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Tamoxifen 40mg Film-Coated Tablets

Informations for option: Tamoxifen 40mg Film-Coated Tablets, show other option

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PACKAGE LEAFLET: INFORMATION FOR THE USER Tamoxifen 10mg, 20mg and 40mg Film-Coated Tablets Tamoxifen Citrate



Read all of this leaflet carefully before

you start using this medicine.

-    Keep this leaflet. You may need to read it again.

-    If you have further questions, please ask your doctor or 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.

The name of your medicine is Tamoxifen

10mg, 20mg or 40mg Film-Coated Tablets.

In the rest of this leaflet it is called Tamoxifen

Tablets.

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


The active ingredient in Tamoxifen Tablets is tamoxifen citrate, which belongs to a group of medicines called anti-oestrogens.

Tamoxifen Tablets are used in the treatment of breast cancer, particularly those types which are made worse by oestrogen. They are also used for the treatment of female infertility when no eggs are produced.


2. BEFORE YOU TAKE TAMOXIFEN TABLETS


Do not take Tamoxifen Tablets if you:

•    are allergic to tamoxifen or any of the other ingredients contained in Tamoxifen Tablets (see list under heading ‘What Tamoxifen Tablets contain’ in section 6)

•    have porphyria

•    are pregnant (if you are pre-menopausal you should be examined by your doctor and have a pregnancy test before starting to take Tamoxifen Tablets).

•    are undergoing anastrozole therapy

•    are being treated for infertility

•    or a close relative have had blood clots in your veins or lungs or have a known inherited condition leading to an increased risk of clotting.

If any of the above statements apply to you, you should not take Tamoxifen Tablets.

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 (antidepressants 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).

Special Warnings

Deep vein thrombosis (blood clots in veins)

The risk of blood clots in veins (also called deep vein thrombosis or DVT) may be increased by taking tamoxifen. They are not usually serious, but if a clot travels to the lungs (pulmonary embolism or PE), it can cause breathlessness, chest pain, collapse or even be fatal. Both DVT and PE are often described as examples of venous thromboembolism (VTE). The risk of blood clots is increased if you are also having anticancer chemotherapy.

There are several other things which raise the risk of blood clots in veins:

•    If you or any of your family have had a blood clot in the veins or lungs before.

•    Being elderly or very overweight.

•    If you are taking another chemotherapy agent other than tamoxifen.


•    Being off your feet because of major surgery, illness or injury.

Talk to your doctor if any of these apply to you.If you are going to have surgery, make sure your doctor knows about it as you may need to stop taking tamoxifen six weeks before the operation to reduce the risk of VTE.

Taking other medicines

Taking another medicine while you are taking Tamoxifen Tablets can affect how it or the other medicine works.

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those you may have bought yourself without a prescription.

Please check with your doctor if you are taking any of the following (or any other medication):

•    Anticoagulants (blood thinning agents) such as warfarin.

•    Rifampicin, a drug used to treat tuberculosis.

•    Mitomycin, also used to treat cancer.

•    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 the parathyroid gland)

Periodic complete blood counts and liver function tests are recommended during tamoxifen therapy.

If you have any doubts about whether you should take this medicine then discuss matters with your doctor before taking it.

Pregnancy and breast-feeding

You should not take Tamoxifen Tablets if you are pregnant or trying to become pregnant since tamoxifen may affect your unborn child. If you are pre-menopausal your doctor will examine you and carry out a pregnancy test before you take Tamoxifen Tablets. In addition you should use extra contraceptive precautions (e.g. condoms) whilst taking Tamoxifen Tablets and for two months after stopping treatment with Tamoxifen Tablets.

Tamoxifen Tablets can make breast-feeding more difficult. You should not breast-feed whilst taking Tamoxifen Tablets.

Driving and operating machines

Tamoxifen Tablets can cause reduced visual acuity and blurred vision; if you are affected do not drive or operate machines.

Important information for patients who have an intolerance to some sugars

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product as it contains lactose.


3. HOW TO TAKE TAMOXIFEN TABLETS


Your doctor will decide the dose which is best for you. Always follow your doctor’s instructions completely and also follow any special instructions or warnings which appear on the pack which the pharmacist has put on the package. If you do not understand, or are in any doubt, ask your doctor or pharmacist.

Unless instructed differently, take your tablets with a glass of water.

For the treatment of breast cancer

The usual dose for adults with breast cancer is 20mg daily. The same dosage is used in the elderly.

For the treatment of infertility

The usual adult dose of tamoxifen for the treatment of infertility is 20mg daily given on the second, third, fourth and fifth days of the monthly cycle. The first day of the monthly cycle is the first day of bleeding. Your doctor may increase the dose to 40mg or 80mg if further courses of treatment are thought necessary.

In women who do not have regular periods, Tamoxifen Tablets can be started on any day. A further course of treatment may be given 45 days later or on the second day of your period if you start bleeding.


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If you take more Tamoxifen Tablets than you should

If you accidentally take too many tablets contact your doctor or pharmacist or nearest hospital casualty department. It is possible that you may get ECG (heart trace) changes. Take this leaflet and any remaining tablets with you to show the doctor or pharmacist.

