Parlodel 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; GTIN: 5013054160014

Patient Information leaflet

PACKAGE INFORMATION
LEAFLET
PARLODEL 1 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, Parlodel 1 mg Tablets will be called
Parlodel.
IN THIS
LEAFLET:
1. What Parlodel is
for
2. Before you take
Parlodel
3. How to take
Parlodel
4. Possible side
effects
5. How to store
Parlodel
6. Further
information
1.
WHAT PARLODEL IS
FOR
Parlodel 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.
Parlodel may be used
for:
•
Stopping breast milk production for medical reasons only, and when you
and your doctor
have
decided that it is necessary. Parlodel 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 dopamine
levels).
2.
BEFORE YOU TAKE
PARLODEL
DO NOT TAKE PARLODEL
IF:
�

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Parlodel 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.
4.1
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).
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.
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. Parlodel 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
Parlodel 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, Parlodel has been
used both
alone and in combination with L