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TAMOXIFEN TABLETS BP 20MG

Active substance(s): TAMOXIFEN CITRATE

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Tamoxifen 20mg Tablets
• Please read this leaflet carefully before you start to take your medicine.
• It gives you important information about your medicine.
• If you want to know more, or you are not sure about anything, ask your
pharmacist or doctor.
• Keep the leaflet until you have finished the medicine.
WHAT'S IN YOUR MEDICINE
• Actavis supplies Tamoxifen Tablets in one strength.
• Each white film-coated tablet contains Tamoxifen Citrate equivalent to 20mg of
tamoxifen.
• The tablets also contain lactose, maize starch, magnesium stearate.
• The coating contains propylene glycol, titanium dioxide (E171),
methylhydroxypropylcellulose (E464).
• Pack size: 28s, 30s, 56s, 60s, 84s, 90s, 100s, 112s, 120s, 168s, 180s, 250s, 500s, 1000s
[*only the marketed pack size will appear on the final leaflet]
• Your tablets are made by Actavis, Barnstaple, EX32 8NS, UK who are also the
Marketing Authorisation holder.
ABOUT YOUR MEDICINE
Tamoxifen is one of a group of medicines called anti-oestrogens.
Tamoxifen Tablets may be used for:
• treatment of breast cancer
• some forms of female infertility.
BEFORE TAKING YOUR MEDICINE
Do not take Tamoxifen Tablets if you:
• have ever had an allergic reaction to Tamoxifen Tablets or any of the ingredients in
the tablet. An allergic reaction may include a rash, itching, difficulty breathing or
swelling of the face, lips, throat or tongue
• are pregnant or plan to become pregnant, tamoxifen must not be used in pregnancy.
If you think you are pregnant do not start treatment and see your doctor immediately
• or anyone in your family has had a blood clot.
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).
Check with your doctor or pharmacist before taking Tamoxifen Tablets if you:
• have been told by your doctor that you have an intolerance to some sugars, as this
medicine contains lactose
• are over weight
• are due to have an operation or be immobile for any length of time
• have been told you have porphyria (a genetic or inherited disorder of the red blood
pigment haemoglobin)
• are breastfeeding

Check with your doctor or pharmacist if you are taking any of the following:
• anticoagulants – medicines used to thin the blood such as warfarin
• rifampicin used in the treatment for tuberculosis
• chemotherapy medicines used to treat cancer
• medicines you can buy without prescription.
• Paroxetine, fluoxetine (e.g. antidepressants)
• Bupropion (antidepressants or aid to smoking cessation)
• Quinidine (for example used in the treatment of cardiac arrhythmia)
• Canicalcet (for treatment of disorders of the parathyroid gland)
Pregnancy and Breastfeeding:
Tamoxifen tablets must not be taken if you are pregnant or planning to become
pregnant. If you are breastfeeding check with your doctor or pharmacist before taking
Tamoxifen Tablets.
Driving and using machines:
Tamoxifen can in some individuals cause side effects that can affect the ability to drive
or operate machinery such as light-headedness and visual disturbances, make sure you
are not affected before driving or operating machinery.
Other precautions you should take:
If you see another doctor or go into hospital, let them know what medicines you are
taking.
TAKING YOUR MEDICINE
Follow your doctor’s instructions. Check the pharmacy label to see how many tablets to
take and how often to take them. If you are still unsure ask your pharmacist or doctor.
The usual dosage(s) are described below:
For Oral Use.
Breast-cancer
Adults
20mg to 40mg daily, either as a single dose or in divided doses
Infertility
20mg daily on days 2, 3, 4 and 5 of the cycle; if necessary the daily dose may be
increased to 40mg then 80mg for subsequent courses; if cycles are irregular, start initial
course on any day, with subsequent course starting 45 days later or on day 2 of cycle if
menstruation occurs.
Children
Not recommended for use in children



Swallow these tablets with water at the same times each day.
Take this medicine for as long as your doctor tells you to.

If you take more Tamoxifen Tablets than you should
If you (or someone else) swallow a lot of the tablets at the same time, or if you think a
child has swallowed any of the tablets, contact your nearest hospital casualty
department or your doctor immediately. If an overdose has been taken there may be
signs such as feeling or being sick, dizziness, tremor, exaggerated reflexes, lack of coordination, fits, abnormalities of heart rhythm.

If you forget to take Tamoxifen tablets
If you forget to take a tablet take one as soon as you remember, unless it is nearly time
to take the next one. Never take two doses together. Take the remaining doses at the
correct time.
AFTER TAKING YOUR MEDICINE
Like all medicines, Tamoxifen Tablets can sometimes cause unwanted side effects.
If the following happens, stop taking Tamoxifen Tablets and tell your doctor
immediately or contact the casualty department at your nearest hospital:
• An allergic reaction: skin rash, swelling of the face, lips, tongue or throat, or
difficulty breathing or swallowing.
This is a very serious but rare side effect. You may need urgent medical attention or
hospitalisation.
Stop taking tamoxifen if you develop the following symptoms as you may have a blood
clot, calf or leg swelling, chest pain, shortness of breath or sudden weakness.
Other Known side effects are:
Effects on the blood: changes in the numbers and types of blood cells. If you develop
bruising, sore throats, nosebleeds or infections tell you doctor who may wish to test your
blood.
Effects on metabolism: increased levels of fat in the blood sometimes with pancreatitis
(pain or tenderness in your upper abdomen). Increased levels of calcium in the blood,
(as seen in blood tests).
Effects on the nervous system: headache, light-headedness.
Effects on the eye: changes in vision or difficulty seeing properly as a result of cataracts
or changes to the cornea or retina.
Effects on the lungs: inflammation of the lungs (may appear as pneumonia, with the
same symptoms, such as breathlessness and cough).
Effects on the stomach: feeling sick, stomach upset.
Effects on the liver: changes in liver function which may cause liver disease such as
hepatitis or jaundice, (yellowing of the skin or eyes).
Effects on the skin: itching in the genital area, hair loss, skin rashes or itchy or peeling
skin.
Effects on the reproductive system: vaginal bleeding or discharge, ovarian cysts,
fibroids (non-cancerous growths in the womb), endometriosis (causes pain in the pelvis
or painful periods) or changes to the endometrium (lining of the womb) such as an
increase in the number of cells or polyps (growths), changes in periods. Tamoxifen has
been reported to increase the chance of cancer of the uterus (womb) in some women.
Others: hot flushes, fluid retention, increase in tumour size or pain.
Tell your doctor if you notice or are worried by any of the side effects listed or notice
any other effects not listed.
STORING YOUR MEDICINE
• Do not use the tablets after the end of the expiry month shown on the product
packaging.
• Store below 25°C in a dry place. Protect from light.
• Do not transfer them to another container.
• KEEP TAMOXIFEN TABLETS OUT OF THE REACH AND SIGHT OF CHILDREN IN A
SECURE PLACE.




REMEMBER that this medicine is for YOU only. NEVER give it to anyone else. It may
harm them, even if their symptoms are the same as yours.
Return all unused medicines to your pharmacist for safe disposal.

Date of last revision: December 2010
If you would like a leaflet with larger text, please contact 01271 311257.

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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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