GENRX PERINDOPRIL/INDAPAMIDE 4/1.25 perindopril erbumine/indapamide hemihydrate 4mg/1.25mg tablet blister pack

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

即購入

製品の特徴 製品の特徴 (SPC)
16-06-2021
公開評価報告書 公開評価報告書 (PAR)
30-11-2017

有効成分:

indapamide hemihydrate,perindopril erbumine

から入手可能:

Apotex Pty Ltd

INN(国際名):

indapamide hemihydrate,Perindopril erbumine

認証ステータス:

Registered

情報リーフレット

                                GENRX PERINDOPRIL/INDAPAMIDE 4/1.25 TABLETS
1
GENRX
PERINDOPRIL/INDAPAMIDE
4/1.25 TABLETS
_Contains the active ingredients perindopril erbumine and indapamide
hemihydrate _
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 GenRx
Perindopril/ Indapamide 4/1.25
tablets. It contains the active
ingredients perindopril and
indapamide, which are used to treat
high blood pressure (also known as
hypertension).
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
(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.
Perindopril/indapamide helps to
lower your blood pressure
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
There is no evidence that this
medicine is addictive.
_USE IN OLDER PEOPLE OR _
_CHILDREN _
Elderly people can generally use
Perindopril/Indapamide 4/1.25
safely. However, some older people
have reduced kidney function - in
wh
                                
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製品の特徴

                                1
AUSTRALIAN PRODUCT INFORMATION
GENRX PERINDOPRIL/INDAPAMIDE 4/1.25 (PERINDOPRIL
ERBUMINE / INDAPAMIDE HEMIHYDRATE) TABLETS
1
NAME OF THE MEDICINE
Perindopril erbumine / indapamide hemihydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains perindopril erbumine 4 mg and indapamide
hemihydrate 1.25 mg, as
the active ingredients.
EXCIPIENTS WITH KNOWN EFFECT
Lactose
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
White, capsule-shaped, biconvex tablets, engraved "4/1.25" on one side
and "APO" on the
other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of hypertension. Treatment should not be initiated with this
combination.
4.2
DOSE AND METHOD OF ADMINISTRATION
Perindopril/Indapamide 4 /1.25 tablets are intended for oral
administration.
DOSAGE
One Perindopril/Indapamide 4/1.25 tablet per day as a single dose,
preferably to be taken in
the morning.
RENAL IMPAIRMENT
In cases of severe renal insufficiency (creatinine clearance below 30
mL/min), the treatment
is contraindicated.
In patients with moderate renal insufficiency (creatinine clearance
from 30 to 60 mL/min), the
maximum dose should be at a low dose or with one component.
In patients with a creatinine clearance greater than 60 mL/min, no
dose adaptation is
required.
Normal medical practice includes periodic control for creatinine and
potassium.
HEPATIC IMPAIRMENT
In severe hepatic impairment, treatment is contraindicated.
2
In patients with moderate hepatic impairment, no dose modification is
required.
ELDERLY PATIENTS
Renal insufficiency is commonly observed in elderly people. Care
should therefore be taken
when prescribing perindopril-containing medicines to elderly
hypertensive patients
The initial daily dose in the elderly should always be at a low dose
or with one component
only, and patients should be monitored closely during the initial
stages of treatment.
Particular care should be taken in elderly patients with congestive
heart failure who have
renal and/or hepatic insuffici
                                
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