TAMOXIFEN FILM-COATED TABLETS
Please read this leaflet carefully before you start to take this medicine. It gives an outline of the more important things you should know. If you want to know more about this medicine, or you are not sure about anything, ask your doctor or pharmacist. You should keep this leaflet throughout your course of treatment.
The Name Of Your Medicine Is Tamoxifen Tablets
Tamoxifen Tablets contain the active ingredient tamoxifen citrate. The tablets come in three strengths, 10mg, 20mg and 40mg.
Other ingredients in your tablets are lactose, maize starch, pregelatinised maize starch, magnesium stearate, methylhydroxypropylcellulose, propylene glycol, Opaspray white (E171 and E464).
Tamoxifen 10mg Film-Coated Tablets are white, circular, film-coated tablets marked TAM10 on one face and CP on the reverse and contain 15.2mg of tamoxifen citrate equivalent to 10mg tamoxifen.
Tamoxifen 20mg Film-Coated Tablets are white, circular, film-coated tablets marked TAM20 on one face and CP on the reverse and contain 30.4mg of tamoxifen citrate equivalent to 20mg tamoxifen.
Tamoxifen 40mg Film-Coated Tablets are white, circular, film-coated tablets marked TAM40 on one face and CP on the reverse and contain 60.8mg of tamoxifen citrate equivalent to 40mg tamoxifen.
Tamoxifen Tablets are available in strip packs of 30 tablets.
Marketing Authorisation Holder:
Manufacturer:
How Does Your Medicine Work?
Tamoxifen belongs to a group of medicines known as anti-oestrogens, which modify the effects of the female hormone, oestrogen.
What Are Tamoxifen Tablets For?
Tamoxifen is used for the treatment of breast growths and some forms of female infertility.
Before Taking This Medicine
You should not take or be given Tamoxifen Tablets if:-
- You have ever had a reaction or been told that you are allergic to tamoxifen or any of the other ingredients in the tablet. Check by reading the list of ingredients above.
- You are pregnant (you should have a pregnancy test before starting to take tamoxifen).
- You are breast-feeding or plan to breast-feed.
- You are being treated for infertility and either you or a close relative are prone to events such as strokes or pulmonary embolism (blood clot on the lung).
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
There is an increased incidence of changes associated with the lining of the womb (Endometrium), including thickening of the lining, polyps and cancer. If you notice any unusual vaginal bleeding or discharges, or any feelings of pain or tightness around the lower stomach area, contact your doctor immediately.
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 thrombo-embolism (VTE).
If you get a painful swelling in your leg or sudden chest pain and difficulty breathing, talk to your doctor at once as these may be signs of blood clots in the veins or lungs.
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.
- Being off your feet because of major surgery, illness or injury.
Talk to your doctor if any of these applies 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 another medicine while you are taking Tamoxifen Tablets can affect how it or the other medicine works. Make sure that your doctor knows what other medicines you are taking. Do not take any other medicines while you are taking Tamoxifen Tablets unless you have told your doctor or pharmacist and asked their advice. This includes medicine you may have bought yourself.
Examples of medicines that can affect Tamoxifen Tablets are:-
- Anticoagulants (blood thinning agents) such as warfarin.
- Rifampicin, a drug used to treat tuberculosis.
- Mitomycin and aminoglutethimide, also used to treat breast cancer.
Taking This Medicine
The usual starting dose for adults for breast growths is 20mg daily. The same dosage is used in the elderly.
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 patients who do not have regular periods, the treatment 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.
Your doctor will decide the dose which is best for you. Always follow your doctor's instructions completely. Also follow any instructions or warnings which appear on the label which the pharmacist has put on the pack. If you do not understand or are in any doubt, ask your doctor or pharmacist.
If your medicine has been given to you in a blister pack, press on the tablet from the blister (or bubble) side, pushing it through the foil. Do not remove the tablet from the blister until you are ready to take it.
Unless told otherwise these tablets should be taken with a glass of water.
You should take these tablets for as long as your doctor tells you to. 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. Never double the next dose to make up for the one missed. Do not stop taking the medicine without talking to your doctor first.
If you accidentally take too many Tamoxifen Tablets you should contact your doctor, pharmacist or nearest hospital casualty department immediately. Take this leaflet and any tablets that you have left to show the doctor or pharmacist.
Are There Any Side-Effects?
Like many medicines tamoxifen may occasionally cause side-effects in some patients, particularly when you first start taking it. Side-effects that some patients have experienced with tamoxifen include hot flushes, breast pain or discomfort (especially at the start of treatment), skin rash, dry skin, hair loss or thinning, itching in the genital area, stomach upsets, weight gain, swelling due to water retention, dizziness, tiredness, confusion, depression, and headache. Periods may be interrupted or stop when taking these tablets. Problems with the lining of the womb or the ovaries may cause heavy or painful periods or “spotting” between periods. There is an increased risk of cancer of the womb in patients taking high doses of tamoxifen for a long time.
There have been reports of blood disorders which may cause fever or chills, sore throats, mouth or throat ulcers, unusual tiredness or weakness, unusual bleeding or unexplained bruises. Tell your doctor if you develop any such problems. Fatty liver, inflammation of the liver, a tendency to gall stones, an increase in the level of liver enzymes or certain fats (triglycerides) in the blood and inflammation of the pancreas or lungs have also been reported.
You should consult your doctor if these side-effects are troublesome or continue.
More serious side-effects include pain, discomfort or swelling in the lower part of the abdomen, unusual vaginal bleeding or discharge, irregular periods, or hazy or blurred vision. If you get these or any other symptoms not described above, tell your doctor.
If you start feeling very sick or vomiting, or develop thirst, loss of appetite, constipation, weak muscles or confusion, tell your doctor, as this may be due to too much calcium in the blood.
You should stop taking Tamoxifen Tablets and tell your doctor IMMEDIATELY if you develop any of the following:
- swelling of the face, lips, tongue or throat.
- difficulty in swallowing or breathing.
- “hives” or nettle rash (known as urticaria).
- swelling or pain in the arms or legs (this could be due to a blood clot or thrombosis).
- pain in the chest (this could be due to a blood clot on the lung).
Also, because of the way this medicine acts on the body, there is a chance that it might cause other unwanted effects that may not occur until months or years after this medicine is used. Tamoxifen could possibly increase the chance of cancer of the uterus (womb) in some women taking it. Discuss this possible effect with your doctor.
Safe Keeping For This Medicine
- Do not take this medicine if the expiry date on the label has passed or if the tablets show signs of 'going off' such as discoloration.
- These tablets should not be stored above 25°C. Store in the original container in which they were given to you in order to protect from light and moisture. Do not transfer Tamoxifen Tablets to another container.
Keep Tamoxifen Tablets in a secure place out of the reach and sight of children.
Remember 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.- Unless your doctor tells you to, do not keep tablets that you no longer need. Give them back to your pharmacist.
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 the Blind.
Date of Revision of Leaflet
March 2007
CP5
103505/2
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