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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

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