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TAMOXIFEN 10 MG FILM COATED TABLETS

Active substance(s): TAMOXIFEN / TAMOXIFEN

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Nolvadex® 10 mg film coated tablets
(tamoxifen citrate)






The name of your medicine is Nolvadex 10 mg film coated tablets, but will
be referred to as Nolvadex throughout this leaflet.
Read all of this leaflet carefully before you start taking 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.
What is in this leaflet:
1. What Nolvadex is and what it is used for
2. What you need to know before you take Nolvadex
3. How to take Nolvadex
4. Possible side effects
5. How to store Nolvadex
6. Contents of the pack and other information

1. WHAT NOLVADEX IS AND WHAT IT IS USED FOR
The name of your medicine is Nolvadex. Nolvadex contains a medicine
called tamoxifen, which belongs to a group of medicines called ‘antioestrogens’.
Oestrogen is a natural substance in your body known as a ‘sex hormone’.
Nolvadex works by blocking the effects of oestrogen.
Nolvadex is used to treat breast cancer. It can also be used to treat
infertility caused by a failure to ovulate properly.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
NOLVADEX
Do not take Nolvadex:
 If you are pregnant or think you might be pregnant (see the section on
‘Pregnancy’ below).
 If you are allergic to tamoxifen or any of the other ingredients of this
medicine (listed in section 6).
 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 Nolvadex if any of the above apply to you. If you are not sure,
talk to your doctor or pharmacist before taking Nolvadex.
Warnings and precautions
In delayed breast reconstruction operation (weeks to years after the
primary breast operation when your own tissue is moved to shape a new
breast) Nolvadex may increase the risk of the formation of blood clots in
the small vessels of the tissue flap which may lead to complications.
Children
This medicine is not for use in children.
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.
Other medicines and Nolvadex
Tell your doctor or pharmacist if you are taking, have recently taken, or
might take any other medicines. This includes medicines that you buy
without a prescription and herbal medicines. This is because Nolvadex can
affect the way some other medicines work and some medicines can have
an effect on Nolvadex.
In particular, tell your doctor or pharmacist if you are taking any of the
following medicines:
 Antidepressants (e.g. paroxetine, fluoxetine).
 Bupropion (used as an antidepressant or aid to smoking cessation).
 Quinidine (for example used in the treatment of cardiac arrhythmia).

Cincalet/cinacalcet (for treatment of disorders of the parathyroid gland).
Blood thinning medicines such as warfarin. These are known as ‘anticoagulants’
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 Nolvadex if you are pregnant. This is because it may affect
your unborn baby.
You should not become pregnant when taking Nolvadex. Please see
your doctor for advice on what contraceptive precautions you should
take, as some may be affected by Nolvadex.
You should see your doctor immediately if you think you may have
become pregnant after starting to take Nolvadex.

Breast-feeding
Talk to your doctor before taking Nolvadex if you are breast-feeding.
Driving and using machines
Nolvadex is not likely to affect your ability to drive or use any tools or
machines. However, tiredness has been reported with the use of Nolvadex
and caution should be observed when driving or operating machinery while
such symptoms persist.
Nolvadex tablets contain lactose and titanium dioxide
 Nolvadex tablets 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 medicinal product.
 Nolvadex tablets contain titanium dioxide. This may cause a problem in
a small number of people who are sensitive to this ingredient.

3. HOW TO TAKE NOLVADEX
Always take Nolvadex 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 one 20 mg tablet daily.
Infertility
The dose for infertility depends on your periods (menstrual cycle).
 If you are having regular periods, the recommended dose is one 20 mg
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 Nolvadex during your next period. If this happens, the usual
dose is 40 mg or 80 mg 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 Nolvadex than you should
If you take more Nolvadex than you should, talk to a doctor or pharmacist
straight away.
If you forget to take Nolvadex
 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 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 Nolvadex 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.
 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 speaking, walking, or holding things, or
difficulty 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’).

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.
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 Nolvadex.
Other possible side effects:
Very common (may affect more than 1 in 10 people)
 Nausea.
 Fluid retention.
 Skin rash.
 Hot flushes.
 Tiredness.
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).
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).
 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 (may affect up to 1 in 10,000 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.
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 NOLVADEX






Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the
carton. The expiry date refers to the last day of that month.
Do not store above 30˚C. Store in the original package to protect from
light.
If your medicine becomes discoloured or shows any signs of
deterioration consult your pharmacist who will advise you what to do.
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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Nolvadex Contains
The active substance is tamoxifen. Each tablet contains 10mg tamoxifen
(as citrate).
The other ingredients are lactose monohydrate, maize starch, gelatin,
croscarmellose sodium, magnesium stearate, hypromellose, macrogol 300
and titanium dioxide.
What Nolvadex looks like and contents of the pack
Round shaped white film coated tablets with "Nolvadex 10" engraved on
one side of the tablet and plain on the reverse.
Available in blister packs containing 30 tablets.
Manufactured by AstraZeneca UK Ltd., Silk Road Business Park,
Macclesfield, Cheshire, SK10 2NA, United Kingdom or Corden Pharma
GmbH, Otto-Hahn-Strasse, 68723 Plankstadt, Germany and procured from
within the EU and repackaged in the UK by the Product Licence holder: CD
Pharma Ltd, Unit 3, Manor Point, Manor Way, Borehamwood, Herts WD6
1EE.
Nolvadex 10 mg film coated tablets
PL: 20492/0543
POM

