Cabergoline Actavis

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Cabergoline 0.5mg

Available from:

Teva Pharma (New Zealand) Limited

INN (International Name):

Cabergoline 0.5 mg

Dosage:

0.5 mg

Pharmaceutical form:

Tablet

Composition:

Active: Cabergoline 0.5mg Excipient: Lactose Leucine

Units in package:

Bottle, glass, Amber, induction seal, polypropylene closure, 2 tablets, 2 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Resolution Chemicals Limited

Therapeutic indications:

Prevention of the onset of lactation in the puerperium only for clearly defined medical reasons: Arrow - Cabergoline is indicated for the inhibition of physiological lactation soon after delivery. 1. After parturition, when breast feeding is contraindicated due to medical reasons related to the mother or the new-born. 2. After stillbirth or abortion. Treatment of hyperprolactinaemic disorders: Cabergoline is indicated for the treatment of dysfunctions associated with hyperprolactinaemia, including amenorrhoea, oligomenorrhoea, anovulation and galactorrhoea. Cabergoline is indicated in patients with prolactin-secreting pituitary adenomas (micro- and macroprolactinomas), idiopathic hyperprolactinaemia, or empty sella syndrome with associated hyperprolactinaemia, which represent the basic underlying pathologies contributing to the above clinical manifestations.

Product summary:

Package - Contents - Shelf Life: Bottle, glass, Amber, induction seal, polypropylene closure - 2 tablets - 2 years from date of manufacture stored at or below 25°C protect from light - Bottle, glass, Amber, induction seal and polypropylene closure - 8 tablets - 2 years from date of manufacture stored at or below 25°C protect from light

Authorization date:

2006-05-01

Patient Information leaflet

ARROW - CABERGOLINE 
CABERGOLINE 0.5 MG TABLET 
WHAT IS IN THIS LEAFLET  
This leaflet answers some common questions about ARROW - CABERGOLINE.  It does not 
contain all the available information.  It does not take the place of talking to your doctor or 
pharmacist.  
All medicines have risks and benefits.  Your doctor has weighed the risks of you using 
ARROW - CABERGOLINE against the expected benefits.  
IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST.  
KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again.  
WHAT ARROW - CABERGOLINE IS USED FOR  
ARROW - CABERGOLINE may be prescribed by your doctor to reduce your body's level of a 
hormone known as prolactin.  ARROW - CABERGOLINE may be needed if your levels of 
prolactin are abnormally high (hyperprolactinaemia).  
Abnormally high prolactin may cause menstrual changes in women, and impotence in men.  
ARROW - CABERGOLINE can also be prescribed to prevent the production of milk in women 
after birth, if breast-feeding is to be prevented for medical reasons.  
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN 
PRESCRIBED FOR YOU.  
Your doctor may have prescribed it for another reason.  
ARROW - CABERGOLINE is only available with a doctor's prescription.  
BEFORE YOU START TO USE IT  
_WHEN YOU MUST NOT USE IT  _
Do not take ARROW - CABERGOLINE if you have an allergy to:  
•  any medicine containing cabergoline  
•  any of the ingredients listed at the end of this leaflet  
•  ergot alkaloids (medicines used to treat migraine)  

Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or 
difficulty breathing; swelling of the face, lips, tongue or ot

Summary of Product characteristics

ARROW - CABERGOLINE 
Cabergoline 0.5mg tablet 
_This product may not be interchangeable with other products containing this _
_ingredient in the New Zealand market. _
PRESENTATION 
Arrow - Cabergoline 0.5 mg tablets are white to off-white, capsule-shaped tablet, 
embossed with 'C | 5' on one side and '> partial score >' on the other side.  In packs 
of 2 or 8 tablets. 
USES 
_ACTIONS _
Cabergoline is a dopaminergic ergoline derivative with potent and long-lasting 
Prolactin-lowering activity. It acts by direct stimulation of the D2-dopamine receptors 
on pituitary lactotrophs, thus inhibiting Prolactin secretion. In rats the compound 
decreases prolactin secretion at oral doses of 3-25 µg/ml, and _in vitro_ at a 
concentration of 45pg/ml. In addition cabergoline exerts a central dopaminergic 
effect via D2 receptor stimulation at oral doses higher than those effective in 
lowering serum Prolactin levels. The long-lasting Prolactin-lowering effects of 
cabergoline is probably due to its long persistence in the target organ as suggested 
by the slow elimination of total radioactivity from the pituitary after a single oral dose 
in rats (t
½
 of approximately 60 hours). 
The pharmacodynamic effects of cabergoline have been studied in healthy women, 
puerperal women and hyperprolactinaemic patients. After a single oral administration 
of cabergoline (0.3-1.5 mg), a significant decrease in serum Prolactin levels was 
observed in each of the populations studied. The effect is prompt (within 3 hours 
from administration) and persistent (up to 7-28 days in healthy volunteers and 
hyperprolactinaemic patients, and up to 14-21 days in puerperal women). The 
Prolactin-lowering effect is dose related both in terms of degree of effect and 
duration of action. 
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