What Tamoxifen Orifarm is and what it is used for
Tamoxifen Orifarm is a so-called anti-estrogen that prevents the action of natural estrogen.
Tamoxifen Orifarm is used in breast cancer, to treat tumors that are dependent on hormones and estrogen for their growth.
Tamoxifen contained in Tamoxifen Orifarm may also be approved to treat other diseases not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Tamoxifen Orifarm
Do not use Tamoxifen Orifarm
- if you are allergic to tamoxifen or any of the other ingredients of this medicine (listed in section 6).
- if you are breastfeeding.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Tamoxifen Orifarm-
- if you get any unusual vaginal bleeding or other gynecological symptoms (eg pain or pressure over the pelvis) when you are taking or have taken Tamoxifen Orifarm. Contact a doctor immediately, as changes may occur in the lining of the uterus (endometrium), and some of them may be serious changes.
- 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.
Menstruation may not occur in women who have not undergone menopause.
In so-called late breast reconstruction (surgery performed some time after the first breast surgery to recreate a breast), tissue is moved to the breast from somewhere else on the body. Use of tamoxifen can then increase the risk of blood clots in the small vessels in the moved tissue , which can lead to complications.
If you are admitted to hospital, tell the healthcare staff that you are taking Tamoxifen Orifarm.
Other medicines and Tamoxifen Orifarm
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. It is especially important to tell the doctor if you are taking:
- paroxetine , fluoxetine (for depression)
- bupropion (for depression or for smoking cessation)
- quinidine (used, among other things, in the treatment of cardiac arrhythmias )
- cinacalcet (for diseases of the parathyroid gland)
Concomitant use of these drugs should be avoided, as the effect of Tamoxifen Orifarm may be reduced.
Also inform 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 .
Tamoxifen Orifarm with food and drink
Tamoxifen Orifarm can be taken regardless of meals.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Do not use Tamoxifen Orifarm 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 taking Tamoxifen Orifarm or within 2 months of stopping treatment. Birth control pills should not be used as contraception.
Breast-feeding
Tamoxifen Orifarm should not be used during breastfeeding. It is not known whether Tamoxifen Orifarm passes into breast milk.
Driving ability and use of machinery
Tamoxifen Orifarm is unlikely to affect your ability to drive or use machines. However, fatigue has been reported with the use of tamoxifen and while fatigue persists caution must be exercised when driving or operating machinery.
You yourself are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or 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 Orifarm contains lactose
Tamoxifen Orifarm contains lactose . If you have an intolerance to certain sugars, you should consult your doctor before taking this medication.
How to take Tamoxifen Orifarm
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
The recommended daily dose is 20-40 mg taken once a day, or divided into two doses. Take the medicine at the same time every day.
The tablet can be divided into two equal doses .
If you have taken too much Tamoxifen Orifarm
Overdose can produce anti-estrogenic effects. If you have ingested too much medicine or if, 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 take Tamoxifen Orifarm
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 have any further questions about this medicine, ask your doctor, pharmacist or nurse.
Possible side effects
Like all medicines, Tamoxifen Orifarm can cause side effects , but not everybody needs them.
Stop taking Tamoxifen Orifarm and contact your doctor immediately if you experience any of the following symptoms ( angioedema ):
- swelling of the face, tongue or throat
- difficulty swallowing
- hives and difficulty breathing.
Stevens-Johnson syndrome
An extremely strong allergic reaction with a skin rash usually in the form of blisters or sores in the mouth and eyes as well as other mucous membranes such as the genitals.
Tamoxifen Orifarm 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 inform about your medication.
Contact a doctor if you experience any of the side effects mentioned in section 2 under the heading “Warnings and precautions”
Other side effects ar
Very common (may affect more than 1 in 10 users):
Flushing, fluid retention, menstrual-like bleeding, vaginal discharge, nausea, rash, fatigue.
Common (may affect up to 1 in 10 users):
Headache, dizziness, abnormal sensations (e.g. change in the way things taste and tingling/tingling sensation in the skin), blood clots (even in small blood vessels), anemia , vomiting, diarrhea, constipation, discomfort and/or inflammation-like symptoms in the tumor area, hair loss, genital itching, changes in the lining of the uterus, reduced number of red blood cells , impaired blood supply to the brain, hypersensitivity reaction (such as hives), vision and eye changes, increased liver values, abnormally high fat deposits in the liver, increased levels of fat in the blood, leg cramps, muscle pain.
Uncommon (may affect up to 1 in 100 users):
Inflammation of the lungs with shortness of breath and cough, cancer of the endometrium, muscle knots in the uterus, temporary increased risk of bleeding due to a reduced number of blood platelets ( thrombocytes ), reduced number of white blood cells , increased calcium levels in the blood, inflammation of the pancreas (pain or tenderness in the upper part of the abdomen) , hives , liver cirrhosis.
Rare (may affect up to 1 in 1,000 users):
Swelling of the ovaries, uterine cancer, ovarian cysts, polyps in the vagina, inflammation of the liver, liver cell damage, liver failure, liver cell death, optic nerve disease and inflammation of the optic nerve (which in a few cases led to blindness), endometriosis which can cause abdominal pain and menstrual-like bleeding. Skin and mucous membrane changes (sometimes serious).
The following side effects have been reported as rare with other tamoxifen preparations:
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 (condition called cutaneous lupus erythematosus), porphyria cutanea tarda which is a type of the 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 therapy so-called radiation dermatitis.
How to store Tamoxifen Orifarm
Keep this medicine out of the sight and reach of children.
Store in the original packaging. Light sensitive.
Use before the expiry date stated on the packaging after EXP. The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among 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 , magnesium stearate, sodium starch glycolate, povidone, microcrystalline cellulose and potato starch.
Appearance and package sizes of the medicine
White or off-white, round, flat tablet with beveled edges, debossed ZT 20 on one side and scored on the other side, diameter 10 mm. The tablet can be divided into two equal doses .
Pack sizes: 14, 20, 21, 28, 30, 35, 40, 42, 50, 56, 60, 63, 91, 98, 100, 105 or 110 tablets.
Not all pack sizes may be marketed.
Orifarm Generics A/S
Energivej 15
5260 Odense S
Denmark
Local representative :
Orifarm Generics AB
Box 56048
102 17 Stockholm
info@orifarm.com