ENALAPRIL SANDOZ enalapril maleate

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

enalapril maleate, Quantity: 5 mg

Available from:

Sandoz Pty Ltd

INN (International Name):

enalapril maleate

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: maize starch; sodium bicarbonate; lactose monohydrate; hyprolose; purified talc; magnesium stearate

Administration route:

Oral

Units in package:

30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS: 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 SANDOZ 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.

Product summary:

Visual Identification: oval, convex, white tablets, with one side scored with markings of "EN 5"; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2005-11-18

Patient Information leaflet

ENALAPRIL SANDOZ
®
1
ENALAPRIL SANDOZ
®
_enalapril maleate tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Enalapril Sandoz.
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 SANDOZ
IS USED FOR
Enalapril Sandoz lowers high blood
pressure, which doctors call
hypertension. It is also used to treat
heart failure.
HYPERTENSION
Everyone has blood pressure. This
pressure helps to 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 Sandoz
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, oft

Summary of Product characteristics

210325-Enalapril Sandoz-pi
Page 1 of 19
AUSTRALIAN PRODUCT INFORMATION
ENALAPRIL SANDOZ
® (ENALAPRIL MALEATE) TABLETS
1
NAME OF THE MEDICINE
Enalapril maleate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Enalapril Sandoz 5 mg tablets contain 5 mg of enalapril maleate.
Enalapril Sandoz 10 mg tablets contain 10 mg of enalapril maleate.
Enalapril Sandoz 20 mg tablets contain 20 mg of enalapril maleate.
_List of excipients with known effect:_
Sugars as lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Enalapril Sandoz 5 mg: oval, convex, white tablets, with one side
scored and marked EN 5.
Enalapril Sandoz 10 mg: oval, convex, red-brown tablets, with one side
scored and marked EN
10.
Enalapril Sandoz 20 mg: oval, convex, orange tablets, with one side
scored and marked EN 20.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
_Hypertension _
Enalapril Sandoz is indicated in the treatment of:
•
All grades of essential hypertension
•
Renovascular hypertension
_Congestive heart failure _
Enalapril Sandoz is indicated for the treatment of all degrees of
symptomatic heart failure. In
such patients, it is recommended that Enalapril Sandoz 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 Sandoz.
The diuretic should, if
possible, be discontinued for two to three days before beginning
therapy with Enalapril Sandoz
to reduce the likelihood of hypotension. (See Section 4.4 Special
warnings and precautions for
210325-Enalapril Sandoz-pi
Page 2 of 19
use) If the patient's blood pressure is not controlled with Enalapril
Sandoz alone, diuretic
t