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TAMOXIFEN 40MG TABLETS

Active substance(s): TAMOXIFEN CITRATE / TAMOXIFEN CITRATE / TAMOXIFEN CITRATE

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EBNUK837a LEA TAMOXIFEN 10mg, 20mg and 40mg TAB TUK

ZINC Ref:

Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
323 mm
160 mm
N/A
N/A

Version:

1

19 May 2017
PANTONE® GREEN C

Colours Used:

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PAGE 1: FRONT FACE (INSIDE OF REEL)

Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines, even those you have bought without
Package leaflet:
prescription. In particular, you should inform your
Information for the patient
doctor if you are taking:
• Paroxetine, fluoxetine (e.g. antidepressants)
Read all of this leaflet carefully before you start
• Bupropion (antidepressants or aid to smoking
taking this medicine because it contains
cessation)
important information for you.
• Keep this leaflet. You may need to read it again. • Quinidine (for example used in the treatment of
cardiac arrythmia)
• If you have any further questions, ask your
• Cinacalcet (for treatment of disorders of the
doctor or pharmacist.
parathyroid gland)
• This medicine has been prescribed for you only.
• any anti-coagulants (used to treat and prevent
Do not pass it on to others. It may harm them,
abnormal blood clotting) e.g. warfarin
even if their signs of illness are the same as
• any cytotoxic drugs (used to kill cancer cells)
yours.
• If you get any side effects, talk to your doctor or • Rifampicin (used to treat tuberculosis).
pharmacist. This includes any possible side
Pregnancy and breast-feeding
effects not listed in this leaflet. See section 4.
You should not take Tamoxifen if you are pregnant
or breast-feeding.
What is in this leaflet
1. What Tamoxifen is and what it is used for
2. What you need to know before you take
Tamoxifen
3. How to take Tamoxifen
4. Possible side effects
5. How to store Tamoxifen
6. Contents of the pack and other information

1

What Tamoxifen is and what it is used
for

If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
taking this medicine. You should use an effective
method of non-hormonal contraception such as
the barrier method (e.g. the diaphragm or
condoms) whilst being treated with Tamoxifen
and for 2 months after treatment has stopped.

Pharma code 630 (001110111)
First bar is 105mm from the top edge of the leaflet.

Driving and using machines
Tamoxifen is not known to affect your ability to
• The name of your medicine is Tamoxifen Tablets drive or operate machinery.
and they belong to a group of drugs called
How to take Tamoxifen
anti-oestrogens.
• Tamoxifen is used to treat:
Always take this medicine exactly as your doctor
• breast cancer
has told you. Check with your doctor or
• certain forms of infertility.
pharmacist if you are not sure.

3

2

What you need to know before you
take Tamoxifen

Do NOT take Tamoxifen:
• if you are allergic to tamoxifen citrate or any of
the other ingredients of this medicine (listed in
section 6)
• if you are to be treated for infertility and you or
your family have a history of blood clots or a
known inherited condition leading to an
increased risk of clotting
• if you are pregnant or planning to become
pregnant
• if you are taking a medicine called ‘anastrozole’
(used to treat breast cancer, see section 2
Taking other medicines).

Before commencing any treatment, pregnancy
must be excluded by having a pregnancy test if
there is any chance that you could be pregnant.
The tablets should be swallowed preferably with
a glass of water.
The recommended dose is:

