PARLODEL

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

BROMOCRIPTINE MESILATE

Available from:

Meda Health Sales Ireland Limited

ATC code:

G02CB01

INN (International Name):

BROMOCRIPTINE MESILATE

Dosage:

2.5 Milligram

Pharmaceutical form:

Tablets

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

bromocriptine

Authorization status:

Marketed

Authorization date:

2007-02-16

Patient Information leaflet

Package leaflet:
Information for the user
PARLODEL
2.5 MG TABLETS
Bromocriptine mesilate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINES 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 Parlodel tablets are and what it is used for
2.
What you need to know before you take Parlodel tablets
3.
How to take Parlodel tablets
4.
Possible side effects
5.
How to store Parlodel tablets
6.
Contents of the pack and other information
1.
WHAT PARLODEL TABLETS ARE AND WHAT IT IS USED FOR
Parlodel tablets contain the active ingredient bromocriptine, which
belongs to a group of medicines
called dopamine agonists and prolactin inhibitors.
Parlodel tablets are used for:
•
Treatment of Parkinson’s disease.
•
Treatment of prolactinomas (a non-cancerous tumour of the pituitary
gland in the brain).
•
Co-treatment of acromegaly with surgery or radiotherapy. Acromegaly is
abnormal growth
caused by high levels of growth hormone.
•
Treatment of hyperprolactinaemia (abnormally high levels of prolactin
causing unexplained
milk secretion and irregular periods in women and lack of sex drive in
men).
•
Treatment of menstrual cycle disorders and female infertility caused
by hyperprolactinaemia
(see above).
•
To prevent lactation (milk production) for medical reasons.
•
Stopping breast milk production for medical reasons only, and when you
and your doctor
have decided that it is necessary. Bromocriptine should not be
routinely used to stop breast
milk production. It should also not be used to relieve symptoms of
painful breast
engorgement after giving birth i

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Parlodel 2.5 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains bromocriptine mesilate equivalent to 2.5 mg of
bromocriptine base.
Excipients: Lactose monohydrate 116.38mg
_For a full list of excipients see section 6.1._
3 PHARMACEUTICAL FORM
Tablet.
Whitish, round tablet, flat with bevelled edges, angle-score and
“2.5 MG” on upper side. The tablet can be divided into
equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
PARKINSON’S DISEASE:
In the treatment of idiopathic Parkinson's disease. PARLODEL has been
used both alone and in combination with
levodopa in the management of previously untreated patients and those
disabled by “on/off” phenomena. PARLODEL
has been used with occasional benefit in patients who do not respond
or are unable to tolerate levodopa and those
whose response to levodopa is declining.
PROLACTINOMAS:
In a number of specialised units, patients who have been shown to have
prolactin secreting adenomas have been treated
successfully with PARLODEL. In particular PARLODEL can be considered
as a first choice of treatment in patients
with macroadenomas and as an alternative to the surgical procedure
transsphenoidal hypophysectomy in patients with
microadenomas.
ACROLMEGALY:
PARLODEL has been used in a number of specialized units as an adjunct
to surgery and/or radiotherapy to reduce
circulating growth hormone levels in the management of acromegalic
patients.
HYPERPROLACTINAEMIA:
For the treatment of hyperprolactinaemia in patients with hypogonadism
and/or galactorrhoea.
MENSTRUAL CYCLE DISORDERS, FEMALE INFERTILITY:
In the treatment of female infertility associated with normal basal
gonadotrophin levels and hyperprolactinaemia
(Absolute or relative).
INHIBITION OF LACTATION FOR MEDICAL REASONS:
Prevention or suppression of post-partum physiological lactation only
where medically indicated (such as in the case of
intrapartum loss, neonatal death, HIV infection of the mother).
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