RENITEC PLUS 20/6 tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

hydrochlorothiazide, Quantity: 6 mg; enalapril maleate, Quantity: 20 mg

Available from:

ORGANON PHARMA PTY LTD

Pharmaceutical form:

Tablet, uncoated

Composition:

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

Administration route:

Oral

Units in package:

30 tablets, 5 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

RENITEC PLUS 20/6 is indicated for the treatment of mild to moderate hypertension. Treatment should not be initiated with this fixed dose combination.

Product summary:

Visual Identification: Blue, rounded triangle shaped tablet engraved with "MSD 734" on one side and a debossed triangle on the other side.; Container Type: Blister Pack; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2000-03-08

Patient Information leaflet

RENITEC
® PLUS 20/6
_Enalapril maleate and hydrochlorothiazide_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about RENITEC PLUS
20/6. 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
PLUS 20/6 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 PLUS
20/6 IS USED FOR
RENITEC PLUS 20/6 lowers high
blood pressure, which doctors call
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 PLUS 20/6
helps to lower your blood pressure.
RENITEC PLUS 20/6 contains two
active ingredients. One of these is
enalapril maleate. It belongs to a
group of medicines called
Angiotensin Converting Enzyme
(ACE) inhibitors. It works by
widening your blood vessels. This
means that blood is able to pass
through them more easily and the
heart doesn't have to pump as hard to
move blood around the body.
The other active ingredient is
hydrochlorothiazide, which is a fluid
tablet or diuretic. It helps reduce the
amount of fluid in the body by
making your kidneys pass more
water and salt.
Both of these active ingredients help

Summary of Product characteristics

Page 1 of 18
AUSTRALIAN PRODUCT INFORMATION
RENITEC

PLUS 20/6
(ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE)
TABLETS
1
NAME OF THE MEDICINE
enalapril maleate and hydrochlorothiazide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
RENITEC PLUS 20/6 (enalapril maleate and hydrochlorothiazide) is a
combination of an
angiotensin
converting
enzyme
inhibitor
(enalapril
maleate)
and
a
diuretic
(hydrochlorothiazide).
Enalapril maleate
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.
Hydrochlorothiazide
Hydrochlorothiazide is a white, or practically white, crystalline
powder. It is slightly soluble in
water, but freely soluble in sodium hydroxide solution.
List of excipients with known effect:
-
sugars as lactose
RENITEC
PLUS
20/6 mg
contains 20 mg
of
enalapril
maleate
and
6 mg
of
hydrochlorothiazide.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
RENITEC PLUS 20/6 (enalapril maleate 20 mg and hydrochlorothiazide 6
mg) tablets are a
blue, rounded triangle shaped tablet with MSD 734 engraved on one side
and a debossed
triangle on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
RENITEC PLUS 20/6 is indicated for the treatment of mild to moderate
hypertension.
Treatment should not be initiated with this fixed dose combination.
4.2
DOSE AND METHOD OF ADMINISTRATION
RENITEC PLUS 20/6 is supplied as tablets for oral administration.
Treatment with RENITEC PLUS 20/6 should only be commenced after
titration of the enalapril
component has been shown not to be effective in achieving the required
lowering of blood
pressure.
Page 2 of 18
HYPERTENSION
In hypertension, the usual dosage of RENITEC PLUS 20/6 is one tablet,
administered once
daily.
PRIOR DIURETIC THERAPY
Symptomatic hypotension may occur following the initial dose of
RENITEC PLUS 20/6; this is
more likely in patients who are volume- or salt-depleted as a result
of prior diuretic therapy.
The diur