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TAMOXIFEN 20MG FILM-COATED TABLETS

Active substance(s): TAMOXIFEN CITRATE / TAMOXIFEN CITRATE

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Package leaflet: Information for the user
Tamoxifen 10mg, 20mg and 40mg Film-Coated Tablets
Tamoxifen Citrate

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Read all of this leaflet carefully before
you start using this medicine because it
contains important information for you.

- Keep this leaflet. You may need to read it
again.
- If you have any further questions, ask your
doctor or pharmacist.
- This medicine has been prescribed for you
only. Do not pass it on to others. It may
harm them, even if their signs of illness are
the same as yours.
- If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet. See section 4.
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.
What is in this leaflet:
1. What Tamoxifen Tablets are and what they
are used for
2. What you need to know before you take
Tamoxifen Tablets
3. How to take Tamoxifen Tablets
4. Possible side effects
5. How to store Tamoxifen Tablets
6. Contents of the pack and other information
1. What Tamoxifen Tablets are and
what they are used for

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Tamoxifen Tablets contain a medicine called
tamoxifen. This belongs to a group of
medicines called ‘anti-oestrogens’.
Oestrogen is a natural substance in your body
known as a ‘sex hormone’. Tamoxifen Tablets
work by blocking the effects of oestrogen.
Tamoxifen Tablets are used to treat breast
cancer.
They are also used to treat infertility in
women caused by a failure to produce and
release eggs (ovulate) properly.
2. What you need to know before you
take Tamoxifen Tablets
Do not take Tamoxifen Tablets:
• if you are allergic to tamoxifen or any of the
other ingredients of this medicine (listed in
section 6)
• if you are pregnant or think you might be
pregnant (see the section on ‘Pregnancy’
below)
• if you are taking anastrozole
• if you are taking any treatment for infertility
• if you have had blood clots in the past and
the doctor did not know what caused them
• if someone in your family has had blood
clots with the cause not known
• if your doctor has told you that you have
an illness which runs in the family that
increases the risk of blood clots.
Do not take Tamoxifen Tablets if any of the
above apply to you. If you are not sure, talk
to your doctor or pharmacist before taking
Tamoxifen Tablets.
Warnings and precautions
Talk to your doctor or pharmacist before
taking Tamoxifen Tablets.
In delayed breast reconstruction operation
(weeks to years after the primary breast
operation when your own tissue is moved to
shape a new breast) Tamoxifen Tablets may
increase the risk of the formation of blood
clots in the small vessels of the tissue flap
which may lead to complications.
Operations
If you are to undergo planned surgery, you
should tell your doctor or pharmacist as they
may wish to consider stopping your
treatment for a short period.

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Children
This medicine is not for use in children.
Other medicines and Tamoxifen Tablets
Tell your doctor or pharmacist if you are
taking, have recently taken or might take any
other medicines. This includes medicines
you buy without a prescription and herbal
medicines. This is because Tamoxifen
Tablets can affect the way some other
medicines work and some medicines can
have an effect on Tamoxifen Tablets.
In particular, you should tell your doctor or

