Renitec

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Enalapril maleate 20mg

Available from:

Organon (New Zealand) Limited

INN (International Name):

Enalapril maleate 20 mg

Dosage:

20 mg

Pharmaceutical form:

Tablet

Composition:

Active: Enalapril maleate 20mg Excipient: Iron oxide red Iron oxide yellow Lactose monohydrate Magnesium stearate Maize starch Sodium bicarbonate Starch

Units in package:

Blister pack, professional sample pack, 30 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Siegfried Evionnaz SA

Therapeutic indications:

Treatment of: · All grades of essential hypertension

Product summary:

Package - Contents - Shelf Life: Blister pack, professional sample pack - 30 tablets - 36 months from date of manufacture stored at or below 25°C. Store in a dry place - Blister pack, - 30 tablets - 36 months from date of manufacture stored at or below 25°C. Store in a dry place

Authorization date:

1983-09-26

Patient Information leaflet

RENITEC
®
1
RENITEC
®
_Enalapril maleate _
NEW ZEALAND CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about RENITEC. 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 RENITEC
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 RENITEC IS
USED FOR
RENITEC 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. RENITEC 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.
RENITEC help

Summary of Product characteristics

Page 1 of 17
NEW ZEALAND DATA SHEET
1 PRODUCT NAME
RENITEC
®
10 mg tablet
RENITEC
®
20 mg tablet
RENITEC
®
M 5 mg tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each RENITEC 10 mg tablet contains 10 mg enalapril maleate
Each RENITEC 20 mg tablet contains 20 mg enalapril maleate
Each RENITEC M 5 mg tablet contains 5 mg enalapril maleate
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
RENITEC M 5 mg tablet: A white, barrel-shaped, biconvex tablet. The
tablet is scored on
one side and is engraved RENITEC on the other. Each tablet contains 5
mg of enalapril
maleate. Dimensions are 8 mm x 7 mm.
RENITEC 10 mg tablet: A rust-red coloured, barrel-shaped, biconvex
tablet. The tablet is
scored on one side and is engraved with the product name on the other
side. Each tablet
contains 10 mg of enalapril maleate. Dimensions are 8 mm x 7 mm.
RENITEC 20 mg tablet: A peach coloured, barrel-shaped, biconvex
tablet. The tablet is plain
on one side and is engraved MSD 714 on the other side. Each tablet
contains 20 mg of
enalapril maleate. Dimensions are 8 mm x 7 mm.
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, RENITEC is also indicated
to:
- Improve survival
- Retard the progression of heart failure
- Reduce hospitalisation for heart failure
•
Prevention of symptomatic heart failure.
In asymptomatic patients with left ventricular dysfunction, RENITEC 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.
Page 2 of 17
RENITEC 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 and is given once daily. The usual
maintenance dos