Acetec
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Patient Information leaflet
(PIL)
14-08-2013
Summary of Product characteristics
(SPC)
14-08-2013
Active ingredient:
Enalapril maleate 20mg; ; ; Enalapril maleate 20mg
Available from:
Viatris Limited
INN (International Name):
Enalapril maleate 20 mg
Dosage:
20 mg
Pharmaceutical form:
Tablet
Composition:
Active: Enalapril maleate 20mg Excipient: Ferrous oxide Lactose monohydrate Magnesium stearate Maize starch Sodium bicarbonate Starch Active: Enalapril maleate 20mg Excipient: Ferrous oxide Lactose monohydrate Magnesium stearate Maize starch Sodium bicarbonate Starch
Units in package:
Blister pack, Cold form laminate/Al/PVC, 30 tablets
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Rolabo Outsourcing SL
Therapeutic indications:
· All grades of essential hypertension. · Renovascular hypertension.
Product summary:
Package - Contents - Shelf Life: Blister pack, Cold form laminate/Al/PVC - 30 tablets - 24 months from date of manufacture stored at or below 25°C protect from light - Bottle, plastic, HDPE - 90 tablets - 24 months from date of manufacture stored at or below 25°C protect from light - Bottle, plastic, HDPE - 100 tablets - 24 months from date of manufacture stored at or below 25°C protect from light - Bottle, plastic, HDPE - 500 tablets - 24 months from date of manufacture stored at or below 25°C protect from light
Authorization date:
1998-10-13
Patient Information leaflet
Page 1 of 5
NEW ZEALAND CONSUMER MEDICINE INFORMATION
ACETEC
_ENALAPRIL MALEATE TABLETS 5 MG, 10 MG & 20 MG _
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 contains the active
ingredient enalapril maleate. It
belongs to a group of medicines
called Angiotensin Converting
Enzyme (ACE) inhibitors.
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 walkin
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Summary of Product characteristics
Page 1 of 15
NEW ZEALAND DATA SHEET
ACETEC
1. PRODUCT NAME
Acetec, 5, 10 & 20 mg, tablet.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg, 10 mg, or 20 mg of enalapril maleate.
Excipients with known effect: Maize starch and lactose.
Allergen declaration: sulfites and sugars as lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Acetec 5 mg tablets are white arc triangle shaped biconvex tablets,
debossed with “5” over “G” on
one side and scoreline on the other side. Each tablet contains 5 mg of
the active ingredient, enalapril
maleate.
Acetec 10 mg tablets are rusty red, arc triangle shaped biconvex
tablets, debossed with “10” over
“G” on one side and scoreline on the other side. Each tablet
contains 10 mg of the active ingredient,
enalapril maleate.
Acetec 20 mg tablets are peach, arc triangle shaped biconvex tablets,
debossed with “20” over “G”
on one side and scoreline on the other side. Each tablet contains 20
mg of the active ingredient,
enalapril maleate.
The tablet can be divided into equal doses.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
Treatment of:
•
All grades of essential hypertension
•
Renovascular hypertension
•
All degrees of heart failure
In patients with symptomatic heart failure, enalapril maleate is also
indicated to:
•
Improve survival
•
Retard the progression of heart failure
•
Reduce hospitalisation for heart failure
•
Prevention of symptomatic heart failure
Page 2 of 15
In asymptomatic patients with left ventricular dysfunction, enalapril
maleate is indicated to:
•
Retard the development of symptomatic heart failure
•
Reduce hospitalisation for heart failure
•
Prevention of coronary ischaemic events in patients with left
ventricular dysfunction
Enalapril maleate is indicated to:
•
Reduce the incidence of myocardial infarction
•
Reduce hospitalisation for unstable angina pectoris.
_4.2_
_DOSE AND METHOD OF ADMINISTRATION_
DOSE
_ESSENTIAL HYPERTENSION_
The initial dose is 5 mg an
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