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NOLVADEX D

Active substance(s): TAMOXIFEN CITRATE

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Blood: Some side effects are only seen when a blood test is taken such as a decrease
in the number of certain types of blood cells. This can make you bruise more easily, get
serious infections, or feel very tired or breathless. There is an increased risk of blood
clots (including clots in small vessels).
Liver: Liver problems, such as jaundice. This causes yellowing of the skin and the
whites of the eyes. Changes in blood tests of liver function. 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, formation of fatty liver
cells, 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).
Other:
Fluid retention.
Increased amounts of fats in your blood (shown by blood tests), sometimes with pain or
tenderness in your upper abdomen (pancreatitis).
Tiredness.
People with breast cancer
At the beginning of treatment for breast cancer, the symptoms of breast cancer
can sometimes get worse. For example, there may be an increase in pain or an
increase in the size of the affected area.
Some people with breast cancer get increased amounts of calcium in their blood
after starting Tamoxifen. If this happens, you may feel very sick, be sick (vomit) a
lot, or be very thirsty. Tell your doctor if this happens because he or she may
want you to have blood tests.
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, 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
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tamoxifen
Do not take your tablets after the expiry date which is stated on the carton and blister label
after ‘Exp’. The expiry date refers to the last day of that month
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not store above 30°C. Store in original pack in order to protect from light. Remember if
your doctor tells you to stop taking this medicine, return any unused tablets to your
pharmacist for safe disposal. Only keep this medicine if your doctor tells you to.
If your tablets become discoloured or show any signs of deterioration, seek the advice of your
pharmacist.

6.Further information
Each film-coated tablet contains 20mg of the active ingredient tamoxifen (as the citrate).
Your medicine also contains the following inactive ingredients: lactose monohydrate,
maize starch, gelatin, croscarmellose sodium type A, magnesium stearate, hypromellose
2910, macrogol 300 and titanium dioxide (E171).
The Tamoxifen are white, octagonal tablets with ‘Nolvadex-D’ imprinted on one side and
plain on the other side and contain 20mg of tamoxifen (as the citrate).
Tamoxifen are produced in packs of 30 tablets.
Manufactured by: AstraZeneca UK Limited, UK.
Procured from within the EU and repackaged by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex HA4 0NU, UK.
Tamoxifen 20mg tablets PL 18799/0776
POM
Leaflet date: 15.02.2016

PACKAGE LEAFLET: INFORMATION FOR THE USER

Tamoxifen 20mg tablets
(tamoxifen citrate)
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 any of the side effects get serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
The name of your medicine is Tamoxifen 20mg tablets but it will be referred to as
Tamoxifen throughout the remainder of this leaflet.
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
Tamoxifen contains 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
works by blocking the effects of oestrogen.
Tamoxifen is used to treat breast cancer.
It is also used to treat infertility in women caused by a failure to produce and release
eggs (ovulate) properly.

2.Before you take Tamoxifen
Do not take Tamoxifen if:
You are allergic (hypersensitive) to tamoxifen or any of the other ingredients of
Tamoxifen (listed in Section 6: Further information).
You have had blood clots in the past and the doctor did not know what caused
them.
Someone in your family has had blood clots with the cause not known.
Your doctor has told you that you have an illness which runs in the family that
increases the risk of blood clots.
You are pregnant (see the section on ‘Pregnancy’ below).
Do not take Tamoxifen if any of the above apply to you. If you are not sure, talk to
your doctor or pharmacist before taking Tamoxifen.
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 (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 parathyroid gland).
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 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 going to have an operation (including planned surgery), tell your doctor or
pharmacist. They may suggest that you stop taking Tamoxifen for a short time.
Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have recently taken, any other
medicines. This includes medicines that you buy without a prescription and herbal
medicines. This is because Tamoxifen can affect the way some medicines work and some
medicines can have an effect on Tamoxifen.
In particular, you should inform your doctor or pharmacist if you are taking any of the
following medicines:
Medicines such as warfarin that are used to thin your blood. These are known as
‘anti-coagulants’.
Rifampicin which is used for tuberculosis (TB).
Anastrozole which is used to treat breast cancer.
Paroxetine, fluoxetine (e.g. antidepressants).
Bupropion (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).
Pregnancy
Do not take Tamoxifen if you are pregnant. This is because it may affect your unborn
baby.
Do not become pregnant while taking Tamoxifen. Ask your doctor for advice on what
contraceptive to use – Tamoxifen affects how well some contraceptives work.
If you are taking Tamoxifen and you think you have become pregnant, tell your
doctor straight away.
Breast-feeding
Talk to your doctor before taking Tamoxifen if you are breast-feeding.
Driving and using machines
Tamoxifen 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 and caution should be observed
when driving or operating machinery while such symptoms persist.
Important information about some of the ingredients of Tamoxifen
Tamoxifen contain lactose, which is a type of sugar. If you have been told by your
doctor that you cannot tolerate or digest some sugars (have an intolerance to some
sugars), talk to your doctor before taking this medicine.
Tamoxifen contain titanium dioxide. This may cause a problem in a small number of
people who are sensitive to this ingredient.

