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3. HOW IS TAMOPLEX TAKEN?
Posology and method of use
Unless your physician prescribes otherwise, use as follows:
2 - 4 tablets of 10 mg per day (= 24 hours), or
1- 2 tablets of 20 mg per day, or
1 tablet of 30 mg per day, or
1 tablet of 40 mg per day.
Take the tablets with an ample amount of water (one glass).
Tell your physician if you have previously been treated with cancer drugs
or if you have received radiation therapy.
What should you do if too much Tamoplex has been used
If you have taken too much Tamoplex, you should contact your physician or
pharmacist immediately. Symptoms that could occur after long-term use of a too
high dose are: dizziness, trembling, a stronger reaction than normal to stimuli
(hyperreflection), co-ordination problems (ataxia), for instance walking as if
you are intoxicated, seizures/spasms (convulsions), cardiac arrhythmia and
depressed breathing. In serious cases your physician will get you to vomit and possibly perform gastric lavage.
What you should do if you forgot to use Tamoplex
If you forget a dose or suddenly discontinue the use of this medicinal product,
the symptoms that existed before the start of this treatment could re-occur.
If you miss a dose, take the tablet as soon as possible. However, if it is almost
time for the next dose,-skip-the missed dose-and go back to your normal dosing schedule.
Do not take two doses at once. If you are not sure what to do, ask your doctor or pharmacist.
Effects that can be expected if treatment with Tamoplex is discontinued
When the use of this medicinal product is suddenly discontinued the symptoms
that existed before the start of this treatment could re-occur.
You should not discontinue this medicinal product suddenly without consulting your physician.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS ?
Like all medicines Tamoplex can have side effects.
The following side effects could occur:
Blood
- disorders in the blood, such as a
reduction in the number of white blood cells (leukopenia / neutropenia) and/or a
reduction in the number of platelets (thrombocytopenia) (this is known by unexpected haemorrhaging and/or bruising).
Nutrition and metabolism
- Often (between 1 and 10% of the users)
an increase of the amount of fat in the blood (hypertriglyceridemia). Sometimes also
an infection of the pancreas occurs (pancreatitis) (see also the section "Warnings and precautions")
- Too much calcium in the blood (hypercalcemia) (see also the section "Warnings and precautions")
Psychic disorders
- depression
Nervous system
- light headedness
-dizziness
- headache
Eye
- eye disorders, such as cloudy vision
(see also the section "Warnings and precautions")
Circulation
- perspiring and hot flashes
- thrombosis, blood clot in the lungs
(lung embolism), blood clot in the brain (cerebral embolism)
Gastro-intestinal
- gastro-intestinal disorders, such as nausea and vomiting
Liver or gall
- liver disorders
Skin
Immediately discontinue the use of
tamoplex if one of the following side effects occurs and contact your physician
immediately or go the emergency room of a nearby hospital.
- Serious skin disorders, amongst
which a serious hypersensitivity reaction with a (high) fever, red blotches on
the skin, joint pain and/or eye infection (Stevens-Johnson syndrome).
- Skin rash with irregular red blotches
(erythema multiforme) and blister forming under the skin or mucous membranes (bullous pemphygoid).
- Hypersensitivity reactions
(amongst which sudden fluid retention in the skin and mucous membranes
(for instance throat or tongue), difficulty breathing and/or itching and -skin rashes,
often an allergic reaction (angio-neurotic oedema).
The above mentioned reactions are very serious side effects. In case these
reactions occur in you it is possible that you have a serious allergic reaction
to Tamoplex. You'll need urgent medical care or be admitted to the hospital.
These very serious side effects rarely occur.
Further the following less serious side effects of the skin could occur:
- skin rash
- hair loss
Muscles and bones
- mild joint pain and infections in the joints
Sexual organs and breasts
- abnormal vaginal blood loss
- vaginal discharge
vaginal itching and/or irritation
- irregular menses or even total
suppression of the menstruation in women
before menopause
- certain disorders in the uterine mucous membrane particularly an excessive
growth of the mucous membrane in the uterus, polyps (benign tumours) and
malignant tumours. According to current information the risk of malignant
tumours of the uterine mucous membrane is two to four times higher with
long-term use of Tamoxifen. See also the section "Warnings and precautions"
- benign tumours of the uterus have been observed (fibromyoma)
- cyst (blister or cavity that can be filled with a liquid) in the ovaries
Generally
- fatigue
- fluid retention
- tumour flare up (see also the section "Warnings and precautions")
Notify your physician or pharmacist if you experience one of the above mentioned side effects as serious or if you have a side effect not mentioned in this leaflet.
5. HOW TO STORE TAMOPLEX
Store below 25 °C
Always keep medicines out of the reach and sight of children.
Expiration date
Do not use Tamoplex after the
date mentioned on the package after "Do not use after" or "exp.". The first
2 numbers indicate the month, the last numbers indicate the year.
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