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TAMOXIFEN 10MG FILM-COATED TABLETS

Active substance: TAMOXIFEN CITRATE

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

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PACKAGE LEAFLET: INFORMATION FOR THE USER

• 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

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1. WHAT TAMOXIFEN TABLETS ARE
AND WHAT THEY ARE USED FOR
The active ingredient in Tamoxifen Tablets is
tamoxifen citrate, which belongs to a group
of medicines called anti-oestrogens.
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.
2. BEFORE YOU TAKE TAMOXIFEN
TABLETS
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 are also having
anticancer chemotherapy.
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.

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

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Tamoxifen 10mg, 20mg, 40mg - 30 Tabs
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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

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 pack 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.

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

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

29831/0195

Tamoxifen 40mg
Film-Coated Tablets

29831/0196

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29831/0194

Tamoxifen 20mg
Film-Coated Tablets

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Marketing Authorisation Holder:
Wockhardt UK Ltd, Ash Road North,
Wrexham, LL13 9UF, UK.
Manufacturer: CP Pharmaceuticals Ltd,
Ash Road North, Wrexham, LL13 9UF, UK.

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Tamoxifen Tablets are available in blister strip
packs of 30 tablets.

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Tamoxifen 40mg Film-Coated Tablets are
white, circular, filmcoated tablets marked
TAM40 on one face and CP on the reverse.

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Tamoxifen 20mg Film-Coated Tablets are
white, circular, filmcoated tablets marked
TAM20 on one face and CP on the reverse.

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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.

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Other ingredients are lactose, maize starch,
pregelatinised maize starch, magnesium
stearate, methylhydroxypropylcellulose,
propylene glycol, Opaspray white (E171 and
E464).

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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)

Tamoxifen 40mg Film-Coated Tablets
contain 60.8mg of tamoxifen citrate
equivalent to 40mg tamoxifen.

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If you experience any of the symptoms
in bold above, you should contact your
doctor immediately.

Tamoxifen 20mg Film-Coated Tablets
contain 30.4mg of tamoxifen citrate
equivalent to 20mg tamoxifen.

This is a service provided by the Royal
National Institute of Blind People.
This leaflet was last revised in 02/2015.

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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.

Tamoxifen 10mg Film-Coated Tablets
contain 15.2mg of tamoxifen citrate
equivalent to 10mg tamoxifen.

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• Unusual vaginal bleeding, vaginal
discharge, itching around the vagina
or pain in your lower stomach

What Tamoxifen Tablets contain
The active ingredient in Tamoxifen Tablets is
Tamoxifen Citrate.

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6. FURTHER INFORMATION

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.

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• 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

Store in the original container or package in
order to protect from light and moisture. Do
not transfer the tablets to another container.

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Do not store above 25°C.

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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).

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4. POSSIBLE SIDE EFFECTS

By reporting side effects you can help
provide more information on the safety of
this medicine.

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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.

Reporting of
side effects
If you get any side
effects, talk to
your doctor,
pharmacist or
nurse. This
includes any
possible side
effects not listed in
this leaflet. You can also report side effects
directly via the yellow card scheme at
www.mhra.gov.uk/yellowcard

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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.

leaflet, please contact your doctor or
pharmacist immediately.

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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.

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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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