3.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.
Breast cancer
The usual dose for breast cancer is one 20mg tablet daily.
Infertility
The dose for infertility depends on your periods (menstrual cycle).
If you are having regular periods, the usual 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 during your next period. If this happens, the usual 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 than you should
If you take more Tamoxifen than you should, talk to a doctor or pharmacist straight
away.
If you forget to take Tamoxifen
If you forget to take a dose, take it 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.
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.
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 blood clot. These include swelling of the calf or leg, chest pain,
being short of breath or suddenly feeling weak.
Sudden onset of weakness or paralysis of the arms or legs, sudden difficulty with
speaking, walking, difficulty in holding things or difficulty in thinking, any of which
may occur because the blood supply in the blood vessels of the brain is reduced.
These symptoms could be signs of a stroke.
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’).
Tell your doctor straight away if you notice any of the following:
Unusual bleeding from your vagina.
Irregular periods.
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. They can
happen during or after treatment with Tamoxifen.
Other possible side effects:
Stomach and gut: Upset stomach or gut (including nausea, vomiting, diarrhoea and
constipation).
Nervous system: Headaches, feeling light-headed. Sensory changes (including taste
disorder and numbness or tingling in the skin).
Reproductive system: Itching of the genitals, bleeding or discharge from the vagina,
ovarian cysts, fibroids in the womb, non-cancerous mass in the inner lining of the vagina
(called vaginal polyp).
Skin and hair: ‘Hot flushes’, skin rashes, itching or peeling skin, thinning of the hair,
inflammation of the skin characterised 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)
Musculoskeletal: Leg cramps, pain in muscles.
Lungs: Inflammation of the lungs. The symptoms may be like pneumonia (such as
feeling short of breath and coughing).
Eyes: Changes to your vision and difficulty seeing. This may be caused by cataracts or
changes to the cornea or retina of your eye. Optic nerve disease including in a small
number of cases, blindness.

Blood: Some side effects are only seen when a blood test is taken such as a decrease
in the number of certain types of blood cells. This can make you bruise more easily, get
serious infections, or feel very tired or breathless. There is an increased risk of blood
clots (including clots in small vessels).
Liver: Liver problems, such as jaundice. This causes yellowing of the skin and the
whites of the eyes. Changes in blood tests of liver function. 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, formation of fatty liver
cells, 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).
Other:
Fluid retention.
Increased amounts of fats in your blood (shown by blood tests), sometimes with pain or
tenderness in your upper abdomen (pancreatitis).
Tiredness.
People with breast cancer
At the beginning of treatment for breast cancer, the symptoms of breast cancer
can sometimes get worse. For example, there may be an increase in pain or an
increase in the size of the affected area.
Some people with breast cancer get increased amounts of calcium in their blood
after starting Tamoxifen. If this happens, you may feel very sick, be sick (vomit) a
lot, or be very thirsty. Tell your doctor if this happens because he or she may
want you to have blood tests.
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, 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
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tamoxifen
Do not take your tablets after the expiry date which is stated on the carton and blister label
after ‘Exp’. The expiry date refers to the last day of that month
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not store above 30°C. Store in original pack in order to protect from light. Remember if
your doctor tells you to stop taking this medicine, return any unused tablets to your
pharmacist for safe disposal. Only keep this medicine if your doctor tells you to.
If your tablets become discoloured or show any signs of deterioration, seek the advice of your
pharmacist.

6.Further information
Each film-coated tablet contains 20mg of the active ingredient tamoxifen (as the citrate).
Your medicine also contains the following inactive ingredients: lactose monohydrate,
maize starch, gelatin, croscarmellose sodium type A, magnesium stearate, hypromellose
2910, macrogol 300 and titanium dioxide (E171).
The Tamoxifen are white, octagonal tablets with ‘Nolvadex-D’ imprinted on one side and
plain on the other side and contain 20mg of tamoxifen (as the citrate).
Tamoxifen are produced in packs of 30 tablets.
Manufactured by: AstraZeneca UK Limited, UK.
Procured from within the EU and repackaged by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex HA4 0NU, UK.
Tamoxifen 20mg tablets PL 18799/0776
POM
Leaflet date: 15.02.2016

PACKAGE LEAFLET: INFORMATION FOR THE USER

Tamoxifen 20mg tablets
(tamoxifen citrate)
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 any of the side effects get serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
The name of your medicine is Tamoxifen 20mg tablets but it will be referred to as
Tamoxifen throughout the remainder of this leaflet.
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
Tamoxifen contains 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
works by blocking the effects of oestrogen.
Tamoxifen is used to treat breast cancer.
It is also used to treat infertility in women caused by a failure to produce and release
eggs (ovulate) properly.

