What is in this leaflet What Genox is used for ... - Chemist Australia
What is in this leaflet What Genox is used for ... - Chemist Australia
What is in this leaflet What Genox is used for ... - Chemist Australia
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<strong>Genox</strong><br />
conta<strong>in</strong>s the active <strong>in</strong>gredient tamoxifen (citrate)<br />
Consumer Medic<strong>in</strong>e In<strong>for</strong>mation<br />
<strong>What</strong> <strong>is</strong> <strong>in</strong> th<strong>is</strong> <strong>leaflet</strong><br />
Th<strong>is</strong> <strong>leaflet</strong> answers some common<br />
questions about <strong>Genox</strong>.<br />
It does not conta<strong>in</strong> all of the<br />
available <strong>in</strong><strong>for</strong>mation. It does not<br />
take the place of talk<strong>in</strong>g to your<br />
doctor or pharmac<strong>is</strong>t.<br />
All medic<strong>in</strong>es have benefits and<br />
r<strong>is</strong>ks. Your doctor has weighed the<br />
r<strong>is</strong>ks of you tak<strong>in</strong>g <strong>Genox</strong> aga<strong>in</strong>st the<br />
benefits they expect it will have <strong>for</strong><br />
you.<br />
If you have any concerns about<br />
tak<strong>in</strong>g th<strong>is</strong> medic<strong>in</strong>e, talk to your<br />
doctor or pharmac<strong>is</strong>t.<br />
Keep th<strong>is</strong> <strong>leaflet</strong> with your medic<strong>in</strong>e.<br />
You may need to read it aga<strong>in</strong>.<br />
<strong>What</strong> <strong>Genox</strong> <strong>is</strong> <strong>used</strong> <strong>for</strong><br />
<strong>Genox</strong> <strong>is</strong> <strong>used</strong> to treat some types of<br />
breast cancer. It can be <strong>used</strong> <strong>in</strong> two<br />
ways:<br />
* to help treat cancer which <strong>is</strong> <strong>in</strong><br />
the breast or has spread from the<br />
breast to other parts of the body<br />
* to help stop the spread of cancer<br />
to other parts of the body after a<br />
breast lump has been removed by<br />
surgery.<br />
<strong>Genox</strong> <strong>is</strong> an anti-oestrogen medic<strong>in</strong>e.<br />
Oestrogen <strong>is</strong> a natural female sex<br />
hormone. In some types of breast<br />
cancer, oestrogen helps the cancer<br />
cells to grow. By block<strong>in</strong>g<br />
oestrogen, <strong>Genox</strong> may slow or stop<br />
the growth of cancer. <strong>Genox</strong> does<br />
not kill cancer cells.<br />
<strong>Genox</strong> helps to treat breast cancer but<br />
does not cure it.<br />
<strong>Genox</strong> may be taken alone or <strong>used</strong> <strong>in</strong><br />
comb<strong>in</strong>ation with surgery,<br />
radiotherapy or other cancer-fight<strong>in</strong>g<br />
drugs to treat your cancer.<br />
Your doctor may have prescribed<br />
<strong>Genox</strong> <strong>for</strong> another reason. Ask your<br />
doctor if you have any questions<br />
about why <strong>Genox</strong> has been<br />
prescribed <strong>for</strong> you.<br />
<strong>Genox</strong> <strong>is</strong> not recommended <strong>for</strong> use <strong>in</strong><br />
children.<br />
Th<strong>is</strong> medic<strong>in</strong>e <strong>is</strong> available only with<br />
a doctor's prescription.<br />
There <strong>is</strong> no evidence that <strong>Genox</strong> <strong>is</strong><br />
addictive.<br />
Be<strong>for</strong>e you take <strong>Genox</strong><br />
When you must not take it<br />
Do not take <strong>Genox</strong> if you are<br />
allergic to medic<strong>in</strong>es conta<strong>in</strong><strong>in</strong>g<br />
tamoxifen or any of the <strong>in</strong>gredients<br />
l<strong>is</strong>ted at the end of th<strong>is</strong> <strong>leaflet</strong>.<br />
Do not take <strong>Genox</strong> if you are<br />
