RENITEC enalapril maleate 10mg tablet

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

enalapril maleate, Quantity: 10 mg

Διαθέσιμο από:

ORGANON PHARMA PTY LTD

Φαρμακοτεχνική μορφή:

Tablet, uncoated

Σύνθεση:

Excipient Ingredients: sodium bicarbonate; magnesium stearate; maize starch; iron oxide red; pregelatinised maize starch; lactose monohydrate

Οδός χορήγησης:

Oral

Μονάδες σε πακέτο:

30

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

HYPERTENSION: Renitec is indicated in the treatment of: - all grades of essential hypertension; - Renovascular hypertension. CONGESTIVE HEART FAILURE: Renitec is indicated for the treatment of all degrees of symptomatic heart failure. In such patients, it is recommended that RENITEC be administered together with a diuretic. LEFT VENTRICULAR DYSFUNCTION: All degrees of left ventricular dysfunction where the left ventricular ejection fraction is less than 35%, irrespective of the presence or severity of obvious symptoms of heart failure.

Περίληψη προϊόντος:

Visual Identification: Rust red, barrel shaped tablet. One side "RENITEC", and the other side scored; Container Type: Blister Pack; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

1991-07-22

Φύλλο οδηγιών χρήσης

RENITEC
®
_Enalapril maleate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about RENITEC. 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 RENITEC
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT RENITEC IS
USED FOR
RENITEC lowers high blood
pressure, which doctors call
hypertension. It is also used to treat
heart failure.
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. You
may feel fine and have no symptoms,
but eventually hypertension can
cause stroke, heart disease and
kidney failure. RENITEC helps to
lower your blood pressure.
HEART FAILURE:
Heart failure means that the heart
muscle 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 working. 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, often first noticed as
swollen ankles and feet.
RENITEC helps to treat heart failure

Αρχείο Π.Χ.Π.

Page 1 of 16
AUSTRALIAN PRODUCT INFORMATION
RENITEC

(ENALAPRIL MALEATE)
TABLETS
1
NAME OF THE MEDICINE
enalapril maleate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Enalapril maleate is a white to off-white crystalline powder. It is
sparingly soluble in water,
soluble in ethanol, and freely soluble in methanol and
dimethylformamide.
RENITEC tablets contain 5 mg, 10 mg or 20 mg enalapril maleate.
List of excipients with known effect:
-
sugars as lactose
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
RENITEC M (enalapril maleate) 5mg, white, barrel-shaped biconvex
compressed tablet,
scored on one side and engraved 'RENITEC' on the other.
RENITEC (enalapril maleate) 10mg, rust-red, barrel-shaped biconvex
compressed tablet,
scored on one side and engraved 'RENITEC' on the other.
RENITEC 20 (enalapril maleate) 20mg, peach barrel-shaped biconvex
compressed tablet
engraved 'MSD714' on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
HYPERTENSION
RENITEC is indicated in the treatment of:
•
All grades of essential hypertension
•
Renovascular hypertension
CONGESTIVE HEART FAILURE
RENITEC is indicated for the treatment of all degrees of symptomatic
heart failure. In such
patients, it is recommended that RENITEC be administered together with
a diuretic.
LEFT VENTRICULAR DYSFUNCTION
All degrees of left ventricular dysfunction where the left ventricular
ejection fraction is less than
35%, irrespective of the presence or severity of obvious symptoms of
heart failure.
4.2
DOSE AND METHOD OF ADMINISTRATION
Page 2 of 16
ESSENTIAL HYPERTENSION
In
patients
who
are
currently
being
treated
with
a
diuretic,
symptomatic
hypotension
occasionally may occur following the initial dose of RENITEC. The
diuretic should, if possible,
be discontinued for two to three days before beginning therapy with
RENITEC to reduce the
likelihood of hypotension (See SECTION 4.4 SPECIAL WARNINGS AND
PRECAUTIONS FOR USE). If
the patient's blood pressure is not controlled with RENITEC alone,
diureti