MALEAN enalapril maleate 20mg tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
16-11-2021
Summary of Product characteristics
(SPC)
26-05-2021
Public Assessment Report
(PAR)
28-11-2017
Active ingredient:
enalapril maleate, Quantity: 20 mg
Available from:
Arrotex Pharmaceuticals Pty Ltd
INN (International Name):
enalapril maleate
Pharmaceutical form:
Tablet
Composition:
Excipient Ingredients: maleic acid; hypromellose; sodium stearylfumarate; lactose monohydrate; croscarmellose sodium
Administration route:
Oral
Units in package:
30
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
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.
Product summary:
Visual Identification: White to off white, round, flat faced, beveled edge tablets with breakline on one side and "20" debossed on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Authorization status:
Licence status A
Authorization date:
2013-05-28
Patient Information leaflet
MALEAN CMI V0.1 Page 1 of 5
MALEAN
_Enalapril maleate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
MALEAN. 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
MALEAN 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 MALEANIS USED
FOR
MALEAN 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. MALEAN
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.
MALEAN helps to t
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Summary of Product characteristics
AUSTRALIAN PI – MALEAN (Enalapril maleate tablets)
1
NAME OF THE MEDICINE
Enalapril maleate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Enalapril maleate is a white or almost white crystalline powder with a
molecular weight of 492.5, a
melting point of about 144°C, and a pKa of 3 and 5.4. It is sparingly
soluble in water, freely soluble in
methanol,
practically
insoluble
in
methylene
chloride.
It
dissolves
in
dilute
solutions
of
alkali
hydroxides.
Malean 5 mg tablets contain 5mg Enalapril maleate
Malean 10 mg tablets contain 10mg Enalapril maleate
Malean 20 mg tablets contain 20mg Enalapril maleate
List Excipients with known effect: sugars as lactose
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Malean 5 mg tablets are white to off white, round, flat-face beveled
edge tablets with breakline on one
side and “5” embossing on the other side.
Malean 10 mg tablets are white to off white, round, flat-face beveled
edge tablets with breakline on
one side “10” embossing on the other side.
Malean 20 mg tablets are white to off white, round, flat-face beveled
edge tablets with breakline on
one side and “20” embossing on the other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
HYPERTENSION
Malean is indicated in the treatment of:
*
All grades of essential hypertension
*
Renovascular hypertension
CONGESTIVE HEART FAILURE
Malean is indicated for the treatment of all degrees of symptomatic
heart failure. In such patients, it is
recommended that Malean 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
ESSENTIAL HYPERTENSION:
In patients who are currently being treated with a diuretic,
symptomatic hypotension occasionally may
occur following the initial dose of Malean. The diuretic should, if
possible, be discontinued
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