pharmacist if you are taking any of the
following medicines:
• Antidepressants (e.g. paroxetine, fluoxetine).
• Bupropion (used as antidepressant or aid
to smoking cessation).
• Quinidine (for example used in the
treatment of cardiac arrhythmia).
• Cinacalcet (for treatment of disorders of
the parathyroid gland).
• Blood thinning medicines such as warfarin.
These are known as ‘anti-coagulants’.
• Rifampicin, which is used for tuberculosis
(TB).
• Medicines known as ‘aromatase inhibitors’
that are used to treat breast cancer. These
include anastrozole, letrozole and
exemestane.
Pregnancy and breast-feeding
Pregnancy
• Do not take Tamoxifen Tablets if you are
pregnant. This is because it may affect
your unborn baby.
• You should not become pregnant while
taking Tamoxifen Tablets. Please see your
doctor for advice on what contraceptive
precautions you should take, as some may
be affected by Tamoxifen Tablets.
• You should see your doctor immediately if
you think you may have become pregnant
after starting to take Tamoxifen Tablets.
Breast-feeding
Talk to your doctor before taking Tamoxifen
Tablets if you are breast-feeding.
Driving and using machines
Tamoxifen Tablets is not likely to affect your
ability to drive or use any tools or machines.
However, tiredness has been reported with
the use of Tamoxifen Tablets and caution
should be observed when driving or operating
machinery while such symptoms persist.
Tamoxifen Tablets contain lactose
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
Always take this medicine exactly as your
doctor has told you. Check with your doctor
or pharmacist if you are not sure.
Breast cancer
The recommended dose for breast cancer is
20mg daily.
Infertility
The dose for infertility depends on your
periods (menstrual cycle).
If you are having regular periods, the
recommended dose is one 20mg tablet daily
on the 2nd, 3rd, 4th and 5th days of your
period.
If this does not work, your doctor may
suggest that you take a higher dose of
Tamoxifen Tablets during your next period. If
this happens, the recommended dose is
40mg or 80mg daily on the 2nd, 3rd, 4th
and 5th days of your period.
If you are not having regular periods, you can
start taking the tablets on any day of the month.
If you take more Tamoxifen Tablets than
you should
If you take more Tamoxifen Tablets than you
should, talk to a doctor or pharmacist
straight away.
If you forget to take Tamoxifen Tablets
If you forget to take a dose, take another as
soon as you remember. However, if it is nearly
time for the next dose skip the missed dose.
Do not take a double dose (two doses at the
same time) to make up for a forgotten dose.
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.
If you have any further questions on the use
of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause
side effects, although not everybody gets
them.
Stop taking Tamoxifen Tablets and tell
your doctor straight away if you notice
any of the following side effects – you
may need urgent medical treatment:
• A severe rash with blisters or peeling of the
skin and possibly blisters in the mouth and
nose (Stevens-Johnson syndrome)
• Severe skin disorder. The symptoms
include redness, blistering and peeling

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Tamoxifen 10mg, 20mg, 40mg - 30 Tabs
Wockhardt UK
FP1567; FP1569; FP1791; FP2195; FP2468
Daman (Kadaiya)
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Tamoxifen_Leaflet_103505-7.ai
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20th & 26th July, 2016
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- 1ST AUG. 2016
- 27TH JAN. 2017
- 30TH JAN. 2017
- 16TH MARCH 2017
- 17TH MARCH 2017

CHANGE CONTROL : Version changes due to change in:
Size/Layout
Regulatory
Non-Regulatory
Changes in detail: • New Regulatory text • Updated Wockhardt logo
• Strength blocks size changed to run to the margins only

Very rare: may affect up to 1 in 10,000

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6. Contents of the pack and other
information

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Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines
you no longer use. These measures will help
protect the environment.

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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.

What Tamoxifen Tablets contain
The active substance is Tamoxifen Citrate.

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

Tamoxifen 10mg
Film-Coated Tablets

Reference number

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

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What Tamoxifen Tablets look like and
contents of the pack
Tamoxifen 10mg Film-Coated Tablets are
white, circular, film-coated tablets marked
TAM10 on one face and CP on the reverse.
Tamoxifen 20mg Film-Coated Tablets are
white, circular, film-coated tablets marked
TAM20 on one face and CP on the reverse.
Tamoxifen 40mg Film-Coated Tablets are
white, circular, film-coated tablets marked
TAM40 on one face and CP on the reverse.

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

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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.

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Rare: may affect up to 1 in 1,000 people
• Changes to the cornea of your eye
• Problems with the nerve that connects
your retina to your brain
• Swelling of the optic nerve
• On occasions more severe liver diseases
have occurred from which some patients
have died. These liver diseases include
inflammation of the liver, liver cirrhosis, liver
cell damage, reduced bile formation, and
failure of the liver. Symptoms may include
a general feeling of being unwell, with or
without jaundice (yellowing of the skin and
eyes)
• Damage to blood vessels causing red or
purple dots in the skin
• Cells normally only found in the lining of
the womb found elsewhere in your body,
cysts on the ovaries, and cancer (the signs
of this are given above)
• Non-cancerous mass in the inner lining of
the vagina (called vaginal polyp).

