TAMOXIFEN 10MG FILM-COATED TABLETS

Active substance: TAMOXIFEN CITRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

are also having anticancer chemotherapy.

Tamoxifen 10mg, 20mg and 40mg
Film-Coated Tablets
Tamoxifen Citrate

There are several other things which raise the risk of blood clots in
veins:
• If you or any of your family have had a blood clot in the veins or
lungs before.
• Being elderly or very overweight.
• If you are taking another chemotherapy agent other than
tamoxifen.
• Being off your feet because of major surgery, illness or injury.

Read all of this leaflet
carefully before you start
using this medicine.
- Keep this leaflet. You may
need to read it again.
- If you have further
questions, please ask your
doctor or pharmacist.
- This medicine has been
prescribed for you
personally and you should
not pass it on to others. It
may harm them, even if
their symptoms are the
same as yours.
The name of your medicine is Tamoxifen 10mg, 20mg or 40mg
Film-Coated Tablets. In the rest of this leaflet it is called Tamoxifen
Tablets.
In this leaflet:
1. What Tamoxifen Tablets are and what they are used for
2. Before you take Tamoxifen Tablets
3. How to take Tamoxifen Tablets
4. Possible side effects
5. How to store Tamoxifen Tablets
6. Further information

1. WHAT TAMOXIFEN TABLETS ARE AND WHAT
THEY ARE USED FOR

Talk to your doctor if any of these apply to you.If you are going to
have surgery, make sure your doctor knows about it as you may
need to stop taking tamoxifen six weeks before the operation to
reduce the risk of VTE.
Taking other medicines
Taking another medicine while you are taking Tamoxifen Tablets can
affect how it or the other medicine works.
Please inform your doctor or pharmacist if you are taking or have
recently taken any other medicines, including those you may have
bought yourself without a prescription.
Please check with your doctor if you are taking any of the following
(or any other medication):
• Anticoagulants (blood thinning agents) such as warfarin.
• Rifampicin, a drug used to treat tuberculosis.
• Mitomycin, also used to treat cancer.
• Paroxetine, fluoxetine (e.g. antidepressants)
• Bupropion (antidepressants or aid to smoking cessation)
• Quinidine (for example used in the treatment of cardiac
arrhythmia)
• Cinacalcet (for treatment of the parathyroid gland)
Periodic complete blood counts and liver function tests are
recommended during tamoxifen therapy.
If you have any doubts about whether you should take this medicine
then discuss matters with your doctor before taking it.

Tamoxifen Tablets are used in the treatment of breast cancer,
particularly those types which are made worse by oestrogen. They
are also used for the treatment of female infertility when no eggs are
produced.

Pregnancy and breast-feeding
You should not take Tamoxifen Tablets if you are pregnant or trying to
become pregnant since tamoxifen may affect your unborn child. If
you are pre-menopausal your doctor will examine you and carry out
a pregnancy test before you take Tamoxifen Tablets. In addition you
should use extra contraceptive precautions (e.g. condoms) whilst
taking Tamoxifen Tablets and for two months after stopping
treatment with Tamoxifen Tablets.

2. BEFORE YOU TAKE TAMOXIFEN TABLETS

Tamoxifen Tablets can make breast-feeding more difficult. You
should not breast-feed whilst taking Tamoxifen Tablets.

The active ingredient in Tamoxifen Tablets is tamoxifen citrate, which
belongs to a group of medicines called anti-oestrogens.

