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The product code(s) for this leaflet is: PL 29831/0194.
Tamoxifen 10mg, 20mg & 40mg Film-Coated Tablets
Tamoxifen 10mg, 20mg and 40mg Film-Coated Tablets
Tamoxifen Citrate
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.
1. What Tamoxifen Tablets are and what they are used for
2. What you need to know before you take Tamoxifen Tablets
3. How to take Tamoxifen Tablets
4. Possible side effects
5. How to store Tamoxifen Tablets
6. Contents of the pack and other information
Tamoxifen Tablets contain a medicine called tamoxifen. This belongs to a group of medicines called ‘anti-oestrogens’.
If you want to know more about how to decide whether tamoxifen is right for you, there is more information for patients on the National Institute for Health and Care Excellence website. Ask your doctor to talk to you about the information which is available for patients.
Oestrogen is a natural substance in your body known as a ‘sex hormone’. Some breast cancers need oestrogen to grow and tamoxifen works by blocking the effects of oestrogen.
Do not take Tamoxifen Tablets if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Tamoxifen Tablets.
Talk to your doctor or pharmacist before taking Tamoxifen Tablets.
If you have a history of hereditary angioedema as Tamoxifen Tablets may cause or worsen symptoms of hereditary angioedema. If you experience symptoms such as swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing, contact a doctor immediately.
In delayed breast reconstruction operation (weeks to years after the primary breast operation when your own tissue is moved to shape a new breast) Tamoxifen Tablets may increase the risk of the formation of blood clots in the small vessels of the tissue flap which may lead to complications.
Tamoxifen therapy may be used to reduce the risk of breast cancer and it can be associated with serious side effects such as blood clots in the veins of your leg (deep vein thrombosis), blood clots in your lungs (pulmonary embolus) and uterine cancer, all of which can be fatal. Other less serious side effects such as hot flushes, vaginal discharge, menstrual irregularities and pelvis pain may also occur.
Whether the benefits of treatment outweigh the risks depends on your age, health history, your level of breast cancer risk and on your personal judgement. Tamoxifen therapy to reduce the risk of breast cancer may not be appropriate for all women at increased risk. All assessments with your healthcare professional of the potential benefits and risks prior to starting therapy are essential. You should understand that tamoxifen reduces, but does not eliminate the risk of breast cancer.
Serious skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with tamoxifen treatment. Stop using tamoxifen and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
If you are to undergo planned surgery, you should tell your doctor or pharmacist as they may wish to consider stopping your treatment for a short period.
This medicine is not for use in children.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines you buy without a prescription and herbal medicines. This is because Tamoxifen Tablets can affect the way some other medicines work and some medicines can have an effect on Tamoxifen Tablets.
In particular, you should tell your doctor or pharmacist if you are taking any of the following medicines:
Women who can become pregnant should use adequate non-hormonal contraception (e.g., barrier contraception) during treatment with tamoxifen and for an additional two months after stopping treatment.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Breast-feeding
Talk to your doctor before taking Tamoxifen Tablets if you are breast-feeding.
Tamoxifen Tablets are not likely to affect your ability to drive or use any tools or machines. However, tiredness has been reported with the use of Tamoxifen Tablets and caution should be observed when driving or operating machinery while such symptoms persist.
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.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose for breast cancer is 20mg daily.
The dose for infertility depends on your periods (menstrual cycle).
The recommended dose for reducing the risk of breast cancer is 20 mg daily for 5 years.
Your healthcare professional will calculate your risk of breast cancer occurring using information about you, your medical history and any family history of breast cancer.
If you take more Tamoxifen Tablets than you should, talk to a doctor or pharmacist straight away.
If you forget to take a dose, take another as soon as you remember. However, if it is nearly time for the next dose skip the missed dose. Do not take a double dose (two doses at the same time) to make up for a forgotten dose.
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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
These effects may mean that there have been changes to the lining of your womb (the endometrium). Sometimes these effects are serious and could include cancer. They can happen during or after treatment with Tamoxifen Tablets.
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and foil. The expiry date refers to the last day of that month.
Do not use this medicine if you notice visible 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.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance 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.
The other ingredients 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.
Tamoxifen 20mg Film-Coated Tablets are white, circular, film-coated tablets marked TAM20 on one face and CP on the reverse.
Tamoxifen 40mg Film-Coated Tablets are white, circular, film-coated tablets marked TAM40 on one face and CP on the reverse.
Tamoxifen Tablets are available in blister strip packs of 30 tablets.
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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
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This leaflet was last revised in 04/2021.
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