PARLODEL

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

BROMOCRIPTINE MESILATE

Dostupné s:

Meda Health Sales Ireland Limited

ATC kód:

G02CB01

INN (Mezinárodní Name):

BROMOCRIPTINE MESILATE

Dávkování:

5 mg Milligram

Léková forma:

Capsules Hard

Druh předpisu:

Product subject to prescription which may be renewed (B)

Terapeutické oblasti:

bromocriptine

Stav Autorizace:

Marketed

Datum autorizace:

2007-02-16

Informace pro uživatele

Package leaflet:
Information for the user
PARLODEL
5 MG HARD CAPSULES
Bromocriptine mesilate
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
The name of your medicine is Parlodel 5 mg hard capsules, which will
be called Parlodel capsules
throughout this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Parlodel capsules are and what it is used for
2.
What you need to know before you take Parlodel capsules
3.
How to take Parlodel capsules
4.
Possible side effects
5.
How to store Parlodel capsules
6.
Contents of the pack and other information
1.
WHAT PARLODEL CAPSULES ARE AND WHAT IT IS USED FOR
Parlodel capsules contain the active ingredient bromocriptine, which
belongs to a group of
medicines called dopamine agonists and prolactin inhibitors.
Parlodel capsules 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).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARLODEL
DO NOT TAKE PARLODEL CAPSULES:
-
If you are allergic to bromocriptine, other similar drugs, or any of
the other ingredients of
this medicine (listed in section 6). An allergic react

Charakteristika produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
PARLODEL 5mg Hard Capsules.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains Bromocriptine Mesilate equivalent to
bromocriptine 5 mg.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard
Hard gelatin capsules with light blue cap and white opaque body
printed “5mg” in ink on one side.
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).
OTHER:
There is insufficient evidence of efficacy of Parlodel in the
treatment of premenstrual symptoms and benign breast
disease. The use of Parlodel in patients with these conditions is
therefore not recommended.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_Adults_
PARLODEL should always be taken during a m