NOLVADEX D

Active substance: TAMOXIFEN CITRATE

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THE FOLLOWING IS DUMMY TEXT
REPRESENTING NON-MARKETED PACKS.
FOR REGULATORY SUBMISSION
PURPOSES ONLY

UK/PIL/Nolvadex D/ONC 13 0012 (based on ONC 13 0005) 2 Apr 2013 MH

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Nolvadex® D tablets
tamoxifen

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.
In this leaflet:
1. What Nolvadex D is and what it is used for
2. Before you take Nolvadex D
3. How to take Nolvadex D
4. Possible side effects
5. How to store Nolvadex D
6. Further information

1.

What Nolvadex D is and what it is used for

Nolvadex D 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’. Nolvadex D works by
blocking the effects of oestrogen.



2.

Nolvadex D 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.

Before you take Nolvadex D

Do not take Nolvadex D if:
• You are allergic (hypersensitive) to tamoxifen or any of the other ingredients of Nolvadex
D (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 Nolvadex D if any of the above apply to you. If you are not sure, talk to your
doctor or pharmacist before taking Nolvadex D.

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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) Nolvadex 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 Nolvadex D 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 Nolvadex D can affect the way some medicines work and some medicines can
have an effect on Nolvadex D.
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 ‘anticoagulants’.
• 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 Nolvadex D if you are pregnant. This is because it may affect your unborn
baby.
• Do not become pregnant while taking Nolvadex D. Ask your doctor for advice on what
contraceptive to use – Nolvadex D affects how well some contraceptives work.
• If you are taking Nolvadex D and you think you have become pregnant, tell your doctor
straight away.
Breast-feeding
Talk to your doctor before taking Nolvadex D if you are breast-feeding.
Driving and using machines
Nolvadex D 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.
Important information about some of the ingredients of Nolvadex D

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Nolvadex D 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 medicine.
Nolvadex D 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 D

Always take Nolvadex D 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 20 mg tablet daily.
Infertility
The dose for infertility depends on your periods (menstrual cycle).
• If you are having regular periods, the usual 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 D
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 D than you should
If you take more Nolvadex D than you should, talk to a doctor or pharmacist straight away.
If you forget to take Nolvadex D
• 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, Nolvadex D can cause side effects, although not everybody gets them.
Stop taking Nolvadex D 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:

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• 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 Nolvadex D.
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.
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Some people with breast cancer get increased amounts of calcium in their blood after
starting Nolvadex D. 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.
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.

5.






6.

How to store Nolvadex D
Check the expiry date on the carton and don’t use the medicine after that date.
Keep your medicine in a safe place where children cannot see it or reach it. Your medicine
could harm them.
Keep your medicine below 30oC.
Keep your tablets in the container they came in (away from strong light).
If your doctor decides to stop your treatment, return any leftover tablets to your pharmacist.
Only keep them if the doctor tells you to.

Further information

What Nolvadex D tablets contain
The active substance is tamoxifen. Each Nolvadex D tablet contains 20 mg of tamoxifen.
The other ingredients are croscarmellose sodium, gelatin, lactose, macrogol, magnesium
stearate, maize starch, methylhydroxypropylcellulose and titanium dioxide.
What Nolvadex D tablets look like and contents of the pack
Nolvadex D tablets are octagonal, white film-coated tablets. They are marked Nolvadex D on
one side. They are produced in packs of 30 and 250. The 30 and 250 tablet packs may not be
available.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation for Nolvadex D is held by AstraZeneca UK Ltd, 600 Capability
Green, Luton, LU1 3LU, UK.
Nolvadex D is manufactured by AstraZeneca UK Ltd, Silk Road Business Park, Macclesfield,
Cheshire, SK10 2NA, UK.

To listen to or request a copy of this leaflet in Braille, large print or audio please
call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the following information:
Product name
Reference number

Nolvadex D
17901/0034

This is a service provided by the Royal National Institute of Blind People.

UK/PIL/Nolvadex D/ONC 13 0012 (based on ONC 13 0005) 2 Apr 2013 MH

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Leaflet prepared: April 2013
© AstraZeneca 2013
Nolvadex is a trade mark of the AstraZeneca group of companies.
ONC 13 0012

UK/PIL/Nolvadex D/ONC 13 0012 (based on ONC 13 0005) 2 Apr 2013 MH

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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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