Tamoxifen Tablets 10mg
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Tamoxifen Tablets 10mg and 40mg
(Tamoxifen Citrate BP)
Please 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 further questions, please ask your doctor or your pharmacist.
■ This medicine has been prescribed for you personally and you should 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 become serious or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
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In this leaflet: | |||
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What this medicine is and what it is used for |
4 |
Possible side effects |
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2 |
Before you take |
5 |
How to store |
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3 |
How to take |
6 |
Further information |
[1 What this medicine is and what it is used for
Tamoxifen belongs to a group of medicines called anti-oestrogens.
It is used to treat certain types of breast cancer and infertility in women, caused by the failure to produce eggs (ovulate).
[2 Before you take
Do not take if:
■ you are pregnant or think you might be pregnant (see 'Pregnancy and breast-feeding' section, column 2)
■ you are allergic to Tamoxifen or any of the other ingredients in these tablets (see information about lactose, column 2 or section 6)
■ you are being treated for infertility and you or your family have a history of blood clots in your veins or, you are known to have an inherited condition which increases the risk of clotting.
■ you are taking anastrozole, used to treat breast cancer
Take special care if:
■ you had vaginal bleeding, vaginal discharge, pelvic pain or pressure when taking Tamoxifen previously
■ you are at risk of developing blood clots due to the following:
- you or your family have a history of blood clots (breast cancer patients)
- you are receiving another chemotherapy agent in addition to Tamoxifen Tablets (breast cancer patients)
- you are overweight
- you are ageing
- you are to have surgery or will be immobile or inactive for a long time. (see ‘Surgery & immobility' section, column 2).
■ you are a child and have McCure Albright Syndrome (MAS). A genetic disease which affects the bones, skin and hormones
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).
If any of the above applies to you, please consult your doctor.
Taking other medicines
Please inform your doctor if you are taking or have recently taken any other medicines, even those obtained without prescription. Some medicines may affect the action or be affected by Tamoxifen In particular, you should tell the doctor if you are taking the following:
■ Paroxetine, fluoxetine (e.g. antidepressants)
■ Bupropion (antidepressants or aid to smoking cessation)
■ Quinidine (for example used in the treatment of cardiac arrhythmia)
■ Cinacalcet (for treatment of disorders of the parathyroid gland)
■ Medicines for thinning the blood (anticoagulants), such as warfarin (their effect may be increased)
■ Other medicines used to treat breast cancer, such as chemotherapy (increased risk of blood clotting) or anastrozole
■ Rifampicin, an antibiotic used to treat various infections (Tamoxifen levels may be reduced)
Surgery or long period of immobility
If you are going to have surgery or you will be immobile or inactive for a long time, make sure your doctor knows.
This is to reduce the risk of blood clots.
Patients being treated for infertility: you may need to stop taking Tamoxifen Tablets 6 weeks before an operation or long period of immobility.
Patients being treated for breast cancer: your doctor will tell you if you should stop or continue taking Tamoxifen Tablets.
Pregnancy and breast-feeding
Do not take Tamoxifen Tablets if you are pregnant or if you think you are pregnant.
You should try not to become pregnant if you are taking Tamoxifen Tablets for the treatment of breast cancer. Sexually active women should use non-hormonal contraception such as a condom or coil.
It is not advisable to breast-feed whilst taking Tamoxifen Tablets, as it is not known if Tamoxifen is present in breast milk.
Driving or using machines
Tamoxifen is unlikely to affect your ability to drive or operate machinery.
Lactose. Important information about the ingredient
This medicine contains lactose. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking the medicine.
0 How to take
You should always take this medicine as prescribed by your doctor. Do not take more than the doctor told you to. Read and follow the instructions on the pharmacist's label. If you are not sure about anything please ask your doctor or pharmacist.
■ Tamoxifen Tablets are for oral use only
■ Take your tablets with a glass of water
It is important that you keep taking Tamoxifen Tablets until the prescribed dose is finished.
Normal doses
The doses stated below and overleaf are guidelines only. You should always take this medicine as prescribed by your doctor. continued....
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Breast cancer
Adults & the elderly: The usual starting dose is 20mg. Pre-menopausal women may have less frequent periods whilst taking Tamoxifen Tablets.
Infertility
Women with regular periods: 20mg of Tamoxifen should be taken on the second, third, fourth and fifth day of the menstrual cycle.
If your initial course of treatment is unsuccessful, your doctor may increase your dose to either 40mg or 80mg daily.