pregnant or plan to get pregnant<br />
with<strong>in</strong> two months of treatment.<br />
<strong>Genox</strong> may cause a m<strong>is</strong>carriage or<br />
harm your develop<strong>in</strong>g baby if you<br />
take it dur<strong>in</strong>g pregnancy. Your<br />
doctor must first check you are not<br />
pregnant be<strong>for</strong>e you start tak<strong>in</strong>g<br />
<strong>Genox</strong>.<br />
Do not take <strong>Genox</strong> if you are<br />
breastfeed<strong>in</strong>g.<br />
<strong>Genox</strong> <strong>is</strong> not recommended dur<strong>in</strong>g<br />
breastfeed<strong>in</strong>g as it <strong>is</strong> not known<br />
whether <strong>Genox</strong> passes <strong>in</strong>to breast<br />
milk.<br />
Do not take <strong>Genox</strong> if the expiry<br />
date (Exp.) pr<strong>in</strong>ted on the pack has<br />
passed.<br />
Do not take <strong>Genox</strong> if the packag<strong>in</strong>g<br />
shows signs of tamper<strong>in</strong>g or the<br />
tablets do not look quite right.<br />
Be<strong>for</strong>e you start to take it<br />
Tell your doctor if you are allergic<br />
to any other medic<strong>in</strong>es, foods, dyes<br />
or preservatives.<br />
Tell your doctor if you have not<br />
been through menopause.<br />
Tell your doctor if you plan to get<br />
pregnant.<br />
Tak<strong>in</strong>g <strong>Genox</strong> dur<strong>in</strong>g pregnancy can<br />
harm the develop<strong>in</strong>g baby. D<strong>is</strong>cuss<br />
th<strong>is</strong> with your doctor. You must use<br />
a non-hormonal barrier method of<br />
contraception, such as a condom or<br />
diaphragm, while you are tak<strong>in</strong>g and<br />
<strong>for</strong> two months after you stop tak<strong>in</strong>g<br />
<strong>Genox</strong>.<br />
Tell your doctor if you have any<br />
medical conditions, especially the<br />
follow<strong>in</strong>g:<br />
* liver problems<br />
* blood clots <strong>in</strong> the legs, lungs,<br />
heart or bra<strong>in</strong><br />
* low platelet count<br />
* low white blood cell count<br />
* unusual vag<strong>in</strong>al bleed<strong>in</strong>g or<br />
d<strong>is</strong>charge.<br />
If you have not told your doctor<br />
about any of the above, tell them<br />
be<strong>for</strong>e you start tak<strong>in</strong>g <strong>Genox</strong>.<br />
GENOX 1
Tak<strong>in</strong>g other medic<strong>in</strong>es<br />
Tell your doctor if you are tak<strong>in</strong>g<br />
any other medic<strong>in</strong>es, <strong>in</strong>clud<strong>in</strong>g any<br />
that you buy without a<br />
prescription from a pharmacy,<br />
supermarket or health food shop.<br />
Some medic<strong>in</strong>es may be affected by<br />
<strong>Genox</strong>, or may affect how well it<br />
works. These <strong>in</strong>clude:<br />
* other medic<strong>in</strong>es <strong>used</strong> to treat<br />
cancer<br />
* medic<strong>in</strong>es <strong>used</strong> to prevent blood<br />
clots such as warfar<strong>in</strong>.<br />
Your doctor can tell you what to do<br />
if you are tak<strong>in</strong>g any of these<br />
medic<strong>in</strong>es.<br />
If you are not sure whether you are<br />
tak<strong>in</strong>g any of these medic<strong>in</strong>es,<br />
check with your doctor or<br />
pharmac<strong>is</strong>t.<br />
Your doctor and pharmac<strong>is</strong>t have<br />
more <strong>in</strong><strong>for</strong>mation on medic<strong>in</strong>es to be<br />
careful with or avoid while tak<strong>in</strong>g<br />
<strong>Genox</strong>.<br />
How to take <strong>Genox</strong><br />
How much to take<br />
The usual start<strong>in</strong>g dose <strong>is</strong> 20mg a<br />
day. Your doctor may <strong>in</strong>crease th<strong>is</strong><br />
dose to 40mg a day, depend<strong>in</strong>g on<br />
