20 mg film-coated tablets
tamoxifen
What Tamoxifen Sandoz is and what it is used for
Tamoxifen Sandoz is used in breast cancer.
Some tumors are dependent on the hormone estrogen for their growth. Tamoxifen Sandoz is a so-called anti-estrogen that prevents the action of natural estrogen.
Tamoxifen contained in Tamoxifen Sandoz may also be approved to treat other diseases not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Tamoxifen Sandoz
Do not use Tamoxifen Sandoz
– if you are allergic to tamoxifen or any other ingredient in this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Tamoxifen Sandoz:
- if you have hereditary (inherited) angioedema because Tamoxifen Sandoz can cause or worsen symptoms of hereditary angioedema. If you get symptoms such as swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing, contact a doctor immediately.
Tamoxifen Sandoz can cause menstrual disturbances and even loss of menstruation in pre-menopausal women.
Changes can occur in the lining of the uterus (endometrium), and some of them can be serious changes or even cancer. Contact your doctor immediately if you experience any unusual vaginal bleeding or other gynecological symptoms (eg pain or pressure over the pelvis) while you are using or have used Tamoxifen Sandoz.
In so-called late breast reconstruction (surgery performed sometime after the first breast surgery to recreate a breast), tissue is moved to the breast from somewhere else on the body. The use of Tamoxifen Sandoz can then increase the risk of blood clots in the small vessels in the moved tissue, which can lead to complications.
Serious skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in association with treatment with Tamoxifen Sandoz. Stop taking Tamoxifen Sandoz and contact your doctor immediately if you notice any of the symptoms associated with the serious skin reactions described in section 4.
Other medicines and Tamoxifen Sandoz
Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines. It is especially important to inform the doctor if you are using:
- paroxetine, fluoxetine (for depression)
- bupropion (for depression or smoking cessation)
- quinidine (used, among other things, in the treatment of cardiac arrhythmias )
- cinacalcet (for diseases of the parathyroid gland)
Concomitant use of these medicines should be avoided, as the effectiveness of Tamoxifen Sandoz may be reduced.
Also, inform the doctor if you are using:
- warfarin (blood thinners to prevent blood clots)
- phenytoin (for epilepsy )
- cytostatics (against cancer)
- rifampicin (for tuberculosis )
Concomitant use of these medicines may mean that the doctor needs to raise or lower the dose of Tamoxifen Sandoz.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Do not use Tamoxifen Sandoz during pregnancy. There is a certain risk that the fetus will be affected. Before starting treatment, pregnancy must be ruled out. You should also not become pregnant while using Tamoxifen Sandoz or within 9 months of stopping treatment. Birth control pills should not be used as contraception. Contact your doctor immediately if you think you are pregnant.
It is not known whether Tamoxifen Sandoz passes into breast milk. Tamoxifen Sandoz should not be used during breastfeeding. Therefore, talk to your doctor before using Tamoxifen Sandoz while breastfeeding.
Driving ability and use of machinery
Tamoxifen Sandoz is unlikely to affect your ability to drive or use machines. However, fatigue has been reported with the use of Tamoxifen Sandoz and while fatigue persists, caution must be exercised when driving or operating machinery.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and side effects. Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Tamoxifen Sandoz contains lactose and sodium
Tamoxifen Sandoz contains lactose. If you have an intolerance to certain sugars, you should consult your doctor before using this medicine.
Tamoxifen Sandoz contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is almost “sodium-free”.
How to use Tamoxifen Sandoz
Always use this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
Your doctor will determine the dose that is right for you. The usual daily dose is 20-40 mg which is taken once a day or is divided into 2 dosing occasions.
The notch is only for you to be able to divide the tablet if you have difficulty swallowing it whole.
If you have used too much Tamoxifen Sandoz
If you have ingested too much medicine or, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you forget to use Tamoxifen Sandoz
If you forget a dose, take it as soon as you remember, then take the next dose at the right time. Do not take a double dose to make up for a missed dose.
