PARLODEL bromocriptine 2.5mg (as mesilate) tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

bromocriptine mesilate, Quantity: 2.87 mg (Equivalent: bromocriptine, Qty 2.5 mg)

Available from:

Sandoz Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: maize starch; lactose monohydrate; disodium edetate; colloidal anhydrous silica; maleic acid; magnesium stearate

Administration route:

Oral

Units in package:

60 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Prevention of onset of lactation in the puerperium for clearly defined medical reasons. Therapy should be continued for 14 days to prevent rebound lactation. Parlodel should not be used to suppress established lactation. Treatment of hyperprolactinaemia where surgery and/or radiotherapy are not indicated or have already been used with incomplete resolution. Precautions should be taken to ensure that the hyperprolactinaemia is not due to severe primary hypothyroidism. Where the cause of hyperprolactinaemia is a prolactin-secreting microadenoma or macroadenoma, Parlodel is indicated for conservative treatment; prior to surgery in order to reduce tumour size and to facilitate removal; after surgery if prolactin level is still elevated. Adjunctive therapy in the management of acromegaly when: (1) The patient refuses surgery and/or radiotherapy; (2) Surgery and/or radiotherapy has been unsuccessful or full effects are not expected for some months; (3) A manifestation of the acromegaly needs to be brought under con

Product summary:

Visual Identification: White tablet, 7mm diameter, coded XC with breakline on one side, Sandoz on the other.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1991-08-21

Patient Information leaflet

PARLODEL®
1
PARLODEL
®
_bromocriptine mesilate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Parlodel.
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
final page. More recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE.
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Parlodel
against the benefits they expect it
will provide.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT PARLODEL IS USED
FOR
Parlodel has several uses. It can be
used for the following medical
conditions:
1.
Prevention/suppression of breast
milk production (lactation) in
women who cannot/do not breast-
feed for medical reasons. If breast
milk production has already
begun, your doctor can advise
you about other methods of
stopping lactation.
2.
Treatment of people who have
high blood levels of a hormone
called prolactin. This condition is
sometimes caused by a type of
tumour called a prolactinoma.
3.
Treatment of acromegaly, a
disease in which the body
produces too much growth
hormone. Parlodel treats this
disease by reducing the level of
growth hormone in the blood.
4.
To relieve symptoms, such as
shaking of the limbs, stiffness and
slowness of movement, in people
with Parkinson's disease. Parlodel
is often used in combination with
other medicines such as levodopa.
Parlodel contains the active
ingredient, bromocriptine. It belongs
to a group of medicines known as the
ergot alkaloids, derived from a type
of fungus.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION PARLODEL
®
(BROMOCRIPTINE MESILATE
)
TABLET AND HARD CAPSULE
1
NAME OF THE MEDICINE
Bromocriptine mesilate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
•
Parlodel tablets and capsules contain bromocriptine mesilate
•
Oral tablets:
➢
2.5 mg bromocriptine (present as 2.9 mg mesilate).
•
Oral capsules:
➢
10 mg bromocriptine (present as 11.5 mg mesilate).
➢
5 mg bromocriptine (present at 5.735 mg mesilate).
•
List of excipients with known effect: lactose and sugars.
•
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Oral tablets:
•
White, coded XC with breakline on one side, SANDOZ on the other side.
Oral capsules:
•
5 mg: opaque white and opaque blue, marked PS
•
10 mg: opaque white
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
•
Prevention of onset of lactation in the puerperium for clearly defined
medical reasons.
Therapy should be continued for 14 days to prevent rebound lactation.
Parlodel should not
be used to suppress established lactation.
•
Treatment of hyperprolactinaemia where surgery and/or radiotherapy are
not indicated or
have already been used with incomplete resolution. Precautions should
be taken to ensure
that the hyperprolactinaemia is not due to severe primary
hypothyroidism. Where the cause
of hyperprolactinaemia is a prolactin-secreting microadenoma or
macroadenoma, Parlodel
is indicated for conservative treatment; prior to surgery in order to
reduce tumour size and
to facilitate removal; after surgery if prolactin level is still
elevated.
•
Adjunctive therapy in the management of acromegaly when:
(1)
The patient refuses surgery and/or radiotherapy
(2)
Surgery and/or radiotherapy has been unsuccessful or full effects are
not expected for
some months
(3) A manifestation of the acromegaly needs to be brought under
control pending surgery
and/or radiotherapy.
2
•
Idiopathic or post-encephalitic Parkinson's disease. It should be
noted that data are not yet
sufficient to evaluate the role of