APO-FOSINOPRIL HCTZ 20/12.5 fosinopril sodium 20 mg and hydrochlorothiazide 12.5 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

fosinopril sodium,hydrochlorothiazide

Available from:

Medis Pharma Pty Ltd

INN (International Name):

Fosinopril sodium,Hydrochlorothiazide

Authorization status:

Registered

Patient Information leaflet

APO-Fosinopril HCTZ 20/12.5 CMI July 2014
APO-FOSINOPRIL HCTZ 20/12.5 TABLETS
_contain the active ingredients fosinopril sodium and
hydrochlorothiazide _
_CONSUMER MEDICINE INFORMATION _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about APO-
FOSINOPRIL HCTZ 20/12.5. It
does not contain all the available
information.
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 APO-FOSINOPRIL
HCTZ 20/12.5, ASK YOUR DOCTOR
OR PHARMACIST.
WHAT APO-
FOSINOPRIL HCTZ
20/12.5 IS USED FOR
APO-FOSINOPRIL HCTZ 20/12.5
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. If 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 APO-_
_FOSINOPRIL HCTZ _
_20/12.5 WORKS _
APO-FOSINOPRIL HCTZ 20/12.5
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 low

Summary of Product characteristics

_APO-FOSINOPRIL HCTZ 20/12.5 _
PRODUCT INFORMATION
NAME OF THE MEDICINE
APO-Fosinopril HCTZ 20/12.5 contains two active drug substances:
fosinopril sodium and
hydrochlorothiazide.
_FOSINOPRIL SODIUM_, chemical name:
L-Proline, 4-cyclohexyl-1-[[[2-methyl-1-(1-oxopropoxy) propoxy]
(4-phenylbutyl)
phosphinyl]acetyl]-, sodium salt, _trans-. _
Molecular formula is C
30
H
45
NNaO
7
P.
Molecular weight is 585.65. Fosinopril sodium
chemical abstract number CAS is 88889-14-9.
_HYDROCHLOROTHIAZIDE_, chemical name:
6-chloro-3,4-dihydro- 2_H_-1,2,4-benzothiadiazine-7-sulfonamide
1,1-dioxide.
Molecular formula is C
7
H
8
CIN
3
O
4
S
2
. Molecular weight is 297.72. The chemical abstract
number CAS is 58-93-5.
_PRODUCT INFORMATION: APO-FOSINOPRIL HCTZ 20/12.5 _
PI 110614
DESCRIPTION
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.
Hydrochlorothiazide is the 3,4-dihydro derivative of chlorothiazide.
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.
Each tablet contains 20 mg fosinopril sodium and 12.5 mg
hydrochlorothiazide. The tablet
also contains the following excipients: lactose, pregelatinised
starch, croscarmellose
sodium, glycerol dibehenate, magnesium stearate and pigment blend
PB-23061.
PHARMACOLOGY
FOSINOPRIL SODIUM
Fosinopril sodium is the ester prodrug of a long acting angiotensin
converting enzyme
(ACE) inhibitor, fosinopril diacid. It is a subclass of ACE inhibitors
containing a
phosphinate group which makes it different from other marketed ACE
inhibitors.
In humans and animals, fosinopril sodium following absorption is
hydrolysed to the
pharmacologically active fosinopril diacid, a specific competitive
inhibitor of angiotensin
converting enzyme (ACE). ACE, a peptidyldipeptidase, catalyses the
conversion of the
decapeptide angiotensin I to the octapeptide ang