FOSIPRIL 10 fosinopril sodium 10 mg tablet blister pack

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: microcrystalline cellulose; lactose monohydrate; crospovidone; povidone; glyceryl behenate

Administration route:

Oral

Units in package:

30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

HYPERTENSION: Treatment of mild to moderate hypertension. Fosinopril is effectine 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, oval tablet, embossed with 'FI' partial score '10' on one side and a partial scoreline on the other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2004-11-16

Patient Information leaflet

FOSIPRIL
®
1
FOSIPRIL
®
_Fosinopril Sodium _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING FOSIPRIL.*
This leaflet answers some common
questions about FOSIPRIL. It does
not contain all the available
information. Some of the information
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.
HEART FAILURE:
Heart failure means that the heart
FOSIPRIL is not addictive.
FOSIPRIL is available only with a
doctor's prescription.
The safety and effectiveness of
FOSIPRIL in children has not been
established.
it contains may not apply to you. It
muscle cannot pump blood strongly
does not take the place of talking to
your doctor or pharmacist.
KEEP THIS LEAFLET.
You may need to refer to it again
later.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING FOSIPRIL, ASK YOUR
DOCTOR OR PHARMACIST.
WHAT IS FOSIPRIL
USED FOR
FOSIPRIL is used for treating high
enough to supply all the blood
needed throughout the body. Heart
failure is not the same as heart attack
and does not mean that the heart
stops. Heart failure may start off with
no symptoms, but as the condition
progresses, patients feel short of
breath or may get tired easily after
light physical activity such as
walking. Some patients may wake up
short of breath at night. Fluid may
collect in different parts of the body,
often first noticed as swollen ankles
and feet.
BEFORE YOU TAKE
FOSIPRIL
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE FOSIPRIL IF:
•
you have an allergy to fosinopril
sodium (the active ingredient in
FOSIPRIL), or to any of the
inactive ingredients listed at the
end of this leaflet.
Symptoms of an allergic reaction
to FOSIPRIL may include skin
rash, itchiness, shortness of
breath, swelling of the face, lips
blood pressure (hypertension) or
or tongue, muscle pain or
heart failure. Both of these are long
term (chronic) diseases so it is
important that you continue to take
your FOSIPRIL every

Summary of Product characteristics

1
AUSTRALIAN PI – FOSIPRIL (FOSINOPRIL SODIUM)
1
NAME OF THE MEDICINE
Fosinopril sodium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fosipril tablets come in two strengths, containing either 10 mg or 20
mg of fosinopril sodium.
The tablets contain lactose monohydrate. For full list of excipients,
see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
FOSIPRIL 10
White oval tablet, embossed with FI, partial score, 10 on one side and
a partial score
on the other side.
FOSIPRIL 20
White capsule-shaped tablet, embossed with FI 20 on one side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC 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.
4.2
D
OSE AND METHOD OF ADMINISTRATION
HYPERTENSION.
2
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
resumed.
Alternatively,
if
diuretic
therapy
cannot
be
dis