PATIENT INFORMATION LEAFLET

TAMOXIFEN Tablets

/ Omg, 20mg & 40mg

Please read all of this leaflet carefully before you start taking this medicine.

Keep the leaflet; you may need to read it again. If you have any questions or are not sure about anything, 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 you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

In this leaflet:

1.    What Tamoxifen Tablets are and what they are used for

2.    Before you take Tamoxifen Tablets

3.    How to take Tamoxifen Tablets

4.    Possible side effects

5.    How to store Tamoxifen Tablets

6.    Further information

1.    What Tamoxifen Tablets are and what they are used for

Tamoxifen is one of a group of medicines called “anti-oestrogens”.

It is used for the treatment of breast cancer and anovulatory infertility (a type of female infertility).

2.    Before you take Tamoxifen Tablets

Do not take these tablets if you:

•    are allergic to tamoxifen or to any of the other ingredients in the tablets (see section 6)

•    are pregnant, think you may be pregnant or you are breast feeding

•    are already taking the medicine anastrozole (also used to treat breast cancer)

•    are taking this medicine for the treatment of infertility and you or your family have a history of strokes or blood clots or a known genetic defect.

Check with your doctor before taking these tablets if you:

•    suffer from leucopenia or thrombocytopenia (blood disorders which mean you have reduced numbers of white blood cells or blood platelets).

Taking other medicines:

Please inform your doctor if you are taking, or have recently taken any other medicines, even those you have bought without prescription.

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)

•    cincalet/cinacalcet (for treatment of disorders of the parathyroid gland).

Also inform your doctor if you are taking any of the following other medicines:

•    oestrogens (often used in hormone replacement therapy/ HRT or the contraceptive pill)

•    anticoagulants (blood thinning tablets like warfarin)

•    rifampicin (used to treat bacterial infections including tuberculosis)

•    other medicines for treating cancer, including chemotherapy.

Other special warnings:

•    The risk of blood clots may be increased by taking this medicine and may be further increased in some patients. This should already have been discussed with you by your doctor, particularly if you have family history of strokes or you are considered more at risk. You may be more at risk if:

•    you are very overweight

■    as you get older

■    you smoke

•    you are immobile or have an injury which means you are immobile

•    you are currently undergoing chemotherapy.

Your doctor may decide to prescribe an anticoagulant (to thin your blood) if you have a number of the risk factors above.

•    If you experience painful swelling in your leg, breathlessness, sudden chest pain or difficulty breathing, tell your doctor IMMEDIATELY as these may be signs of a blood clot.

■ If you need an operation or are going to be immobile for a while and you are taking this medicine for the treatment of infertility, your doctor should stop this medication at least six weeks before. If you are taking this medicine for breast cancer your doctor will need to discuss this with you as treatment will only be stopped if the risk of blood clots is considered to outweigh the risks of interrupting your treatment.

•    Tell your doctor immediately if you get any abnormal vaginal bleeding, vaginal discharge, pelvic pain or pressure. These could be signs of changes which may possibly occur in the womb (thickening of the lining of the womb, polyps and cancer), due to taking tamoxifen.

•    During clinical trials with tamoxifen a number of tumours in other parts of the body have been reported following the treatment of breast cancer. It has not however been established if this is necessarily due to taking tamoxifen or not.

•    It is very important that your doctor checks your progress at regular visits, to make sure that this medicine is working properly and to check for unwanted effects. Regular blood tests, including blood platelet counts may be performed.

Pregnancy and breast feeding:

You may be examined before starting your treatment with tamoxifen, to ensure that you are not pregnant and this may include taking a pregnancy test. You should also ensure you use a suitable form of contraception (a non-hormonal method e.g. condoms) whilst taking this medicine and this should have been discussed with your doctor. Tell your doctor immediately if you think you have become pregnant whilst taking this medicine. If it is your intention to become pregnant you must discuss this with your doctor as this is not advised, and it is also recommended that you should wait at least 2 months after finishing treatment before becoming pregnant.

You should not breast feed whilst taking this medicine.

Effects on driving or operating machinery:

This medicine should not affect your ability to drive or to operate machinery. However, if you think you are affected do not drive or operate machinery.

Important information about an ingredient of Tamoxifen Tablets:

This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3.    How to take Tamoxifen Tablets

Swallow the tablet whole with water.

Always take the medicine exactly as directed by your doctor. Your doctor will decide the dose that is best for you. The pharmacist’s label will tell you how many tablets to take and how often. If you are not sure about anything, ask your doctor or pharmacist.

