Nolvadex 10mg
Out of date information, search anotherTHE FOLLOWING IS DUMMY TEXT REPRESENTING NON-MARKETED PACKS.
FOR REGULATORY SUBMISSION PURPOSES ONLY
Patient Information Leaflet
Nolvadex®
tamoxifen
Please read this leaflet carefully before you take your medicine. This leaflet only gives a summary of the information available on your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.
What you should know about your medicine
The name of your medicine is Nolvadex. The active ingredient is tamoxifen. Your medicine also contains the following inactive ingredients: croscarmellose sodium, gelatin, lactose, macrogol, magnesium stearate, maize starch, methylhydroxypropylcellulose and titanium dioxide.
Nolvadex tablets contain 10 mg of tamoxifen.
Nolvadex tablets are produced in packs of 30 and 250.
Tamoxifen is one of a group of medicines called anti-oestrogens.
The Marketing Authorisation for Nolvadex is held by AstraZeneca UK Limited, 600 Capability Green, Luton, LU1 3LU, UK. Nolvadex is manufactured by AstraZeneca UK Limited, Silk Road Business Park, Macclesfield, Cheshire, SK10 2NA, UK.
Nolvadex is used to treat breast cancer. It can also be used to treat infertility caused by a failure to ovulate properly.
Before taking your medicine
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.
Tiredness has been reported with the use of Nolvadex and caution should be observed when driving or operating machinery while such symptoms persist.
Taking other medicines
Please inform your doctor if you are taking, or have recently taken any other medicines, even those you have bought without prescription. In particular, you should inform your doctor if you are taking:
• 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)
• Are you pregnant?
• Are you breast-feeding?
• Are you taking any anticoagulant tablets?
• Have you ever had an allergic reaction to Nolvadex, or to any of its ingredients?
• Do you or your family have a history of blood clots or a known inherited condition leading to an increased risk of clotting?
If the answer is yes to any of these questions, tell your doctor or pharmacist. Nolvadex should not be taken by women who are pregnant or breast-feeding and it can also interact with certain types of anticoagulant medicine, and a drug called rifampicin (for tuberculosis). Nolvadex should not be taken with aromatase inhibitors such as anastrozole, letrozole or exemestane.
You should not become pregnant when taking Nolvadex. Please see your doctor for advice on what contraceptive precautions you should take, as some may be affected by Nolvadex. You should see your doctor immediately if you think you may have become pregnant after starting to take Nolvadex.
Nolvadex tablets contain lactose and titanium dioxide. These may cause a problem in a small number of people who are sensitive to them.
Taking your medicine
Follow your doctor’s instructions about when and how to take your medicine. Also read the label. Your pharmacist can also help if you are not sure.
The usual dosage to treat breast cancer is 20 mg daily. The daily dose can either be taken as a single dose every day or the dose can be divided in two and taken in the morning and evening.
The dosage for infertility depends on the menstrual cycle. In women who are having regular periods, treatment usually begins by taking 20 mg of Nolvadex daily on the second, third, fourth and fifth days of the menstrual cycle. If this is not successful, your doctor may increase the dosage on these days to 40 mg or 80 mg daily. In women who are not having regular periods, the treatment can be started on any day.
If you forget to take a dose, take it as soon as you remember and then carry on as before.
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.
After taking your medicine
As with all medicines, undesirable events can sometimes be experienced with Nolvadex. Occasionally, a few people can suffer from stomach or gut upsets (including nausea, vomiting, diarrhoea and constipation), headaches, light-headedness, sensory changes (including taste disorder and numbness or tingling in the skin), menstrual disturbances, hot flushes, genital itching, vaginal discharge or bleeding, fluid retention, leg cramps, muscle pain, hypertriglyceridemia (increased levels of fats in your blood) sometimes with pancreatitis (pain or tenderness in your upper abdomen), skin rashes or itching or peeling skin, thinning of the hair, inflammation of the lungs (which may present with the same symptoms as pneumonia, such as breathlessness and cough) or tiredness.
Other possible events are changes in vision or difficulty seeing properly as a result of cataracts or changes to the cornea or retina. Cases of optic nerve diseases have been reported in patients receiving tamoxifen and, in a small number of cases, blindness has occurred. Other possible events are an increased risk of blood clots (including clots in small vessels), ovarian cysts, certain liver problems such as jaundice and 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 possible events are effects on the endometrium (lining of the womb) which may also be seen as vaginal bleeding, or fibroids (causes enlargement of the womb) which may also be seen as discomfort in the pelvis or as vaginal bleeding. Cases of non-cancerous mass in the inner lining of the vagina (called vaginal polyps) have been reported, but are uncommon. 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. 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. Very rarely, cases of inflammation of the skin characterised by rash or erythema, very often on areas exposed to light (a condition called cutaneous lupus erythematosus) and cases of 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), have been reported.
It is important that you tell your doctor immediately if you have any unusual vaginal bleeding, vaginal discharge or discomfort in the pelvis such as pain or pressure when you are taking Nolvadex or anytime afterwards. This is because a number of changes to the lining of the womb (the endometrium) may occur, some of which may be serious and could include cancer.
At the beginning of treatment for breast cancer, the symptoms of the disease can sometimes get worse, for example an increase in pain or an increase in the size of the affected tissue. In addition, if you get excessive nausea, vomiting or thirst, tell your doctor because this may mean that there are changes in the amount of calcium in your blood and your doctor may want to check on this.
Do not be alarmed by this list of possible events. You may not have any of them.
If you get any other undesirable events or if you think your medicine is causing any problems, tell your doctor or pharmacist.
STOP TAKING Nolvadex and contact your doctor immediately in any of the following situations:
• If you develop symptoms of a blood clot such as calf or leg swelling, chest pain, shortness of breath or sudden weakness.
• If you develop difficulty in breathing with or without swelling of the face, lips, tongue and/or throat.
• If you develop swelling of the face, lips, tongue and/or throat which may cause difficulty swallowing.
• If you develop swelling of the hands, feet or ankles.
• If you develop urticaria (nettle rash or hives).
Storing your medicine
Check the expiry date on the carton and don’t use the medicine after that date.
Keep your medicine in a safe place where children cannot see it or reach it. Your medicine could harm them.
Keep your medicine below 30oC.
Keep your tablets in the container they came in (away from strong light).
If your doctor decides to stop treatment, return any leftover tablets to your pharmacist. Only keep them if the doctor tells you to.
Further information
This leaflet does not contain the complete information on Nolvadex. If you have any questions, or are not sure about anything, ask your doctor or pharmacist.
Remember: This medicine is only for you. Only a doctor can prescribe it for you. Never give it to someone else. It may harm them even if their symptoms are the same as yours.
The information applies only to Nolvadex.
Leaflet updated: April 2013 © AstraZeneca 2013
Nolvadex is a trade mark of the AstraZeneca group of companies.
ONC 13 0011
UK/PIL/Nolvadex 10mg/ONC 13 0011 (based on ONC 13 0004) 2 Apr 2013 MH Page 5 of 5