APO-PERINDOPRIL ARGININE perindopril arginine 5 mg tablet blister pack

Kraj: Australia

Język: angielski

Źródło: Department of Health (Therapeutic Goods Administration)

Składnik aktywny:

perindopril arginine, Quantity: 5 mg

Dostępny od:

Arrotex Pharmaceuticals Pty Ltd

INN (International Nazwa):

perindopril arginine

Forma farmaceutyczna:

Tablet, film coated

Skład:

Excipient Ingredients: iron oxide yellow; isomalt; magnesium stearate; hypromellose; brilliant blue FCF aluminium lake; titanium dioxide; hyprolose; colloidal anhydrous silica; macrogol 8000

Droga podania:

Oral

Sztuk w opakowaniu:

30, 100

Typ recepty:

(S4) Prescription Only Medicine

Wskazania:

Treatment of hypertension and the treatment of heart failure. In such patients it is recommended that perindopril arginine be given with a diuretic and/or digoxin under close medical supervision. (The safety and efficacy of perindopril arginine has not been demonstrated for New York Heart Association Category IV patients); and 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.

Podsumowanie produktu:

Visual Identification: Light green coloured, capsule-shaped, biconvex, film coated tablets, with notch and engraved APO on one side and P 5 on the other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Status autoryzacji:

Licence status A

Data autoryzacji:

2012-04-26

Ulotka dla pacjenta

APO-PERINDOPRIL ARGININE
1
APO-PERINDOPRIL
ARGININE
_Perindopril Arginine _
CONSUMER MEDICINE INFORMATION
FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about this medicine. 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 this medicine
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 THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Perindopril Arginine tablets.
It contains the active ingredient
perindopril arginine.
Perindopril belongs to a group of
medicines called angiotensin
converting enzyme (ACE) inhibitors.
It is used to treat high blood pressure,
heart failure or coronary artery
disease.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is available only with
a doctor's prescription.
_HIGH BLOOD PRESSURE _
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.
Perindopril arginine helps lower your
blood pressure.
_HEART FAILURE _
Heart failure means that the heart
muscle cannot pump blood strongly
enough to

Charakterystyka produktu

1
AUSTRALIAN PRODUCT INFORMATION –
APO-PERINDOPRIL ARGININE (PERINDOPRIL ARGININE)
TABLETS
1
NAME OF THE MEDICINE
Perindopril Arginine.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg, 5 mg or 10 mg perindopril arginine, as
the active ingredient.
3
PHARMACEUTICAL FORM
2.5 MG TABLETS:
White coloured, round shaped, biconvex, film coated tablets, with
engraved “APO” on one side
and “2.5” on the other side.
5 MG TABLETS:
Light green coloured, capsule-shaped, biconvex, film coated tablets,
with notch and engraved
“APO” on one side and “P 5” on the other side.
10 MG TABLETS:
Green coloured, round shaped, biconvex, film coated tablets, with
engraved “APO” on one
side and “P 10” on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
The treatment of hypertension.
•
The treatment of heart failure. In such patients it is recommended
that perindopril
arginine be given with a diuretic and/or digoxin under close medical
supervision. (The
safety and efficacy of perindopril arginine 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, 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.
4.2
DOSE AND METHOD OF ADMINISTRATION
Perindopril Arginine tablets are intended for oral administration.
HYPERTENSION
The usual starting dose is one perindopril arginine
5 mg tablet 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 one perindopril arginine
10 mg tablet once daily.
A starting dose of one perindopril arginine
2.5 mg tablet per day is recommended in the
following patients who may be at risk of ACE inhibitor-induced
hypotension:
2
Combination with a Diuretic
The administration of perindopril arginine to patients currently
treate