HYFORIL 20/12.5 mg fosinopril sodium 20mg and hydrochlorothiazide 12.5mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

fosinopril sodium,hydrochlorothiazide

Available from:

Sun Pharma ANZ Pty Ltd

INN (International Name):

Fosinopril sodium,Hydrochlorothiazide

Authorization status:

Registered

Patient Information leaflet

HYFORIL CMI V5 Oct 08
Page 1 of 13
HYFORIL
® 10/12.5 MG AND HYFORIL
® 20/12.5 MG
_FOSINOPRIL + HYDROCHLOROTHIAZIDE TABLETS_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about HYFORIL 10/12.5 MG
and
HYFORIL 20/12.5 MG (fosinopril + hydrochlorothiazide tablets).
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 HYFORIL 10/12.5 MG or HYFORIL 20/12.5 MG against the benefits
it is
expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT USING/TAKING THIS MEDICINE, ASK YOUR
DOCTOR
OR PHARMACIST.
Keep this leaflet with this medicine. You may need to read it again.
WHAT HYFORIL 10/12.5 MG AND HYFORIL 20/12.5 MG ARE USED FOR
HYFORIL
10/12.5
MG
and
HYFORIL
20/12.5
MG
contain
two
medicines,
fosinopril
sodium
and
hydrochlorothiazide.
Both
medicines
reduce
blood
pressure, but work in different ways. Fosinopril belongs to the class
of medicines
called Angiotensin Converting Enzyme (ACE) inhibitors that act on the
heart and
blood vessels. Hydrochlorothiazide is a diuretic, i.e., it works by
making your
kidneys pass more water and salt. Together fosinopril and
hydrochlorothiazide
lower high blood pressure.
Your doctor would have prescribed HYFORIL 10/12.5 MG or HYFORIL
20/12.5
MG (fosinopril + hydrochlorothiazide tablets) for the following:

treatment of high blood pressure if treatment of high blood pressure
is not
satisfactory with fosinopril alone.
Fosinopril and hydrochlorothiazide tablets are not suitable for
initial therapy of
high blood pressure.
Your doctor may prescribe HYFORIL 10/12.5 MG or HYFORIL 20/12.5 MG for
another reason. Ask your doctor if you have any questions about why
HYFORIL
10/12.5 MG or HYFORIL 20/12.5 MG has been prescribed for you.
HYFORIL CMI V5 Oct 08
Page 2 of 13
There is no evidence that HYFORIL 10/12.5 MG or HYFORIL 20/12.5 MG
tablets
are addictive.
Fosinopril + hydrochlorothiazide may af

Summary of Product characteristics

HYFORIL PI V4 Nov 2007
Page 1 of 15
HYFORIL 10/12.5 MG AND HYFORIL 20/12.5 MG
(FOSINOPRIL 10 MG + HYDROCHLOROTHIAZIDE 12.5 MG
&
FOSINOPRIL 20 MG + HYDROCHLOROTHIAZIDE 12.5 MG)
NAME OF THE MEDICINE
FOSINOPRIL + HYDROCHLOROTHIAZIDE TABLETS 10 + 12.5 MG
Each tablet contains:
Fosinopril sodium
10 mg
Hydrochlorothiazide Ph. Eur.
12.5 mg
FOSINOPRIL + HYDROCHLOROTHIAZIDE TABLETS 20 + 12.5 MG
Each tablet contains:
Fosinopril sodium
20 mg
Hydrochlorothiazide Ph. Eur.
12.5 mg
FOSINOPRIL SODIUM
STRUCTURE
CAS number 88889-14-9
HYDROCHLOROTHIAZIDE
STRUCTURE
CAS Number: 58-93-5
HYFORIL PI V4 Nov 2007
Page 2 of 15
DESCRIPTION
HYFORIL 10/12.5 MG and HYFORIL 20/12.5 MG Tablets contains contain
Fosinopril sodium and
hydrochlorothiazide.
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. Fosinopril sodium is
designated chemically as: _L_-proline,
4-cyclohexyl-1- [[[2-methyl-1- (1-oxopropoxy) propoxy] (4-phenylbutyl)
phosphinyl]acetyl]-, sodium salt,
_trans-_. The empiric formula of fosinopril sodium is C
30
H
45
NNaO
7
P. The molecular weight of fosinopril
sodium is: 585.65.
_Fosinopril sodium: _
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.
The
empiric
formula
of
hydrochlorothiazide is: C
7
H
8
CIN
3
O
4
S
2
and molecular Weight is: 297.72.
_Hydrochlorothiazide: _
HYFORIL 10/12.5 MG and HYFORIL 20/12.5 MG contains the following
inactive ingredients: Anhydrous
Lactose, Crospovidone, Povidone, Microcrystalline Cellulose, Colloidal
Anhydrous Silica, Purified Talc.
PHARMACOLOGY
PHARMACODYNAMICS
_FOSINOPRIL SODIUM:_
ACE,
a
peptidyldipeptidase,
catalyzes
the
conversion
of
the
decapeptide
angiotensin
I
to
the
octapeptide angiotensin II. Angiotensin II is a potent vasoconstrictor
and it also stimulates aldosterone
secretion