For breast cancer: The usual dose is one 20 mg tablet daily. However, your doctor may prescribe you a different dose.

For infertility: If you are menstruating regularly, then your initial course of treatment will be 20 mg daily, to be taken on the second, third, fourth and fifth days of the menstrual cycle (day 1 of menstrual cycle is considered as the first day of bleeding). If this treatment proves unsuccessful, then your doctor may increase the dosage during subsequent menstrual periods, to 40 mg and then 80 mg daily.

If you are not menstruating regularly, your initial course of treatment may begin on any day. If this treatment is unsuccessful, then your doctor may prescribe you a subsequent course of treatment which may begin 45 days later, with the dosage increased to 40 mg and then 80 mg daily. If menstruation occurs, then commence the next course of treatment on the second day of the cycle.

If you have taken too many tablets:

Contact your doctor straight away or go to the nearest hospital casualty department. Take with you any remaining tablets and the pack so that the medicine can be identified.

If you forget to take a dose:

Take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and continue with your normal dosing schedule. DO NOT DOUBLE THE DOSE.

4.    Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If any of the following occur SEEK MEDICAL HELP IMMEDIATELY:

■    painful swelling in a leg, breathlessness, sudden chest pain or difficulty breathing (these may be signs of a blood clot or stroke)

•    swelling of the face, mouth or throat (these could be signs of a serious allergic reaction).

Other side effects which you should tell your doctor about IMMEDIATELY include:

•    severe skin reactions (symptoms may include raised itchy red lumps, skin swelling or peeling or blistering of the skin, mouth, eyes or genitals)

■    abnormal vaginal bleeding or discharge, pelvic pain or pressure, feeling bloated. Cysts, fibroids, polyps or thickening of the womb lining and cancer of the womb have been reported

•    eye problems including changes to the cornea or retina and cataracts, changes in vision such as complete or some loss of vision, blurred vision or pain in the eye

•    changes in the blood which may result in frequent infections and symptoms such as sore throat, mouth ulcers, fever, flu-like symptoms, tiredness, anaemia and unexplained bleeding or bruising

•    inflammation of the lungs which causes breathlessness, cough and a raised temperature.

Tell your doctor or pharmacist if you suffer from any of the side effects listed in the sections below.

Other side effects reported include:

•    menstrual disturbances or your periods stopping

■    vaginal itching or irritation

•    loss of hair

•    skin rashes, hot flushes

•    leg cramps

•    stomach upsets

•    headache or light headedness

■    swelling due to water retention

•    tumour flare

•    high levels of calcium in the blood (symptoms may include nausea, vomiting and feeling thirsty).

Other side effects reported rarely include:

•    an increase in a type of fat in the blood (known as triglycerides), in some cases with inflammation of the pancreas, which causes severe pain in the abdomen and back

•    liver problems (symptoms include yellowing of the skin or whites of the eyes, pale stools and dark urine) or changes in liver enzyme levels.

It may be possible to control some side effects if your doctor reduces the dose, but if not then it may be necessary to stop treatment with this medicine.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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 Tablets

Keep this medicine in the pack provided and protect from heat, light and moisture.

KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.

Do not take the tablets if the expiry date on the pack has passed. If you have any medicines that are out of date, return them to your pharmacist for safe disposal.

6.    Further information

Ingredients:

Tamoxifen tablets are available in three strengths and contain either 10mg, 20mg or 40mg of the active ingredient tamoxifen (as citrate). The tablets also contain the following other ingredients: lactose, microcrystalline cellulose, povidone, carmellose sodium and magnesium stearate.

What the medicine looks like:

Tamoxifen Tablets 10 mg are white round tablets and marked with the company logo on one side and A388 on the other side. Tamoxifen Tablets 20 mg are white round tablets and marked with the company logo on one side and A389 on the other side. Tamoxifen Tablets 40 mg are white round tablets and marked with the company logo on one side and A390 on the other side. The tablets are available in pack sizes of 28, 30,42, 50, 56,

60, 84, 90, 100, 112 and 250 tablets. (Not all sizes may be marketed.)

Who makes this medicine and holds the Product Licence:

Crescent Pharma Limited, Units 3 &4, Quidhampton Business Units, Polhampton Lane, Overton, Hants, RG25 3ED, UK.

Date leaflet prepared: October 2015

If you would like this leaflet in a different format please contact the licence holder at the above address.