What is in this leaflet by liaoqinmei


									TAMOXEN® 20
tamoxifen citrate 20 mg tablets

Consumer Medicine Information
What is in this leaflet

This leaflet answers some common questions about TAMOXEN® 20.
It does not contain all 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
TAMOXEN® against the benefits it is expected to have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may want to read it again.

What TAMOXEN® 20 is used for

The name of your medicine is TAMOXEN® 20. It contains the active ingredient
tamoxifen citrate.

TAMOXEN® 20 is used to treat breast cancer.

Your doctor may have prescribed TAMOXEN® 20 for another reason.

Ask your doctor if you have any questions about why TAMOXEN® 20 was
prescribed for you.

How TAMOXEN® 20 works

TAMOXEN® 20 is known as an antioestrogen, which is used to reduce the effects of
female sex hormones.

If a woman has breast cancer, oestrogen may help the cancer cells to grow. TAMOXEN®
20 will help treat breast cancer by blocking oestrogen. TAMOXEN® 20 does not kill
cancer cells, but it stops or slows their growth.

Although many women have been helped by TAMOXEN® 20, it is not a cure for breast

Tamoxen CMI V0.3 March 2008                                                              1
TAMOXEN® 20 can be used in two ways. It can help treat a cancer which is in, or has
spread from, the breast. In women who have had a cancer lump removed, TAMOXEN®
20 may decrease or prevent the spread of cancer cells to other parts of the body.

There is no evidence that TAMOXEN® 20 is addictive.

Before you take TAMOXEN® 20

When you must not take TAMOXEN® 20

Do not take TAMOXEN® 20 if:
• You are allergic to the active ingredient or any of the inactive ingredients mentioned
   at the end of this leaflet under Product Description.
• It is past its expiry date or the packaging appears to have been tampered with.
• You are pregnant or intend to become pregnant; also if you plan to get pregnant
   within two months after treatment.
• You are breastfeeding or intend to breastfeed. It is unknown if tamoxifen passes into
   breast milk.

Tell your doctor before you start to take TAMOXEN® 20 if you are pregnant or
intend to become pregnant, are breastfeeding or intend to breastfeed.

Discuss contraception with your doctor. Although TAMOXEN® 20 blocks female
hormones, it is not a contraceptive. You should see your doctor immediately if you think
you may have become pregnant after starting to take TAMOXEN® 20

Before you start to take TAMOXEN®

Tell your doctor if you have allergies to:
• Any other medicines, especially if they are in the same drug class as tamoxifen
• Any other substances, including foods, preservatives or dyes.

Tell your doctor if you plan on becoming pregnant or will be breastfeeding while
you are using TAMOXEN® 20.

Tell your doctor if you have or have had any medical conditions, especially the
• Any blood disorders or problems, such as low white-cell counts (leukopenia) or low
    platelet counts (thrombocytopenia)
• Any liver problems, such as hepatitis
• Unusual bleeding or discharge from the vagina
• Blurred eyesight or other problems with your eyes.

Tamoxen CMI V0.3 March 2008                                                           2
Taking other medicines

Tell your doctor if you are taking any other medicine, including any that you buy
without a prescription from your pharmacy, supermarket or health food shop.

In particular, tell your doctor if you take any of the following:
• Anticoagulants, such as warfarin and phenindione, used to reduce the ability of the
    blood to form clots
• Rifampicn, an antibiotic used to treat tuberculosis (TB).

These medicines may be affected by TAMOXEN® 20, or may affect how well it works.
You may need to use different amounts of your medicine, or you may need to take
different medicines. Your doctor will advise you.

How to take TAMOXEN® 20

TAMOXEN® 20 should only be used as directed by your doctor. It is very important that
you always follow your doctor’s instructions about how many tablets you should take,
how often you should take them and for how long. Do NOT stop taking TAMOXEN® 20
without first checking with your doctor.

The usual recommended dose for adults is 20mg once daily (one TAMOXEN® 20 tablet).
Doses may be increased to 40mg daily.

Swallow TAMOXEN® tablets whole with a glass of water. Do not chew or crush the

The dosage recommendation and duration of treatment will be determined for your
specific condition by your doctor. Do NOT take any more than prescribed by your doctor.

If you forget to take your dose

Take your dose as soon as you remember, and continue to take it as you would normally.

If it is almost time for your next dose, skip the dose you missed and take your next dose
when you are meant to.

Do not take a double dose to make up for the dose you missed.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering when to take your medicine, ask your pharmacist for
some hints.

Tamoxen CMI V0.3 March 2008                                                            3
If you take too much

Immediately telephone your doctor, or the Poisons Information Centre (telephone
13 11 26) or go to Accident and Emergency at your nearest hospital, if you think you
or anyone else has taken too much TAMOXEN® 20.

