Dostinex

País: Nova Zelândia

Língua: inglês

Origem: Medsafe (Medicines Safety Authority)

Ingredientes ativos:

Cabergoline 0.5mg

Disponível em:

Pfizer New Zealand Limited

DCI (Denominação Comum Internacional):

Cabergoline 0.5 mg

Dosagem:

0.5 mg

Forma farmacêutica:

Tablet

Composição:

Active: Cabergoline 0.5mg Excipient: Lactose Leucine

Unidades em pacote:

Bottle, glass, 2 tablets

Classe:

Prescription

Tipo de prescrição:

Prescription

Fabricado por:

Olon SpA

Indicações terapêuticas:

Prevention of the onset of lactation in the puerperium only for clearly defined medical reasons: DOSTINEX is indicated for the inhibition of physiological lactation soon after delivery. 1. After parturition, when breast feeding is contraindicated due to medical reasons related to the mother or the new-born. 2.After stillbirth or abortion.

Resumo do produto:

Package - Contents - Shelf Life: Bottle, plastic, HDPE bottle PP child resistant cap (inner cap desiccant) - 2 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE bottle PP child resistant cap (inner cap desiccant) - 8 tablets - 24 months from date of manufacture stored at or below 25°C

Data de autorização:

1993-03-18

Folheto informativo - Bula

_DOSTINEX_®
1
DOSTINEX
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING DOSTINEX?
Dostinex contains the active ingredient cabergoline. Dostinex may be
needed if your levels of a hormone known as prolactin are
abnormally high (hyperprolactinaemia). Dostinex can also be prescribed
to prevent the production of milk in women after birth.
For more information, see Section 1. Why am I using Dostinex? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE DOSTINEX?
Before starting treatment, your doctor will need to do some tests to
detect any underlying heart, lung, or kidney disease. Do not
take if you have or have had any scarring or thickening of the lungs
with shortness of breath; heart valve disorder; any swelling or
inflammation around the heart or lungs; or any abnormal formation of
tissue outside the stomach wall.
Do not take if you have an allergy to any medicine containing
cabergoline, ergot alkaloids or any of the ingredients listed. For
more information, see Section 2. What should I know before I use
Dostinex? In the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with cabergoline and affect how it works.
A list of these medicines is in Section 3. What if I am
taking other medicines? In the full CMI.
4.
HOW DO I USE DOSTINEX?
To treat hyperprolactinaemia the recommended starting dose is half a
tablet taken twice a week. Your doctor will generally start
you on a low dose and may gradually increase your dose.
To prevent the production of breast milk, the recommended dose is two
tablets taken as a single dose, on the first day after
delivery of your baby. More instructions can be found in Section 4.
How do I use Dostinex? In the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING DOSTINEX?
THINGS YOU
SHOULD DO

Follow your doctor's requests for tests and report anything unusual to
your doctor such as difficulty in
breathing, chest pain or swel

Características técnicas

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Page 1 of 11
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
DOSTINEX
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each DOSTINEX tablet contains 0.5 mg cabergoline.
EXCIPIENT(S) WITH KNOWN EFFECT

Lactose anhydrous
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Cabergoline 0.5 mg tablets are flat, capsule shaped tablets, 4 x 8 mm,
scored, white tablets,
engraved “PU” on one side and “700” on the reverse side.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Prevention of the onset of lactation in the puerperium only for
clearly defined medical reasons:_
DOSTINEX is indicated for the inhibition of physiological lactation
soon after delivery.
1.
After parturition, when breast-feeding is contraindicated due to
medical reasons related to
the mother or the new-born.
2.
After stillbirth or abortion.
_Treatment of hyperprolactinaemic disorders_: DOSTINEX is indicated
for the treatment of
dysfunctions associated with hyperprolactinaemia, including
amenorrhoea, oligomenorrhoea,
anovulation, and galactorrhoea. DOSTINEX is indicated in patients with
prolactin-secreting
pituitary adenomas (micro-
and macroprolactinomas), idiopathic hyperprolactinaemia, or
empty
sella
syndrome
with
associated
hyperprolactinaemia,
which
represent
the
basic
underlying pathologies contributing to the above clinical
manifestations.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSTINEX is to be administered by the oral route. Since in clinical
studies DOSTINEX has
been mainly administered with food since the tolerability of this
class of compound is improved
with food, it is recommended that DOSTINEX be preferably taken with
meals.
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Supersedes: pfddostt10723
Page 2 of 11
_Inhibition of physiological lactation_: DOSTINEX should be
administered during the first day
post-partum. The recommended therapeutic dose is 1 mg (two 0.5 mg
tablets) as a single dose.
_Treatment of hyperprolactinaemic disorders_: The recommended initial
dosage of DOSTINEX
i