NORPROLAC quinagolide 75 micrograms tablet

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

quinagolide hydrochloride, Quantity: 0.0819 mg (Equivalent: quinagolide hydrochloride, Qty 75 microgram)

Available from:

Ferring Pharmaceuticals Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: colloidal anhydrous silica; magnesium stearate; hypromellose; maize starch; microcrystalline cellulose; lactose monohydrate

Administration route:

Oral

Units in package:

30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Hyperprolactinaemia (idiopathic or originating from a prolactin- secreting pituitary microadenoma or macroadenoma) associated with its clinical manifestations such as galactorrhoea, oligomenorrhoea, amenorrhoea, infertility and reduced libido.

Product summary:

Visual Identification: Off-white, bevelled edge, NORPROLAC (circular) on one side and 75 on the other.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

1994-10-26

Patient Information leaflet

NORPROLAC
® TABLETS
_quinagolide_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Norprolac.
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 this medicine
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 NORPROLAC IS
TAKEN FOR
Norprolac is used to treat people who
have high blood levels of a hormone
called prolactin. This condition is
sometimes caused by a type of
tumour called a prolactinoma.
Norprolac contains the active
ingredient, quinagolide.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is only available with
a doctor's prescription. It is not
addictive.
There is not enough information to
recommend its use in children.
BEFORE YOU TAKE
NORPROLAC
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE NORPROLAC IF YOU HAVE
AN ALLERGY TO:
•
quinagolide (the active
ingredient) or any of the other
ingredients listed at the end of
this leaflet.
Some of the symptoms of an allergic
reaction may include shortness of
breath, wheezing or difficulty
breathing; swelling of the face, lips,
tongue or other parts of the body;
rash, itching or hives on the skin.
DO NOT TAKE THIS MEDICINE IF YOU
HAVE PROBLEMS WITH YOUR KIDNEYS
OR LIVER.
There is no experience with the use
of this medicine in people whose
kidney or liver function is impaired.
DO NOT TAKE IT AFTER THE EXPIRY DATE
PRINTED ON THE PACK OR IF THE
PACKAGING IS TORN OR SHOWS SIGNS OF
TAMPERING.
In that case, return it to your
pharmacist.
_BEFORE YOU START TO TAKE IT_
TELL YOUR DOCTOR IF YOU HAVE HAD
ANY TYPE OF MENTAL ILLNESS (E.G.
SCHIZOPHRENIA).
Your doctor may want to take special
precautions while you

Summary of Product characteristics

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#16849-v10 AUSTRALIAN PI - NORPROLAC
® (QUINAGOLIDE) TABLETS
1 NAME OF THE MEDICINE
quinagolide (as hydrochloride)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Tablets containing 25, 50, 75 or 150 micrograms (0.025, 0.050, 0.075
or 0.150 mg)
quinagolide as hydrochloride.
NORPROLAC Tablets also contain the following inactive excipients:
silica, magnesium
stearate, hypromellose, starch-maize, cellulose, lactose monohydrate,
iron oxide red
(25 microgram tablet only), indigo carmine (50 microgram tablet only).
3 PHARMACEUTICAL FORM
Oral tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hyperprolactinaemia (idiopathic or originating from a
prolactin-secreting pituitary
microadenoma or macroadenoma) associated with its clinical
manifestations such as
galactorrhoea, oligomenorrhoea, amenorrhoea, infertility and reduced
libido.
4.2 DOSE AND METHOD OF ADMINISTRATION
NORPROLAC tablets should be taken once a day at bedtime with some
food. The
optimal dose must be titrated individually on the basis of the
prolactin-lowering effect
and tolerability.
With the 'starter pack', treatment begins with 25 micrograms/day for
the first three days,
followed by 50 micrograms/day for a further three days. From Day 7
onwards, the
recommended dose is 75 micrograms/day. If necessary, the daily dose
may then be
increased stepwise at intervals not shorter than one week until the
optimal individual
response is attained.
The usual maintenance dosage is 75 to 150 micrograms/day. Daily doses
of 300
micrograms or higher doses are required in less than one-third of the
patients. In such
cases, the daily dosage may be increased in steps of 75 to 150
micrograms at intervals
not shorter than four weeks.
There is no evidence of reduced tolerability or altered dosage
requirements in elderly
patients.
2/9
#16849-v10
4.3 CONTRAINDICATIONS
•
Hypersensitivity to the drug.
•
For procedure during pregnancy see SECTION 4.6 FERTILITY, PREGNANCY
AND
LACTATION.
•
Impaired hepatic or renal function.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
F