Do this even if there are no signs of discomfort or poisoning.

While you are using TAMOXEN® 20

Things you must do

•   Always follow your doctor’s instructions carefully.
•   Tell your doctor if you become pregnant while taking TAMOXEN® 20.
•   If you are about to start taking a new medicine, tell your doctor and pharmacist that
    you are taking TAMOXEN® 20.

Things you must not do

•   Do not stop taking TAMOXEN® 20 without your doctor’s permission.
•   Do not use TAMOXEN® 20 to treat any other complaint unless your doctor says so.
•   Do not give this medication to anyone else, even if their symptoms seem similar to

Things to be careful of

Be careful driving or operating machinery until you know how TAMOXEN® 20
affects you. TAMOXEN® 20 may cause dizziness or light-headedness in some people.

Side effects

All medicines can have unwanted effects. Sometimes they are serious, most of the time
they are not. Do not be alarmed by this list of possible side effects. You may not
experience any of them.

Tell your doctor if you notice any of the following and they worry you:
• Nausea and vomiting
• Hot flushes
• Swelling of the hands, ankles and feet (oedema)
• Change in or stopping of periods
• Intense itching around the vagina and genitals
• Dizziness and light-headedness

Tamoxen CMI V0.3 March 2008                                                            4
•   Leg cramps.

These are the more common side effects of TAMOXEN® 20. Mostly, these are mild and

Also tell your doctor if you notice any of the following:
• Skin rashes and skin irritation
• Bleeding from the vagina
• Discharge from the vagina
• Liver problems (unusual fat deposits in the liver, hepatitis, jaundice/yellow eyes)
• Bald spots or thinning of the hair
• Headaches.

These are less common side effects of TAMOXEN® 20.

Rare side effects of TAMOXEN® 20 are:
• Increased risk of blood clots
• Decrease in the number of white cells in the blood (leukopenia)
• Bruising and decrease in the normal clotting ability of the blood (caused by fewer
   "platelets" and known as thrombocytopenia)
• Thickening of the normal lining of the uterus (womb)
• Growths (polyps) in the lining of the uterus
• High level of calcium in the blood of patients with advanced cases of breast cancer
   (your doctor may detect this in a blood test); you may notice this as nausea, vomiting
   or excessive thirst
• Swellings in the ovaries, called cysts (usually only in younger women, that is, before
   the menopause)
• Blurry or poor eyesight, and changes to the eyes
• Higher triglyceride (fat) levels in the blood, sometimes with pancreatitis (pain or
   tenderness in your upper abdomen)
• Thromboembolism (blockage of a blood vessel by a blood clot). This may occur more
   frequently if other cancer drugs are also being taken.

Recent studies have shown that treatment with tamoxifen may increase the risk of cancer
of the uterus (womb). Cancer of the womb is usually found early and can be treated
quickly. Any abnormal vaginal discharge or bleeding should be investigated by your
doctor. DO NOT stop taking tamoxifen if your doctor has chosen it to treat your breast
cancer. Treatment of your breast cancer is more urgent than the low risk of developing
cancer of the womb which may develop many years later on or not at all.

Tamoxen CMI V0.3 March 2008                                                             5
If any of the following happen, stop taking TAMOXEN® 20 and tell your doctor
immediately, or go to Accident and Emergency at your nearest hospital:
• Swelling of the face, lips, mouth or throat which may cause difficulty in swallowing
    or breathing.

These are very serious, but rare, side effects. You may need urgent medical attention or

Other side effects not listed above may also occur in some people. Tell your doctor if you
notice any other effects.

After using TAMOXEN® 20


Keep TAMOXEN® 20 in the original packaging until you need to take it.

Store below 25°C in a dry place, out of the reach of children. TAMOXEN® 20 should be
kept away from light and moisture.


Return any unused or out of date medicine to your pharmacist.

Product description

What TAMOXEN® 20 looks like

TAMOXEN® 20 tablets are white and round with a notch on one side. They are available
in blisters of 60 tablets.


As well as the active ingredient, tamoxifen citrate, TAMOXEN® 20 also contains some
inactive ingredients. These are lactose, sodium starch glycollate, povidone,
microcrystalline cellulose, magnesium stearate, titanium dioxide, hypromellose and
macrogol 4000.

Tamoxen CMI V0.3 March 2008                                                             6

TAMOXEN® 20 is supplied in Australia by:

Genepharm Pty Ltd
3/10 Inglewood Place
Baulkham Hills NSW 2153
Tel: 1800 678 302

This leaflet was prepared in December 2007.

Australian Register Number

TAMOXEN® 20 tamoxifen citrate 20 mg tablets: AUST R 145982

Tamoxen CMI V0.3 March 2008                                  7

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