Package leaflet · information for the user
Tamoxifen Citrate 20 mg
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 any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
1.What Tamoxifen Citrate is and what it is used for
Tamoxifen is a tablet that blocks the effect of oestrogen, a sex hormone, in some parts of the body, while acting a little like oestrogen in others. Because of this it is used in conditions where oestrogen affects how tissue grows. Your doctor has prescribed this medicine for you after considering your own situation, and may want to see you regularly while you take it. It is prescription-only and must not be given to anyone else.
2.What you need to know before you use Tamoxifen Citrate
Some conditions make this medicine unsuitable, and some need extra checks, so tell your doctor about your full medical history before you start.
Do not use it if
- Do not use tamoxifen if you are allergic to tamoxifen or to any of the other ingredients listed in section 6.
- Do not use tamoxifen if you are pregnant or breastfeeding.
- Do not use tamoxifen if you have ever had a blood clot in a vein or in the lungs, unless your doctor has weighed this up and told you to take it.
- Do not use tamoxifen if you are taking anastrozole or a similar medicine that lowers oestrogen, unless your doctor has told you to take both.
- Do not use tamoxifen together with a medicine called anagrelide.
- Do not use tamoxifen if you have unexplained bleeding from the vagina that has not yet been investigated, until your doctor has checked it.
Warnings and precautions
- Talk to your doctor before using tamoxifen if you have ever had a blood clot, or if clots run in your family, because this medicine makes clots more likely. The risk is higher if you are not moving about, for example after an operation or on a long journey. Tell any surgeon or dentist that you take tamoxifen.
- Talk to your doctor before using tamoxifen if you have any problem with the lining of your womb, or have had one. Report any unusual bleeding from the vagina, spotting between periods, or a change in discharge, straight away, even if it seems small.
- Talk to your doctor before using tamoxifen if you have liver problems, as your doctor may want to check your liver with blood tests.
- Talk to your doctor before using tamoxifen if you have cataracts or any other eye problem, or if your sight changes while you are taking it.
- Talk to your doctor before using tamoxifen if you have been told your blood fats (triglycerides) are high, or if you have had inflammation of the pancreas.
- Talk to your doctor before using tamoxifen if you have a low number of white blood cells or platelets, or if you bruise or bleed easily.
- Talk to your doctor if you are having a general anaesthetic or a long flight, so that steps can be taken to lower the risk of a clot.
Other medicines and Tamoxifen Citrate
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including ones bought without a prescription, herbal remedies and supplements. It is especially important to mention blood thinners such as warfarin (medicines that stop the blood clotting so easily), because tamoxifen can make their effect much stronger and cause bleeding; certain antidepressants, particularly paroxetine and fluoxetine, which can stop tamoxifen working properly; rifampicin, and medicines for epilepsy; anagrelide; and anastrozole or similar hormone medicines. Do not take St John's wort (a herbal remedy for low mood) with tamoxifen. If you are unsure, show the pack to your pharmacist.
Pregnancy, breastfeeding and fertility
Do not take tamoxifen if you are pregnant, think you may be pregnant, or are planning to become pregnant, as it may harm an unborn baby. Do not breastfeed while taking it. If you could become pregnant, use a reliable non-hormonal method of contraception, such as condoms or a copper coil, during treatment and for the period your doctor advises afterwards; hormonal contraceptives may not be suitable. Tell your doctor straight away if you become pregnant. Tamoxifen may change your periods or stop them for a time, but this does not mean you cannot become pregnant. It may also affect fertility; discuss this with your doctor if you plan to have children.
Driving and using machines
Tamoxifen may make you feel tired, dizzy or light-headed, and some people notice changes in their sight. If you are affected, do not drive, cycle or use tools or machines until you feel normal again. If your sight changes in any way, stop driving and tell your doctor.
3.How to use Tamoxifen Citrate
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. It is a tablet that you swallow whole with a drink of water. You can take it with or without food, and it helps to take it at about the same time each day. Your doctor decides the amount and how long you should take it, sometimes for several years, so do not change or stop treatment yourself even if you feel well. If you forget a tablet, take the next one at the usual time; do not take a double amount to make up for a forgotten one. If you take more tablets than your doctor told you to, contact your doctor straight away or go to the nearest hospital, and take the pack with you.
4.Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop and get medical help straight away
- Any unusual bleeding from the vagina, spotting between periods, bleeding after the menopause, a change in discharge, or pain or pressure in the lower tummy. Contact your doctor promptly so the lining of the womb can be checked.
- Pain, warmth, redness or swelling in one leg, which can be a blood clot in a vein. Get medical help now.
- Sudden breathlessness, chest pain or coughing up blood, which can be a clot in the lungs. Call the emergency services.
- Sudden severe headache, trouble speaking, or weakness or numbness on one side of the body, which can be a stroke. Call the emergency services.
- Yellowing of the skin or the whites of the eyes, dark urine, or pain in the upper right side of the tummy, which can be a liver problem. Get medical help now.
- Severe pain in the upper tummy that spreads to the back, with being sick, which can be inflammation of the pancreas. Get medical help now.
- A severe allergic reaction, or severe blistering or peeling of the skin. Get emergency help at once.
Other possible side effects
- Hot flushes and sweating, including at night
- Feeling sick, or discomfort in the stomach
- Fluid build-up, so that your ankles, feet or hands swell
- Vaginal dryness, itching or discharge
- Irregular periods, or periods stopping
- Headache or dizziness
- Feeling tired or weak
- Muscle cramps, or aching joints and bones
- Thinning of the hair
- Skin rash, or a change in the skin
- Changes in mood, or feeling low
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist — including any not listed in this leaflet. You can also report them directly to us at pv@ergopharm.net or through our reporting form, and to your national reporting system. By reporting side effects you help provide more information on the safety of this medicine.
5.How to store Tamoxifen Citrate
Keep this medicine out of the sight and reach of children. Store below 30 degrees Celsius in the original pack, protected from light and moisture. Do not use this medicine after the expiry date printed on the carton and the blister foil; the expiry date refers to the last day of that month. Do not use the tablets if the blister is torn or the tablets look damaged or discoloured. Do not throw medicines away in your household waste or down the toilet. Take medicines you no longer need back to your pharmacy for safe disposal. This helps protect the environment.
6.Contents of the pack and other information
Each tablet contains tamoxifen (as tamoxifen citrate) as the active substance. The other ingredients are the fillers, binder, lubricant and film coat that form the tablet; the full list is printed on the carton. The tablets are film-coated and are supplied in blister strips inside a cardboard carton, in packs of 10 to 100 tablets. Not all pack sizes may be available in your country. Every carton carries a printed square barcode (a GS1 DataMatrix) and a verification code that you can enter at ergopharm.net to check the pack is genuine. Manufactured under GMP conditions by Ergopharm, Vadodara, Gujarat, India.