ACETEC 20 enalapril maleate 20mg tablet blister pack

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

enalapril maleate, Quantity: 20 mg

Commercializzato da:

Alphapharm Pty Ltd

Forma farmaceutica:

Tablet, uncoated

Composizione:

Excipient Ingredients: maize starch; sodium bicarbonate; lactose monohydrate; magnesium stearate; pregelatinised maize starch; Colour

Via di somministrazione:

Oral

Confezione:

30 tablets

Tipo di ricetta:

(S4) Prescription Only Medicine

Indicazioni terapeutiche:

Hypertension. All grades of essential hypertension; renovascular hypertension. Congestive heart failure. Treatment of all degrees of symptomatic heart failure. In such patients it is recommended that enalapril maleate 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.

Dettagli prodotto:

Visual Identification: Peach, arc triangle shaped biconvex tablet, debossed with "20" over "G" on one side scoreline on the other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Stato dell'autorizzazione:

Licence status A

Data dell'autorizzazione:

2000-08-18

Foglio illustrativo

ACETEC
_Enalapril maleate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ACETEC. 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 ACETEC
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 ACETEC IS USED
FOR
ACETEC 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. ACETEC 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 ankles and feet.
ACETEC helps to treat heart failure,
whether

Scheda tecnica

AUSTRALIAN PRODUCT INFORMATION
ACETEC
_Enalapril maleate tablets _
1
NAME OF THE MEDICINE
enalapril maleate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Enalapril maleate is a white to off-white crystalline powder. It is
sparingly soluble in water, soluble in ethanol,
and freely soluble in methanol and dimethylformamide.
Acetec tablets contain 2.5 mg, 5 mg, 10 mg or 20 mg enalapril maleate.
Excipients of known effect: Sugars as lactose, sulfites and soya bean
products.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Acetec 2.5
:
Each tablet contains 2.5 mg of enalapril maleate. The tablets are
white, oval shaped,
biconvex and debossed with “2.5” score line “G” on one side
and score line on the
other side.
Acetec 5
:
Each tablet contains 5 mg of enalapril maleate. The tablets are white,
arc triangle
shaped, biconvex and debossed with “5” over “G” on one side
and score line on
the other side.
Acetec 10
:
Each tablet contains10 mg of enalapril maleate. The tablets are rusty
red, arc
triangle shaped, biconvex and debossed with “10” over “G” on
one side and score
line on the other side.
Acetec 20
:
Each tablet contains 20 mg of enalapril maleate. The tablets are
peach, arc triangle
shaped, biconvex and debossed with “20” over “G” on one side
score line on the
other side.
*Some pack sizes and strengths may not be marketed.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_-_
_ _
HYPERTENSION:
All grades of essential hypertension and renovascular hypertension.
_-_
_ _
CONGESTIVE HEART FAILURE_:_
Treatment of all degrees of symptomatic heart failure. In such
patients, it is
recommended that enalapril maleate 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
ESSENTIAL HYPERTENSION
In patients who a