PERINDOPRIL APOTEX perindopril erbumine 2 mg tablet blister pack

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

有效成分:

perindopril erbumine, Quantity: 2 mg

可用日期:

Arrotex Pharmaceuticals Pty Ltd

药物剂型:

Tablet

组成:

Excipient Ingredients: microcrystalline cellulose; magnesium stearate; iron oxide red; lactose monohydrate; colloidal anhydrous silica

给药途径:

Oral

每包单位数:

30 tablets

处方类型:

(S4) Prescription Only Medicine

疗效迹象:

PERINDOPRIL APOTEX is indicated for: The treatment of hypertension; The treatment of heart failure. In such patients it is recommended that PERINDOPRIL APOTEX 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 who are stable on concomitant therapy and have no heart failure, to reduce the risk of non-fatal myocardial infarction or cardiac arrest.

產品總結:

Visual Identification: Light pink to pink coloured capsule shaped tablets debossed with P & 9 on either side of the break line on one side and deep break line on the other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

授权状态:

Registered

授权日期:

2018-09-18

资料单张

PERINDOPRIL APOTEX TABLETS
1
PERINDOPRIL APOTEX
_Perindopril erbumine _
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 perindopril. It does
not contain all the available
information about this medicine. It
does not take the place of talking to
your doctor or pharmacist. If you get
any side effects, talk to your doctor,
pharmacist or nurse. This includes
any possible side effects not listed in
this leaflet.
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 want to read it again.
WHAT THIS MEDICINE IS
USED FOR
Perindopril is used to treat high blood
pressure (also known as
hypertension), heart failure or
coronary artery disease.
Perindopril belongs to a group of
medicines called angiotensin
converting enzyme (ACE) inhibitors.
_HIGH BLOOD PRESSURE _
Perindopril helps to lower your blood
pressure. Everyone has blood
pressure, which 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 worried you are. You
have high blood pressure when your
blood pressure stays higher than is
needed, even when you are 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. Untreated high blood
pressure can lead to serious health
problems, such as stroke, heart
disease and kidney failure.
_HEART FAILURE _
Perindopril helps to treat heart
failure. Heart failure means that the
heart muscle is not pumping blood
strongly enough to circulate blood
around the body properly. Heart
failure is not the same as a heart
attack and does not mean that the
heart stops working. Heart failure
may start off with no symptoms

产品特点

1
AUSTRALIAN PRODUCT INFORMATION –
PERINDOPRIL APOTEX (PERINDOPRIL ERBUMINE)
1
NAME OF THE MEDICINE
Perindopril erbumine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2 mg, 4 mg or 8 mg perindopril erbumine.
Excipients with known effects:
▪
lactose monohydrate
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
2 mg tablets – light pink to pink-coloured capsule-shaped tablets
debossed with ‘P’ and ‘9’ on
either side of the score line on one side and deep break-line on other
side. AUST R 304690.
4 mg tablets – white to off-white capsule-shaped tablets debossed
with ‘P’ and ‘5’ on either
side of the score line on one side and deep break-line on other side.
AUST R 304691.
8 mg tablets – white to off-white capsule-shaped tablets debossed
with ‘P’ and ‘6’ on either
side of the break-line on one side and break-line on other side. AUST
R 304692.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Perindopril 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
Do not break the 2 mg tablet.
HYPERTENSION
The usual starting dose 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 2 mg once daily is recommended in the following
patients who may be at risk
of angiotensin converting enzyme (ACE) inhibitor-induced hypotension:
2
▪
Combinat