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TAMOXIFEN 10MG TABLETS

Active substance(s): TAMOXIFEN CITRATE

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TEVA UK Ref:

Version:

231-30-62929-W LEA TAMOXIFEN A/S TAB 30 TUK
TAMOXIFEN 10 mg, 20 mg
AND 40 mg TABLETS
PACKAGE LEAFLET:
INFORMATION FOR THE USER
Read all of this leaflet carefully before you start
taking this medicine.
• 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. Do
not pass it on to others. It may harm them, even
if their symptoms 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.
IN THIS LEAFLET:
1. What Tamoxifen is and what it is used for
2. Before you take Tamoxifen
3. How to take Tamoxifen
4. Possible side effects
5. How to store Tamoxifen
6. Further information

1

WHAT TAMOXIFEN IS AND WHAT IT IS
USED FOR

2

BEFORE YOU TAKE TAMOXIFEN

Do NOT take Tamoxifen if you:
• are allergic (hypersensitive) to tamoxifen citrate
or any of the other ingredients of this medicine
• 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
• are pregnant or planning to become pregnant
• are taking a medicine called ‘anastrazole’ (used
to treat breast cancer, see section 2 Taking other
medicines).
Take special care with Tamoxifen
Talk to your doctor before you start to take this
medicine if you:
• have or any member of your family has a history
of blood clots, symptoms of which include pain
or swelling in the calf of one leg and/or sudden
breathlessness. If you experience these
symptoms while taking Tamoxifen, you should
speak to your doctor immediately
• are severely overweight, if you are elderly,
following surgery or if you are immobile as there
is an increased chance of a blood clot forming
• are being treated for breast cancer and are also
receiving chemotherapy, as your doctor may also
prescribe an anticoagulant to prevent blood clots
• 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 (antidepressant or aid to smoking
cessation), quinidine (for example used in the
treatment of cardiac arrhythmia) and
cincalet/cinacalcet (for treatment of disorders of
the parathryroid gland
• have experienced abnormal vaginal 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 need to have a liver function test whilst you
are taking these tablets, make sure you have told
the doctor that you are taking Tamoxifen, as it can
affect the results of this test.
Taking other medicines
Please do not take anastrazole (used to treat breast
cancer) while you are taking this medicine.
Please inform your doctor if you are taking, or have
recently taken any other medicines, even those you
have bought without prescription. In particular, you
should inform your doctor if you are taking:
• Paroxetine, fluoxetine (e.g. antidepressants)

REG0068635

Version 3.6

12 June 2015

• Bupropion (antidepressants or aid to smoking
cessation)
• Quinidine (for example used in the treatment of
cardiac arrythmia)
• Cinacalcet (for treatment of disorders of the
parathyroid gland)
• any anti-coagulants (used to treat and prevent
abnormal blood clotting) e.g. warfarin
• any cytotoxic drugs (used to kill cancer cells)
• Rifampicin (used to treat tuberculosis).
Pregnancy and breast-feeding
You should not take Tamoxifen if you are pregnant
or are planning to become pregnant. 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. Ask your doctor for
advice if you are not sure.
Breast-feeding is not recommended whilst taking
Tamoxifen.
Driving and using machines
Tamoxifen is not known to affect your ability to
drive or operate machinery.

3

• The name of your medicine is Tamoxifen Tablets
and they belong to a group of drugs called
anti-oestrogens.
• Tamoxifen is used to treat:
• breast cancer
• certain forms of infertility.

4

HOW TO TAKE TAMOXIFEN

Always take Tamoxifen exactly as your doctor has
told you. You should check with your doctor or
pharmacist if you are not sure.
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 usual 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 initial course of treatment is unsuccessful it
may be repeated, with higher doses if necessary,
up to a maximum of 80 mg daily in single or
divided doses.
• If you do not have regular periods
10 mg twice a day or 20 mg once a day for four
days. This initial course of treatment may begin
on any day.
If you do not menstruate after the initial course
of treatment, your doctor may give you a further
course with increased dosage starting 45 days
later. If you do menstruate after the initial course
of treatment, the next course should start on day
2 of that menstrual cycle.
If you take more Tamoxifen than you should
If you (or someone else) swallow a lot of the tablets
all together, or if you think a child has swallowed
any of the tablets, contact your nearest hospital
casualty department or your doctor immediately.
Please take this leaflet, any remaining tablets and
the container with you to the hospital or doctor so
that they know which tablets were consumed.
If you forget to take Tamoxifen
If you forget to take a tablet, take one as soon as
you remember, unless it is nearly time to take the
next one. Do not take a double dose to make up for
a forgotten dose.
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
product, ask your doctor or pharmacist.

