资料单张
MONOPLUS
®
_Fosinopril sodium/hydrochlorothiazide_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING MONOPLUS.
This leaflet answers some of the
common questions about Monoplus.
It does not contain all the available
information. Some of the information
it contains may not apply to you. It
does not take the place of talking to
your doctor or pharmacist.
KEEP THIS LEAFLET.
You may need to read it again.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING MONOPLUS, ASK YOUR DOCTOR
OR PHARMACIST.
WHAT MONOPLUS IS
USED FOR
Monoplus is used to lower high
blood pressure (hypertension).
Everyone has blood pressure. This
pressure helps get your blood all
around your body. Your blood
pressure may be different at different
times of the day, depending on how
busy or worried you are. You have
hypertension (high blood pressure),
this means that your blood pressure
stays higher than is needed, even
when you are relaxed.
There are usually no symptoms of
hypertension. The only way of
knowing that you have hypertension
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,
including stroke, heart disease and
kidney failure.
_HOW MONOPLUS WORKS_
Monoplus tablets contain two
medicines, fosinopril sodium and
hydrochlorothiazide. Both medicines
reduce blood pressure, but work
different ways.
Fosinopril sodium belongs to a group
of medicines called angiotensin
converting enzyme (ACE) inhibitors.
It works by widening your blood
vessels, reducing the pressure in the
vessels (reducing 'blood pressure')
and by making it easier for your heart
to pump blood around your body.
This helps your heart to work better
by increasing the supply of oxygen to
your heart.
Hydrochlorothiazide is a diuretic
(fluid tablet). It helps reduce the
amount of excess fluid in the body by
increasing the amount of urine
produced. It also lowers high blood
pressure, particularly when combined
with other blood pressure reducing
medicines s
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产品特点
Monoplus V4.0 1 November 2012
1
PRODUCT INFORMATION
MONOPLUS
NAME OF THE MEDICINE
MONOPLUS
is available in two tablet strengths:
MONOPLUS 10/12.5 containing - fosinopril sodium 10 mg /
hydrochlorothiazide 12.5 mg
MONOPLUS 20/12.5 containing - fosinopril sodium 20 mg /
hydrochlorothiazide 12.5 mg
Fosinopril sodium is designated chemically as:
_L_-proline, 4-cyclohexyl-1- [[[2-methyl-1- (1-oxopropoxy) propoxy] (4-phenylbutyl) phosphinyl]acetyl]-
, sodium salt, _trans-_._ _
Hydrochlorothiazide is the 3,4-dihydro derivative of chlorothiazide defined chemically as 6-chloro-3,4-
dihydro-2_H_-1,2,4-benzothiadiazine-7-sulphonamide 1,1-dioxide.
DESCRIPTION
_FOSINOPRIL SODIUM:_
Fosinopril sodium is the ester prodrug of a long-acting angiotensin converting enzyme (ACE) inhibitor,
fosinopril diacid. It is a sub-class of ACE inhibitors containing a phosphinate group which makes it
different from other marketed ACE inhibitors.
Its structural formula is:
Fosinopril sodium is a white to off-white crystalline powder. It is soluble in water (100 mg/mL),
methanol, and ethanol and slightly soluble in hexane.
Its empiric formula is C
30
H
45
NNaO
7
P with a molecular weight of 585.65.
CAS number 88889-14-9
Monoplus V4.0 1 November 2012
2
_HYDROCHLOROTHIAZIDE:_
The structural formula is:
It is a white or practically white, crystalline powder which is very slightly soluble in water; soluble in
acetone; sparingly soluble in ethanol (96%) but it dissolves in dilute solutions of alkali hydroxides. The
empirical formula is C
7
H
8
CIN
3
O
4
S
2
with a molecular weight of 297.72. CAS Number 58-93-5
Inactive ingredients in both strengths of MONOPLUS tablets are lactose, lactose anhydrou
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