OGEN - Discount Pharmacy Australia

OGEN*
Piperazine oestrone sulfate
Consumer Medicine Information
What is in this leaflet
Please read this leaflet carefully
before taking OGEN. This leaflet
answers some common questions
about OGEN. It does not contain all
the available information and 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 this medicine
against the expected benefits it will
have for you.
Take OGEN as instructed and follow
the advice given in this leaflet.
If you have any concerns about
taking this medicine, ask your
doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What OGEN is used for
OGEN belongs to a group of
medicines called oestrogens.
Oestrogens are female hormones
produced by the body and are
necessary for the sexual development
of the female and for the control of
the menstrual cycle during child
bearing years.
OGEN is used to treat one or more of
the following:
* to provide additional hormone
when the body does not produce
enough of its own
* to manage symptoms of
menopause such as hot flashes,
itching, burning or dryness in or
around the vagina.
Other hormones called progestogens
may be prescribed at the same time as
OGEN. This is known as Hormone
Replacement Therapy or HRT.
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.
This medicine is only available with
a doctor's prescription.
Before you take OGEN
See your doctor for a physical
examination before you start to take
OGEN. In deciding to give you
OGEN, your doctor has weighed the
benefits of taking OGEN against the
possible side effects and risks.
When you must not take it
Do not take OGEN if:
* you are allergic to OGEN, any
other oestrogen or any of the
ingredients listed at the end of
this leaflet.
* you have a previous history of
herpes gestationis.
* you have unusual lipid
(cholesterol and triglyceride)
metabolism.
* you suffer from thickening of
bones around the ear which may
lead to deafness (otosclerosis),
particularly if this has worsened
during pregnancy.
* you have problems with your
liver
* you have high blood pressure
* you suffer from Sickle-cell
anaemia (a disorder of red blood
cells).
* you have, or have had, breast
cancer, cancer of the genital
organs or other hormone related
cancers.
* you have, or have had, a tendency
to form blood clots
Do not take OGEN if you have
unusual bleeding and the cause has
not been diagnosed by your doctor.
Do not take OGEN if you are
pregnant or think you may be
pregnant.
It may affect your developing baby if
you take it during pregnancy.
Do not breast-feed if you are
taking OGEN.
The active ingredient in OGEN
passes into breast milk and there is a
possibility that your baby may be
affected.
Do not take OGEN after the expiry
date printed on the pack, if the
packaging is torn or shows signs of
tampering or the tablets do not
look quite right.
If it has expired or is damaged, return
it to your pharmacist for disposal.
If you are not sure whether you
should start taking OGEN, talk to
your doctor.
Before you start to take it
Tell your doctor if you have
allergies to any other medicines,
foods, preservatives or dyes.
OGEN* 1

Tell your doctor if you have or
have had any of the following
medical conditions:
* epilepsy
* diabetes
* migraines
* asthma
* heart disease
* kidney or liver disease
* history of problems during
pregnancy
If you are going to have any
laboratory test (e.g. blood or urine),
or an operation, tell your doctor that
you are taking OGEN.
If you have not told your doctor
about any of the above, tell him/her
before you start taking OGEN.
Taking other medicines
Tell your doctor or pharmacist if
you are taking any other
medicines, including any that you
get without a prescription from
your pharmacy, supermarket or
health food shop.
Some medicines may need to be used
with care while taking OGEN. These
include:
* medicines used to relieve
swelling, itching and other skin
problems, e.g. antihistamines or
corticosteroids.
* medicines used to treat nervous,
mental and emotional disorders.
* medicines used to treat heart
conditions.
* thyroid hormones.
* medicines used to prevent blood
clots.
* medicines used to treat or prevent
troubled breathing or asthma.
* medicines used to control blood
pressure or diabetes.
* medicines to control epilepsy or
depression.
Other specific drugs that need to be
used with care while taking OGEN:
* Bromocriptine (used to treat
Parkinson's Disease or to stop
lactation)
* Rifampicin (an antibiotic used to
treat or prevent some infections)
* Pethidine (used for pain relief)
* Caffeine (in some medicines to
treat mental fatigue, migraine or
motion sickness)
* Cyclosporin (used to treat severe
immune disorders or to prevent
rejection after a transplant)
These medicines may be affected by
OGEN or may affect how well it
works. You may need different
amounts of your medicines, or you
may need to take different medicines.
Your doctor and pharmacist have
more information on medicines to be
careful with or avoid while taking
this medicine. This is especially
important if your doctor changes
your dose or if you start taking a new
medicine.