4

POSSIBLE SIDE EFFECTS

Like all medicines, Tamoxifen can cause side
effects, although not everybody gets them.
If the following happens, stop taking the tablets
and tell your doctor immediately or go to the
casualty department at your nearest hospital:
• an allergic reaction (swelling of the lips, face or
neck leading to severe difficulty in breathing; skin
rash or hives)
• blistering/bleeding of the lips, eyes, nose and
genitals (Stevens-Johnson syndrome).

Approved

Page 1 of 3

TEVA UK Ref:

Version:

231-30-62929-W LEA TAMOXIFEN A/S TAB 30 TUK
These are very serious but rare side effects. You may
need urgent medical attention or hospitalisation.
These side effects may occur with certain
frequencies, which are defined as follows:
Very common: affects more than 1 user in 10.
Common: affects 1 to 10 users in 100.
Uncommon: affects 1 to 10 users in 1,000.
Rare: affects 1 to 10 users in 10,000.
Very rare: affects less than 1 user in 10,000.
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.
You should speak to your doctor or nurse at once if
you notice any of the following gynaecological
symptoms:
• Abnormal vaginal bleeding including menstrual
irregularities
• 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 possible side effects:
Very common (affects more than 1 user in 10)
• Nausea.
• Fluid retention.
• Skin rash.
• Hot flushes.
Common (affects 1 to 10 users in 100)
• 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.
• Increased levels of fats in the blood.
Uncommon (affects 1 to 10 users in 1,000)
• 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 (affects 1 to 10 users in 10,000)
• 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

REG0068635

Version 3.6

4

12 June 2015

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).
• A severe rash with blisters or peeling of the skin
and possibly blisters in the mouth and nose
(Stevens-Johnson syndrome).
• 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 (affects less than 1 user in 10,000)
• 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).
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
By reporting side effects you can help provide
more information on the safety of this medicine.

5

HOW TO STORE TAMOXIFEN

Keep out of the reach and sight of children.
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 Tamoxifen after the expiry date that is
stated on the outer packaging. The expiry date
refers to the last day of that month.
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 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: June 2015
280 x 160
62929-W
PL 00289/0477-0479

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322K082070215

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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
1.3.2
mockup-pil-uk-pl-00289-0477-0478-0479-tamoxifen-10mg-20mg-40mg-tablet
s-62929

APPROVALS
Signed by
Kristina Mills

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Server Date
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Page 3 of 3

TEVA UK Ref:

Version:

231-30-40348-A LEA TAMOXIFEN 10mg & 20mg TAB TUK

1

09 July 2015

PAGE 1: FRONT FACE (INSIDE OF REEL)

PACKAGE LEAFLET:
INFORMATION FOR THE USER
Read all of this leaflet carefully before you start
taking this medicine.
• 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. Do
not pass it on to others. It may harm them,
even if their symptoms 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.
IN THIS LEAFLET:

• Quinidine (for example used in the treatment of
cardiac arrythmia)
• Cinacalcet (for treatment of disorders of the
parathyroid gland)
• any anti-coagulants (used to treat and prevent
abnormal blood clotting) e.g. warfarin
• any cytotoxic drugs (used to kill cancer cells)
• Rifampicin (used to treat tuberculosis).
Pregnancy and breast-feeding
You should not take Tamoxifen if you are pregnant
or are planning to become pregnant. 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. Ask your doctor for advice if you are not
sure.
Breast-feeding is not recommended whilst taking
Tamoxifen.

1. What Tamoxifen is and what it is used for
2. Before you take Tamoxifen
3. How to take Tamoxifen
4. Possible side effects
5. How to store Tamoxifen
6. Further information

Driving and using machines
Tamoxifen is not known to affect your ability to
drive or operate machinery.

3

Pharma code 188 (0111101)
First bar is 105mm from the top edge of the leaflet.

