Bromocriptine 1mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Bromocriptine mesilate

Available from:

Meda Pharmaceuticals Ltd

ATC code:

G02CB01

INN (International Name):

Bromocriptine mesilate

Dosage:

1mg

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

Package Information Leaflet
Bromocriptine 1 mg & 2.5 mg
Tablets
Bromocriptine mesilate
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.
•
In this leaflet, Bromocriptine 1 mg & 2.5 mg Tablets
will be called Bromocriptine.
In this leaflet:
1. What Bromocriptine is for
2. Before you take Bromocriptine
3. How to take Bromocriptine
4. Possible side effects
5. How to store Bromocriptine
6. Further information
1. 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 tall or to
have large hands and feet. This is called acromegaly
(reduces growth hormone levels)
•
Treating Parkinson’s Disease (increases

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
BROMOCRIPTINE 1mg 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 1.147mg, equivalent to 1mg 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 edged with a
break score and
coded “1 MG” on 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, Bromocriptine ha