PARLODEL 5mg Hard Capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

BROMOCRIPTINE MESILATE

Available from:

Mylan IRE Healthcare Limited

ATC code:

G02CB; G02CB01

INN (International Name):

BROMOCRIPTINE MESILATE

Dosage:

5 mg milligram(s)

Pharmaceutical form:

Capsule, hard

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Prolactine inhibitors; bromocriptine

Authorization status:

Not marketed

Authorization date:

2007-02-16

Patient Information leaflet

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 CAPSULES
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 allerg

Summary of Product characteristics

Health Products Regulatory Authority
30 November 2020
CRN00C1YK
Page 1 of 10
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