Bromocriptine 2.5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Bromocriptine mesilate

Available from:

A A H Pharmaceuticals Ltd

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; GTIN: 5025903001065

Patient Information leaflet

BROMOCRIPTINE 2.5 MG TABLETS
PATIENT INFORMATION LEAFLET
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
*
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. Do not pass it on to
others. It
may harm them, even if their symptoms are the same as yours.
Your medicine is called Bromocriptine 2.5mg Tablets but will be
referred to
as Bromocriptine throughout this leaflet. Please note that the leaflet
also
contains information about other strengths available, Bromocriptine
1mg
Tablets, Bromocriptine 5mg Capsules and Bromocriptine 10mg Capsules.
IN THIS LEAFLET:
What Bromocriptine is for
Before you take Bromocriptine
How to take Bromocriptine
Possible side effects
How to store Bromocriptine
Further information
WHAT BROMOCRIPTINE IS FOR
Bromocriptine belongs to a group of medicines called dopamine agonists
and prolactin inhibitors.
It works by increasing the release of dopamine in the brain, which
treats
diseases where you need more of this substance. It also works by
decreasing the release of prolactin and growth hormone in the body,
which
treats diseases where you need less of these substances.
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. 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 application) and/or a painkiller.
*
Treating fertility and period problems usually caused by not having
the
right amount of prolactin. This includes polycystic ovary syndrome
(reduces prolactin levels)
*
Treating non-cancerous tumours in the brain called prolactinomas
(reduces prolactin levels)
*
Treating diseases where too much growth hormone is made, which
causes people to be very ta

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