Do not take Tamoxifen Tablets if you:
• are allergic to tamoxifen or any of the other ingredients contained
in Tamoxifen Tablets (see list under heading ‘What Tamoxifen
Tablets contain’ in section 6)
• have porphyria
• are pregnant (if you are pre-menopausal you should be examined
by your doctor and have a pregnancy test before starting to take
Tamoxifen Tablets).
• are undergoing anastrozole therapy
• are being treated for infertility
• or a close relative have had blood clots in your veins or lungs or
have a known inherited condition leading to an increased risk of
clotting.
If any of the above statements apply to you, you should not take
Tamoxifen Tablets.
Take special care
Co-administration with the following drugs should be avoided
because a reduction of the effect of tamoxifen cannot be excluded:
paroxetine, fluoxetine (e.g. antidepressants), bupropion
(antidepressants or aid to smoking cessation), quinidine (for example
used in the treatment of cardiac arrhythmia), cincalet/cinacalcet (for
treatment of disorders of the parathyroid gland).
Special Warnings
Deep vein thrombosis (blood clots in veins)
The risk of blood clots in veins (also called deep vein thrombosis or
DVT) may be increased by taking tamoxifen. They are not usually
serious, but if a clot travels to the lungs (pulmonary embolism or PE),
it can cause breathlessness, chest pain, collapse or even be fatal.
Both DVT and PE are often described as examples of venous
thromboembolism (VTE). The risk of blood clots is increased if you

Driving and operating machines
Tamoxifen Tablets can cause reduced visual acuity and blurred
vision, if you are affected do not drive or operate machines.
Important information for patients who have an intolerance
to some sugars
If you have been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this medicinal
product, as it contains lactose.

3. HOW TO TAKE TAMOXIFEN TABLETS
Your doctor will decide the dose which is best for you. Always follow
your doctor’s instructions completely and also follow any special
instructions or warnings which appear on the label which the
pharmacist has put on the package. If you do not understand, or are
in any doubt, ask your doctor or pharmacist.
Unless instructed differently, take your tablets with a glass of water.
For the treatment of breast cancer
The usual dose for adults with breast cancer is 20mg daily. The
same dosage is used in the elderly.
For the treatment of infertility
The usual adult dose of tamoxifen for the treatment of infertility is
20mg daily given on the second, third, fourth and fifth days of the
monthly cycle. The first day of the monthly cycle is the first day of
bleeding. Your doctor may increase the dose to 40mg or 80mg if
further courses of treatment are thought necessary.
In women who do not have regular periods, Tamoxifen Tablets can be

started on any day. A further course of treatment may be given 45
days later or on the second day of your period if you start bleeding.
If you take more Tamoxifen Tablets than you should
If you accidentally take too many tablets contact your doctor or
pharmacist or nearest hospital casualty department. It is possible
that you may get ECG (heart trace) changes. Take this leaflet and any
remaining tablets with you to show the doctor or pharmacist.
If you miss a dose of Tamoxifen Tablets
If you forget to take a dose, take another as soon as you remember.
If it is almost time for your next dose, then do not take the missed
dose at all. Do not take a double dose to make up for a forgotten
tablet.
Stopping treatment with Tamoxifen Tablets
You should continue to take Tamoxifen Tablets for as long as your
doctor tells you to. Do not stop taking the medicine without talking to
your doctor first.

