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

Kraj: Australia

Język: angielski

Źródło: Department of Health (Therapeutic Goods Administration)

Składnik aktywny:

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

Dostępny od:

Alphapharm Pty Ltd

Forma farmaceutyczna:

Tablet

Skład:

Excipient Ingredients: sodium bicarbonate; microcrystalline cellulose; lactose; colloidal anhydrous silica; magnesium stearate

Droga podania:

Oral

Sztuk w opakowaniu:

30

Typ recepty:

(S4) Prescription Only Medicine

Wskazania:

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

Podsumowanie produktu:

Visual Identification: White, capsule shaped, biconvex tablet debossed with 'PTI' on one side of the tablet and 'M2' on the other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Status autoryzacji:

Registered

Data autoryzacji:

2021-05-12

Ulotka dla pacjenta

PERISYL
® COMBI
_perindopril erbumine and indapamide hemihydrate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about PERISYL COMBI.
It does not contain all the available
information. 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 PERISYL
COMBI against the benefits expected
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT PERISYL COMBI
IS
The name of your medicine is
PERISYL COMBI. 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 PERISYL COMBI
IS USED FOR
YOU HAVE BEEN PRESCRIBED
PERISYL COMBI FOR HIGH BLOOD
PRESSURE.
PERISYL COMBI is available only
with a doctor's prescription.
There is no evidence that PERISYL
COMBI is addictive.
_WHY PERISYL COMBI 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.
PERISYL COMBI helps to lower
your blood pressure.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
BEFORE YOU TAKE
PERISYL COMBI
There are some people who should
not take PERISYL COMBI. Please
read the lists below. If you think any
o

Charakterystyka produktu

AUSTRALIAN PRODUCT INFORMATION
PERISYL
® COMBI
_perindopril erbumine and indapamide hemihydrate tablet _
1
NAME OF THE MEDICINE
Perindopril erbumine and Indapamide hemihydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each PERISYL COMBI 2/0.625 tablet contains 2 mg of perindopril
erbumine and 0.625 mg indapamide
hemihydrate as the active ingredients.
Each PERISYL COMBI 4/1.25 tablet contains 4 mg of perindopril erbumine
and 1.25 mg indapamide
hemihydrate as the active ingredients.
Excipient with known effect: Lactose
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
PERISYL COMBI
2/0.625
White, capsule shaped, biconvex tablet debossed with “P” to the
left of the score and
“TI” to the right of the score on one side of the tablet and
“M” to the left of the score
and “1” to the right of the score on the other side of the tablet.
PERISYL COMBI
4/1.25
White, capsule shaped, biconvex tablet debossed with “PTI” on one
side of the tablet
and “M2” on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PERISYL COMBI 4/1.25
Treatment of hypertension. Treatment should not be initiated with this
combination.
PERISYL COMBI 2/0.625
Treatment of hypertension.
4.2
DOSE AND METHOD OF ADMINISTRATION
Treatment should be started at the normal dose equivalent to
perindopril erbumine 2 mg/indapamide
hemihydrate 0.625 mg per day as a single dose, 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 PERISYL
COMBI 4/1.25 daily.
ELDERLY PATIENTS
Renal insufficiency is commonly observed in elderly people. Care
should therefore be taken when prescribing
perindopril-containing products to elderly hypertensive patients.
The initial dose in the elderly should always be equivalent to
perindopril erbumine 2 mg/indapamide
hemihydrate 0.625 mg daily, and patients should be monitored closely
during the initial stages of treatment.
Particular care should be taken in elderly patients