COVERSYL PLUS 5/1.25 perindopril arginine 5mg and indapamide hemihydrate 1.25 mg film-coated tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

perindopril arginine, Quantity: 5 mg; indapamide hemihydrate, Quantity: 1.25 mg

Available from:

Servier Laboratories (Aust) Pty Ltd

INN (International Name):

indapamide hemihydrate,perindopril arginine

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: magnesium stearate; macrogol 6000; maltodextrin; sodium starch glycollate type A; colloidal anhydrous silica; lactose monohydrate; Colour

Administration route:

Oral

Units in package:

30 tablet (commercial presentation), 10 tablet (medical sample)

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of hypertension. Treatment should not be initiated with this combination.

Product summary:

Visual Identification: White, rod-shaped film-coated tablet (8mm long and 4mm wide).; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2007-01-31

Patient Information leaflet

COVERSYL
® PLUS LD
2.5/0.625; COVERSYL
®
PLUS 5/1.25
_perindopril (pronounced per-in-do-pril) and indapamide (pronounced
in-dap-a-mide)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about COVERSYL PLUS.
It does not contain all the available
information about this medicine.
Reading this leaflet 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 COVERSYL
PLUS against the expected benefits
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 COVERSYL
PLUS IS
The name of your medicine is
COVERSYL PLUS. The medicine
contains the active ingredients
perindopril arginine and indapamide
hemihydrate. Perindopril belongs to a
group of medicines called
angiotensin converting enzyme
(ACE) inhibitors. Indapamide
belongs to a group of medicines
called diuretics (a type of "water"
tablet).
WHAT COVERSYL
PLUS IS USED FOR
YOU HAVE BEEN PRESCRIBED
COVERSYL PLUS FOR HIGH BLOOD
PRESSURE.
COVERSYL PLUS is available only
with a doctor's prescription.
There is no evidence that
COVERSYL PLUS is addictive.
_WHY COVERSYL PLUS IS_
_USED FOR HIGH BLOOD_
_PRESSURE_
Everyone has blood pressure. This
pressure helps to circulate blood all
around the body. Your blood
pressure may be different at different
times of the day, depending on how
busy or stressed you are. You have
high blood pressure (also known as
hypertension) when your blood
pressure stays higher than is needed,
even when you are calm and relaxed.
If high blood pressure is not treated it
can lead to serious health problems.
You may feel fine and have no
symptoms, but eventually it can
cause stroke, heart disease and
kidney failure.
COVERSYL PLUS helps to lower
your blood pressure.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY COVERSYL
PLUS HAS BEEN PRESCRIBED FOR YOU.
BEFORE YOU TAKE
COVERSYL PLUS
There are some pe

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
COVERSYL® PLUS (PERINDOPRIL ARGININE / INDAPAMIDE HEMIHYDRATE)
Version: 23
1/35
AUSTRALIAN PRODUCT INFORMATION
COVERSYL
® PLUS (PERINDOPRIL ARGININE / INDAPAMIDE
HEMIHYDRATE) FILM-COATED TABLETS
1
NAME OF THE MEDICINE
Perindopril arginine / indapamide hemihydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active components of COVERSYL PLUS are perindopril arginine and
indapamide hemihydrate. Each
COVERSYL PLUS LD 2.5/0.625 tablet contains 2.5 mg of perindopril
arginine and 0.625 mg of indapamide
hemihydrate. Each COVERSYL PLUS 5/1.25 tablet contains 5 mg of
perindopril arginine and 1.25 mg of
indapamide hemihydrate.
Excipient with known effect: contains sugars as lactose
For the full list of excipients, _see section _6.1 - List of
excipients.
3
PHARMACEUTICAL FORM
COVERSYL PLUS LD 2.5/0.625 is a white rod-shaped film-coated tablet
with an embossed line on both faces.
COVERSYL PLUS 5/1.25 is a white, rod-shaped film-coated tablet.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
COVERSYL PLUS 5/1.25
Treatment of hypertension. Treatment should not be initiated with this
combination.
COVERSYL PLUS LD 2.5/0.625
Treatment of hypertension.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Treatment should be started at the normal dose of one COVERSYL PLUS LD
2.5/0.625 tablet per day as a
single dose, preferably to be taken in the morning before a meal.
In cases where target blood pressure is not achieved, the dose should
be titrated to one tablet of COVERSYL
PLUS 5/1.25 daily.
ELDERLY PATIENTS
Renal insufficiency is commonly observed in elderly people. Care
should therefore be taken when
prescribing perindopril-containing medicines to elderly hypertensive
patients.
The initial dose in the elderly should always be one tablet of
COVERSYL PLUS LD 2.5/0.625 daily, and
patients should be monitored closely during the initial stages of
treatment.
Particular care should be taken in elderly patients with congestive
heart failure who have renal and/or
AUSTRALIAN PRODUCT INFORMATION
COVERSYL® PLUS (P