Cabaser 1 mg Tablet

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Cabergoline

Boleh didapati daripada:

Pfizer Healthcare Ireland

Kod ATC:

N04BC; N04BC06

INN (Nama Antarabangsa):

Cabergoline

Dos:

1 milligram(s)

Borang farmaseutikal:

Tablet

Jenis preskripsi:

Product subject to prescription which may not be renewed (A)

Kawasan terapeutik:

Dopamine agonists; cabergoline

Status kebenaran:

Marketed

Tarikh kebenaran:

1999-10-29

Risalah maklumat

Page 1 of 6
2022-0082815
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CABASER
®
1 MG TABLETS
cabergoline
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.
WHAT IS IN THIS LEAFLET
1. What Cabaser is and what it is used for
2. What you need to know before you take Cabaser
3. How to take Cabaser
4. Possible side effects
5. How to store Cabaser
6. Contents of the pack and other information
1. WHAT CABASER IS AND WHAT IT IS USED FOR
Cabaser is used to treat the symptoms of Parkinson’s disease.
It is used after your doctor has tried other treatments that have not
worked or for people who are
already taking other medicines for this illness to help control other
symptoms.
This medicine contains the active ingredient cabergoline which acts in
a similar way to a
chemical in the body called dopamine. Patients with Parkinson’s
disease do not have enough of
this chemical.
Cabergoline belongs to a group of medicines called dopamine agonists.
You must talk to a doctor or pharmacist if you do not feel better or
if you feel worse.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CABASER
DO NOT TAKE CABASER

If you are allergic (hypersensitive) to cabergoline, to other
medicines called ergot alkaloids
or any of the other ingredients of this medicine (listed in section
6).

If you will be treated with Cabaser for a long period and have or had
fibrotic reactions
(scar tissue) affecting your heart.

If you have been told you have a problem affecting your heart valves.

If you have a previous history of respiratory or cardiac disorde

Ciri produk

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cabaser 1 mg Tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1mg of cabergoline.
Excipients with known effect:
Each tablet also contains 75.4mg of anhydrous lactose.
For the full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Tablets
White, oval, both sides concave tablets, one side scored and engraved
“7” on the left of the breakline and “01” on the
right of it.
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 sections 4.3, 4.4 & 4.8).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Cabergoline is for oral administration. Since the tolerability of
dopaminergic agents is improved when administered with
food, it is recommended that cabergoline be taken with meals.
Cabergoline is intended for chronic, long term treatment.
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 1 mg 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
should be done at weekly (initial weeks) or bi-weekly intervals, up to
optimal doses.
T