CABERGOLINE 0.5 MILLIGRAM TABLETS 0.5 Milligram Tablets

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

CABERGOLINE

Dostupné s:

Arrow Generics Limited

INN (Mezinárodní Name):

CABERGOLINE

Dávkování:

0.5 Milligram

Léková forma:

Tablets

Druh předpisu:

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

Stav Autorizace:

Withdrawn

Datum autorizace:

2013-04-29

Informace pro uživatele

UK/H/955/01/DC 
2 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

CABERGOLINE 0.5MG TABLETS 

_cabergoline _

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE. 
- 
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. Do not pass it on
to others. It may harm them, even if their 
symptoms are the same as yours. 
- 
If  any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet, please 
tell your doctor or pharmacist. 

IN THIS LEAFLET:  
1. 
What Cabergoline 0.5mg Tablets are and what they are used for 
2. 
Before you take Cabergoline 0.5mg Tablets 
3. 
How to take Cabergoline 0.5mg Tablets 
4.  
Possible side effects 
5. 
How to store Cabergoline 0.5mg Tablets 
6. 
Further information. 

1. 
WHAT CABERGOLINE 0.5MG TABLETS ARE AND WHAT THEY ARE USED FOR 

Cabergoline belongs to a group of medicines known as prolactin
inhibitors.  Cabergoline prevents lactation 
(production of milk) by decreasing the level of a hormone known as
prolactin.   

Cabergoline 0.5mg Tablets are also used to  reduce abnormol
quantities of the hormone prolactin in the 
blood. 

2. 
BEFORE YOU TAKE CABERGOLINE 0.5MG TABLETS 

Do not take Cabergoline 0.5mg Tablets 
- 
if you are allergic (hypersensitive) to cabergoline or other ergot
alkaloids medicines (e.g bromocriptine), 
or to any of the other ingredients of Cabergoline 0.5mg Tablets 
- 
if you have uncontrolled high blood pressure 
- 
if you have swelling of the hands, feet and high blood pressure
during  or after pregnancy (pre-
eclampsia, eclampsia) 
- 
if you have ever suffered from or are being treated for psychosis
(currently or in the past) or if you are at 
risk of psychosis during pregnancy or after childbirth 
- 
if you have ever been diagnosed in the past with problems
described as fibroti

Charakteristika produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cabergoline 0.5mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 0.5mg cabergoline.
Excipient: lactose monohydrate 75mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
A white to off-white, capsule-shaped tablet, embossed with ‘C | 5’ 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
Inhibition of lactation for medical reasons.
Hyperprolactimaemic disorders.
Prolactin secreting pituitary adenomas.
Idiopathic hyperprolactinaemia.
It is recommended that the medicinal product is initially prescribed by an appropriate specialist or after consulting a
specialist.
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 be preferably
taken with meals for all the therapeutic indications.
_TREATMENT OF HYPERPROLACTINAEMIC DISORDERS_
The recommended initial dosage of cabergoline is 0.5mg per week given in one (single 0.5 mg) or two (separate 0.25
mg) doses (e.g. on Monday and Thursday) per week.
The weekly dose should be increased gradually, preferably by adding 0.5mg per week at monthly intervals until an
optimal therapeutic response is achieved.
The therapeutic dosage is usually 1mg per week and ranges from 0.25mg to 2mg cabergoline per week.
Doses of cabergoline up to 4.5mg per week have been used in hyperprolactinaemic patients. The maximum daily dose
should not exceed 3mg/day.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 25/03/2013_
_CR