how you respond to th<strong>is</strong> medic<strong>in</strong>e.<br />
Patients with liver problems may<br />
need smaller doses.<br />
Follow all directions given to you<br />
by your doctor and pharmac<strong>is</strong>t<br />
carefully.<br />
How to take <strong>Genox</strong><br />
Swallow the tablets with a glass of<br />
water at about the same time each<br />
day.<br />
<strong>Genox</strong> tablets can be taken with or<br />
without food.<br />
If you <strong>for</strong>get to take <strong>Genox</strong><br />
If it <strong>is</strong> almost time <strong>for</strong> your next<br />
dose, skip the dose you m<strong>is</strong>sed and<br />
take your next dose when you are<br />
meant to.<br />
Otherw<strong>is</strong>e, take the m<strong>is</strong>sed dose as<br />
soon as you remember, and then go<br />
back to tak<strong>in</strong>g your tablets as you<br />
would normally.<br />
Do not take a double dose to make<br />
up <strong>for</strong> the dose you m<strong>is</strong>sed.<br />
If you are not sure what to do, ask<br />
your doctor or pharmac<strong>is</strong>t.<br />
How long to take <strong>Genox</strong> <strong>for</strong><br />
<strong>Genox</strong> helps control your condition<br />
but does not cure it, so it <strong>is</strong> important<br />
to take it every day.<br />
Keep tak<strong>in</strong>g <strong>Genox</strong> <strong>for</strong> as long as<br />
your doctor recommends.<br />
You may need to keep tak<strong>in</strong>g <strong>Genox</strong><br />
long term, <strong>for</strong> several years.<br />
If you stop tak<strong>in</strong>g <strong>Genox</strong> aga<strong>in</strong>st<br />
your doctor's advice, the cancer may<br />
get worse.<br />
If you take too much <strong>Genox</strong><br />
(overdose)<br />
Immediately telephone your<br />
doctor, or the Po<strong>is</strong>ons In<strong>for</strong>mation<br />
Centre (telephone 13 11 26) if you<br />
th<strong>in</strong>k you or anyone else may have<br />
taken too much <strong>Genox</strong>. Do th<strong>is</strong><br />
even if there are no signs of<br />
d<strong>is</strong>com<strong>for</strong>t or po<strong>is</strong>on<strong>in</strong>g.<br />
While you are tak<strong>in</strong>g<br />
<strong>Genox</strong><br />
Th<strong>in</strong>gs you must do<br />
Be<strong>for</strong>e start<strong>in</strong>g any new medic<strong>in</strong>e,<br />
tell your doctor or pharmac<strong>is</strong>t that<br />
you are tak<strong>in</strong>g <strong>Genox</strong>.<br />
Tell all the doctors, dent<strong>is</strong>ts and<br />
pharmac<strong>is</strong>ts who are treat<strong>in</strong>g you<br />
that you are tak<strong>in</strong>g <strong>Genox</strong>.<br />
If you become pregnant while<br />
tak<strong>in</strong>g <strong>Genox</strong>, or with<strong>in</strong> two<br />
months of stopp<strong>in</strong>g treatment, tell<br />
your doctor immediately.<br />
Tell your doctor immediately if<br />
you notice any unusual vag<strong>in</strong>al<br />
bleed<strong>in</strong>g or d<strong>is</strong>charge.<br />
The use of <strong>Genox</strong> may be associated<br />
with an <strong>in</strong>creased r<strong>is</strong>k of cancer of<br />
the uterus. Although unusual<br />
bleed<strong>in</strong>g and d<strong>is</strong>charge from the<br />
vag<strong>in</strong>a are possible side effects of<br />
<strong>Genox</strong>, they are also symptoms of<br />
uter<strong>in</strong>e cancer and should be<br />
thoroughly <strong>in</strong>vestigated by your<br />
doctor.<br />
V<strong>is</strong>it your doctor regularly so they<br />
can check on your progress.<br />
You will need to have regular<br />
gynaecological check-ups while you<br />
are tak<strong>in</strong>g <strong>Genox</strong>. You doctor may<br />
also order regular blood tests to<br />
check your calcium levels, white<br />
