APO-ENALAPRIL enalapril maleate 5 mg tablet blister pack

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Aktiva substanser:

enalapril maleate, Quantity: 5 mg

Tillgänglig från:

Arrotex Pharmaceuticals Pty Ltd

INN (International namn):

enalapril maleate

Läkemedelsform:

Tablet

Sammansättning:

Excipient Ingredients: croscarmellose sodium; hypromellose; sodium stearylfumarate; maleic acid; lactose monohydrate

Administreringssätt:

Oral

Enheter i paketet:

30

Receptbelagda typ:

(S4) Prescription Only Medicine

Terapeutiska indikationer:

HYPERTENSION ,Enalapril is indicated in the treatment of all grades of essential hypertension and renovascular hypertension. ,CONGESTIVE HEART FAILURE ,Enalapril 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 percent, irrespective of the presence or severity of obvious symptoms of heart failure.

Produktsammanfattning:

Visual Identification: White to off white, round, flat faced, beveled edge tablets with breakline on one side and "5" debossed on the other side.; Container Type: Carton; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Bemyndigande status:

Licence status A

Tillstånd datum:

2013-05-28

Bipacksedel

APO-Enalapril Tablets
1
APO-ENALAPRIL
_Contains the active ingredient enalapril (as enalapril maleate) _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about this medicine. 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 THIS MEDICINE IS
USED FOR
Enalapril is used to treat:
•
heart failure
•
high blood pressure (also known
as hypertension)
Enalapril belongs to a group of
medicines called Angiotensin
Converting Enzyme (ACE)
inhibitors.
One of the ways enalapril helps
lower blood pressure and treat heart
failure is that it widens blood vessels.
This means that blood is able to pass
through them more easily and the
heart doesn't have to pump as hard to
move blood around the body. This
also means that when you place extra
demands on your heart, such as
during exercise, the heart may cope
better so you may not get short of
breath as easily.
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.
HEART F

Produktens egenskaper

1
AUSTRALIAN PI - APO-ENALAPRIL (ENALAPRIL MALEATE)
1
NAME OF THE MEDICINE
Enalapril maleate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet (5 mg, 10 mg and 20mg) contains enalapril maleate as the
active ingredient.
EXCIPIENTS WITH KNOWN EFFECT
sugars as lactose
For the full list of excipients see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
5 MG TABLETS
White to off white, round, flat-face beveled edge tablets with
breakline on one side and “5”
debossed on the other side.
10 MG TABLETS
White to off white, round, flat-face beveled edge tablets with
breakline on one side and “10”
debossed on the other side.
20 MG TABLETS
White to off white, round, flat-face beveled edge tablets with
breakline on one side and “20”
debossed on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Enalapril is indicated in the treatment of:
•
HYPERTENSION
o
All grades of essential hypertension
o
Renovascular hypertension
•
CONGESTIVE HEART FAILURE
All degrees of symptomatic heart failure. In such patients, it is
recommended that APO-
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.
2
4.2
DOSE AND METHOD OF ADMINISTRATION
ESSENTIAL HYPERTENSION
In
patients
who
are
currently
being
treated
with
a
diuretic,
symptomatic
hypotension
occasionally may occur following the initial dose of APO-Enalapril.
The diuretic should, if
possible, be discontinued for two to three days before beginning
therapy with APO-Enalapril
to reduce the likelihood of hypotension (see section 4.4-Special
warnings and precautions for
use). If the patient's blood pressure is not controlled with
APO-Enalapril alone, diuretic therapy
may be resumed. If the diuretic cannot be discontinued an initial dose
of 2.5mg (break the
5mg tablet) should be used under medical supervision for at least one
hour to determin