4. POSSIBLE SIDE EFFECTS
Like many medicines Tamoxifen Tablets may cause side effects in
some patients, although not everybody gets them.
You should contact your doctor IMMEDIATELY if you develop
any of the following:
• Painful swelling of your leg, sudden chest pain or difficulty
breathing
The risk of blood clots in veins (also called deep vein thrombosis or
DVT) may be increased by taking Tamoxifen Tablets. They usually
occur in the leg and are not usually serious, but if a clot travels to
the lungs (pulmonary embolism or PE), it can cause breathlessness,
chest pain, collapse or can even be fatal. Both DVT and PE are often
described as examples of venous thromboembolism (VTE).
• Signs of an allergic or sensitivity reaction e.g.:
 swelling of the face, lips, tongue or throat
 difficulty in breathing
 “hives” or nettle rash (known as urticaria)
 redness and blistering of the skin
• Unusual vaginal bleeding, vaginal discharge, itching
around the vagina or pain in your lower stomach
This may be a sign of changes in the lining of the womb (the
endometrium), including thickening of the lining, polyps and cancer
of the womb, particularly with higher doses or long term treatment.
If you experience any of the symptoms in bold above, you
should contact your doctor immediately.
Other side effects include:
• hot flushes
• weight gain
• leg cramps
• swelling due to water retention
• skin rash
• dry skin
• hair loss or thinning
• stomach upsets
• dizziness / light-headedness
• tiredness
• confusion
• depression
• headache
• hazy or blurred vision, very rarely blindness
• pain at the cancer site
• blood disorders which may cause fever or chills, sore throats,
mouth or throat ulcers, unusual tiredness or weakness, unusual
bleeding or unexplained bruises
• feeling sick or vomiting, loss of appetite, thirst, constipation or
weak muscles due to too much calcium in the blood
• inflammation of the lungs which may cause a dry cough, difficulty
in breathing, swelling of the ends of the fingers, bluish
discolouration of the skin and fever
• inflammation of the pancreas which may result in stomach pain
radiating to the back
• an increase in the level of liver enzymes or certain fats
(triglycerides) in the blood, or inflammation of the liver (which may
cause yellowing of the skin), non-alcoholic steatohepatiats
(reversible on withdrawal) and cirrhosis (this is associated with the
following risk factors: Being overweight or obese, insulin

resistance, diabetes, orhyperlipidaemia)
If your side effects are severe you may need to reduce the dose of
your Tamoxifen Tablets or it may be necessary to stop treatment.If
any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please contact your doctor or
pharmacist immediately.

5. HOW TO STORE
TAMOXIFEN
TABLETS
Keep out of the reach and
sight of children.
Do not take this medicine if
the expiry date on the label
has passed. The expiry date
refers to the least day of that
month.Tamoxifen Tablets should not be taken if they show signs of
deterioration such as discoloration.
Do not store above 25°C.
Store in the original container or package in order to protect from
light and moisture. Do not transfer the tablets to another container.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required.These measures will help to protect the environment.

6. FURTHER INFORMATION
What Tamoxifen Tablets contain
The active ingredient in Tamoxifen Tablets is Tamoxifen Citrate.
Tamoxifen 10mg Film-Coated Tablets contain 15.2mg of tamoxifen
citrate equivalent to 10mg tamoxifen.
Tamoxifen 20mg Film-Coated Tablets contain 30.4mg of tamoxifen
citrate equivalent to 20mg tamoxifen.
Tamoxifen 40mg Film-Coated Tablets contain 60.8mg of tamoxifen
citrate equivalent to 40mg tamoxifen.
Other ingredients are lactose, maize starch, pregelatinised maize
starch, magnesium stearate, methylhydroxypropylcellulose,
propylene glycol, Opaspray white (E171 and E464).
What Tamoxifen Tablets look like and contents of the pack
Tamoxifen 10mg Film-Coated Tablets are white, circular, filmcoated
tablets marked TAM10 on one face and CP on the reverse.
Tamoxifen 20mg Film-Coated Tablets are white, circular, filmcoated
tablets marked TAM20 on one face and CP on the reverse.
Tamoxifen 40mg Film-Coated Tablets are white, circular, filmcoated
tablets marked TAM40 on one face and CP on the reverse.
Tamoxifen Tablets are available in blister strip packs of 30 tablets.
Marketing Authorisation Holder: Wockhardt UK Ltd, Ash Road
North, Wrexham, LL13 9UF, UK.
Manufacturer: CP Pharmaceuticals Ltd, Ash Road North, Wrexham,
LL13 9UF, UK.
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or
audio please call, free of charge:
0800 198 5000 (UK Only)
Please be ready to give the following information:
Product name

Reference number

Tamoxifen 10mg Film-Coated Tablets

29831/0194

Tamoxifen 20mg Film-Coated Tablets

29831/0195

Tamoxifen 40mg Film-Coated Tablets

29831/0196

This is a service provided by the Royal National Institute of Blind
People.
Date of leaflet preparation: September 2011
103505/4
214480
DD/DRUGS/207

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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