Cabergoline 1mg tablets

País: Reino Unido

Idioma: inglés

Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes activos:

Cabergoline

Disponible desde:

A A H Pharmaceuticals Ltd

Código ATC:

N04BC06

Designación común internacional (DCI):

Cabergoline

Dosis:

1mg

formulario farmacéutico:

Oral tablet

Vía de administración:

Oral

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 04090100; GTIN: 5025903006800

Información para el usuario

CABERGOLINE 1MG TABLETS/
CABERGOLINE 2MG TABLETS
(cabergoline)
Your medicine is known by either of the above names, but will be
referred to
as Cabergoline throughout the following:
PATIENT INFORMATION LEAFLET
IN THIS LEAFLET
1) What Cabergoline is and what it is used for
2) What you need to know before you take Cabergoline
3) How to take Cabergoline
4) Possible side effects
5) How to store Cabergoline
6) Contents of the pack and other information
1) 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 1mg and 2mg 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.
2) WHAT YOU NEED TO KNOW BEFORE YOU TAKE CABERGOLINE
DO NOT TAKE CABERGOLINE IF YOU:

are allergic to cabergoline or other ergot alkaloids (e.g.
bromocriptine), or
any of the other ingredients of this medicine (listed in section 6)

have swelling of the hands, feet and a high blood pressure during
pregnancy (pre-eclampsia, eclampsia)

have uncontrolled high blood pressure

will be treated with CABERGOLINE for a long period and have or had
fibrotic
reactions (scar tissue) affecting the lungs, back of the abdomen and
kidneys or heart.
Before you are given Cabergoline your doctor will arrange for you to
have
tests to assess the condition of your heart. Your doctor will continue
to
monitor your medical condition while taking Cabergoline.
WARNINGS AND PRECAUTIONS
If you have any of the following health problems you must inform your
doctor before taking Cabergoline as the medicinal product may be
unsuitable for you.

cardiovascular disease

stomach ulcer or bleeding in the gastrointestinal tract. (this
condition can
cause black faeces or vomit

Ficha técnica

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Cabergoline 1mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1mg cabergoline.
Excipient: lactose monohydrate 74.5mg.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
A white to off-white, oval-shaped tablet, embossed with ‘C | 1’ on
one side and
‘partial score >’ on the other side.
The tablet can be divided into equal halves.
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 section 4.3, 4.4 and 4.8).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Cabergoline is to be administered by the oral route.
In order to reduce the risk of gastrointestinal undesirable effects it
is
recommended that cabergoline is taken with meals for all therapeutic
indications.
ADULTS AND ELDERLY PATIENTS
As expected for dopamine agonists, dose response for both efficacy and
side
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 1mg
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. The maximum daily dose should not
exceed 3mg/day. In view of the long half-life of the compound,
increments of
the daily dose of 0.5-1mg cabergoline should be made at weekly
(initial
weeks)