Women with irregular periods: The initial course of 20mg may begin on any day. If there is no sign of bleeding, another course of treatment with Tamoxifen may begin after 45 days. The dosage may be increased up to 40mg and then 80mg daily.
However, if there is any bleeding, the next course should begin on the second day of the menstrual cycle.
If you forget to take Tamoxifen Tablets
Take them as soon as you remember. Do not take a double dose to make up for forgotten individual doses.
If you have taken more Tamoxifen Tablets than you should
Consult your doctor or the nearest hospital casualty department immediately. Take this leaflet or some tablets with you so that people will know what you have taken.
[4 Possible side effects
Like all medicines, Tamoxifen Tablets can cause side effects, although not everybody gets them.
If any of the side effects become serious, your doctor may reduce the dosage to less than 20mg a day, so that the disease is still under control but the side effects are reduced.
In the event that the side effects do not respond to the lower dosage, your doctor may decide to stop your treatment.
Please note: You should only stop taking this medicine if your doctor tells you to.
Contact your doctor immediately if you notice any of the
following:
Symptoms of a stroke, such as:
■ sudden weakness or paralysis of the arms or legs
■ sudden difficulty with speaking, difficulty in holding things or difficulty in thinking
Any of these symptoms may occur because the blood supply in the blood vessels of the brain is reduced.
Symptoms of changes to the lining of the womb, including thickening of the lining, growths (polyps) and cancer of the uterus, such as:
■ unusual vaginal bleeding
■ vaginal discharges,
■ feelings of pain or tightness around the lower stomach area
Symptoms of blood clots in the veins or lungs, such as:
■ Painful swelling in your leg
■ Sudden chest pain
■ Difficulty in breathing
If you have the symptoms above, your doctor may need to stop your Tamoxifen treatment.
The risk of developing blood clots in your veins is increased by taking Tamoxifen but they are not usually serious. However, if a clot travels to the lungs it can cause breathlessness, chest pain, collapse or even be fatal.
Symptoms which may indicate a serious allergic reaction, such as:
■ difficulty in breathing or dizziness
Common side effects
■ hot flushes
■ stomach upset, pain or discomfort or feeling bloated
■ headache
■ feeling light-headed
■ leg cramp
Occasional side effects
■ itching and inflammation around the genitals
■ fluid retention
■ loss of hair (alopecia)
■ swelling of the ovaries
Rare side effects
■ skin rashes, including skin eruptions and blistering of the skin, eyes and genitals (Stevens-Johnston syndrome)
■ poor vision
■ clouding of lens & blurred vision (cataracts)
■ inflammation of or damage to the optic nerve. In a small number of cases it may cause blindness
■ inflammation of the pancreas
■ worsening of tumour related symptoms
■ low white blood count
■ fall in blood platelet count
■ growths in the uterus
■ decrease in white blood cells known as neutrophils
■ severe liver problems such as fatty liver, blockage in the bile duct, inflammation of the liver
■ increase in blood fat levels known as triglycerides
Very rare side effects
■ inflammation of the air sacs in the lungs
■ confusion, loss of appetite, pains, aches and weakness due to high blood calcium levels
If any of the side effects become serious or you notice any side effects not listed, you should contact your doctor.
© How to store
Keep out of reach and sight of children.
Protect from heat, light and moisture.
Store in the original package.
Do not take after the expiry date, which is stated on the carton after EXP. The expiry date refers to the last day of that month.
If your doctor tells you to stop taking your medicine you should return any remaining tablets to the pharmacist, unless your doctor tells you to keep them at home.
Further information
What Tamoxifen Tablets contain
Active ingredient:
Each 10mg tablet contains 15.2mg of tamoxifen citrate BP Each 40mg tablet contains 60.8mg of tamoxifen citrate BP
Other ingredients: Lactose BP, microcrystalline cellulose BP, carmellose sodium BP, magnesium stearate BP, portable water HSE
(see information on the ingredient lactose, section 2)
What Tamoxifen Tablets look like and the contents of the pack
Tamoxifen tablets are white tablets. They are available in blister packs of 30 tablets. They may also become available in packs of 50 and 100 tablets.
Marketing Authorisation Holder & Manufacturer:
ZeCare Ltd.
Unit 5 Blenheim Court,
Brownfields, Welwyn Garden City,
Hertfordshire,
AL71AN
Product Licence Number:
PL 24581/0031: Tamoxifen Tablets 10mg PL 24581/0035: Tamoxifen Tablets 40mg ZeCa^
Limited
Date of Revision : December 2010 code: zc-ver.5s