Tamoxifen 20mg Tablets
Out of date information, search anotherNolvadex-D® 20mg Tablets
(tamoxifen citrate)
PACKAGE LEAFLET: INFORMATION FOR THE USER
Your medicine is available using the name Nolvadex-D 20mg Tablets but will be referred to as Nolvadex-D throughout the leaflet.
Read all of this leaflet carefully before you start taking 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
■ If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Nolvadex-D is and what it is used for
2. Before you take Nolvadex-D
3. How to take Nolvadex-D
4. Possible side effects
5. How to store Nolvadex-D
6. Further information
1. What Nolvadex-D is and what it is used for
Nolvadex-D contains a medicine called tamoxifen. This belongs to a group of medicines called 'anti-oestrogens'.
Oestrogen is a natural substance in your body known as a 'sex hormone'. Nolvadex-D works by blocking the effects of oestrogen.
■ Nolvadex-D is used to treat breast cancer.
■ It is also used to treat infertility in women caused by a failure to produce and release eggs (ovulate) properly.
2. Before you take Nolvadex-D Do not take Nolvadex-D if:
■ You are allergic (hypersensitive) to tamoxifen or any of the other ingredients of Nolvadex-D (listed in Section 6: Further information).
■ You have had blood clots in the past and the doctor did not know what caused them.
■ Someone in your family has had blood clots with the cause not known.
■ Your doctor has told you that you have an illness which runs in the family that increases the risk of blood clots.
■ You are pregnant (see the section on 'Pregnancy' below).
Do not take Nolvadex-D if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Nolvadex-D.
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 (antidepressant or aid to smoking cessation), quinidine (for example used in the treatment of cardiac arrhythmia) and cincalet/cinacalcet (for treatment of disorders of the parathyroid gland).
In delayed breast reconstruction operation (weeks to years after the primary breast operation when your own tissue is moved to shape a new breast) Nolvadex may increase the risk of the formation of blood clots in the small vessels of the tissue flap which may lead to complications.
Operations
If you are going to have an operation (including planned surgery), tell your doctor or pharmacist. They may suggest that you stop taking Nolvadex-D for a short time.
Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines. This includes medicines that you buy without a prescription and herbal medicines.
This is because Nolvadex-D can affect the way some medicines work and some medicines can have an effect on Nolvadex-D.
In particular, you should inform your doctor or pharmacist if you are taking any of the following medicines:
■ Medicines such as warfarin that are used to thin your blood. These are known as 'anticoagulants'.
■ Rifampicin which is used for tuberculosis (TB).
■ Anastrozole which is used to treat breast cancer.
■ Paroxetine, fluoxetine (e.g. antidepressants).
■ Bupropion (antidepressant or aid to smoking cessation).
■ Quinidine (for example used in the treatment of cardiac arrhythmia).
■ Cinacalcet (for treatment of disorders of the parathyroid gland).
Pregnancy
■ Do not take Nolvadex-D if you are pregnant. This is because it may affect your unborn baby.
■ Do not become pregnant while taking Nolvadex-D. Ask your doctor for advice on what contraceptive to use - Nolvadex-D affects how well some contraceptives work.
■ If you are taking Nolvadex-D and you think you have become pregnant, tell your doctor straight away.
Breast-feeding
Talk to your doctor before taking Nolvadex-D if you are breastfeeding.
Driving and using machines
Nolvadex-D is not likely to affect your ability to drive or use any tools or machines. However, tiredness has been reported with the use of Nolvadex and caution should be observed when driving or operating machinery while such symptoms persist.
Important information about some of the ingredients of Nolvadex-D
■ Nolvadex-D tablets contain lactose, which is a type of sugar. If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine.
■ Nolvadex-D tablets contain titanium dioxide. This may cause a problem in a small number of people who are sensitive to this ingredient.
3. How to take Nolvadex-D
Always take Nolvadex-D exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Breast cancer
The usual dose for breast cancer is one 20 mg tablet daily.
Infertility
The dose for infertility depends on your periods (menstrual cycle).
■ If you are having regular periods, the usual dose is one 20 mg tablet daily on the 2nd, 3rd, 4th and 5th days of your period.
■ If this does not work, your doctor may suggest that you take a higher dose of Nolvadex-D during your next period. If this happens, the usual dose is 40 mg or 80 mg daily on the 2nd, 3rd, 4th and 5th days of your period.
■ If you are not having regular periods, you can start taking the tablets on any day of the month.
If you take more Nolvadex-D than you should
If you take more Nolvadex-D than you should, talk to a doctor or pharmacist straight away.
If you forget to take Nolvadex-D
■ If you forget to take a dose, take it 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.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Nolvadex-D can cause side effects, although not everybody gets them.
Stop taking Nolvadex-D and tell your doctor straight away if you notice any of the following side effects - you may need urgent medical treatment:
■ Symptoms of a blood clot. These include swelling of the calf or leg, chest pain, being short of breath or suddenly feeling weak.
