Cabergoline 1 mg Tablets

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Cabergoline

זמין מ:

Renata Pharmaceuticals (Ireland) Limited

קוד ATC:

N04BC06

INN (שם בינלאומי):

Cabergoline

טופס פרצבטיות:

Tablet

איזור תרפויטי:

cabergoline

מצב אישור:

Not marketed

תאריך אישור:

2023-10-13

עלון מידע

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CABERGOLINE 1 MG AND 2 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 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 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 CABERGOLINE
DO NOT TAKE CABERGOLINE
• 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 have swollen hands and feet and have high blood pressure.
• If you have uncontrolled high blood pressure.
• If you will be treated with Cabergoline for a long period and have
or had fibrotic reactions
(scar tissue) affecting your heart.
�

מאפייני מוצר

Health Products Regulatory Authority
16 October 2023
CRN00CYLQ
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cabergoline 1 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1 mg of cabergoline.
Excipient(s) with known effect:
Each tablet also contains 75 mg of anhydrous lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
7.5 × 4 mm, oval shaped, white coloured tablets, having scored on one
side 'c' on left, '2' on right and plain on other side.
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
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 interv