Serophene

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Clomifene citrate 50mg

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Clomifene citrate 50 mg

Dosage:

50 mg

Pharmaceutical form:

Tablet

Composition:

Active: Clomifene citrate 50mg

Units in package:

Blister pack, 1x10, 10 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Plantex Ltd

Therapeutic indications:

Clomiphene citrate is indicated for the treatment of ovulatory failure in patients desiring pregnancy, and whose husbands are fertile and potent. Impediments to this goal must be excluded or adequately treated before beginning therapy. Administration of clomiphene citrate is indicated only in patients with demonstrated ovulatory dysfunction and in whom the following conditions apply: 1. Normal liver function. 2. Physiologic indications of normal endogenous oestrogen (as estimated from vaginal smears, endometrial biopsy, assay of urinary oestrogen, or from bleeding in response to progesterone). Reduced oestrogen levels, while less favourable do not prevent successful therapy. 3. Clomiphene citrate therapy is not effective for those patients with primary pituitary or ovarian failure. It cannot substitute for appropriate therapy of other disturbances leading to ovulatory dysfunction, e.g., diseases of the thyroid or adrenals. 4. Particularly careful evaluation prior to clomiphene citrate therapy should be done in patients with abnormal uterine bleeding. It is most important that neoplastic lesions are detected.

Product summary:

Package - Contents - Shelf Life: Blister pack, - 10 tablets - 60 months from date of manufacture stored at or below 25°C protect from light

Authorization date:

1990-08-30

Patient Information leaflet

SEROPHENE
®
1
SEROPHENE
®
_Clomiphene citrate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about SEROPHENE.
It does not contain all of 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 taking SEROPHENE
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS INFORMATION WITH THE
MEDICINE.
You may want to read it again later.
WHAT SEROPHENE IS
USED FOR
SEROPHENE is a medicine
containing clomiphene citrate. It is
used to stimulate the development of
ovarian follicles when normal
ovulation does not occur.
_HOW DOES SEROPHENE _
_WORK? _
SEROPHENE appears to work by
increasing the output of the
hormones FSH (follicle stimulating
hormone) and LH (luteinizing
hormone), which stimulate the ovary
to cause follicle growth so that an
egg may be released at mid-cycle.
SEROPHENE is only available on
prescription from your doctor.
SEROPHENE is not addictive. This
medicine does not interfere with your
ability to drive a car or operate
machinery.
YOUR DOCTOR MAY HAVE PRESCRIBED
SEROPHENE FOR ANOTHER REASON.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY
SEROPHENE HAS BEEN PRESCRIBED
FOR YOU.
BEFORE YOU TAKE
SEROPHENE
_WHEN YOU MUST NOT TAKE IT _
Do not take SEROPHENE if:

you are pregnant

you are breastfeeding

you have liver disease or a history
of liver disease

you have abnormal menstruation
or vaginal bleeding

you have enlarged ovaries or
ovarian cysts not due to
polycystic ovary disease

you are suffering from depression

you have a blood clot

you have problems with your
eyesight

you have uncontrolled thyroid
disease

you have problems with your
adrenal gland

you have a pituitary tumour

you have hormone-dependent
tumours
DO NOT TAKE SEROPHENE IF YOU
ARE ALLERGIC TO IT OR ANY OF THE
INGREDIENTS LISTED AT THE EN

Summary of Product characteristics

__________________________________________________________________________________________________
Version: A003-0815
Page 1 of 11
Supersedes: A002-0615
SEROPHENE
CLOMIPHENE CITRATE TABLETS
PRESENTATION
Clomiphene citrate 50 mg in a round, flat, bevel-edged tablet of
approximately 8
mm diameter. It is scored on one side and embossed S on the other.
USES
_ _
_ACTIONS _
Clomiphene citrate, an orally administered, non-steroidal agent, may
induce
ovulation in selected anovulatory women.
Clomiphene citrate is a drug of considerable pharmacological potency.
Careful
evaluation and selection of the patient and close attention to the
timing of the dose
is mandatory prior to treatment with clomiphene citrate. Conservative
selection and
management of the patient contribute to successful therapy of
anovulation.
Clomiphene citrate induces ovulation in most selected anovulatory
patients.
The various criteria for ovulation include: an ovulation peak of
oestrogen excretion
followed by a biphasic basal body temperature curve; urinary excretion
of
pregnanediol at post-ovulatory levels and, endometrial histologic
findings
characteristic of the luteal phase.
A review of eleven publications appearing between 1964 and 1978 showed
that
pregnancy occurred in 35% of 5154 patients with ovulatory dysfunction
who
received clomiphene citrate.
Pregnancies following Clomiphene Citrate
a
(No. of patients studied - 5154)
Patients Ovulating
b
= 75 % (50-94%)
Ovulatory Cycles
= 53 % (33-69%)
Patients Pregnant
= 35 % (11-52%)
Patients Pregnant
= 46 % (22-61%)
Patients Ovulating
Live Births
= 86 % (74-99.8%)
Abortions
= 14 % (0.2-26%)
Single Births
= 90 % (67-100%)
Surviving
= 99 % (98.2-100%)
Multiple Births
= 10 % (0-33%)
Surviving
= 96 % (82-100%)
a) Includes patients receiving other than recommended dosage regimen.
b) average from studies.
Clomiphene citrate therapy appears to mediate ovulation through
increased output
of pituitary gonadotropins. These stimulate the maturation and
endocrine activity of
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