What Tamoxifen Mylan is and what it is used for
Some tumors are dependent on the hormone estrogen for their growth. Tamoxifen Mylan is a so-called anti-estrogen that prevents the action of natural estrogen.
Tamoxifen Mylan is used in breast cancer.
What you need to know before taking Tamoxifen Mylan
Do not take Tamoxifen Mylan
- if you are allergic (hypersensitive) to tamoxifen or any of the other ingredients in Tamoxifen Mylan).
- if you are breastfeeding.
Warnings and precautions
Talk to your doctor or pharmacist before taking Tamoxifen Mylan:
- If you have hereditary (inherited) angioedema because Tamoxifen Mylan may 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.
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 (such as pain or pressure over the pelvis) while you are taking or have taken Tamoxifen Mylan.
At the beginning of the treatment, some manifestations of the disease may become worse, e.g. 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 content in the blood has changed, and the doctor should then take certain blood samples.
Talk to your doctor if you think you have any of these or other problems with your medication.
Stop taking Tamoxifen Mylan and contact your doctor immediately if you experience any of the following symptoms ( angioedema ):
- You find it difficult to breathe
- You get swelling of the face, lips, tongue, and/or throat which can make swallowing difficult
- You get hives
If you are admitted to the hospital, tell the healthcare staff that you are taking Tamoxifen Mylan.
Tamoxifen Mylan can in rare cases 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.
In so-called late breast reconstruction (surgery that is done 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 Mylan 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 Mylan. Stop taking Tamoxifen Mylan 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 Mylan
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.
You must inform the doctor that you are taking:
- paroxetine, fluoxetine (for depression)
- bupropion (for depression or smoking cessation)
- quinidine (used, among other things, in the treatment of cardiac arrhythmias )
- cinacalcet (for the treatment of diseases of the parathyroid gland)
Concomitant use of these medicines should be avoided, as the effect of Tamoxifen Mylan may be reduced.
Also, inform the doctor if you are taking:
- 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.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Do not use Tamoxifen Mylan during pregnancy. There is a certain risk that the fetus will be affected. Before starting treatment, pregnancy must be ruled out. You should not become pregnant while taking Tamoxifen Mylan 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 or for advice on contraception.
It is not known whether Tamoxifen Mylan passes into breast milk. Tamoxifen Mylan should not be used during breastfeeding. Therefore, talk to your doctor before using Tamoxifen Mylan while breastfeeding.
Driving ability and use of machinery
Tamoxifen Mylan is unlikely to affect your ability to drive or use machines. However, fatigue has been reported with the use of Tamoxifen Mylan 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 Mylan contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is almost ‘sodium-free’.
How to take Tamoxifen Mylan
Always take Tamoxifen Mylan as directed by your doctor. 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. Take the medicine at the same time every day. Ask your doctor or pharmacist if you are unsure.
If you have taken too much Tamoxifen Mylan
Overdose can produce anti-estrogenic effects. If you have ingested too much medicine, always contact your doctor or the nearest hospital for an assessment of the risk and advice.
If you forget to take Tamoxifen Mylan
If you forget a dose, take it as soon as you remember, then take the next dose at the right time. Do not take 2 doses at the same time
If you stop taking Tamoxifen Mylan
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, Tamoxifen Mylan can cause side effects, although not everybody gets them.
Stop taking Tamoxifen Mylan 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 are preceded by fever and flu-like symptoms ( Stevens-Johnson syndrome and toxic epidermal necrolysis ) – these side effects are rare.
- Swelling of the face, lips, tongue, or throat, difficulty swallowing or breathing ( angioedema ). Tamoxifen Mylan can cause or worsen symptoms of hereditary angioedema.
Very common (affects more than 1 in 10 users) :
Flushing, fluid retention, menstrual-like bleeding, vaginal discharge, nausea, rash, fatigue.
Common (affects more than 1 in 100 users):
Headache, dizziness, abnormal sensations (e.g. change in the way things taste and tingling/tingling sensation in the skin), anemia, blood clots (even in small blood vessels), vomiting, diarrhea, constipation, hair loss, vaginal itching, changes in the lining of the uterus, worsened blood supply to the brain, leg cramps, increased liver values, increased levels of fat in the blood, hypersensitivity reaction, vision and eye changes, abnormally high-fat deposits in the liver, muscle pain.
Uncommon (affects less than 1 in 100 users ):
Cancer of the lining of the uterus, muscle knots in the uterus, increased risk of bleeding due to reduced number of blood platelets ( thrombocytes ), reduced number of white blood cells ( leukopenia ), inflammation of the pancreas (pain or tenderness in the upper part of the abdomen), hives, liver cirrhosis, inflammation of the lungs with shortness of breath and cough, increased calcium levels in the blood.
Rare (affects less than 1 in 1,000 users):
Transient swelling of the ovaries, uterine cancer, ovarian cysts, polyps in the vagina, discomfort and/or inflammation-like symptoms in the tumor area, skin and mucosal changes (sometimes severe), vasculitis, reduced number of white blood cells ( neutropenia, agranulocytosis see Warnings and precautions), biliary congestion, liver inflammation, liver cell damage, liver failure, liver cell death. Endometriosis can cause pain in the stomach and menstrual-like bleeding. Optic nerve disease and inflammation of the optic nerve (which in a few cases has led to blindness).
The following side effects have been reported as rare with other tamoxifen preparations: Loss of appetite, fatigue, constipation, anxiety, depression, confusion, and uterine cancer.
Very rare (affects less than 1 in 10,000 users):
Skin disease with rash and redness (a condition called cutaneous lupus erythematosus). Porphyria cutanea tarda which is a type of metabolic disease porphyria that can cause symptoms such as skin reactions and hypersensitivity to sunlight. Skin inflammation with red 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.
If any of the side effects get worse or if you notice any side effects not mentioned in this information, contact your doctor or pharmacist.
How to store Tamoxifen Mylan
Store in the original packaging. Light sensitive.
Store out of 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.
The medicine must not be thrown into the drain or among the household waste. Ask the pharmacist how to deal with 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 corresponding to tamoxifen 20 mg per tablet.
- Other ingredients are mannitol, corn starch, magnesium stearate, croscarmellose sodium
Appearance and package sizes of the medicine
The tablet is white and curved with a diameter of 9.5 mm. The tablet has a score and is marked TN/20 on one side and G on the other side.
Package size:
100 tablets
Marketing Authorisation Holder
Mylan AB
Box 23033
104 35 Stockholm
Manufacturer
Delpharm Lille SAS
Parc d’activités de Roubaix Est
22 Rue de Toufflers
CS50070
59452 Lys Lez Lannoy
France
Mylan Hungary Kft./Mylan Hungary Ltd.
Mylan utca 1.,
Komárom, 2900,
Hungary