UK Edition. Click here for US version.
TAMOXIFEN 10MG TABLETS
Active substance(s): TAMOXIFEN CITRATE
PAGE 1: FRONT FACE (INSIDE OF REEL)
medicines, even those you have bought without
prescription. In particular, you should inform your
doctor if you are taking:
• Paroxetine, fluoxetine (e.g. antidepressants)
Information for the patient
• Bupropion (antidepressants or aid to smoking
Read all of this leaflet carefully before you start
• Quinidine (for example used in the treatment of
taking this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it again. • Cinacalcet (for treatment of disorders of the
• If you have any further questions, ask your
• any anti-coagulants (used to treat and prevent
doctor or pharmacist.
abnormal blood clotting) e.g. warfarin
• This medicine has been prescribed for you only.
• any cytotoxic drugs (used to kill cancer cells)
Do not pass it on to others. It may harm them,
• Rifampicin (used to treat tuberculosis).
even if their signs of illness are the same as
Pregnancy and breast-feeding
• If you get any side effects, talk to your doctor or You should not take Tamoxifen if you are pregnant
pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
If you are pregnant or breast-feeding, think you
What is in this leaflet
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
1. What Tamoxifen is and what it is used for
taking this medicine. You should use an effective
2. What you need to know before you take
method of non-hormonal contraception such as
the barrier method (e.g. the diaphragm or
3. How to take Tamoxifen
condoms) whilst being treated with Tamoxifen
4. Possible side effects
and for 2 months after treatment has stopped.
5. How to store Tamoxifen
6. Contents of the pack and other information
Driving and using machines Tamoxifen is not
What Tamoxifen is and what it is used known to affect your ability to drive or operate
machinery. However, Tamoxifen can cause
problems with your ability to see and caution
• The name of your medicine is Tamoxifen Tablets should be observed while driving or operating
and they belong to a group of drugs called
machinery while you have such symptoms.
• Tamoxifen is used to treat:
How to take Tamoxifen
• breast cancer
Always take this medicine exactly as your doctor
• certain forms of infertility.
has told you. Check with your doctor or
What you need to know before you
pharmacist if you are not sure.
Before commencing any treatment, pregnancy
Do NOT take Tamoxifen:
must be excluded by having a pregnancy test if
• if you are allergic to tamoxifen citrate or any of there is any chance that you could be pregnant.
the other ingredients of this medicine (listed in The tablets should be swallowed preferably with
a glass of water.
• if you are to be treated for infertility and you or
The recommended dose is:
your family have a history of blood clots or a
Adults and the elderly
known inherited condition leading to an
• For the treatment of breast cancer
increased risk of clotting
20 mg a day. Your doctor will assess whether this
• if you are pregnant or planning to become
dose is appropriate for you.
• if you are taking a medicine called ‘anastrozole’ • For the treatment of infertility, if you have
(used to treat breast cancer, see section 2
10 mg twice a day or 20 mg once a day on days 2,
Taking other medicines).
3, 4 and 5 of the menstrual cycle (the first day of
Warnings and precautions
bleeding is counted as day 1 of the cycle). If the
Talk to your doctor or pharmacist before taking
initial course of treatment is unsuccessful it may be
repeated, with higher doses if necessary, up to a
• if you have or any member of your family has a
maximum of 80 mg daily in single or divided doses.
history of blood clots, symptoms of which
• If you do not have regular periods
include pain or swelling in the calf of one leg
10 mg twice a day or 20 mg once a day for four
and/or sudden breathlessness. If you
days. This initial course of treatment may begin
experience these symptoms while taking
on any day.
Tamoxifen, you should speak to your doctor
If you do not menstruate after the initial course of
treatment, your doctor may give you a further
• if you are severely overweight, if you are
course with increased dosage starting 45 days
elderly, following surgery or if you are
later. If you do menstruate after the initial course
immobile as there is an increased chance of a
of treatment, the next course should start on day
blood clot forming
2 of that menstrual cycle.
• 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
cardiac arrhythmia) and cincalet/cinacalcet (for the hospital or doctor so that they know which
tablets were consumed.
treatment of disorders of the parathryroid
gland. Co-administration should be avoided
If you forget to take Tamoxifen
because a reduction of the effect of Tamoxifen
If you forget to take a tablet, take one as soon as
cannot be excluded.
you remember, unless it is nearly time to take the
• if you have experienced abnormal vaginal
next one. Do not take a double dose to make up
bleeding including menstrual irregularities,
for a forgotten dose.
vaginal discharge, and pelvic pain or pressure
If you stop taking Tamoxifen
while taking Tamoxifen in the past.
Do not stop taking your medicine without talking
If you experience any of these symptoms when to your doctor first even if you feel better.
taking Tamoxifen you should speak to your
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.
If you need to have a liver function test whilst you
Possible side effects
are taking these tablets, make sure you have told
the doctor that you are taking Tamoxifen, as it can Like all medicines, this medicine can cause side
affect the results of this test.
effects, although not everybody gets them.
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
breast cancer) while you are taking this medicine. casualty department at your nearest hospital:
• an allergic reaction (swelling of the lips, face or
Tell your doctor or pharmacist if you are taking,
neck leading to severe difficulty in breathing;
have recently taken or might take any other
skin rash or hives)
Pharma code 672 (010100001)
First bar is 105mm from the top edge of the leaflet.
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Top of page cut-off to middle of registration mark: 44 mm.
TAMOXIFEN 10 mg, 20 mg
AND 40 mg TABLETS
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
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
• 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.
You should speak to your doctor or nurse at once
if you notice any of the following gynaecological
• Abnormal vaginal bleeding including menstrual
• Vaginal discharge
• A feeling of discomfort in the lower tummy
(pelvis) such as pain or pressure.
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 of the
endometrium/uterus. They can happen during
or after treatment with Tamoxifen.
Other side effects:
Very common: may affect more than 1 in 10
• Fluid retention.
• Skin rash.
• Hot flushes.
• Vaginal bleeding. Vaginal discharge.
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).
• Leg cramp.
• Changes in the womb (including changes to its
lining and benign growths).
• Feeling light-headed.
• Itching of the genitals.
• Thinning of the hair.
• 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
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
• 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
light (a condition called cutaneous lupus
• Recall phenomenon (an acute inflammatory
reaction confined to areas previously treated
Do not be concerned by this list of possible side
effects. You may not get any of them.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. 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 or search for MHRA
Yellow Card in the Google Play or Apple App
By reporting side effects you can help provide
more information on the safety of this medicine.
How to store Tamoxifen
Keep this medicine out of the sight and reach of
DO NOT store above 25°C, and keep the tablets in
the original bottle or carton supplied. Do not
transfer them to another container.
Do not use this medicine after the expiry date that
is stated on the carton. The expiry date refers to
the last day of that month.
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 to protect the environment.
Contents of the pack and other
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
What Tamoxifen tablets look like and contents of
• 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
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 November 2017
160 x 323
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THIS IS A REPRESENTATION OF AN ELECTRONIC RECORD THAT WAS SIGNED ELECTRONICALLY AND THIS
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE
Teva Pharmaceuticals Europe B.V
Meaning of Signature
Regulatory Affairs Approval
06-Dec-2017 02:08:08 PM
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