ZEDACE Captopril 50mg tablet blister pack

Land: Australien

Sprache: Englisch

Quelle: Department of Health (Therapeutic Goods Administration)

Wirkstoff:

captopril, Quantity: 50 mg

Verfügbar ab:

Alphapharm Pty Ltd

Darreichungsform:

Tablet, uncoated

Zusammensetzung:

Excipient Ingredients: microcrystalline cellulose; lactose; maize starch; stearic acid; sodium starch glycollate

Verabreichungsweg:

Oral

Einheiten im Paket:

90 tablets

Verschreibungstyp:

(S4) Prescription Only Medicine

Anwendungsgebiete:

HYPERTENSION. Treatment of hypertension. In using Zedace, consideration should be given to the risk of neutropenia/ agranulocytosis (see Precautions). Zedace is effective alone and in combination with other antihypertensive agents, especially thiazide-type diuretics. The hypotensive effects of captopril and thiazides are approximately additive. MYOCARDIAL INFRACTION. Zedace may be used to improve survival following myocardial infarction in clinically stable patients with left ventricular dysfunction, manifested as an ejection fraction less than or equal to 40%, and to decrease the incidence of overt heart failure and subsequent hospitalisations for congestive heart failure in these patients. The efficacy data for the use of captopril following myocardial infarction are strongest for commencement of therapy beyond three days postinfarction. HEART FAILURE. Treatment of heart failure. It is recommended that Zedace be administered together with a diuretic in symptomatic patients. DIABETIC NEPHROPATHY. Zedace is also indicated in the treatment of diabetic nephropathy in patients with type I insulin- dependent diabetes mellitus.

Produktbesonderheiten:

Visual Identification: White, oval, biconvex tablet, approx. 11.3mm x 5.8mm, with "CT/50" on one side and "G" on the reverse.; Container Type: Blister Pack; Container Material: PVC/PVDC/PE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Berechtigungsstatus:

Licence status A

Berechtigungsdatum:

1996-10-10

Gebrauchsinformation

ZEDACE
_contains the active ingredient captopril_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Zedace.
It does not contain all of 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 Zedace 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 ZEDACE IS USED
FOR
Zedace is used for treating high
blood pressure (hypertension),
certain heart conditions, and certain
kidney conditions associated with
diabetes. These are long term
(chronic diseases) so it is important
that you continue to take your Zedace
every day.
Zedace contains captopril. Captopril
belongs to a group of medicines
called angiotensin converting
enzyme (ACE) inhibitors.
ACE inhibitors work to lower your
blood pressure to normal levels if it
is too high. Zedace also acts to help
your heart or kidneys to work better.
Your doctor will tell you why you
need to take Zedace. Never let
anyone else take your medicine.
There is no evidence that it is
addictive or habit forming.
This medicine is only available only
with a doctor’s prescription.
Zedace is not recommended for use
in children as there have been not
enough studies of its effects in
children. However, it may be
necessary for a child with
hypertension and kidney problems to
take this medicine, if this is the case
your doctor will discuss all the
possible risks and benefits to the
child before starting therapy.
BEFORE YOU TAKE
ZEDACE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE ZEDACE IF YOU ARE
ALLERGIC TO:
•
YOU MUST NOT TAKE ZEDACE IF YOU
ARE PREGNANT OR MAY BECOME
PREGNANT
•
MEDICAL CONDITIONS KNOW AS
IDIOPATHIC ANGIOEDEMA OR
HEREDITARY ANGIOEDEMA
•
YOU MUST NOT TAKE ZEDACE IF YOU
HAVE EVER HAD AN ALLERGY TO
ZEDACE OR ANY OF THE
INGREDIENTS LISTED AT THE END OF
THIS

Fachinformation

AUSTRALIAN PRODUCT INFORMATION
ZEDACE
_Captopril tablet, uncoated _
1
NAME OF THE MEDICINE
Captopril
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Captopril is a white to almost white, crystalline powder. It is a
highly specific competitive inhibitor of
angiotensin I converting enzyme, the enzyme responsible for the
conversion of angiotensin I to angiotensin
II.
Each Zedace tablet 12.5 mg contains 12.5 mg of captopril as the active
ingredient.
Each Zedace tablet 25 mg contains 25 mg of captopril as the active
ingredient.
Each Zedace tablet 50 mg contains 50 mg of captopril as the active
ingredient.
Excipients with known effect: Zedace also contains sugars (as lactose)
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Zedace tablet 12.5 mg: white elongated tablet with partial bisect and
“G” on one side and partial bisect and
“C12.5” on the other.
Zedace tablet 25 mg: white, octagonal, biconvex tablet, approx. 6.5 mm
in diameter, quadrisected on one side
with one character “C”, “T”, “2” and “5” in each
quadrant and “G” on the reverse.
Zedace tablet 50 mg: white oval, biconvex tablet, approx. 11.3 mm x
5.8 mm, with “CT/50” on one side and
“G” on the reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
HYPERTENSION
Treatment of hypertension.
In using Zedace, consideration should be given to the risk of
neutropenia/agranulocytosis (see
SECTION 4.4
SPECIAL WARNINGS AND
PRECAUTIONS FOR USE
).
Zedace is effective alone and in combination with other
antihypertensive agents, especially thiazide-type
diuretics. The hypotensive effects of captopril and thiazides are
approximately additive.
MYOCARDIAL INFARCTION
Zedace may be used to improve survival following myocardial infarction
in clinically stable patients with left
ventricular dysfunction, manifested as an ejection fraction ≤ 40%,
and to decrease the incidence of overt heart
failure and subsequent hospitalisations for congestive heart failure
in these patients. The efficacy data for the
u