Dostinex 500 microgram Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CABERGOLINE

Available from:

Pfizer Hellas S.A. 243 Messoghion Ave., Neo Psychiko 15451, Athens, Greece

ATC code:

G02CB03

INN (International Name):

CABERGOLINE 0.5500 µg

Pharmaceutical form:

TABLET

Composition:

CABERGOLINE 0.5500 µg

Prescription type:

POM

Therapeutic area:

OTHER GYNECOLOGICALS

Authorization status:

Authorised

Authorization date:

2006-11-29

Patient Information leaflet

12_2
Page 1 of 6
2015-0012078
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DOSTINEX
® 500 MICROGRAM TABLETS
cabergoline
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Dostinex is and what it is used for
2.
What you need to know before you take Dostinex
3.
How to take Dostinex
4.
Possible side effects
5
How to store Dostinex
6.
Contents of the pack and other information
1.
WHAT DOSTINEX IS AND WHAT IT IS USED FOR
-
This medicine 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.
-
Dostinex is used to suppress breast milk production (lactation) where
it is considered
essential, but should not be used for routine suppression of
lactation, or the relief of
symptoms of postpartum pain and engorgement, which can be adequately
treated with
simple analgesics and breast support.
-
Dostinex can also be used to treat conditions caused by hormonal
disturbance which can
result in high levels of prolactin being produced. This includes high
levels of prolactin
caused by tumours of the pituitary gland in both men and women,
missing or irregular
periods, infertility, milk secretion (for women).
-
Dostinex should only be used in adults. It is not suitable for
children under the age of 16
years.
-
You must talk to a doctor or

Summary of Product characteristics

Ref: DX 11_1
Page 1 of 12
2015-0012078
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Dostinex 500 microgram Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 micrograms cabergoline.
Excipients with known effect:
Each tablet also contains 75.9 mg anhydrous lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
4 x 8 mm capsule-shaped, flat, white tablets. Scored, with a letter P
on one side of the score
and U on the other on one face; and “700” with a short score in
the middle of the upper and
lower extremity of the tablet surface on the opposite face of the
tablet. The tablet can be
divided into equal halves.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cabergoline is indicated for the treatment of dysfunctions associated
with
hyperprolactinaemia in female patients, including amenorrhoea,
oligomenorrhoea,
anovulation and galactorrhoea. Cabergoline is indicated in patients
with prolactin-
secreting
pituitary adenomas (micro and macroprolactinomas), idiopathic
hyperprolactinaemia, or
empty sella syndrome with associated hyperprolactinaemia, which
represents the basic
underlying pathologies contributing to the above manifestations.
It may be used to suppress lactation where it is considered essential,
but should not be used
for the routine suppression of lactation, or for the relief of
symptoms of post-partum pain and
engorgement, which can be adequately treated with simple analgesics
and breast support.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Cabergoline is to be administered by the oral route. In clinical
studies, cabergoline has been
mainly administered with food and since the tolerability of this class
of compounds is
improved with food, it is recommended that cabergoline is preferably
taken with meals for all
the therapeutic indications.
Ref: DX 11_1
Page 2 of 12
2015-0012078
_Treatment of Hyperprolactinaemic disorders:_
The recommended initial dosage of cabergoline is 0.5 mg per week given
in one or two (one
half o