If you miss a dose of Tamoxifen Tablets

If you forget to take a dose, take another as soon as you remember. If it is almost time for your next dose, then do not take the missed dose at all. Do not take a double dose to make up for a forgotten tablet.

Stopping treatment with Tamoxifen Tablets

You should continue to take Tamoxifen Tablets for as long as your doctor tells you to. Do not stop taking the medicine without talking to your doctor first.


leaflet, please contact your doctor or pharmacist immediately.

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.


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4. POSSIBLE SIDE EFFECTS


5. HOW TO STORE TAMOXIFEN TABLETS


Like many medicines Tamoxifen Tablets may cause side effects in some patients, although not everybody gets them.

You should contact your doctor IMMEDIATELY if you develop any of the following:

   Painful swelling of your leg, sudden chest pain or difficulty breathing

The risk of blood clots in veins (also called deep vein thrombosis or DVT) may be increased by taking Tamoxifen Tablets. They usually occur in the leg and are not usually serious, but if a clot travels to the lungs (pulmonary embolism or PE), it can cause breathlessness, chest pain, collapse or can even be fatal. Both DVT and PE are often described as examples of venous thromboembolism (VTE).

   Signs of an allergic or sensitivity reaction e.g.:

o swelling of the face, lips, tongue or throat o difficulty in breathing o “hives” or nettle rash (known as urticaria) o redness and blistering of the skin

   Unusual vaginal bleeding, vaginal discharge, itching around the vagina or pain in your lower stomach

This may be a sign of changes in the lining of the womb (the endometrium), including thickening of the lining, polyps and cancer of the womb, particularly with higher doses or long term treatment.

If you experience any of the symptoms in bold above, you should contact your doctor immediately.

Other side effects include:

•    hot flushes

•    weight gain

•    leg cramps

•    swelling due to water retention

•    skin rash

•    dry skin

•    hair loss or thinning

•    stomach upsets

•    dizziness / light-headedness

•    tiredness

•    confusion

•    depression

•    headache

•    hazy or blurred vision, very rarely blindness

•    pain at the cancer site

•    blood disorders which may cause fever or chills, sore throats, mouth or throat ulcers, unusual tiredness or weakness, unusual bleeding or unexplained bruises

•    feeling sick or vomiting, loss of appetite, thirst, constipation or weak muscles due to too much calcium in the blood

•    inflammation of the lungs which may cause a dry cough, difficulty in breathing, swelling of the ends of the fingers, bluish discolouration of the skin and fever

•    inflammation of the pancreas which may result in stomach pain radiating to the back

•    an increase in the level of liver enzymes or certain fats (triglycerides) in the blood, or inflammation of the liver (which may cause yellowing of the skin), non-alcoholic steatohepatiats (reversible on withdrawal) and cirrhosis (this is associated with the following risk factors: Being overweight or obese, insulin resistance, diabetes, orhyperlipidaemia)

If your side effects are severe you may need to reduce the dose of your Tamoxifen Tablets or it may be necessary to stop treatment.If any of the side effects gets serious, or if you notice any side effects not listed in this


Keep out of the reach and sight of children.

Do not take this medicine if the expiry date on the pack has passed. The expiry date refers to the least day of that month.Tamoxifen Tablets should not be taken if they show signs of deterioration such as discoloration.

Do not store above 25°C.

Store in the original container or package in order to protect from light and moisture. Do not transfer the tablets to another container.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.These measures will help to protect the environment.


6. FURTHER INFORMATION


What Tamoxifen Tablets contain

The active ingredient in Tamoxifen Tablets is Tamoxifen Citrate.

Tamoxifen 10mg Film-Coated Tablets contain 15.2mg of tamoxifen citrate equivalent to 10mg tamoxifen.

Tamoxifen 20mg Film-Coated Tablets contain 30.4mg of tamoxifen citrate equivalent to 20mg tamoxifen.

Tamoxifen 40mg Film-Coated Tablets contain 60.8mg of tamoxifen citrate equivalent to 40mg tamoxifen.

Other ingredients are lactose, maize starch, pregelatinised maize starch, magnesium stearate, methylhydroxypropylcellulose, propylene glycol, Opaspray white (E171 and E464).

What Tamoxifen Tablets look like and contents of the pack

Tamoxifen 10mg Film-Coated Tablets are white, circular, filmcoated tablets marked TAM10 on one face and CP on the reverse.

Tamoxifen 20mg Film-Coated Tablets are white, circular, filmcoated tablets marked TAM20 on one face and CP on the reverse.

Tamoxifen 40mg Film-Coated Tablets are white, circular, filmcoated tablets marked TAM40 on one face and CP on the reverse.

Tamoxifen Tablets are available in blister strip packs of 30 tablets.

Marketing Authorisation Holder:

Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK.

Manufacturer: CP Pharmaceuticals Ltd,

Ash Road North, Wrexham, LL13 9UF, UK.

Other formats:

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

Tamoxifen 10mg Film-Coated Tablets

29831/0194

Tamoxifen 20mg Film-Coated Tablets

29831/0195

Tamoxifen 40mg Film-Coated Tablets

29831/0196

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


This leaflet was last revised in 02/2015.


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