык: английский

Источник: Department of Health (Therapeutic Goods Administration)

Активный ингредиент:

enalapril maleate

Доступна с:

Sandoz Pty Ltd

ИНН (Международная Имя):

enalapril maleate

Статус Авторизация:

Registered

тонкая брошюра

ENALAPRIL AN
1
ENALAPRIL AN
_enalapril maleate tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Enalapril AN.
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 it is expected to
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 AN IS
USED FOR
The name of your medicine is
Enalapril AN. It contains the active
ingredient enalapril maleate.
Enalapril AN is used to lower high
blood pressure (hypertension). It is
also used to treat heart failure.
HYPERTENSION
Everyone has blood pressure. This
pressure helps to circulate the 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 AN 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

Характеристики продукта

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AUSTRALIAN PRODUCT INFORMATION
ENALAPRIL AN TABLETS (ENALAPRIL MALEATE)
1
NAME OF THE MEDICINE
Enalapril maleate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Enalapril is the ethyl ester of the parent diacid, enalaprilat.
Enalapril maleate is a white to off-
white crystalline powder.
Melting point: approximately 144
°
C
Solubility: sparingly soluble in water, freely soluble in methanol,
practically insoluble in
methylene chloride. It dissolves in dilute solutions of alkali
hydroxides.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Enalapril AN 5 mg (AUST R 188552) – oval, convex, white tablets,
with one side scored and
marked EN 5.
Enalapril AN 10 mg (AUST R 188553) – oval, convex, red-brown
tablets, with one side scored
and marked EN 10.
Enalapril AN 20 mg (AUST R 188554) – oval, convex, orange tablets,
with one side scored
and marked EN 20.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
_Hypertension _
Enalapril AN is indicated in the treatment of:
•
All grades of essential hypertension
•
Renovascular hypertension.
_Congestive heart failure _
Enalapril AN is indicated for the treatment of all degrees of
symptomatic heart failure. In such
patients it is recommended that Enalapril AN 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
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
_ESSENTIAL HYPERTENSION _
In
patients
who
are
currently
being
treated
with
a
diuretic,
symptomatic
hypotension
occasionally may occur following the initial dose of Enalapril-PS. The
diuretic should, if
possible, be discontinued for two to three days before beginning
therapy with Enalapril AN to
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Page 2 of 18
reduce the likelihood of hypotension. (See Section 4.4 Special
warnings and precautions for
use.) If the patient'