Parlodel 5mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Bromocriptine mesilate

Available from:

Viatris UK Healthcare Ltd

ATC code:

N04BC01

INN (International Name):

Bromocriptine mesilate

Dosage:

5mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06070100; GTIN: 5013054160045

Patient Information leaflet

PATIENT INFORMATION
LEAFLET
PARLODEL 1 MG & 2.5 MG
TABLETS
PARLODEL 5MG & 10MG CAPSULES
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 & 2.5 mg Tablets will be called
Parlodel Tablets and Parlodel 5mg &
10mg Capsules 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:
• For the 1 mg and 2.5 mg strengths. 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 (red

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Parlodel 5mg Capsules
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.
Each capsule contains 11.47mg of bromocriptine mesilate Ph Eur
equivalent to 10 mg of bromocriptine base.
Excipients with known effect:
Each tablet contains 0.5mg di-sodium edetate
Each tablet contains 116.38 mg Lactose monohydrate
For
a
full
list
of
excipients
see
section
6.1
3
PHARMACEUTICAL FORM
Light blue and white opaque hard gelatin capsules imprinted with ‘5
mg’ on
the capsule body.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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 Levodopa in the management of previously
untreated patients and those disabled by 'on-off' phenomena. Parlodel
has
been used with occasional benefit in patients who do not respond to or
are
unable to tolerate Levodopa and those whose response to Levodopa is
declining.
PREMENSTRUAL SYMPTOMS AND BENIGN BREAST DISEASE
(See section 4.4 Special