APO-CABERGOLINE cabergoline 500 micrograms tablets bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Cabergoline

Available from:

Apotex Pty Ltd

INN (International Name):

Cabergoline

Patient Information leaflet

APO-CABERGOLINE
TABLETS
_Contains the active ingredient cabergoline_
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 cabergoline. 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-
Cabergoline tablets. It contains the
active ingredient cabergoline.
It is used to:
•
treat abnormally high levels of
prolactin (hyperprolactinaemia).
•
prevent the production of milk in
women after birth, if breast
feeding is to be prevented for
medical reasons.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you. Your
doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
_HOW IT WORKS_
Cabergoline works by stimulating the
receptors which inhibit the secretion
of hormone known as prolactin, thus
reducing your body's level of
prolactin
Abnormally high prolactin may cause
menstrual changes in women,
impotence in men and breast changes
in both sexes
There is no evidence that this
medicine is addictive.
_USE IN CHILDREN_
T

Summary of Product characteristics

Product Information – Australia
APO-CABERGOLINE Tablet
Page 1
APO-CABERGOLINE TABLET
NAME OF THE MEDICINE
Cabergoline
Chemical Name:
1-[(6a_R_,9_R_,10a_R_)-7-allyl-4,6,6a,7,8,9,10,10a-octahydroindole[4,3-_fg_]-
quinoline-9-carbonyl]-1-(3-dimethyl-aminopropyl)-3-ethylurea
Structural Formula:
Molecular Formula:
C
26
H
37
N
5
O
2
Molecular Weight:
451.62
CAS Registry Number:
81409-90-7
DESCRIPTION
Cabergoline is a dopaminergic ergoline derivative, which has a potent
and long lasting prolactin (PRL)-
lowering activity.
Each tablet contains cabergoline as the active ingredient. In
addition, each tablet contains the
following inactive ingredients: lactose anhydrous and magnesium
stearate.
PHARMACOLOGY
PHARMACOLOGICAL ACTIONS
Cabergoline is a dopaminergic ergoline derivative with a potent and
long lasting PRL-lowering activity.
It acts by direct stimulation of the D
2
-dopamine receptors on pituitary lactotrophs, thus inhibiting PRL
secretion.
In addition, cabergoline exerts a central dopaminergic effect via D
2
receptor stimulation at oral doses
higher than those effective in lowering serum PRL levels.
The long lasting PRL-lowering effect of cabergoline is probably due to
its long persistence in the target
organ, as suggested by the slow elimination of total radioactivity
from the pituitary after a single oral
dose in rats (t
1/2
of approximately 60 hours).
The pharmacodynamic effects of cabergoline have been studied in
healthy volunteers, puerperal
women
and
hyperprolactinaemic
patients.
After
a
single
oral
administration
of
cabergoline
(300microgram - 1.5mg) a significant decrease in serum PRL levels was
observed in each of the
populations studied. The effect is prompt (within 3 hours from
administration) and persistent (up to 7-
Product Information – Australia
APO-CABERGOLINE Tablet
Page 2
28 days in healthy volunteers and hyperprolactinaemic patients and up
to 14-21 days in puerperal
women). The PRL-lowering effect is dose-related both in terms of
degree of effect and duration of
action.
There
are
limited
clini