Parlodel 2.5mg tablets

Država: Velika Britanija

Jezik: engleski

Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivni sastojci:

Bromocriptine mesilate

Dostupno od:

Meda Pharmaceuticals Ltd

ATC koda:

G02CB01

INN (International ime):

Bromocriptine mesilate

Doziranje:

2.5mg

Farmaceutski oblik:

Oral tablet

Administracija rute:

Oral

Razred:

No Controlled Drug Status

Tip recepta:

Valid as a prescribable product

Proizvod sažetak:

BNF: 06070100; GTIN: 5013054160021 5013054160038

Uputa o lijeku

Page 1 of 2
PACKAGE INFORMATION LEAFLET
PARLODEL
® 2.5MG 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 2.5mg 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

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Parlodel 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 “2.5MG” on the 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 combinati