Adults and the elderly
• For the treatment of breast cancer
20 mg a day. Your doctor will assess whether this
dose is appropriate for you.
• For the treatment of infertility, if you have
regular periods
10 mg twice a day or 20 mg once a day on days 2,
3, 4 and 5 of the menstrual cycle (the first day of
bleeding is counted as day 1 of the cycle). If the
Warnings and precautions
initial course of treatment is unsuccessful it may be
Talk to your doctor or pharmacist before taking
repeated, with higher doses if necessary, up to a
Tamoxifen:
• if you have or any member of your family has a maximum of 80 mg daily in single or divided doses.
• If you do not have regular periods
history of blood clots, symptoms of which
10 mg twice a day or 20 mg once a day for four
include pain or swelling in the calf of one leg
days. This initial course of treatment may begin
and/or sudden breathlessness. If you
on any day.
experience these symptoms while taking
If you do not menstruate after the initial course of
Tamoxifen, you should speak to your doctor
treatment, your doctor may give you a further
immediately
course with increased dosage starting 45 days
• if you are severely overweight, if you are
later. If you do menstruate after the initial course
elderly, following surgery or if you are
of treatment, the next course should start on day
immobile as there is an increased chance of a
2 of that menstrual cycle.
blood clot forming
• if you are being treated for breast cancer and
If you take more Tamoxifen than you should
are also receiving chemotherapy, as your
If you (or someone else) swallow a lot of the
doctor may also prescribe an anticoagulant to
tablets all together, or if you think a child has
prevent blood clots
swallowed any of the tablets, contact your nearest
• if you are taking any of the following drugs
hospital casualty department or your doctor
paroxetine, fluoxetine (e.g. antidepressants),
immediately. Please take this leaflet, any
bupropion (antidepressant or aid to smoking
remaining tablets and the container with you to
cessation), quinidine (used in the treatment of
the hospital or doctor so that they know which
cardiac arrhythmia) and cincalet/cinacalcet (for tablets were consumed.
treatment of disorders of the parathryroid
If you forget to take Tamoxifen
gland. Co-administration should be avoided
If you forget to take a tablet, take one as soon as
because a reduction of the effect of Tamoxifen
you remember, unless it is nearly time to take the
cannot be excluded.
next one. Do not take a double dose to make up
• if you have experienced abnormal vaginal
for a forgotten dose.
bleeding including menstrual irregularities,
vaginal discharge, and pelvic pain or pressure
while taking Tamoxifen in the past.
If you experience any of these symptoms when
taking Tamoxifen you should speak to your
doctor immediately.

If you stop taking Tamoxifen
Do not stop taking your medicine without talking
to your doctor first even if you feel better.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

Possible side effects
If you need to have a liver function test whilst you
are taking these tablets, make sure you have told
Like all medicines, this medicine can cause side
the doctor that you are taking Tamoxifen, as it can
effects, although not everybody gets them.
affect the results of this test.
If the following happens, stop taking the tablets
Other medicines and Tamoxifen
and tell your doctor immediately or go to the
Please do not take anastrozole (used to treat
casualty department at your nearest hospital:
breast cancer) while you are taking this medicine. • an allergic reaction (swelling of the lips, face or
neck leading to severe difficulty in breathing;
skin rash or hives)

4

REG0170182

Version 2.2

Approved

Page 1 of 3

Top of page cut-off to middle of registration mark: 44 mm.

TAMOXIFEN 10 mg, 20 mg
AND 40 mg TABLETS

ZINC Ref:

EBNUK837a LEA TAMOXIFEN 10mg, 20mg and 40mg TAB TUK
Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
323 mm
160 mm
N/A
N/A

Version:

1

19 May 2017
PANTONE® GREEN C

Colours Used:

BLACK
CUTTER

PAGE 2: REAR FACE (OUTSIDE OF REEL)

• blistering/bleeding of the lips, eyes, nose and
genitals (Stevens-Johnson syndrome).
These are very serious but rare side effects. You
may need urgent medical attention or
hospitalisation.



You should speak to your doctor if you notice any
of the following side effects as these are all
symptoms of a blood clot. You may need urgent
medical treatment:



• The symptoms of a blood clot include pain and
swelling of the calf or leg, chest pain, being
short of breath or suddenly feeling weak.



Stop taking Tamoxifen and tell your doctor straight
away if you notice any of the following side
effects – you may need urgent medical treatment:
• Symptoms of a stroke. These include sudden
onset of the following: weakness of the arms or
legs, being unable to move the arms or legs,
difficulty speaking, walking, or holding things,
or difficulty thinking. These symptoms are
caused by a reduced blood supply in the brain.

being unwell, with or without jaundice
(yellowing of the skin and eyes).
Damage to blood vessels causing red or purple
dots in the skin.
Severe skin disorder. The symptoms include
redness, blistering and peeling.
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).



