DOSTINEX TABLET 0.5MG

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

CABERGOLINE

Boleh didapati daripada:

PFIZER (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

CABERGOLINE

Unit dalam pakej:

2 Tablets; 8 Tablets

Dikeluarkan oleh:

Pfizer Italia S.r.l.

Risalah maklumat

Pfizer Confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
DOSTINEX
®
TABLET
Cabergoline (0.5 mg)
PLD Title
: Dostinex Tablet
PLD Date
: 20 January 2020
Country
: Malaysia
Reference Document
: Malaysia LPD dated 02 August 2018
Reason for Change
: To align with current effective Malaysia LPD (dated 02 August 2018)
: Revise as per new template
: PfLEET Number: 2019-0052724, To update as per BOH comments
: To update serial number and to remove phone number for reporting
side effects
Pfizer Confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
DOSTINEX TABLET
Cabergoline (0.5 mg)
2
WHAT IS IN THIS LEAFLET
1. What Dostinex is used for
2. How Dostinex works
3. Before you use Dostinex
4. How to use Dostinex
5. While you are using it
6. Side effects
7. Storage and Disposal of Dostinex
8. Product Description
9. Manufacturer and Product Registration
Holder
10.
Date of Revision
WHAT DOSTINEX IS USED FOR
Dostinex is used to prevent the
production of milk in women after child
birth, if breast-feeding is to be prevented
for medical reasons.
Dostinex may be prescribed by your
doctor to reduce your body's level of a
hormone known as prolactin. Dostinex
may be needed if your levels of prolactin
are abnormally high
(hyperprolactinaemia).
HOW DOSTINEX WORKS
Dostinex is an oral tablet that contains
cabergoline and belongs to a class of
medicines called ‘dopamine agonists’.
Dopamine is produced naturally in the
body and helps to transmit messages to
the brain.
Cabergoline mimics the action of
dopamine to reduce the production of
prolactin in the blood. Prolactin is the
hormone which stimulates the breast to
produce milk.
BEFORE YOU USE DOSTINEX
-
_When you must not use it_
You are allergic to cabergoline, to
other medicines called ergot
alkaloids, or to any of the other
ingredients in the tablet
-
You have heart valve disorder
-
You have had fibrotic reactions (scar
tissue) affecting your abdomen, heart
or lungs.
_Pregnancy and lactation_
If you are pregnant or planning to get
pregnant, discuss this with your

Ciri produk

Pfizer Confidential
Page 1 of 9
LPD Title : Cabergoline
LPD Date : 02 August 2018
Country : Malaysia
Reference : CDS 05 February 2013
Reason for Change : To update Sections 4.4, 4.7 and 4.8 based on BOH recommendation.
Update to storage condition & Nature and Contents of Container
PFIZER
DOSTINEX
*
Cabergoline
1. NAME OF THE MEDICINAL PRODUCT
DOSTINEX
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Available as tablets each containing 0.5 mg Cabergoline.
3. PHARMACEUTICAL FORM
Tablets
4. CLINICAL PARTICULARS
4.1. Therapeutic indications
Inhibition/Suppression of Physiological Lactation:
Cabergoline is indicated for 1) the inhibition of physiological lactation soon after parturition
and 2) suppression of established lactation.
Treatment of Hyperprolactinaemic Disorders:
Cabergoline is indicated for the treatment of hyperprolactinemic disorders.
4.2. Posology and method of administration
General:
Cabergoline tablets are for oral administration. Since the tolerability of dopaminergic agents
is improved when administered with food, it is recommended that cabergoline be taken with
meals.
In patients known to be intolerant to dopaminergic drugs, the likelihood of adverse events
may b e lessened by starting therapy with cabergoline at reduced doses (e.g., 0.25 mg once a
week) with subsequent gradual increase until the therapeutic dosage is reached. If persistent
or severe adverse events occur, temporary reduction of dosage followed by a more gradual
increase (e.g., increments of 0.25 mg per week every two weeks) may increase tolerability.