|
COMPOSITION
Each tablet contains:
Tamoxifen citrate, 30.40 mg. (equivalent to 20 mg. Tamoxifen).
Excipients: dicalcium phosphate dihydrate, povidone (Kollidon 25), sodium starch glycollate (Primojel), magnesium stearate, colloidal silica (Aerosil 200), microcrystalline cellulose (Avicel PH 101).
ACTIVITY
Tamoxifen is a non-steroidal anti-oestrogen, it lacks androgenic properties.
CONTRAINDICATIONS
Tamoxifeno ratiopharm is contraindicated in patients with known hypersensitivity to tamoxifen.
PRECAUTIONS
Regular blood analyses are recommended specially in patients with high cholesterol and high triglyceride levels and low level of white blood cells and low platelet level. Serum calcium should also be controlled regularly.
Tell your doctor immediately if you experience abnormal vaginal bleeding any time during or after the treatment.
MEDICAMENTOSUS INTERACTIONS
When Tamoxifeno ratiopharm is used in combination with coumarin-type anticoagulants, a significant increase in anticoagulant effect may occur. Where such co-administration is initiated, careful monitoring of the patient is recommended.
WARNINGS
Pregnancy and lactation: Tamoxifeno ratiopharm must not be administered during pregnancy. Premenopausal patients must be carefully examined before commencing treatment to exclude the possibility of pregnancy. Use of a contraceptive method is recommended during treatment so as to avoid pregnancy.
It is not known if tamoxifen is excreted in human milk and therefore the medicine is not recommended during lactation. The decision either to discontinue nursing or discontinue Tamoxifeno ratiopharm should take into account the importance of the medicine to the mother.
Use in children: Tamoxifeno ratiopharm is not indicated for use in children.
Effect on ability to drive and operate machinery: There is no evidence that tamoxifen results in impairment of these activities.
POSOLOGY
Adults (including the elderly): The dosage range is 20 to 40 mg. daily given in either divided doses of 10 or 20 mg. twice daily or as a single daily dose of 20 or 40 mg. once daily.
OVERDOSAGE
Acute overdosage in humans has not been reported. On theoretical grounds an overdosage would be expected to cause an enhancement of the anti-oestrogenic side effects. Animal studies have shown that extreme overdosage (100 to 200 times the recommended daily dose) may produce oestrogenic effects. There is no specific antidote to overdosage and treatment must therefore be symptomatic.
In the case of an overdose or accidental ingestion, immediately consult the local poison control centre and indicate the product and amount taken.
ADVERSE REACTIONS
In a proportion of pre-menstrual women treated with tamoxifen, suppression of menstruation and cystic ovarian swelling have occasionally been observed.
A small number of patients, in which the condition also affects their bones, developed increased serum calcium concentrations.
Other reactions include hot flushes, vaginal bleeding (see Precautions), vaginal discharge and pruritus vulvae or more general side effects such as gastrointestinal intolerance, tumour flare, confusion, skin rash and occasionally fluid retention and alopecia may occur.
When such side effects are severe, it may be possible to control them by a simple reduction of dosage without loss of control of the disease. If side effects do not respond to this measure, it may be necessary to stop the treatment.
Temporary reductions in platelet count have been observed during treatment with tamoxifen in some patients. The platelet counts have recovered during treatment and no haemorrhagic tendency has been reported.
A number of cases of visual disturbances, including reports of corneal changes, cataracts and retinopathy have been described in patients receiving tamoxifen therapy. On rare occasions tamoxifen has been associated with changes in liver enzyme levels and on occasions with a spectrum of more severe liver abnormalities, including fatty liver, cholestasis and hepatitis.
If you experience any other adverse affect not mentioned above, consult your doctor or pharmacist.
EXPIRY
Do not use this product after the expiry date printed on the carton.
ALL MEDICATIONS MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN.
/ BUY TAMOXIFEN /
|
|
CONTACT INFORMATION