blood cell and platelet counts.<br />
Th<strong>in</strong>gs you must not do<br />
Do not use <strong>Genox</strong> to treat any<br />
other conditions unless your doctor<br />
tells you to.<br />
Do not give <strong>Genox</strong> to anyone else,<br />
even if they have the same<br />
condition as you.<br />
Th<strong>in</strong>gs to be careful of<br />
Be careful driv<strong>in</strong>g or operat<strong>in</strong>g<br />
mach<strong>in</strong>ery until you know how<br />
<strong>Genox</strong> affects you.<br />
<strong>Genox</strong> may cause dizz<strong>in</strong>ess,<br />
lightheadedness or blurred v<strong>is</strong>ion <strong>in</strong><br />
some people. If th<strong>is</strong> occurs, do not<br />
drive, operate mach<strong>in</strong>ery or do<br />
anyth<strong>in</strong>g else that could be<br />
dangerous.<br />
GENOX 2
Side effects<br />
Tell your doctor or pharmac<strong>is</strong>t as<br />
soon as possible if you do not feel<br />
well while you are tak<strong>in</strong>g <strong>Genox</strong>.<br />
Like all other medic<strong>in</strong>es, <strong>Genox</strong> may<br />
have unwanted side effects <strong>in</strong> some<br />
people. Sometimes they are serious,<br />
most of the time they are not. You<br />
may need medical treatment if you<br />
get some of the side effects.<br />
Do not be alarmed by th<strong>is</strong> l<strong>is</strong>t of<br />
possible side effects.<br />
You may not experience any of them.<br />
Ask your doctor or pharmac<strong>is</strong>t to<br />
answer any questions you may<br />
have.<br />
Tell your doctor if you notice any<br />
of the follow<strong>in</strong>g and they worry<br />
you:<br />
* hot flushes<br />
* nausea, vomit<strong>in</strong>g, stomach upset<br />
* mild sk<strong>in</strong> rash, itch<strong>in</strong>g<br />
* headache<br />
* dizz<strong>in</strong>ess or lightheadedness<br />
* hair loss or th<strong>in</strong>n<strong>in</strong>g<br />
* swell<strong>in</strong>g <strong>in</strong> your hands, feet or<br />
ankles<br />
* itch<strong>in</strong>g around the vag<strong>in</strong>a or<br />
genitals.<br />
Tell your doctor immediately if<br />
you notice any of the follow<strong>in</strong>g:<br />
* problems with your eyesight<br />
* unusual vag<strong>in</strong>al bleed<strong>in</strong>g or<br />
d<strong>is</strong>charge<br />
* changes <strong>in</strong> your menstrual<br />
periods<br />
* pa<strong>in</strong> <strong>in</strong> the bones or at the site of<br />
your cancer<br />
* yellow<strong>in</strong>g of the sk<strong>in</strong> and eyes<br />
* dark coloured ur<strong>in</strong>e.<br />
Tell your doctor immediately or go<br />
to Accident and Emergency at the<br />
nearest hospital if you notice any<br />
of the follow<strong>in</strong>g:<br />
* sharp, stabb<strong>in</strong>g pa<strong>in</strong> or swell<strong>in</strong>g<br />
<strong>in</strong> the gro<strong>in</strong>, chest or leg<br />
* cough<strong>in</strong>g up blood, sudden<br />
shortness of breath<br />
* loss of appetite, thirst, nausea,<br />
vomit<strong>in</strong>g, constipation and<br />
stomach pa<strong>in</strong>, sometimes together<br />
with confusion and muscle<br />
weakness due to high calcium<br />
levels <strong>in</strong> the blood<br />
* severe upper stomach pa<strong>in</strong> with<br />
nausea and vomit<strong>in</strong>g<br />
* signs of frequent <strong>in</strong>fections such<br />
as fever, chills, sore throat or<br />
mouth ulcers<br />
* bleed<strong>in</strong>g or bru<strong>is</strong><strong>in</strong>g more easily<br />
than normal<br />
* severe bl<strong>is</strong>ters, or bleed<strong>in</strong>g <strong>in</strong> the<br />
lips, eyes, nose, mouth or genitals<br />
* swell<strong>in</strong>g of the face, lips, tongue<br />
or other parts of the body,<br />
shortness of breath, wheez<strong>in</strong>g or<br />
