Consumer Medicine Information
What is in this leaflet
This leaflet is designed to provide
you with answers to some common
questions about this medicine. It
does not contain all the available
information and does not take the
place of talking with your doctor.
All medicines have risks and
benefits. Your doctor has more
information about this medicine than
is contained in this leaflet. Also,
your doctor has had the benefit of
taking a full and detailed history
from you and is in the best position
to make an expert judgement to meet
your individual needs.
If you have any concerns about
taking this medicine, talk to your
doctor or pharmacist.
Keep this leaflet with this
You may need to read it again.
AN is used for
RALOXIFENE AN belongs to a
group of non-hormonal medicines
called Selective Estrogen Receptor
Modulators (SERMs). When a
woman reaches menopause, the level
of the female sex hormone,
oestrogen, goes down.
RALOXIFENE AN mimics some of
the beneficial effects of oestrogen
RALOXIFENE AN is used to
prevent and treat osteoporosis in
women after menopause.
Osteoporosis causes your bones to
become thin and fragile - it is
especially common in women after
menopause. While osteoporosis may
have no symptoms at first, it makes
your bones more likely to break,
especially in your spine, hips and
wrists. Osteoporosis may also cause
back pain, loss of height and a curved
Fractures may occur during normal,
everyday activity, such as lifting, or
from minor injury that would not
ordinarily fracture normal bone.
RALOXIFENE AN is also used to
reduce the risk of invasive breast
cancer in women with osteoporosis
after menopause and reduce the
risk of invasive breast cancer in
women at high risk of invasive
breast cancer after menopause.
Breast cancer is invasive when it has
spread outside the milk duct or
milk-making glands and has grown
into normal tissue inside the breast.
Invasive cancers can spread cancer to
other parts of the body through the
bloodstream and lymphatic system.
Your doctor may have prescribed
RALOXIFENE AN for another
Ask your doctor if you have any
questions about why
RALOXIFENE AN has been
prescribed for you.
This medicine is available only with
a doctor's prescription.
Before you take
Tell your doctor if you have any of
the following conditions or if you
have ever experienced any of these
When you must not take
Do not take
* if you have not been through
menopause. RALOXIFENE AN
is only for use by women after
menopause and must not be
taken by women who could still
have a baby.
* if you have had an allergic
reaction to RALOXIFENE AN or
any of the ingredients listed at the
this leaflet (see 'Product
Description'). Signs of an
allergic reaction may include a
skin rash, itching, shortness of
breath or swelling of the face,
lips or tongue.
* if you are being treated or have
been treated for blood clots.
* if the packaging is torn or shows
signs of tampering, or if the
tablets do not look quite right.
* if the expiry date on the pack has
passed. If you take this medicine
after the expiry date has passed, it
may not work as well.
If you are not sure whether you
should start taking
RALOXIFENE AN, talk to your
doctor or pharmacist.
Before you start taking
You must tell your doctor:
* if you have any unexplained
* if you are at risk of blood clots.
* if you are, or know you will be
immobilised for some time, e.g.,
being wheel-chair bound or
having to stay in bed while
recovering from an operation or
* if you have liver disease.
* if you are intolerant of lactose.
RALOXIFENE AN contains a
small amount of lactose (about
150 mg) which
is unlikely to affect you.
* if you have menopausal
symptoms, such as hot flushes.
RALOXIFENE AN does not
treat hot flushes.
* if you are breastfeeding.
* if you are on oestrogen or
hormone replacement therapy
* if you have or have had high
blood fats (triglycerides) caused
* if you have previously had a
stroke, or if you have ever had
other risk factors for stroke such
as a mini-stroke (transient
ischaemic attack) or a type of
irregular heartbeat called atrial
* if you have had breast cancer.
RALOXIFENE AN has not
been fully studied in women
who have a history of breast
Before starting and while taking
RALOXIFENE AN you should have
breast examinations and
mammograms, as directed by your
Doctor. RALOXIFENE AN does not
eliminate the chance of developing
breast cancers, you need these
examinations to find any breast
cancers as early as possible.
RALOXIFENE AN is not intended
to be taken by men.
RALOXIFENE AN has no
known effect on driving or the
ability to use machinery.
Taking other medicines
Tell your doctor if you are taking
any other medicines, including any
that you buy without a
prescription from your pharmacy,
supermarket or health food shop.
Some medicines and
RALOXIFENE AN may interfere
with each other. These include:
* medicines for your heart such as
digitalis drugs (e.g. digoxin) or
blood thinning drugs such as
warfarin. Your doctor may need
to adjust the dose of these
* hormone replacement therapy
(HRT) or oestrogens.
* lipid-lowering drugs including
Your doctor or pharmacist has more
information on medicines to be
careful with or avoid while taking
Tell your doctor about these things
before taking RALOXIFENE AN.
How to take
Carefully follow all directions
given to you by your doctor or
These may differ from the
information contained in this leaflet.
