Apo-Bromocriptine

País: Nova Zelanda

Idioma: anglès

Font: Medsafe (Medicines Safety Authority)

ingredients actius:

Bromocriptine mesilate 2.9mg equivalent to bromocriptine 2.5 mg (2.9 - 3.0 mg)

Disponible des:

Apotex NZ Ltd

Designació comuna internacional (DCI):

Bromocriptine mesilate 2.9 mg (equivalent to bromocriptine 2.5 mg; 2.9 - 3.0 mg)

Dosis:

2.5 mg

formulario farmacéutico:

Tablet

Composición:

Active: Bromocriptine mesilate 2.9mg equivalent to bromocriptine 2.5 mg (2.9 - 3.0 mg) Excipient: Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose

Unidades en paquete:

Bottle, plastic, Amber HDPE, 30 tabs, 30 tablets

clase:

Prescription

tipo de receta:

Prescription

Fabricat per:

Teva Czech Industries s.r.o.

indicaciones terapéuticas:

Prolactin dependent menstrual cycle disorders (Amenorrhoea, oligomenorrhoea, galactorrhoea), and/or female infertility associated with hyperprolactinaemia or luteal phase deficiency: · Bromocriptine may normalise the menstrual cycle and/or induce ovulation without ovarian overstimulation. Treatment with bromocriptine is not curative and it is not effective in treating ovarian failure.

Resumen del producto:

Package - Contents - Shelf Life: Bottle, plastic, Amber HDPE - 30 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, Amber HDPE - 100 tablets - 36 months from date of manufacture stored at or below 25°C

Data d'autorització:

1994-11-28

Informació per a l'usuari

New Zealand Consumer Medicine Information
APO-BROMOCRIPTINE
_BROMOCRIPTINE MESYLATE _
2.5mg Tablets
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using
Apo-Bromocriptine.
This leaflet answers some common questions about Apo-Bromocriptine. 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
Apo-Bromocriptine against the benefits they expect it will have for
you.
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 APO-BROMOCRIPTINE IS USED FOR
The name of your medicine is Apo-Bromocriptine tablet. It contains the
active
ingredient bromocriptine (as bromocriptine mesylate).
Apo-Bromocriptine is used for:
•
prolactin dependent menstrual cycle disorders (amenorrhoea,
oligomenorrhoea, galactorrhoea)
•
hyperprolactinaemia in man
•
prolactinomas
•
acromegaly
•
inhibition of lactation
•
Parkinson’s disease
Your doctor may have prescribed Apo-Bromocriptine for another reason.
Ask your doctor if you have any questions about why Apo-Bromocriptine
has been
prescribed for you.
This medicine is available only with a doctor's prescription.
There is no evidence that this medicine is addictive.
2
Apo-Bromocriptine should not be administered to children.
BEFORE YOU USE APO-BROMOCRIPTINE
_ _
_WHEN YOU MUST NOT USE IT _
Do not use Apo-Bromocriptine if:
•
YOU
ARE
HYPERSENSITIVE
TO,
OR
HAVE
HAD
AN
ALLERGIC
REACTION
TO
BROMOCRIPTINE OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS
LEAFLET.
Symptoms of an allergic reaction may include: cough, shortness of
breath, wheezing,
difficulty breathing or tightness in chest; swelling of the face,
lips, tongue, throat or
other parts of the body; rash, itching or hives on the skin; fainting;
or hay fever-like
symptoms.
IF YOU THINK YOU ARE HAVING AN ALLERGIC REACTION, DO NOT TAKE ANY MORE
OF THE
ME

Fitxa tècnica

NEW ZEALAND DATA SHEET
APO-BROMOCRIPTINE
Please refer to Medsafe website (www.medsafe.govt.nz) for the most
recent datasheet Page 1
1
APO-BROMOCRIPTINE
(2.5MG TABLETS)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Bromocriptine mesylate 2.5mg tablets
Chemical Structure:
EXCIPIENT(S) OF KNOWN EFFECT
APO-BROMOCRIPTINE contains lactose.
If you have been told by your doctor that you have intolerance to some
sugars contact your doctor
before taking this medicinal product.
Contains 135 mg of lactose monohydrate per 50 mg and 85 mg of lactose
monohydrate per
100 mg.
This should be taken into account in patients with diabetes mellitus.
APO-BROMOCRIPTINE does not contain gluten.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Bromocriptine 2.5mg tablets are white, oval, slope-faced & flat-faced
tablets with bevelled edges.
Scored and engraved 2.5 on the right side on slope side, plain on flat
side. Each tablet contains
2.87mg bromocriptine mesylate which provides 2.5mg bromocriptine and
typically weighs 140mg.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PROLACTIN
DEPENDENT
MENSTRUAL
CYCLE
DISORDERS
(
Amenorrhoea,
oligomenorrhoea,
galactorrhoea),
and/or
female
infertility
associated
with
hyperprolactinaemia
or
luteal
phase
deficiency.
APO-BROMOCRIPTINE
Please refer to Medsafe website (www.medsafe.govt.nz) for the most
recent datasheet Page 2
Bromocriptine
may
normalise
the
menstrual
cycle
and/or
induce
ovulation
without
ovarian
overstimulation. Treatment with bromocriptine is not curative and it
is not effective in treating ovarian
failure.
HYPERPROLACTINAEMIA IN MAN:
Prolactin-related hypogonadism (oligospermia, loss of libido,
impotence) and galactorrhoea.
PROLACTINOMAS:
Bromocriptine may result in a reduction in size of pituitary
prolactin-secreting micro- or macro-
adenomas. It can be used alone or prior to radiation or surgery for
excision of the tumour. It can also
be used post-surgery if prolactin levels are still elevated.
ACROMEGALY:
Used as an adjunct to, or as an alternative to radiatio