If you stop using Tamoxifen Sandoz
Do not stop taking your medication unless your doctor advises you to stop.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
In rare cases, Tamoxifen Sandoz can affect the white blood cells so that the defense against infection deteriorates. If you get an infection with symptoms such as fever with a greatly worsened general condition or fever with local infection symptoms such as sore throat/pharynx/mouth or vomiting, you should see a doctor as soon as possible so that a lack of white blood cells ( agranulocytosis ) can be ruled out via a blood test. It is important that you then have information about your medication.
Stop taking Tamoxifen Sandoz and contact your doctor immediately if you notice any of the following side effects – you may need urgent medical attention:
- Swelling of the face, lips, tongue, or throat, difficulty swallowing or breathing ( angioedema ). Tamoxifen Sandoz can cause or worsen symptoms of hereditary angioedema.
Stop taking Tamoxifen Sandoz and contact your doctor immediately or go to the nearest emergency department if you experience any of the following symptoms:
- Reddish, non-raised, target-like, or round spots on the trunk, often with blisters in the center, scaly skin, and sores in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms ( Stevens-Johnson syndrome and toxic epidermal necrolysis ) – these side effects are rare.
At the beginning of the treatment, some manifestations of the disease may become worse, for example, the pain may increase, and/or the diseased tissue may increase in size. If you also have severe nausea and vomiting, you should contact your doctor. The reason may be that the calcium level in the blood has changed, and your doctor will then need to take certain blood samples.
Very common (may affect more than 1 in 10 users):
- skin rash, fluid retention
- vaginal discharge, vaginal bleeding
- flushing, nausea, fatigue
Common (may affect up to 1 in 10 users):
- hypersensitivity reaction
- headache, dizziness, leg cramps, muscle pain, hair loss, visual disturbances
- blood clots (even in small blood vessels), the impaired blood supply to the brain, and lack of red blood cells ( anemia )
- vomiting, diarrhea, constipation
- vaginal itching, changes in the endometrium
- abnormal sensations (e.g. change in the way things taste and tingling/tingling sensation in the skin)
- increased levels of fat in the blood, abnormally high-fat deposits in the liver, elevated liver values
Uncommon (may affect up to 1 in 100 users):
- cancer of the endometrium, muscle tumor of the uterus
- increased risk of bleeding due to reduced number of blood platelets ( thrombocytes ), reduced number of white blood cells ( leukopenia )
- elevated calcium values in the blood
- inflammation of the lungs with shortness of breath and cough
- inflammation of the pancreas (pain or tenderness in the upper abdomen)
- liver cirrhosis
- hives
Rare (may affect up to 1 in 1,000 users):
- discomfort and/or inflammation-like symptoms in the tumor area
- decreased number of white blood cells ( neutropenia, agranulocytosis )
- endometriosis can cause abdominal pain and menstrual-like bleeding, ovarian cysts, polyps in the vagina, uterine cancer, temporary swelling of the ovaries
- biliary congestion, hepatitis (jaundice), liver failure, tissue death in the liver, liver cell damage
- inflammation of the optic nerve and optic nerve disease (which in a few cases has led to blindness)
- skin and mucous membrane changes (sometimes serious)
- vasculitis
- loss of appetite, fatigue, constipation, anxiety, depression, confusion
Very rare (may affect up to 1 in 10,000 users):
- skin disease with rash and redness (a condition called cutaneous lupus erythematosus)
- porphyria cutanea tarda is a type of metabolic disease porphyria that can cause symptoms such as skin reactions and hypersensitivity to sunlight
- skin inflammation with redness, swelling, and/or blisters on the skin after radiation treatment, so-called radiation dermatitis
See a doctor immediately if you experience sudden weakness and/or paralysis in the arms or legs, sudden difficulty speaking, walking, difficulty holding things, or difficulty thinking. These symptoms can occur due to impaired blood supply to the brain and be signs of a stroke.
How to store Tamoxifen Sandoz
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is tamoxifen citrate equivalent to tamoxifen 20 mg
- Other ingredients are lactose monohydrate, sodium starch glycolate, povidone, microcrystalline cellulose, magnesium stearate, dye titanium dioxide (E171), hypromellose, and macrogol.
Appearance and package sizes of the medicine
Off-white, round, biconvex film-coated tablet, scored on one side.
Pack sizes: 30 and 100 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sandoz A/S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
Haupt Pharma Amareg GmbH, Donaustaufer Strasse 378, 93055 Regensburg, Germany