APO-FOSINOPRIL fosinopril sodium 10mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

fosinopril sodium, Quantity: 10 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Fosinopril sodium

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: zinc stearate; crospovidone; lactose

Administration route:

Oral

Units in package:

30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

HYPERTENSION - Treatment of mild to moderate hypertension. FOSINOPRIL is effective alone as initial therapy or in combination with other antihypertensive agents. The antihypertensive effects of FOSINOPRIL and diuretics used concomitantly are approximately additive. Data have not been provided to support the use of FOSINOPRIL in severe or renovascular hypertension. HEART FAILURE - Management of heart failure when added to conventional therapy, including diuretics.

Product summary:

Visual Identification: White, capsule shaped biconvex tablet with indents, engraved "APO" on one side and "FOS-10" on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2006-08-31

Patient Information leaflet

APO-FOSINOPRIL
_Contains the active ingredient fosinopril sodium_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about fosinopril. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.apotex.com.au.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Fosinopril. It contains the active
ingredient fosinopril.
It is used to treat:
•
high blood pressure
(hypertension)
•
heart failure.
Both of these are long term (chronic)
diseases so it is important that you
continue to take your medicine every
day.
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 hea

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – APO-FOSINOPRIL TABLETS
(FOSINOPRIL SODIUM)
1
NAME OF THE MEDICINE
Fosinopril Sodium.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg or 20 mg of fosinopril sodium, as the
active ingredient.
For the full list of excipients see section 6.1 List of excipients
3
PHARMACEUTICAL FORM
10 MG TABLETS:
White, capsule shaped biconvex tablets with indents, engraved
“APO” on one side and “FOS-10”
on the other side.
20 MG TABLETS:
White, oval, biconvex tablets engraved “APO” on one side and
“FOS-20” on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
HYPERTENSION
Treatment of mild to moderate hypertension.
Fosinopril is effective alone as initial therapy or in combination
with other antihypertensive agents.
The antihypertensive effects of fosinopril and diuretics used
concomitantly are approximately
additive.
Data
have
not
been
provided
to
support
the
use
of
fosinopril
in
severe
or
renovascular
hypertension.
HEART FAILURE
Fosinopril is indicated for management of heart failure when added to
conventional therapy,
including diuretics.
4.2
DOSE AND METHOD OF ADMINISTRATION
HYPERTENSION
Patients Not Being Treated with Diuretics
The recommended initial dose of fosinopril is 10 mg once a day. The
usual dose range required to
maintain blood pressure control is 10 to 40 mg/day administered as a
single dose. Fosinopril
should be taken at the same time each day. Dosage should then be
adjusted according to blood
pressure response. If blood pressure is not adequately controlled with
fosinopril alone, a diuretic
may be added.
Patients Currently Being Treated with Diuretics (or who may be volume
depleted)
The diuretic should preferably be discontinued for several days prior
to beginning therapy with
fosinopril in order to reduce the risk of an excessive hypotensive
response (see 4.4 SPECIAL
WARNINGS AND PRECAUTIONS FOR USE). If blood pressure is inadequately
controlled after an
observation period of approximately four weeks, diuretic therapy may
be