Bromocriptine 2.5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Bromocriptine mesilate

Available from:

DE Pharmaceuticals

ATC code:

G02CB01

INN (International Name):

Bromocriptine mesilate

Dosage:

2.5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06070100

Patient Information leaflet

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
BROMOCRIPTINE 2.5MG TABLETS
(bromocriptine mesilate)
Your medicine is available using the name Bromocriptine
2.5mg Tablets but will be referred to as Bromocriptine
throughout this leaflet.
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 Bromocriptine is and what it is used for
2.
What you need to know before you take Bromocriptine
3.
How to take Bromocriptine
4.
Possible side effects
5.
How to store Bromocriptine
6.
Contents of the pack and other information
1.
WHAT BROMOCRIPTINE IS AND WHAT IT IS USED
FOR
Bromocriptine belongs to a group of drugs known as
dopamine-receptor stimulants, which stop the hormone
prolactin being produced by the pituitary gland.
Bromocriptine may be used for:

stopping breast milk production for medical reasons
only, and when you and your doctor have decided that it
is necessary

to stop the production of milk in men and women who
produce too much prolactin hormone, and also in women
who have recently had a baby

to treat tumours which release prolactin, breast disease
or breast pain, problems with the menstrual cycle, or
infertility

to reduce the amount of growth hormone in the blood

occasionally to treat Parkinson’s disease.
Bromocriptine should not routinely be used to stop breast
milk production. It should also not be used to relieve
symptoms of painful breast engorgement after giving birth if
these can be adequately treated with non-medical means
(such as firm breast support, ice ap

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
BROMOCRIPTINE 2.5mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: Ergotaman-3`, 6`, 18-trione,
2-bromo-12`-hydroxy-2`-(1-
methylethyl-5`-(2-methylpropyl)-, (5`alpha)-mono-methanesulphonate.
Bromocriptine mesilate 2.87mg, equivalent to 2.5mg of bromocriptine
base.
For a full list of excipients see section 6.1
3
PHARMACEUTICAL FORM
Tablet: Each tablet is round, white, flat, with a bevelled edge,
angle-scored and coded
with “2.5 MG” on the upper side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
INHIBITION OF LACTATION FOR MEDICAL REASONS
Prevention or suppression of post-partum physiological lactation only
where
medically indicated (such as in case of intrapartum loss, neonatal
death, HIV
infection of the mother).
Bromocriptine 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.
HYPERPROLACTINAEMIA
The treatment of hyperprolactinaemia in men and women with
hypogonadism
and/or galactorrhoea.
MENSTRUAL CYCLE DISORDERS AND FEMALE INFERTILITY
Amenorrhoea and oligomenorrhoea, with or without galactorrhoea.
Drug-induced hyperprolactinaemic disorders.
Polycystic ovary syndrome.
Some infertile women with oligomenorrhoea or amenorrhoea and
galactorrhoea may be unduly sensitive to prolactin. Bromocriptine has
been
used successfully in the treatment of a number of infertile women with
galactorrhoea who do not have demonstrable hyperprolactinaemia.
PROLACTINOMAS
To reduce tumour size, particularly in those at risk of optic nerve
compression.
ACROMEGALY
Bromocriptine has been used in a number of specialised units, as an
adjunct to
surgery and/or radiotherapy to reduce circulating growth hormone in
the
management of acromegalic patients.
PARKINSON’S DISEASE
In the treatment of idiopathic Parkinson's Disease, Bromocr