Very rare: may affect up to 1 in 10,000 people
• 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).

Not known: frequency cannot be estimated from
the available data
• Gastro-intestinal intolerance
• Bone pain
• Inflammation of the skin characterized by rash
or erythema, very often on areas exposed to
You should speak to your doctor or nurse at once
light (a condition called cutaneous lupus
if you notice any of the following gynaecological
erythematosus).
symptoms:
• Abnormal vaginal bleeding including menstrual • Recall phenomenon (an acute inflammatory
reaction confined to areas previously treated
irregularities
with radiotherapy).
• Vaginal discharge
• A feeling of discomfort in the lower tummy
Do not be concerned by this list of possible side
(pelvis) such as pain or pressure.
effects. You may not get any of them.
These effects may mean that there have been
Reporting of side effects
changes to the lining of your womb (the
If you get any side effects, talk to your doctor or
endometrium). Sometimes these effects are
pharmacist. This includes any possible side effects
serious and could include cancer of the
not listed in this leaflet. You can also report side
endometrium/uterus. They can happen during
effects directly via the Yellow Card Scheme at:
or after treatment with Tamoxifen.
www.mhra.gov.uk/yellowcard
Other side effects:
By reporting side effects you can help provide
more information on the safety of this medicine.
Very common: may affect more than 1 in 10
people
How to store Tamoxifen
• Nausea.
• Fluid retention.
Keep this medicine out of the sight and reach of
• Skin rash.
children.
• Hot flushes.
DO NOT store above 25°C, and keep the tablets in
the original bottle or carton supplied. Do not
Common: may affect up to 1 in 10 people
transfer them to another container.
• Anaemia (a blood problem which means you
Do not use this medicine after the expiry date that
have too few red blood cells).
is stated on the carton. The expiry date refers to
• Changes in vision due to cataracts or changes
the last day of that month.
to the retina of your eye.
• Increased amounts of fats in your blood (shown Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
by blood tests).
throw away medicines you no longer use. These
• Leg cramp.
• Changes in the womb (including changes to its measures will help to protect the environment.

5












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.

Uncommon: may affect up to 1 in 100 people
• Blood problems. This can make you bruise
more easily, get serious infections, or feel very
tired or breathless.
• 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).
Rare: may affect up to 1 in 1,000 people
• Severe blood problems. This can make you
bruise more easily, get serious infections, or
feel very tired or breathless.
• 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

REG0170182

Version 2.2

6

Contents of the pack and other
information

What Tamoxifen tablets contain:
• The active ingredient is either 15.2 mg of
Tamoxifen citrate which is equivalent to 10 mg
of tamoxifen, 30.4 mg of Tamoxifen citrate
which is equivalent to 20 mg of tamoxifen or
60.8 mg of Tamoxifen citrate which is equivalent
to 40 mg of tamoxifen.
• The other ingredients are mannitol (E421),
povidone (E1201), sodium starch glycolate,
colloidal silicon dioxide (E551), magnesium
stearate (E572), hypromellose (E464),
polyethylene glycol and the colour, titanium
dioxide (E171).
What Tamoxifen tablets look like and contents of
the pack:
• Tamoxifen 10 mg Tablet: Round biconvex white
coated tablets 7 mm diameter with one face
blank, the reverse face marked '10' above score
line and 'T' below.
• Tamoxifen 20 mg Tablet: Round biconvex white
coated tablets 9.5 mm diameter with one face
blank, the reverse face marked '20' above score
line and 'T' below.
• Round biconvex white coated tablets 11.1 mm
diameter with one face blank, the reverse face
marked '40' above the score line and 'T' below.
• The tablets are available in packs of 30 and 250
tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder and company
responsible for manufacture: TEVA UK Limited,
Eastbourne, BN22 9AG.
This leaflet was last revised in May 2017
PL 00289/0477-0479

Approved

EBNUK837a
40348-C
160 x 323

Page 2 of 3

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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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