1

WHAT TAMOXIFEN IS AND WHAT IT IS
USED FOR

2

BEFORE YOU TAKE TAMOXIFEN

HOW TO TAKE TAMOXIFEN

Always take Tamoxifen exactly as your doctor has
told you. You should check with your doctor or
• The name of your medicine is Tamoxifen Tablets pharmacist if you are not sure.
and they belong to a group of drugs called
Before commencing any treatment, pregnancy
anti-oestrogens.
must be excluded by having a pregnancy test if
• Tamoxifen is used to treat:
there is any chance that you could be pregnant.
• breast cancer
The tablets should be swallowed preferably with
• certain forms of infertility.
a glass of water.
The usual dose is:
Adults and the elderly
• For the treatment of breast cancer
Do NOT take Tamoxifen if you:
20 mg a day. Your doctor will assess whether
• are allergic (hypersensitive) to tamoxifen citrate
this dose is appropriate for you.
or any of the other ingredients of this medicine
• For the treatment of infertility, if you have
• are to be treated for infertility and you or your
regular periods
family have a history of blood clots or a known
10 mg twice a day or 20 mg once a day on days
inherited condition leading to an increased risk
2, 3, 4 and 5 of the menstrual cycle (the first day
of clotting
of bleeding is counted as day 1 of the cycle).
• are pregnant or planning to become pregnant
If the initial course of treatment is unsuccessful
• are taking a medicine called ‘anastrazole’ (used
it may be repeated, with higher doses if
to treat breast cancer, see section 2 Taking
necessary, up to a maximum of 80 mg daily in
other medicines).
single or divided doses.
Take special care with Tamoxifen
• If you do not have regular periods
Talk to your doctor before you start to take this
10 mg twice a day or 20 mg once a day for four
medicine if you:
days. This initial course of treatment may begin
• have or any member of your family has a history
on any day.
of blood clots, symptoms of which include pain
If you do not menstruate after the initial course
or swelling in the calf of one leg and/or sudden
of treatment, your doctor may give you a
breathlessness. If you experience these
further course with increased dosage starting
symptoms while taking Tamoxifen, you should
45 days later. If you do menstruate after the
speak to your doctor immediately
initial course of treatment, the next course
• are severely overweight, if you are elderly,
should start on day 2 of that menstrual cycle.
following surgery or if you are immobile as there
If you take more Tamoxifen than you should
is an increased chance of a blood clot forming
• are being treated for breast cancer and are also If you (or someone else) swallow a lot of the
receiving chemotherapy, as your doctor may also tablets all together, or if you think a child has
prescribe an anticoagulant to prevent blood clots swallowed any of the tablets, contact your nearest
hospital casualty department or your doctor
• co-administration with the following drugs
immediately. Please take this leaflet, any
should be avoided because a reduction of the
remaining tablets and the container with you to
effect of Tamoxifen cannot be excluded:
the hospital or doctor so that they know which
paroxetine, fluoxetine (e.g. antidepressants),
tablets were consumed.
bupropion (antidepressant or aid to smoking
cessation), quinidine (for example used in the
If you forget to take Tamoxifen
treatment of cardiac arrhythmia) and
If you forget to take a tablet, take one as soon as
cincalet/cinacalcet (for treatment of disorders of you remember, unless it is nearly time to take the
the parathryroid gland
next one. Do not take a double dose to make up
• have experienced abnormal vaginal bleeding
for a forgotten dose.
including menstrual irregularities, vaginal
If you stop taking Tamoxifen
discharge, and pelvic pain or pressure while
Do not stop taking your medicine without talking
taking Tamoxifen in the past.
If you experience any of these symptoms when to your doctor first even if you feel better.
If you have any further questions on the use of
taking Tamoxifen you should speak to your
this product, ask your doctor or pharmacist.
doctor immediately.
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, Tamoxifen can cause side
affect the results of this test.
effects, although not everybody gets them.
Taking other medicines
If the following happens, stop taking the tablets
Please do not take anastrazole (used to treat
and tell your doctor immediately or go to the
breast cancer) while you are taking this medicine. casualty department at your nearest hospital:
• an allergic reaction (swelling of the lips, face or
Please inform your doctor if you are taking, or
neck leading to severe difficulty in breathing;
have recently taken any other medicines, even
skin rash or hives)
those you have bought without prescription. In

blistering/bleeding of the lips, eyes, nose and
particular, you should inform your doctor if you
genitals (Stevens-Johnson syndrome).
are taking:
These
are very serious but rare side effects. You
• Paroxetine, fluoxetine (e.g. antidepressants)
may need urgent medical attention or
• Bupropion (antidepressants or aid to smoking
hospitalisation.
cessation)

4

REG0170182

Version 0.3

Approved

Page 1 of 4

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

TAMOXIFEN 10 mg, 20 mg
AND 40 mg TABLETS

TEVA UK Ref:

Version:

231-30-40348-A LEA TAMOXIFEN 10mg & 20mg TAB TUK

1

PAGE 2: REAR FACE (OUTSIDE OF REEL)

These side effects may occur with certain
frequencies, which are defined as follows:
Very common: affects more than 1 user in 10.
Common: affects 1 to 10 users in 100.
Uncommon: affects 1 to 10 users in 1,000.
Rare: affects 1 to 10 users in 10,000.
Very rare: affects less than 1 user in 10,000.
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.
You should speak to your doctor or nurse at once
if you notice any of the following gynaecological
symptoms:
• Abnormal vaginal bleeding including menstrual
irregularities
• 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 possible side effects:
Very common (affects more than 1 user in 10)
• Nausea.
• Fluid retention.
• Skin rash.
• Hot flushes.








