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NOLVADEX 10MG

Active substance(s): TAMOXIFEN CITRATE POLYMORPH A

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Package leaflet: Information for the patient
Nolvadex®
tamoxifen
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 ‘anti-oestrogens’.
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 ‘anti-coagulants’
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



3.

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.

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 Website: 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 30oC. Store your tablets in the original package. Keep the blister
strip in the carton. This will protect your medicine from light and moisture.



6.

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.

Contents of the pack and other information

What Nolvadex Contains
The active substance is tamoxifen. Each tablet contains Tamoxifen Citrate Ph. Eur. 15.2 mg
equivalent to 10 mg tamoxifen.
The other ingredients are croscarmellose sodium, gelatin, lactose, macrogol, magnesium
stearate, maize starch, methylhydroxypropylcellulose and titanium dioxide.
What Nolvadex looks like and contents of the pack
Nolvadex 10 mg Tablets are white to off-white, round, biconvex, film-coated tablets, with
markings on one face and plain on the reverse.
They come in packs (blister strips or bottles) of 30 tablets or 250 tablets. Not all pack sizes may
be marketed.
Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation for Nolvadex is held by AstraZeneca UK Limited, 600
Capability Green, Luton, LU1 3LU, UK.
Nolvadex is manufactured by AstraZeneca UK Limited, 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
17901/0033

This is a service provided by the Royal National Institute of Blind People.
Leaflet updated: September 2015
© AstraZeneca 2015
Nolvadex is a trade mark of the AstraZeneca group of companies.
ONC 14 0052a

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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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