Parlodel 10mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Bromocriptine mesilate

Available from:

Dowelhurst Ltd

ATC code:

N04BC01

INN (International Name):

Bromocriptine mesilate

Dosage:

10mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06070100

Patient Information leaflet

T5008856
Patient Information Leaflet
Parlodel 1 mg & 2.5 mg Tablets
Parlodel 5 mg & 10 mg 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 and
Parlodel 5 mg & 10 mg 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
(reduces growth hormone

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Parlodel 10mg 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.
For a full list of excipients see section 6.1
3
PHARMACEUTICAL FORM
White, opaque hard shell capsule imprinted with ’10 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 warnings and precautions for use).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Parlodel should always be taken with food.
A number of disparate