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).
A severe rash with blisters or peeling of the
skin and possibly blisters in the mouth and
nose (Stevens-Johnson syndrome).
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 (affects less than 1 user in 10,000)
• 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).
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
By reporting side effects you can help provide
more information on the safety of this medicine.

5

HOW TO STORE TAMOXIFEN

Keep out of the reach and sight of children.
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 Tamoxifen after the expiry date that is
Common (affects 1 to 10 users in 100)
stated on the outer packaging. The expiry date
• Anaemia (a blood problem which means you
refers to the last day of that month.
have too few red blood cells).
Medicines should not be disposed of via
• Changes in vision due to cataracts or changes
wastewater or household waste. Ask your
to the retina of your eye.
• Increased amounts of fats in your blood (shown pharmacist how to dispose of medicines no
longer required. These measures will help to
by blood tests).
protect the environment.
• Allergic reactions.
• Leg cramp.
FURTHER INFORMATION
• Changes in the womb (including changes to its
lining and benign growths).
What
Tamoxifen
tablets contain:
• Headache.
• The active ingredient is either 15.2 mg of
• Feeling light-headed.
Tamoxifen citrate which is equivalent to 10 mg
• Itching of the genitals.
of tamoxifen, 30.4 mg of Tamoxifen citrate
• Thinning of the hair.
which is equivalent to 20 mg of tamoxifen or
• Vomiting.
60.8 mg of Tamoxifen citrate which is equivalent
• Diarrhoea.
to 40 mg of tamoxifen.
• Constipation.

The other ingredients are mannitol (E421),
• Changes in blood tests of liver function.
povidone (E1201), sodium starch glycolate,
• Formation of fatty liver cells.
colloidal silicon dioxide (E551), magnesium
• Muscle pain.
stearate (E572), hypromellose (E464),
• Increased levels of fats in the blood.
polyethylene glycol and the colour, titanium
Uncommon (affects 1 to 10 users in 1,000)
dioxide (E171).
• Blood problems. This can make you bruise
more easily, get serious infections, or feel very What Tamoxifen tablets look like and contents of
the pack:
tired or breathless.
• Tamoxifen 10 mg Tablet: Round biconvex white
• Changes to your vision and difficulty seeing.
coated tablets 7 mm diameter with one face
• Swelling of the pancreas. This may cause
blank, the reverse face marked '10' above score
moderate to severe pain in the stomach.
line and 'T' below.
• Changes in the amount of calcium in your
• Tamoxifen 20 mg Tablet: Round biconvex white
blood. The signs may include feeling very sick,
coated tablets 9.5 mm diameter with one face
being sick a lot or being thirsty. Tell your doctor
blank, the reverse face marked '20' above score
if this happens because he or she may want
line and 'T' below.
you to have blood tests.
• Inflammation of the lungs. The symptoms may • Round biconvex white coated tablets 11.1 mm
diameter with one face blank, the reverse face
be like pneumonia (such as feeling short of
marked '40' above the score line and 'T' below.
breath and coughing).
• The tablets are available in packs of 30 and 250
• Liver cirrhosis (problems with your liver).
tablets. Not all pack sizes may be marketed.
Rare (affects 1 to 10 users in 10,000)
Marketing Authorisation Holder and Manufacturer
• Severe blood problems. This can make you
Marketing Authorisation holder and company
bruise more easily, get serious infections, or
responsible for manufacture: TEVA UK Limited,
feel very tired or breathless.
Eastbourne, BN22 9AG.
• Changes to the cornea of your eye.
• Problems with the nerve that connects your
This leaflet was last revised: June 2015.
retina to your brain.
PL 00289/0477-0479
• Swelling of the optic nerve.
• On occasions more severe liver diseases have
occurred from which some patients have died.
40348-A
These liver diseases include inflammation of

6

160 x 323

REG0170182

Version 0.3

Approved

Page 2 of 4

09 July 2015

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
40348-A.LEA_10-20MG_TAB_TUK-signed2

APPROVALS
Signed by
Arun Ramachandran

REG0170182

Meaning of Signature
Regulatory Affairs Approval

Version 0.3

Approved

Server Date
09-Sep-2015 03:59:36 PM

Page 3 of 4

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
40348-A.LEA_10-20MG_TAB_TUK-signed2

APPROVALS
Signed by
Arun Ramachandran

REG0170182

Meaning of Signature
Regulatory Affairs Approval

Version 0.3

Approved

Server Date
09-Sep-2015 03:59:36 PM

Page 4 of 4

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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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