INDOSYL MONO 4 perindopril erbumine 4mg tablet blister pack

Country: Аустралија

Језик: Енглески

Извор: Department of Health (Therapeutic Goods Administration)

Активни састојак:

perindopril erbumine, Quantity: 4 mg

Доступно од:

Servier Laboratories (Aust) Pty Ltd

INN (Међународно име):

Perindopril erbumine

Фармацеутски облик:

Tablet, uncoated

Састав:

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

Пут администрације:

Oral

Јединице у пакету:

30

Тип рецептора:

(S4) Prescription Only Medicine

Терапеутске индикације:

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

Резиме производа:

Visual Identification: A white elongated rod shaped biconvex uncoated tablet with rounded ends, being 8mm long, 4mm in width and 2.75mm in depth with a breakline scored on both faces.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Статус ауторизације:

Licence status A

Датум одобрења:

2013-02-04

Информативни летак

INDOSYL MONO (PERINDOPRIL ERBUMINE)
1
INDOSYL MONO 2
INDOSYL MONO 4
INDOSYL MONO 8
_perindopril (pronounced per-in-do-pril) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about INDOSYL MONO.
It does not contain all the available
information. It does not take the
place of talking to your doctor,
pharmacist or nurse. 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 taking INDOSYL
MONO against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR, PHARMACIST OR NURSE. KEEP
THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT INDOSYL
MONO IS
The name of your medicine is
INDOSYL MONO. The medicine
contains the active ingredient
perindopril erbumine. Perindopril
belongs to a group of medicines
called angiotensin converting
enzyme (ACE) inhibitors.
WHAT INDOSYL
MONO IS USED FOR
INDOSYL MONO is available only
with a doctor's prescription.
INDOSYL MONO 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.
INDOSYL MONO helps lower your
blood pressure.
You may be prescribed INDOSYL
MONO for heart failure. Heart
failure means that the heart muscle
cannot pump blood strongly

Карактеристике производа

AUSTRALIAN PRODUCT INFORMATION - INDOSYL MONO (PERINDOPRIL ERBUMINE)
Version: 11
1/24
AUSTRALIAN PRODUCT INFORMATION
INDOSYL MONO (PERINDOPRIL ERBUMINE) UNCOATED TABLETS
1
NAME OF THE MEDICINE
Perindopril erbumine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each INDOSYL MONO 2 tablet contains 2 mg of perindopril erbumine. Each
INDOSYL MONO 4 tablet
contains 4 mg of perindopril erbumine. Each INDOSYL MONO 8 tablet
contains 8 mg of perindopril
erbumine.
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 MONO 2: Round biconvex white uncoated tablets. INDOSYL MONO 4:
Rod-shaped biconvex
scored white uncoated tablets. INDOSYL MONO 8: Round biconvex green
uncoated tablets with a Servier
logo on one face and a heart logo on the other face.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
INDOSYL MONO is indicated for:
•
the treatment of hypertension;
•
the treatment of heart failure. In such patients it is recommended
that INDOSYL MONO be given with a
diuretic and/or digoxin under close medical supervision. (The safety
and efficacy of INDOSYL MONO 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
D
OSE AND METHOD OF ADMINISTRATION
HYPERTENSION
The usual starting dose is one INDOSYL MONO 4 (4 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 INDOSYL MONO 8 (8 mg) tablet once daily.
A starting dose of one INDOSYL MONO 2 (2 mg) tablet once daily is
recommended in the following patients
who may be at risk of ACE inhibitor-induced hypotension:
•
_Combination with a Diuretic _
The administration of INDOSYL MONO t