trouble breath<strong>in</strong>g.<br />
Other side effects not l<strong>is</strong>ted above<br />
may also occur <strong>in</strong> some patients.<br />
Tell your doctor if you notice<br />
anyth<strong>in</strong>g that <strong>is</strong> mak<strong>in</strong>g you feel<br />
unwell.<br />
Some changes <strong>in</strong> the body may ar<strong>is</strong>e<br />
from the breast cancer itself, rather<br />
than the treatment. For th<strong>is</strong> reason,<br />
contact your doctor immediately if<br />
you notice any of the follow<strong>in</strong>g:<br />
* unusual vag<strong>in</strong>al bleed<strong>in</strong>g or<br />
d<strong>is</strong>charge<br />
* pa<strong>in</strong> or redden<strong>in</strong>g around the<br />
tumour<br />
* bone pa<strong>in</strong><br />
* loss of appetite, thirst, nausea,<br />
vomit<strong>in</strong>g, constipation and<br />
stomach pa<strong>in</strong>, sometimes together<br />
with confusion and muscle<br />
weakness due to high calcium<br />
levels <strong>in</strong> the blood.<br />
After tak<strong>in</strong>g <strong>Genox</strong><br />
Storage<br />
Keep <strong>Genox</strong> where children cannot<br />
reach it.<br />
A locked cupboard at least<br />
one-and-a-half metres above the<br />
ground <strong>is</strong> a good place to store<br />
medic<strong>in</strong>es.<br />
Keep your tablets <strong>in</strong> the pack until<br />
it <strong>is</strong> time to take them.<br />
If you take the tablets out of the pack<br />
they may not keep well.<br />
Keep the tablets away from light.<br />
Keep your tablets <strong>in</strong> a cool dry<br />
place where the temperature stays<br />
below 30 degrees C.<br />
Do not store <strong>Genox</strong> or any other<br />
medic<strong>in</strong>e <strong>in</strong> the bathroom or near a<br />
s<strong>in</strong>k.<br />
Do not leave <strong>Genox</strong> <strong>in</strong> the car or on<br />
w<strong>in</strong>dow sills.<br />
Heat and dampness can destroy some<br />
medic<strong>in</strong>es.<br />
D<strong>is</strong>posal<br />
If your doctor tells you to stop<br />
tak<strong>in</strong>g <strong>Genox</strong>, or your tablets have<br />
passed their expiry date, ask your<br />
pharmac<strong>is</strong>t what to do with any<br />
that are left over.<br />
Product description<br />
<strong>What</strong> it looks like<br />
<strong>Genox</strong> comes <strong>in</strong> 2 strengths of<br />
tablets:<br />
* <strong>Genox</strong> 10 - round, white tablet<br />
marked TN over 10 on one side<br />
and G on the reverse<br />
* <strong>Genox</strong> 20 - round, white, scored<br />
tablet marked TN over 20 on one<br />
side and G on the reverse.<br />
Each pack conta<strong>in</strong>s 60 tablets.<br />
Ingredients<br />
The active <strong>in</strong>gredient <strong>in</strong> <strong>Genox</strong> <strong>is</strong><br />
tamoxifen (as tamoxifen citrate):<br />
* each <strong>Genox</strong> 10 tablet conta<strong>in</strong>s<br />
10mg of tamoxifen<br />
* each <strong>Genox</strong> 20 tablet conta<strong>in</strong>s<br />
20mg of tamoxifen.<br />
The tablets also conta<strong>in</strong>:<br />
* mannitol<br />
* maize starch<br />
* croscarmellose sodium<br />
* magnesium stearate.<br />
The tablets are gluten free.<br />
GENOX 3
Supplier<br />
<strong>Genox</strong> <strong>is</strong> supplied by:<br />
Alphapharm Pty Limited<br />
(ABN 002 359 739)<br />
Chase Build<strong>in</strong>g 2<br />
Wentworth Park Road<br />
Glebe NSW 2037<br />
Phone: (02) 9298 3999<br />
Medical In<strong>for</strong>mation<br />
Phone: 1800 028 365<br />
<strong>Australia</strong>n reg<strong>is</strong>tration numbers:<br />
<strong>Genox</strong> 10 - AUST R 40063<br />
<strong>Genox</strong> 20 - AUST R 40065<br />
Th<strong>is</strong> <strong>leaflet</strong> was prepared on<br />
14 December 2001.<br />
GENOX 4