Parlodel 2.5 mg Tablets

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:

2.5 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Prolactine inhibitors; bromocriptine

Authorization status:

Marketed

Authorization date:

2007-02-16

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PARLODEL 2.5 MG TABLETS
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.
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 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 level of prolactin
in the blood) in men
with hypogonadism (a low sperm count, lack of sex drive and inability
to achieve an erection)
and/or galactorrhoea (unexplained milk secretion).

Treatment of hyperprolactinaemia (abnormally high level of prolactin
in the blood) in women
with hypogonadism (infrequent periods, hot flushes, vaginal dryness),
irregular periods,
infertility and/or galactorrhoea (unexplained milk secretion).

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. Brom

Summary of Product characteristics

Health Products Regulatory Authority
27 May 2022
CRN009Q64
Page 1 of 10
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 with known effect:
Each tablet contains 116.38 mg lactose monohydrate.
For the 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
PROLACTINOMAS:
Treatment of prolactin-secreting pituitary micro- or macro-adenomas.
Parlodel may be used prior to surgery in order to reduce
tumour size and to facilitate removal.
ACROMEGALY:
Parlodel has been used as an adjunct to surgery and/or radiotherapy,
or in management of acromegalic patients with a
contraindication to or for whom surgery is not suitable.
HYPERPROLACTINAEMIA:
For the treatment of hyperprolactinaemia:
In male patients with hypogonadism (oligospermia, loss of libido,
impotence) and or galactorrhoea.
In female patients with hypogonadism (amenorrhea, hot flushes, and
vaginal dryness), menstrual irregularity, female infertility
and or galactorrhoea.
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, etc.).
Parlodel is not recommended for the routine suppression of lactation
or for the relief of symptoms of post-partum pain and
engorgement which can be adequately treated with non-pharmacological
intervention (such as firm breast support, ice
application) and/or simple analgesics.
PARKINSON'S DISEASE:
Treatment of the signs and symptoms of idiopathic Parkinson disease;
Parlodel is indicated as adjunctive treatment to
levodopa (alone or in combination with other antiparkinsonian drugs)
in pa