Do not use this medicine if you notice visible
signs of deterioration such as discoloration.

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Uncommon: may affect up to 1 in 100
people
• Changes to your vision and difficulty seeing
• Swelling of the pancreas. This may cause
moderate to severe pain in the stomach
• Changes in the amount of calcium in your
blood. The signs may include feeling very
sick, being sick a lot or being thirsty. Tell
your doctor if this happens because he
or she may want you to have blood tests
• Inflammation of the lungs. The symptoms
may be like pneumonia (such as feeling
short of breath and coughing)
• Liver cirrhosis (problems with your liver).

Keep out of the sight and reach of
children.
Do not use this medicine after the expiry
date which is stated on the carton and foil.
The expiry date refers to the last day of that
month.

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Common: may affect up to 1 in 10 people
• Anaemia (a blood problem which means
you have too few red blood cells)
• Changes in vision due to cataracts or
changes to the retina of your eye
• Increased amounts of fats in your blood
(shown by blood tests)
• Allergic reactions
• Leg cramp
• Changes in the womb (including changes
to its lining and benign growths)
• Headache
• Feeling light-headed
• Itching of the genitals
• Thinning of the hair
• Vomiting
• Diarrhoea
• Constipation
• Changes in blood tests of liver function
• Formation of fatty liver cells
• Muscle pain
• Sensory changes (including taste disorder
and numbness or tingling in the skin)
• Increased risk of blood clots (including
clots in small vessels).

5. How to store Tamoxifen Tablets

29831/0194

Tamoxifen 20mg
Film-Coated Tablets

29831/0195

Tamoxifen 40mg
Film-Coated Tablets

29831/0196

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Other possible side effects:
Very common: may affect more than 1 in
10 people
• Nausea
• Fluid retention
• Skin rash
• Hot flushes
• Tiredness.

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

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These effects may mean that there have
been changes to the lining of your womb
(the endometrium). Sometimes these effects
are serious and could include cancer. They
can happen during or after treatment with
Tamoxifen Tablets.

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

This is a service provided by the Royal
National Institute of Blind People.
This leaflet was last revised in 03/2017

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Tell your doctor straight away if you
notice any of the following:
• Unusual bleeding from your vagina.
• Irregular periods.
• Vaginal discharge.
• A feeling of discomfort in the lower tummy
(pelvis) such as pain or pressure.

people
• Inflammation of the skin characterized by
rash or erythema, very often on areas
exposed to light
(a condition
called
cutaneous lupus
erythematosus)
• A skin condition
characterised by
skin blisters in
areas exposed
to the light, this
is due to the
increased liver production of a special
group of cell pigments (called porphyrins)
• Radiation recall - skin rash involving
redness, swelling, and/or blistering (like
severe sunburn) of the skin after receiving
radiation therapy.

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• Severe blood problems. This can make
you bruise more easily, get serious
infections, or feel very tired or breathless.
• Erythema multiforme, a skin reaction which
has symptoms such as: itchy reddish
purple patches on the skin, especially on
the palms of the hands and soles of the
feet, ‘hive-like’ raised swollen areas on the
skin, tender areas on the surfaces of the
mouth, eyes and private parts. You may
have a high temperature (fever) and feel
very tired.
• Symptoms of a blood clot. These include
swelling of the calf or leg, chest pain, being
short of breath or suddenly feeling weak.
• Symptoms of a stroke. These include
sudden onset of the following: weakness
or paralysis of the arms or legs, being
unable to move the arms or legs, sudden
difficulty with speaking, walking, difficulty in
holding things or difficulty in thinking.
These symptoms are caused by a reduced
blood supply in the brain.
• Difficulty in breathing.
• Swelling of the face, lips, tongue or throat
which may make it difficult to swallow.
• Swelling of the hands, feet or ankles.
• Nettle rash (also called ‘hives’ or ‘urticaria’).

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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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