How to take OGEN
Follow all directions given to you
by your doctor or pharmacist
carefully.
They may differ from the
information contained in this leaflet.
If you do not understand the
instructions on the label, ask your
doctor or pharmacist for help.
How much to take
Your doctor will tell you how much
OGEN to take. This will vary
depending on the condition for
which you are being treated. OGEN
should be used at the lowest effective
dose to treat your condition.
Your doctor may tell you to take
OGEN every day or in repeating
cycles with a short break in between.
How to take OGEN
Swallow the tablets whole with a
full glass of water.
When to take OGEN
Take OGEN at about the same
time each day.
Taking it at the same time each day
will have the best effect. It will also
help you remember when to take it.
How long to take it
Continue taking your medicine for
as long as your doctor tells you.
Your doctor will prescribe OGEN for
the shortest duration necessary to
effectively treat your condition.
If you forget to take it
If it is almost time for your next
dose, skip the dose you missed and
take your next dose when you are
meant to.
Otherwise, take it as soon as you
remember, and then go back to
taking your medicine as you would
normally.
Do not take a double dose to make
up for the dose that you missed.
This may increase the chance of you
getting an unwanted side effect.
If you are not sure what to do, ask
your doctor or pharmacist.
If you have trouble remembering
to take your medicine, ask your
pharmacist for some hints.
If you take too much
(overdose)
Immediately telephone your doctor
or Poison Information Centre
(telephone 13 11 26) for advice or
go to the Accident and Emergency
(Casualty) Department at your
nearest hospital if you think you or
anyone else may have taken too
much OGEN. Do this even if there
are no signs of discomfort or
poisoning.
You may need urgent medical
attention.
The symptoms of taking too much
OGEN may include nausea and
vomiting.
OGEN* 2

While you are taking
OGEN
Use OGEN exactly as your doctor
has prescribed.
Tell your doctor immediately if you
have unusual vaginal bleeding.
Oestrogens, such as OGEN, can
increase the chance of getting
cancer of the uterus. Vaginal
bleeding after menopause may be a
warning sign. Your doctor should
check any unusual vaginal
bleeding to find out the cause. Tell
all doctors, dentists and
pharmacists who are treating you
that you are taking OGEN.
Tell your doctor or pharmacist
that you are taking OGEN if you
are about to be started on any new
medicines.
If you are going to have surgery,
tell the surgeon or anaesthetist that
you are taking this medicine.
You may need to stop taking OGEN
if you are going to have surgery or
prolonged bed-rest.
If you are about to have any blood
tests, tell your doctor that you are
taking this medicine.
It may interfere with the results of
some tests.
Tell your doctor if you feel that
OGEN is not helping your condition.
Visit your doctor regularly. Your
doctor needs to check your progress
and see whether you need to keep
taking OGEN.
Regularly check your breasts for any
lumps and have regular professional
breast examinations and
mammograms, as recommended by
your doctor.
Always discuss with your doctor any
problems or difficulties during or
after taking OGEN.
Things you must not do
Do not change your dose or stop
taking OGEN without first checking
with your doctor.
Do not use OGEN to treat any
other complaints unless your
doctor says so.
Do not use OGEN to prevent heart
disease, heart attacks or strokes.
Using oestrogens, such as OGEN,
may increase your chances of getting
heart attacks, strokes, blood clots and
breast cancer.
Do not smoke while you are being
treated with OGEN.
The risks of heart problems are
increased by smoking.
Do not give this medicine to anyone
else, even if they have the same
condition as you.
Things to be careful of
Be careful driving or operating
machinery until you know how
OGEN affects you.
This medicine may cause dizziness,
drowsiness or fatigue in some
people. If you have any of these
symptoms, do not drive, operate
machinery or do anything else that
could be dangerous.
If you feel light-headed, dizzy or
faint when getting out of bed or
standing up, get up slowly.
Standing up slowly, especially when
you get up from bed or chairs, will
help your body get used to the
change in position and blood
pressure. If this problem continues
or gets worse, talk to your doctor.
Side effects
Tell your doctor or pharmacist as
soon as possible if you do not feel
well while you are taking or soon
after you are finished taking
OGEN.
OGEN helps most people for whom
it is prescribed but it may have
unwanted side effects in a few
people. All medicines can have side
effects. Sometimes they are serious,
most of the time they are not. You
may need medical treatment if you
get some of the side effects.
If you are over 65 years of age you
may have an increased chance of
getting side effects.
