INDOSYL COMBI 4/1.25 perindopril erbumine 4mg / indapamide hemihydrate 1.25mg tablet blister pack

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

perindopril erbumine, Quantity: 4 mg; indapamide hemihydrate, Quantity: 1.25 mg

זמין מ:

Servier Laboratories (Aust) Pty Ltd

טופס פרצבטיות:

Tablet, uncoated

הרכב:

Excipient Ingredients: hydrophobic colloidal silica anhydrous; lactose monohydrate; magnesium stearate; microcrystalline cellulose

מסלול נתינה (של תרופות):

Oral

יחידות באריזה:

30 tablets

סוג מרשם:

(S4) Prescription Only Medicine

סממני תרפויטית:

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

leaflet_short:

Visual Identification: White, 8mm x 4mm rod-shaped tablets (unscored).; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

מצב אישור:

Registered

תאריך אישור:

2000-05-16

עלון מידע

INDOSYL COMBI 4/1.25
1
INDOSYL COMBI 4/1.25
_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 INDOSYL COMBI
4/1.25. 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 INDOSYL
COMBI 4/1.25 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 INDOSYL
COMBI 4/1.25 IS
The name of your medicine is
INDOSYL COMBI 4/1.25. The
medicine contains the active
ingredients perindopril erbumine 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 INDOSYL
COMBI 4/1.25 IS USED
FOR
YOU HAVE BEEN PRESCRIBED
INDOSYL COMBI 4/1.25 FOR HIGH
BLOOD PRESSURE.
INDOSYL COMBI 4/1.25 is
available only with a doctor's
prescription.
There is no evidence that INDOSYL
COMBI 4/1.25 is addictive.
_WHY INDOSYL COMBI 4/1.25 _
_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.
INDOSYL COMBI 4/1.25 helps to
lower your blood pressure.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY INDOSYL
COMBI 4/1.25 HA

מאפייני מוצר

AUSTRALIAN PRODUCT INFORMATION
INDOSYL COMBI 4/1.25 (PERINDOPRIL ERBUMINE / INDAPAMIDE HEMIHYDRATE)
Version: 16
1/35
AUSTRALIAN PRODUCT INFORMATION - INDOSYL COMBI 4/1.25
(PERINDOPRIL ERBUMINE / INDAPAMIDE HEMIHYDRATE) UNCOATED
TABLETS
1
NAME OF THE MEDICINE
Perindopril erbumine / indapamide hemihydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active components of INDOSYL COMBI 4/1.25 are perindopril erbumine
and indapamide hemihydrate.
Each INDOSYL COMBI 4/1.25 tablet contains 4 mg of perindopril erbumine
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
INDOSYL COMBI 4/1.25 is a white rod-shaped uncoated tablet.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Treatment of hypertension. Treatment should not be initiated with this
combination.
4.2
D
OSE AND METHOD OF ADMINISTRATION
One INDOSYL COMBI 4/1.25 tablet per day as a single dose, preferably
to be taken in the morning.
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 daily dose in the elderly should always be at a low dose
or with one component only, 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
hepatic insufficiency (see_ section 4.4 - Special warnings and
precautions for use_).
PATIENTS WITH RENAL INSUFFICIENCY
In cases of severe renal insufficiency (creatinine clearance below 30
mL/min), the treatment is
contraindicated.
In patients with moderate renal insufficiency (creatinine clearance
30-60 mL/min), the maximum dose
should be a low dose or with one component only.
In patients with a creatinine clearance greater than 60 mL/min, no
dose adaptation is required.
Normal medical practice includes periodic control fo