■ Sudden onset of weakness or paralysis of the arms or legs, sudden difficulty with speaking, walking, difficulty in holding things or difficulty in thinking, any of which may occur because the blood supply in the blood vessels of the brain is reduced. These symptoms could be signs of a stroke.
■ Difficulty in breathing.
■ Swelling of the face, lips, tongue or throat which may make it difficult to swallow.
■ Swelling of the hands, feet or ankles.
■ Nettle rash (also called 'hives' or 'urticaria').
Tell your doctor straight away if you notice any of the following:
■ Unusual bleeding from your vagina.
■ Irregular periods.
■ A feeling of discomfort in the lower tummy (pelvis) such as
pain or pressure.
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 Nolvadex-D.
Other possible side effects:
Stomach and gut: Upset stomach or gut (including nausea, vomiting, diarrhoea and constipation).
Nervous system: Headaches, feeling light-headed. Sensory changes (including taste disorder and numbness or tingling in the skin).
Reproductive system: Itching of the genitals, bleeding or discharge from the vagina, ovarian cysts, fibroids in the womb, non-cancerous mass in the inner lining of the vagina (called vaginal polyp).
Skin and hair: 'Hot flushes', skin rashes, itching or peeling skin, thinning of the hair, inflammation of the skin characterised by rash or erythema, very often on areas exposed to light (a condition called cutaneous lupus erythematosus), a skin condition characterised by skin blisters in areas exposed to the light, this is due to the increased liver production of a special group of cell pigments (called porphyrins).
Musculoskeletal: Leg cramps, pain in muscles.
Lungs: Inflammation of the lungs. The symptoms may be like pneumonia (such as feeling short of breath and coughing).
Eyes: Changes to your vision and difficulty seeing. This may be caused by cataracts or changes to the cornea or retina of your eye. Optic nerve disease including in a small number of cases, blindness.
Blood: Some side effects are only seen when a blood test is taken such as a decrease in the number of certain types of blood cells. This can make you bruise more easily, get serious infections, or feel very tired or breathless. There is an increased risk of blood clots (including clots in small vessels).
Liver: Liver problems, such as jaundice. This causes yellowing of the skin and the whites of the eyes. Changes in blood tests of liver function. On occasions more severe liver diseases have occurred from which some patients have died. These liver diseases include inflammation of the liver, liver cirrhosis, liver cell damage, formation of fatty liver cells, reduced bile formation, and failure of the liver. Symptoms may include a general feeling of being unwell, with or without jaundice (yellowing of the skin and eyes).
Other:
Fluid retention.
Increased amounts of fats in your blood (shown by blood tests), sometimes with pain or tenderness in your upper abdomen (pancreatitis). Tiredness.
People with breast cancer
■ At the beginning of treatment for breast cancer, the symptoms of breast cancer can sometimes get worse. For example, there may be an increase in pain or an increase in the size of the affected area.
■ Some people with breast cancer get increased amounts of calcium in their blood after starting Nolvadex-D. If this happens, you may feel very sick, be sick (vomit) a lot, or be very thirsty. Tell your doctor if this happens because he or she may want you to have blood tests.
Do not be concerned by this list of possible side effects. You may not get any of them.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
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 Nolvadex-D
■ Check the expiry date on the carton and do not use the medicine after that date.
■ Keep out of the sight and reach of children.
■ Do not store above 30°C.
■ Store in original package.
■ If your doctor decides to stop your treatment, return any leftover tablets to your pharmacist. Only keep them if the doctor tells you to.
■ If your medicine becomes discoloured or show any other signs of deterioration, you should seek the advice of your pharmacist.
■ Do not dispose of medicines in household rubbish. Any unused medicine should be returned to a pharmacist (chemist) who will dispose of them properly. This will help to protect the environment.
6. Further information
What Nolvadex-D contains
The active substance is tamoxifen.
Each film-coated tablet contains 20mg of tamoxifen (as the citrate).
The other ingredients are lactose, maize starch, gelatin, croscarmellose sodium type A, magnesium stearate, methylhydroxypropylcellulose, macrogol 300 and titanium dioxide (E171).
What Nolvadex-D looks like and contents of the pack
Nolvadex-D are round, white film-coated tablets marked Nolvadex 20 on one side and plain on reverse.
Your medicine is available in blister packs of 30 and 60 tablets.
Manufacturer
Manufactured by: Biofabri, S.L., C/A Relva s/n, 36400 O Porrino, Pontevedra, Spain.
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0633 POM
Leaflet revision and issue date: 15.05.15 Nolvadex-D® is a registered trademark of AstraZeneca.
To listen to or request a copy of this leaflet in Braille, large print or audio please call 01302 365000 and ask for Regulatory Department.
Please be ready to give the following information:
Product name Nolvadex-D 20mg Tablets
Reference number 21828/0633
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