Oestrogens, such as OGEN, may
increase your chances of getting
heart attacks, strokes and blood clots.
The risk of heart disease is also
increased if you have high blood
pressure, high cholesterol, diabetes,
are overweight, or if you smoke.
Do not be alarmed by the following
lists of side effects. You may not
experience any of them.
Ask your doctor or pharmacist to
answer any questions you may
have.
Tell your doctor or pharmacist if
you notice any of the following and
they worry you:
* nausea, vomiting, pain, cramps or
gas in the abdomen, constipation,
diarrhoea, mouth ulcers, sore
mouth
* changes in appetite
* skin rash, acne, itchiness,
darkening of skin, sensitivity to
light, abnormal hair loss or
growth, red lumps
* headache, migraines, dizziness,
tiredness, drowsiness, unusual
jerky muscle movements
* changes in sexual desire
* inability to sleep or feeling
depressed
* painful periods, premenstrual
type symptoms, vaginal thrush,
burning and stinging while
urinating, changes in vaginal
discharge
* problems with wearing contact
lenses
* problems with breathing
* weight gain or loss
* fluid retention
Tell your doctor as soon as possible
if you notice any of the following:
* confusion or memory loss
OGEN* 3

* lumps or change in your breasts
* unusual vaginal bleeding
Although these side effects are not
common, they may require further
medical assessment for serious
conditions, such as dementia, breast
cancer, ovarian cancer or cancer of
the uterus.
Tell your doctor immediately or go
to Casualty at your nearest
hospital if you notice any of the
following:
* painful swelling in a leg
* chest pain or shortness of breath
* severe headaches or changes in
speech or vision
* severe upper abdominal pain.
The above list includes side effects
that may indicate serious conditions
that require urgent medical attention
or hospitalisation, such as blood clots
in the lungs, heart attack, stroke or
gallbladder disease. Such side effects
are not common.
Tell your doctor or pharmacist if
you notice anything that is making
you feel unwell.
Other side effects not listed above
may also occur in some people.
Some side effects (for example,
changes in blood pressure or
decreased glucose tolerance) can only
be found when your doctor conducts
tests from time to time to check your
progress.
After taking OGEN
Storage
Keep your tablets in the pack until
it is time to take them.
If you take the tablets out of the pack
they may not keep well.
Keep your tablets in a cool dry
place where the temperature stays
below 30 degrees Celsius.
Do not store OGEN or any other
medicine in the bathroom or near a
sink. Do not leave it on a
windowsill or in the car.
Heat and dampness can destroy some
medicines.
Keep OGEN where children
cannot reach it.
A locked cupboard at least
one-and-a-half metres above the
ground is a good place to store
medicines.
Disposal
If your doctor tells you to stop taking
OGEN or the expiry date has passed,
ask your pharmacist what to do with
any medicine that is left over.
Product Description
What it looks like
OGEN tablets are available in blister
packs containing 56 tablets and
bottles containing 100 tablets. There
are two strengths of tablets available,
0.625 mg and 1.25 mg.
The 0.625 mg tablet is yellow and
scored, with U/3772 marked on both
sides. The 1.25 mg tablet is peach
and scored, with U/3773 marked on
both sides.
Ingredients
Active Ingredients:
* OGEN 0.625 contains 0.73 mg
piperazine oestrone sulfate
equivalent to 0.625 mg sodium
oestrone sulfate.
* OGEN 1.25 contains 1.46 mg
piperazine oestrone sulfate
equivalent to 1.25 mg sodium
oestrone sulfate.
Other ingredients include: lactose,
hydroxypropylcellulose, cellulose
microcrystalline, potassium
phosphate-dibasic, trometamol,
sodium starch glycolate, silica
colloidal anhydrous, magnesium
stearate, vegetable oil -
hydrogenated, quinoline yellow CI
47005 (0.625 tablet) and sunset
yellow FCF CI 15985 (0.625 and
1.25 tablets).
Supplier
OGEN is supplied in Australia by:
Pharmacia Australia Pty Limited
ACN 000 185 526
59 Kirby Street
Rydalmere NSW 2116
For medical enquiries call 1300 362
486.
Australian Registration
Numbers
OGEN 0.625 mg bottle:
AUST R 56965
OGEN 0.625 mg blister pack:
AUST R 56966
OGEN 1.25 mg bottle:
AUST R 56973
OGEN 1.25 mg blister pack:
AUST R 56974
This leaflet was prepared in August
2004.
(C) Copyright 2004
* Registered Trademark
OGEN* 4