Cabergoline Aurobindo 0.5 mg tablets

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

ATC code:

G02CB03

INN (International Name):

CABERGOLINE 0.5 mg

Pharmaceutical form:

TABLET

Composition:

CABERGOLINE 0.5 mg

Prescription type:

POM

Therapeutic area:

OTHER GYNECOLOGICALS

Authorization status:

Authorised

Authorization date:

2023-09-25

Patient Information leaflet

1.3.1 SPC, LABELLING AND PACKAGE LEAFLET
MARKETING AUTHORISATION APPLICATION
CABERGOLINE AUROBINDO 0.5 MG TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER
CABERGOLINE AUROBINDO 0.5 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 Aurobindo is and what it is used for
2.
What you need to know before you take Cabergoline Aurobindo
3.
How to take Cabergoline Aurobindo
4.
Possible side effects
5.
How to store Cabergoline Aurobindo
6.
Contents of the pack and other information
1.
WHAT CABERGOLINE AUROBINDO IS AND WHAT IT IS USED FOR
Cabergoline Aurobindo contains cabergoline which belongs to a group of
medicines known as
prolactin inhibitors. Prolactin is a hormone that is formed in the
pituitary gland of your brain.
Cabergoline Aurobindo decreases the levels of the hormone prolactin.
Cabergoline Aurobindo is used:
•
to interrupt/inhibit lactation (milk production) for medical reasons.
•
to treat hormonal disturbances as a result of high prolactin levels,
such as missing or irregular
periods, infertility or milk flow not associated with childbirth.
•
to treat high levels of prolactin due to a tumour in the pituitary
gland.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CABERGOLINE AUROBINDO
DO NOT TAKE CABERGOLINE AUROBINDO
•
If you are allergic to cabergoline, other ergot alkaloids (e.g.
bromocriptine), or to any of the other
ingredients of this medicine (listed in section 6)
•
If you have severe liver disease.
•
If you have (or have had in the past) psychos

Summary of Product characteristics

1.3.1 SPC, LABELLING AND PACKAGE LEAFLET
MARKETING AUTHORISATION APPLICATION
CABERGOLINE AUROBINDO 0.5 MG TABLETS
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Cabergoline Aurobindo 0.5 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 0.5 mg of cabergoline.
Excipients with known effect: Each film-coated tablet contains 74.75
mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White to off-white, capsule shaped, approximately 8mm x 4mm, flat
faced, bevel edged, uncoated
tablets debossed with ‘C 0.5’ on one side and break line on other
side.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Inhibition or suppression of postpartum lactation:
Cabergoline Aurobindo is indicated for the prevention of postpartum
lactation immediately after
delivery and for the suppression of ongoing lactation for medical
reasons, such as:
•
After delivery, when breastfeeding is contraindicated for mother- or
child-related medical
reasons.
•
After stillbirth or abortion
•
Hyperprolactinemia postpartum after a pregnancy following treatment
with a dopamin-agonist
Treatment of hyperprolactinaemic disorders:
Cabergoline Aurobindo is indicated for the treatment of dysfunctions
related to hyperprolactinaemia,
such as amenorrhoea, oligomenorrhoea, anovulation and galactorrhoea.
Cabergoline Aurobindo is
indicated in patients with prolactin-secreting pituitary adenoma
(micro- and macroprolactinoma),
idiopathic hyperprolactinaemia or empty sella syndrome associated with
hyperprolactinaemia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The maximum dose of 3 mg/day of Cabergoline Aurobindo must not be
exceeded.
Inhibition of post-partum lactation:
Cabergoline Aurobindo should be administered during the first 24 hours
post-partum. The
recommended therapeutic dosage is 1 mg (2 tablets of 0.5 mg)
Cabergoline Aurobindo given as a
single dose.
1.3.1 SPC, LABELLING AND PACKAGE LEAFLET
MA