PERISYL perindopril erbumine 8 mg tablet blister pack

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

perindopril erbumine, Quantity: 8 mg

זמין מ:

Alphapharm Pty Ltd

טופס פרצבטיות:

Tablet

הרכב:

Excipient Ingredients: lactose; microcrystalline cellulose; magnesium stearate; sodium bicarbonate; colloidal anhydrous silica; chlorophyllin-copper complex aluminium lake

מסלול נתינה (של תרופות):

Oral

יחידות באריזה:

30 tablets

סוג מרשם:

(S4) Prescription Only Medicine

סממני תרפויטית:

PERISYL is indicated for: ,1) the treatment of hypertension; ,2) the treatment of heart failure. In such patients it is recommended that perindopril be given with a diuretic and/or digoxin under close medical supervision. (The safety and efficacy of perindopril has not been demonstrated for New York Heart Association Category IV patients); and ,3) patients with established coronary artery disease (see CLINICAL TRIALS) who are stable on concomitant therapy and have no heart failure, to reduce the risk of non-fatal myocardial infarction or cardiac arrest.

leaflet_short:

Visual Identification: Green colored mottled, round, biconvex tablets debossed with "PT8" on one side of the tablet & "M" on the other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

מצב אישור:

Registered

תאריך אישור:

2021-05-12

עלון מידע

PERISYL
®
_perindopril erbumine_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about PERISYL.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking PERISYL 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 IS USED
FOR
The active ingredient of PERISYL,
perindopril belongs to a group of
medicines called Angiotensin
Converting Enzyme Inhibitors (ACE
Inhibitors).
PERISYL is available only with a
doctor's prescription.
PERISYL lowers high blood
pressure, a condition which doctors
call hypertension.
Everyone has blood pressure. This
pressure helps get your blood all
around the body. Your blood
pressure may be different at different
times of the day, depending on how
busy or worried you are. You have
high blood pressure when your blood
pressure stays higher than is needed,
even when you are calm or relaxed.
There are usually no symptoms of
high blood pressure. The only way of
knowing that you have it 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 it can cause stroke, heart
disease and kidney failure.
PERISYL helps lower your blood
pressure.
You may be prescribed PERISYL for
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. Some people develop
heart failure after having had a heart
attack. However there are also other
causes of heart failure.
Heart failure may start off with no
symptoms, but as the condition
progresses, you may feel short

מאפייני מוצר

AUSTRALIAN PRODUCT INFORMATION
PERISYL
®
_perindopril erbumine tablet _
_ _
1
NAME OF THE MEDICINE
Perindopril erbumine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each PERISYL tablet contains 2 mg, 4 mg or 8 mg of perindopril
erbumine as the active ingredient.
Excipient with known effect: Sugars as lactose
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
PERISYL 2 mg
Green coloured mottled, round, biconvex tablets debossed with “PT”
over “2” on one
side of the tablet & “M” on the other side.
PERISYL 4 mg
Green coloured mottled, capsule shaped, biconvex tablets with side
notch, debossed
with “PT4” on one side of the tablet & “M” on the other side.
PERISYL 8 mg
Green coloured mottled, round, biconvex tablets debossed with
“PT8” on one side of
the tablet & “M” on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PERISYL is indicated for:
•
the treatment of hypertension;
•
the treatment of heart failure. In such patients it is recommended
that perindopril be given with a diuretic
and/or digoxin under close medical supervision. (The safety and
efficacy of perindopril has not been
demonstrated for New York Heart Association Category IV patients); and
•
patients
with
established
coronary
artery
disease
(see
Section
5.1
PHARMACODYNAMIC
PROPERTIES) who are stable on concomitant therapy and have no heart
failure, to reduce the risk of non-
fatal myocardial infarction or cardiac arrest.
4.2
DOSE AND METHOD OF ADMINISTRATION
HYPERTENSION
The usual starting dose of perindopril is 4 mg once daily, taken in
the morning. Optimum control of blood
pressure is achieved by increasing the dose, titrating it against the
blood pressure to a maximum of 8 mg once
daily.
A starting dose of 2 mg per day of perindopril is recommended in the
following patients who may be at risk
of ACE inhibitor-induced hypotension:
PERISYL
®
– PRODUCT INFORMATION
2
_Combination with a Diuretic _
The administration of perindopril to patients under current diureti