MONACE fosinopril sodium 10 mg tablet blister pack

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

fosinopril sodium, Quantity: 10 mg

Διαθέσιμο από:

Alphapharm Pty Ltd

INN (Διεθνής Όνομα):

Fosinopril sodium

Φαρμακοτεχνική μορφή:

Tablet, uncoated

Σύνθεση:

Excipient Ingredients: microcrystalline cellulose; sodium starch glycollate; pregelatinised maize starch; hyprolose; crospovidone; glyceryl behenate

Οδός χορήγησης:

Oral

Μονάδες σε πακέτο:

14, 100, 56, 28, 30

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

MONACE is indicated for the treatment of mild to moderate hypertension. MONACE is effective alone as initial therapy or in combination with other antihypertensive agents. The antihypertensive effects of MONACE and diuretics used concomitantly are approximately additive. Data have not been provided to support the use of MONACE in severe or renovascular hypertension. Heart failure: MONACE is indicated for the management of heart failure when added to conventional therapy, including diuretics.

Περίληψη προϊόντος:

Visual Identification: White to off-white, arc-rectangular shaped tablet, with 'G' scoreline 'G' on one side and 'FS' scoreline '10' on the other side.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Καθεστώς αδειοδότησης:

Licence status A

Ημερομηνία της άδειας:

2005-11-08

Φύλλο οδηγιών χρήσης

MONACE
_fosinopril sodium_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking Monace
tablets.
This leaflet answers some common
questions about Monace 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 benefits and
risks. Your doctor has weighed the
risks of you taking Monace tablets
against the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT MONACE IS USED
FOR
Monace is used for treating high
blood pressure (hypertension) or
heart failure. Both of these are long
term (chronic) diseases so it is
important that you continue to take
your Monace tablets 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. You have
hypertension (high blood pressure)
when your blood pressure stays
higher than is needed, even when you
are calm and 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.
HEART FAILURE
Heart failure means that the heart
muscle is weak and cannot pump
blood strongly 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 may
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, ofte

Αρχείο Π.Χ.Π.

AUSTRALIAN PRODUCT INFORMATION
MONACE
_fosinopril sodium tablets _
1
NAME OF THE MEDICINE
Fosinopril sodium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Monace tablet contains 10 mg or 20mg of fosinopril sodium as the
active ingredient.
List of excipients with known effect: Monace tablets also contain
traces of benzoates and sulfites.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
MONACE 10: Fosinopril sodium 10 mg tablets; white to off-white,
arc-rectangular shaped, with “G

G” on
one side and “FS

10” on the other side.
MONACE 20: Fosinopril sodium 20 mg tablets; white to off-white,
capsule shaped, with “G

G” on one side
and “FS

20” on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
HYPERTENSION:
Monace is indicated in the treatment of mild to moderate hypertension.
Monace is effective alone as initial therapy or in combination with
other antihypertensive agents. The
antihypertensive effects of Monace and diuretics used concomitantly
are approximately additive.
Data have not been provided to support the use of Monace in severe or
renovascular hypertension.
HEART FAILURE
Monace is indicated for the management of heart failure when added to
conventional therapy, including
diuretics.
4.2
DOSE AND METHOD OF ADMINISTRATION
HYPERTENSION
_FOR HYPERTENSIVE PATIENTS NOT BEING TREATED WITH DIURETICS: _
The recommended initial dose of Monace is 10 mg once a day. The usual
dose range required to maintain
blood pressure control is 10 to 40 mg per day administered as a single
dose. Monace 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 Monace alone, a diuretic may be
added.
_FOR HYPERTENSIVE 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 Monace in
order to reduce the risk of an excessive