2.Before you take Tamoxifen
Do not take Tamoxifen if:
You are allergic (hypersensitive) to tamoxifen or any of the other ingredients of
Tamoxifen (listed in Section 6: Further information).
You have had blood clots in the past and the doctor did not know what caused
them.
Someone in your family has had blood clots with the cause not known.
Your doctor has told you that you have an illness which runs in the family that
increases the risk of blood clots.
You are pregnant (see the section on ‘Pregnancy’ below).
Do not take Tamoxifen if any of the above apply to you. If you are not sure, talk to
your doctor or pharmacist before taking Tamoxifen.
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 (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 parathyroid gland).
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 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 going to have an operation (including planned surgery), tell your doctor or
pharmacist. They may suggest that you stop taking Tamoxifen for a short time.
Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have recently taken, any other
medicines. This includes medicines that you buy without a prescription and herbal
medicines. This is because Tamoxifen can affect the way some medicines work and some
medicines can have an effect on Tamoxifen.
In particular, you should inform your doctor or pharmacist if you are taking any of the
following medicines:
Medicines such as warfarin that are used to thin your blood. These are known as
‘anti-coagulants’.
Rifampicin which is used for tuberculosis (TB).
Anastrozole which is used to treat breast cancer.
Paroxetine, fluoxetine (e.g. antidepressants).
Bupropion (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).
Pregnancy
Do not take Tamoxifen if you are pregnant. This is because it may affect your unborn
baby.
Do not become pregnant while taking Tamoxifen. Ask your doctor for advice on what
contraceptive to use – Tamoxifen affects how well some contraceptives work.
If you are taking Tamoxifen and you think you have become pregnant, tell your
doctor straight away.
Breast-feeding
Talk to your doctor before taking Tamoxifen if you are breast-feeding.
Driving and using machines
Tamoxifen 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 and caution should be observed
when driving or operating machinery while such symptoms persist.
Important information about some of the ingredients of Tamoxifen
Tamoxifen contain lactose, which is a type of sugar. If you have been told by your
doctor that you cannot tolerate or digest some sugars (have an intolerance to some
sugars), talk to your doctor before taking this medicine.
Tamoxifen contain titanium dioxide. This may cause a problem in a small number of
people who are sensitive to this ingredient.

3.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.
Breast cancer
The usual dose for breast cancer is one 20mg tablet daily.
Infertility
The dose for infertility depends on your periods (menstrual cycle).
If you are having regular periods, the usual 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 during your next period. If this happens, the usual 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 than you should
If you take more Tamoxifen than you should, talk to a doctor or pharmacist straight
away.
If you forget to take Tamoxifen
If you forget to take a dose, take it 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.
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.
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 blood clot. These include swelling of the calf or leg, chest pain,
being short of breath or suddenly feeling weak.
Sudden onset of weakness or paralysis of the arms or legs, sudden difficulty with
speaking, walking, difficulty in holding things or difficulty in thinking, any of which
may occur because the blood supply in the blood vessels of the brain is reduced.
These symptoms could be signs of a stroke.
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’).
Tell your doctor straight away if you notice any of the following:
Unusual bleeding from your vagina.
Irregular periods.
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. They can
happen during or after treatment with Tamoxifen.
Other possible side effects:
Stomach and gut: Upset stomach or gut (including nausea, vomiting, diarrhoea and
constipation).
Nervous system: Headaches, feeling light-headed. Sensory changes (including taste
disorder and numbness or tingling in the skin).
Reproductive system: Itching of the genitals, bleeding or discharge from the vagina,
ovarian cysts, fibroids in the womb, non-cancerous mass in the inner lining of the vagina
(called vaginal polyp).
Skin and hair: ‘Hot flushes’, skin rashes, itching or peeling skin, thinning of the hair,
inflammation of the skin characterised 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)
Musculoskeletal: Leg cramps, pain in muscles.
Lungs: Inflammation of the lungs. The symptoms may be like pneumonia (such as
feeling short of breath and coughing).
Eyes: Changes to your vision and difficulty seeing. This may be caused by cataracts or
changes to the cornea or retina of your eye. Optic nerve disease including in a small
number of cases, blindness.

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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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