How much to take
The usual dose of RALOXIFENE
AN is one tablet per day.
How to take it
RALOXIFENE AN tablets should be
swallowed whole with a glass of
When prescribed for the treatment or
prevention of osteoporosis,
RALOXIFENE AN should be taken
in conjunction with supplementary
calcium if daily calcium intake is
When to take it
It does not matter what time of day
you take your tablet. However, it is
best to take it at the same time each
day as this will help you remember to
The days of the week are printed on
the blister foil to help you take your
tablet each day.
You may take RALOXIFENE
AN with or without food.
How long do I take it
For maximum benefit,
RALOXIFENE AN is intended
for long-term use.
RALOXIFENE AN without
first talking to your doctor.
If you forget to take it
If it is almost time for your next
dose, skip the tablet you missed
and take your next dose when you
are meant to.
Otherwise, take it as soon as you
remember then go back to taking
your medicine as you would
Do not take a double dose to make
up for the dose that you missed.
If you are not sure what to do, ask
your doctor or pharmacist.
If you take too much
Immediately telephone your doctor
or the Australian Poisons
Information Centre (13 11 26), or
the New Zealand National Poisons
Information Centre (0800 POISON
or 0800 764 766), or go to the
Accident and Emergency
Department at your nearest
hospital, if you think that you or
anyone else has taken too much
Do this even if there are no signs of
discomfort or poisoning.
In adults, symptoms of an overdose
may include leg cramps and
In children, symptoms of an
overdose may include coordination
problems, dizziness, vomiting, rash,
diarrhoea, repetitive shaking, and
While you are taking
Things you must do
It is important that you remember
to take RALOXIFENE AN daily
and at the dose prescribed by your
Tell all doctors and pharmacists
who are treating you that you are
taking RALOXIFENE AN.
While you are taking
RALOXIFENE AN, tell your
doctor or pharmacist before you
start any new medicine.
If you become pregnant while
taking RALOXIFENE AN, tell
Tell your doctor if you are
immobilised for some time, e.g.,
being wheel-chair bound or having
to stay in bed while recovering
from an operation or illness.
If you are going on a long plane or
car trip, you should move about
Tell your doctor if you have any
Things you must not do
Do not stop taking
RALOXIFENE AN without first
checking with your doctor.
Do not give RALOXIFENE AN to
anyone else, your doctor has
prescribed it specifically for you.
Tell your doctor or pharmacist as
soon as possible if you experience
any undesirable effect or feel
unwell while you are taking
Like other medicines,
RALOXIFENE AN may cause some
unwanted side effects. These are
likely to vary from patient to patient.
The majority of side effects seen with
RALOXIFENE AN have been mild.
Tell your doctor if you notice any
of the following side effects and
they worry you:
* hot flushes
* leg cramps
* muscle spasms
* swelling of hands, feet and legs
* flu-like symptoms
These are the more common side
effects of RALOXIFENE AN.
Tell your doctor immediately or go
to the Accident and Emergency
Department at your nearest
hospital if you notice any of the
* severe pain or swelling in your
* severe stomach pain
* problems with your eyesight
* shortness of breath or pain on
In clinical trials of RALOXIFENE
blood clots in the veins (venous
occurred in less than
1% of RALOXIFENE AN
patients. This is a serious side
effect. You may need urgent
medical attention or
Tell your doctor if you notice
anything unusual or if you are
concerned about any aspect of your
health, even if you think the
problems are not associated with
this medicine and are not referred
to in this leaflet.
Clinical trials using RALOXIFENE
AN have shown that:
* Women taking RALOXIFENE
AN have less swelling, tenderness
and pain in their breasts than
* Unlike oestrogen,
RALOXIFENE AN has no effect
on the uterus and is unlikely to
cause vaginal bleeding or
Keep your tablets in the blister
pack until it is time to take them.
Keep your tablets in a cool, dry
place where the temperature stays
below 25 degrees C.
All medicines should be kept where
young children cannot reach them.
There will be an expiry date (month,
year) on your RALOXIFENE AN
The medicine should not be taken
after this date because it may have
lost some of its strength.
If your doctor tells you to stop taking
RALOXIFENE AN or you find that
the tablets have passed their expiry
date, please return any leftover
tablets to your pharmacist.
What it looks like
RALOXIFENE AN tablets are
white to off-white,oval, biconvex,
film coated tablets with ‘C’ on one
side and ‘12’ on the other side.
In Australia RALOXIFENE AN
tablets come in packs of 28 tablets.
Active Ingredient – raloxifene.
hydrochloride which is equivalent to
56 mg raloxifene.
Inactive Ingredients -,
povidone, polysorbate 80,
cellulose, colloidal anhydrous
silica, magnesium stearate,
opadry white 12B580000
RALOXIFENE AN is a product of:
Amneal Pharma Australia Pty Ltd
12 River Street
South Yarra VIC 3141
AUST R 207899
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