Pergolide 1mg tablets

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

Wirkstoff:

Pergolide mesilate

Verfügbar ab:

Teva UK Ltd

ATC-Code:

N04BC02

INN (Internationale Bezeichnung):

Pergolide mesilate

Dosierung:

1mg

Darreichungsform:

Oral tablet

Verabreichungsweg:

Oral

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Valid as a prescribable product

Produktbesonderheiten:

BNF: 04090100; GTIN: 5016192092216

Gebrauchsinformation

PACKAGE LEAFLET: INFORMATION FOR THE USER
PERGOLIDE 50 MICROGRAMS, 250 MICROGRAMS AND 1 MG TABLETS
(PERGOLIDE MESILATE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
x
Keep this leaflet. You may need to read it again.
x
If you have any further questions, ask your doctor or pharmacist.
x
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
x
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1.
WHAT PERGOLIDE IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PERGOLIDE
3.
HOW TO TAKE PERGOLIDE
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE PERGOLIDE
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT PERGOLIDE IS AND WHAT IT IS USED FOR
Pergolide belongs to a group of drugs known as dopamine receptor
agonists.
Pergolide is used to help control and reduce the effects or symptoms
of Parkinson’s disease when patients are
intolerant to or have failed alternate treatments with other
medicines.
Pergolide is sometimes used with other medicines that contain
levodopa, e.g. Madopar
£
and Sinemet
£
.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PERGOLIDE
DO NOT TAKE PERGOLIDE IF YOU:
x
are allergic (hypersensitive) to pergolide or any of the other
ingredients of this medicine listed in
section 6
x
have a known sensitivity to any other ‘ergot’ medicines e.g.
bromocriptine or lisuride, or 'ergot'
medicines used to treat or prevent migraine e.g. ergotamine or
methysergide
x
have ever experienced shortness of breath, chest or back pain, swollen
legs or heart trouble after
previously taking ergot medicines
x
have or had fibrotic reactions (scar tissue) affecting your heart
x
have heart valve problems.
x
are pregnant or breast-feeding.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING PERGOLIDE IF YOU:
x
have or had

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Pergolide 1 milligram Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains, as the active ingredient, pergolide mesilate
equivalent to
1 milligram of pergolide.
3.
PHARMACEUTICAL FORM
Tablet: light pink, rectangular shaped, scored, marked ‘G’.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Second-line therapy of Parkinson’s disease, or as adjunctive
treatment to levodopa,
when treatment with dopamine agonist is considered and when non-ergot
alkaloids
are contraindicated or are no longer adequate.
The treatment should be initiated under specialist supervision. The
benefit of
continuing treatment should be regularly reassessed
taking into account
the risk of
fibrotic reactions and valvulopathy (see sections 4.3, 4.4 and 4.8).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration to adults only.
_Monotherapy _
The following titration should be used for initiation of pergolide as
monotherapy:
Day
Morning
Noon
Evening
Total Dosage
1
-
-
50 micrograms
50 micrograms
2 – 4
-
50 micrograms
50 micrograms
100 micrograms
5 – 7
50 micrograms
50 micrograms
100 micrograms
200 micrograms
8 – 10
100 micrograms
100 micrograms
100 micrograms
300 micrograms
11 – 13
100 micrograms
150 micrograms
150 micrograms
400 micrograms
14 – 17
200 micrograms
200 micrograms
200 micrograms
600 micrograms
18 – 21
250 micrograms
250 micrograms
250 micrograms
750 micrograms
22 – 24
500 micrograms
250 micrograms
250 micrograms
1000 micrograms
25 – 27
500 micrograms
500 micrograms
250 micrograms
1250 micrograms
28 – 30
500 micrograms
500 micrograms
500 micrograms
1500 micrograms
After day 30, the daily dose should be increased by at most 250
micrograms twice a
week until an optimal therapeutic response is achieved. Pergolide
mesilate is usually
administered in divided doses 3 times per day.
In clinical studies of pergolide as monotherapy, the mean dose was
2100 micrograms
per day at 3 months and 2510 micrograms per day at 1 ye