Blind or partially sighted? Is this
leaflet hard to see or read?
Call 020 8236 3190 to obtain a leaflet
in a format suitable for you.
Nolvadex is a registered trademark.
Date of preparation: 14th February 2017

PACKAGE LEAFLET: INFORMATION FOR THE USER

Tamoxifen 10 mg film coated tablets
(tamoxifen citrate)
The name of your medicine is Tamoxifen 10 mg film coated tablets, but will
be referred to as Tamoxifen throughout this leaflet.







Quinidine (for example used in the treatment of cardiac arrhythmia).
Cincalet/cinacalcet (for treatment of disorders of the parathyroid gland).
Blood thinning medicines such as warfarin. These are known as ‘anticoagulants’
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.

Read all of this leaflet carefully before you start taking 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.

Pregnancy and breast-feeding
Pregnancy

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

Breast-feeding

1. WHAT TAMOXIFEN IS AND WHAT IT IS USED FOR
The name of your medicine is Tamoxifen. Tamoxifen contains a medicine
called tamoxifen, which belongs to a group of medicines called ‘antioestrogens’.
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 can also be used to treat
infertility caused by a failure to ovulate properly.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
TAMOXIFEN
Do not take Tamoxifen:
 If you are pregnant or think you might be pregnant (see the section on
‘Pregnancy’ below).
 If you are allergic to tamoxifen or any of the other ingredients of this
medicine (listed in section 6).
 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 if any of the above apply to you. If you are not sure,
talk to your doctor or pharmacist before taking Tamoxifen.
Warnings and precautions
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.
Children
This medicine is not for use in children.
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.
Other medicines and Tamoxifen
Tell your doctor or pharmacist if you are taking, have recently taken, or
might take any other medicines. This includes medicines that you buy
without a prescription and herbal medicines. This is because Tamoxifen
can affect the way some other medicines work and some medicines can
have an effect on Tamoxifen.
In particular, tell your doctor or pharmacist if you are taking any of the
following medicines:
 Antidepressants (e.g. paroxetine, fluoxetine).
 Bupropion (used as an antidepressant or aid to smoking cessation).





Do not take Tamoxifen if you are pregnant. This is because it may
affect your unborn baby.
You should not become pregnant when taking Tamoxifen. Please see
your doctor for advice on what contraceptive precautions you should
take, as some may be affected by Tamoxifen.
You should see your doctor immediately if you think you may have
become pregnant after starting to take Tamoxifen.

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.
Tamoxifen tablets contain lactose and titanium dioxide
 Tamoxifen tablets 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 medicinal product.
 Tamoxifen tablets 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. Check with
your doctor or pharmacist if you are not sure.
Breast cancer
The recommended dose for breast cancer is one 20 mg tablet daily.
Infertility
The dose for infertility depends on your periods (menstrual cycle).
 If you are having regular periods, the recommended dose is one 20 mg
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 40 mg or 80 mg 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 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 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.
 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 speaking, walking, or holding things, or
difficulty 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’).
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.
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:
Very common (may affect more than 1 in 10 people)
 Nausea.
 Fluid retention.
 Skin rash.
 Hot flushes.
 Tiredness.
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).
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).
 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 (may affect up to 1 in 10,000 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.
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 this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the
carton. The expiry date refers to the last day of that month.
Do not store above 30˚C. Store in the original package to protect from
light.
If your medicine becomes discoloured or shows any signs of
deterioration consult your pharmacist who will advise you what to do.
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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Tamoxifen Contains
The active substance is tamoxifen. Each tablet contains 10mg tamoxifen
(as citrate).
The other ingredients are lactose monohydrate, maize starch, gelatin,
croscarmellose sodium, magnesium stearate, hypromellose, macrogol 300
and titanium dioxide.
What Tamoxifen looks like and contents of the pack
Round shaped white film coated tablets with "Nolvadex 10" engraved on
one side of the tablet and plain on the reverse.
Available in blister packs containing 30 tablets.
Manufactured by AstraZeneca UK Ltd., Silk Road Business Park,
Macclesfield, Cheshire, SK10 2NA, United Kingdom or Corden Pharma
GmbH, Otto-Hahn-Strasse, 68723 Plankstadt, Germany and procured from
within the EU and repackaged in the UK by the Product Licence holder: CD
Pharma Ltd, Unit 3, Manor Point, Manor Way, Borehamwood, Herts WD6
1EE.
Tamoxifen 10 mg film coated tablets
PL: 20492/0543
POM

Blind or partially sighted? Is this
leaflet hard to see or read?
Call 020 8236 3190 to obtain a leaflet
in a format suitable for you.
Date of preparation: 14th February 2017

Expand Transcript

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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