Cabergoline 2mg tablets

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

Werkstoffen:

Cabergoline

Beschikbaar vanaf:

Sigma Pharmaceuticals Plc

ATC-code:

N04BC06

INN (Algemene Internationale Benaming):

Cabergoline

Dosering:

2mg

farmaceutische vorm:

Oral tablet

Toedieningsweg:

Oral

klasse:

No Controlled Drug Status

Prescription-type:

Valid as a prescribable product

Product samenvatting:

BNF: 04090100

Bijsluiter

CABERGOLINE 2MG TABLETS
PATIENT INFORMATION LEAFLET
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
• 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 only. Do not pass it on
to
others. It may harm them, even if their signs of illness are the same
as
yours.
• If you get any side effects, talk to your doctor or pharmacist.
This includes
any possible side effects not listed in this leaflet See section 4.
Your medicine is called Cabergoline 2mg Tablets but will be referred
to as
Cabergoline throughout this Patient Information Leaflet. Please note
that the
leaflet also contains information about other strength of the
medicine,
Cabergoline 1mg Tablets
WHAT IS IN THIS LEAFLET:
What Cabergoline is and what it is used for
What you need to know before you take Cabergoline
How to take Cabergoline
Possible side effects
How to store Cabergoline
Contents of the pack and other information
WHAT CABERGOLINE IS AND WHAT IT IS USED FOR
Cabergoline belongs to a group of medicines known as dopamine
agonists.
Cabergoline acts in a similar way to a chemical present in the nervous
system called dopamine. Patients with Parkinson’s disease do not
have
enough of this important chemical.
Cabergoline is used to treat Parkinson’s disease. It can be used
either taken
alone or in combination with levodopa, as second choice following
non-ergot
derived therapies.
Treatment under a specialist is required.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CABERGOLINE
DO NOT TAKE CABERGOLINE IF YOU
• are allergic to cabergoline, other ergot alkaloids (e.g.
bromocriptine), or to
any of the other ingredients of this medicine (listed in section 6)
• have swelling of the hands and feet and a high blood pressure
during
pregnancy (preeclampsia, eclampsia)
• have uncontrolled high blood pressure
• have ever been diagnosed in the past with problems described as
fi

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Cabergoline 2mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2 mg cabergoline.
Excipient(s) with known effect: lactose 150.6 mg
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
_ _
The tablet can be divided into equal doses.
_ _
White, capsule-shaped, biconvex tablets with scores on both sides. One
side is debossed with
‘CBG’ and ‘2’ on either side of the score.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_TREATMENT OF PARKINSON’S DISEASE: _
If treatment with a dopamine agonist is being considered, cabergoline
is
indicated as second line therapy in patients who are intolerant or
fail treatment
with a non-ergot compound, as monotherapy, or as adjunctive treatment
to
levodopa plus dopa-decarboxylase inhibitor in the management of the
signs
and symptoms of Parkinson's disease.
Treatment should be initiated under specialist supervision. The
benefit of
continued 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
Posology
Adults and older people:
As expected for dopamine agonists, dose response for both efficacy and
undesirable
effects appears to be linked to individual sensitivity. Optimization
of dose should be
obtained through slow initial dose titration, from starting doses of
0.5mg cabergoline
(de novo patients) and 1 mg cabergoline (patients on L dopa) daily.
The dosage of
concurrent levodopa may be gradually decreased, while the dosage of
cabergoline is
increased, until the optimum balance is determined. In view of the
long half-life of the
compound, increments of the daily dose of 0.5-1 mg cabergoline should
be done at
weekly (initial weeks) or bi-weekly intervals, up to optimal doses.
The recommended therapeutic dosage is 2 to 3 mg cabergoline /day as
adjuvant
therapy to levodopa/carbidopa. The maximum dose of 3mg/day of
cabergoline must
no