Contents
Tamoxifen Sandoz is a non-steroidal anti-estrogen drug used in the treatment of breast cancer. The active substance of the drug is tamoxifen, which inhibits the binding of estrogens to hormones in the cytoplasm, thus limiting the cell division in tissues. Tamoxifen is well absorbed from the gastrointestinal tract and is extensively metabolized. The medicine is in the form of film-coated tablets and can only be obtained with a prescription.
Tamoxifen Sandoz, Producent: Sandoz/Lek Polska
form, dose, packaging | availability category | the active substance |
coated tablets; 20 mg; 30 tablets | prescription drug | tamoxifen |
Action
Tamoxifen Sandoz is a non-steroidal anti-estrogenic drug, the active substance of which is tamoxifen. This substance inhibits the binding of estrogens to hormones in the cytoplasm.
Tamoxifen Sandoz – indications for admission
Tamoxifen Sandoz intended for the treatment of:
- adjuvant treatment after primary breast cancer treatment,
- advanced metastatic breast cancer.
Tamoxifen Sandoz and contraindications
Contraindications to taking Tamoxifen Sandoz are:
- allergy to any ingredient of the preparation,
- severe thrombocytopenia,
- leukopenia or hyperkalaemia (individual benefit-risk assessment is recommended),
- pregnancy period,
- the period of breastfeeding.
Tamoxifen Sandoz – dosage
Tamoxifen Sandoz is in the form of film-coated tablets and is intended for oral use. The preparation should be taken with a meal, swallowed whole. Do not exceed the recommended dose as it may endanger your life or health.
- Usually 20 mg / day, if needed, the dose can be increased to 40 mg / day. A treatment duration of at least 5 years is recommended in the adjuvant treatment of early breast cancer with estrogen receptor positive tumor diagnosis.
Tamoxifen Sandoz – warnings
- Women taking the preparation should use an effective method of contraception while taking the drug, and for 2 months after the end of the treatment.
- See your doctor if you experience any of the following symptoms in premenopausal women: vaginal bleeding, irregular bleeding, vaginal discharge, pelvic pressure sensation or pelvic pain. Your doctor will decide what to do next.
- During tamoxifen treatment, patients with an intact uterus are required to undergo gynecological examination every year for changes in the mucosa.
- The doctor decides how often to examine patients with metastatic tumors.
- An ophthalmological examination should be performed at the beginning of treatment with the preparation. This is necessary as visual disturbances may occur during the use of the drug.
- A 2-3 fold increase in the risk of venous thromboembolism may occur while taking the drug. The risk is increased in the following situations: obesity, old age, and the simultaneous use of chemotherapy. Consult your doctor if you experience any symptoms of venous disease.
- Healthy patients taking Tamoxifen Sandoz should have regular blood counts along with platelets, liver function and serum calcium levels.
- Tamoxifen Sandoz may contain lactose, therefore people with galactose intolerance, primary lactase deficiency or malabsorption of glucose-galactose should not take it.
Tamoxifen Sandoz with other drugs
- The use of tamoxifen with other hormones that contain oestrogens (e.g. oral contraception) may reduce each other’s effect.
- The use of drugs that inhibit platelet aggregation with this medicine may lead to a greater likelihood of bleeding or the thrombocytopenia phase.
- Simultaneous administration of anticoagulants (coumarin, warfarin) may prolong prothrombin time and coagulation disorders (coagulation parameters should be monitored, especially in the initial phase of treatment).
- Plasma levels of tamoxifen and the weakening of its action arise during the simultaneous use of aminoglutethimide.
Tamoxifen Sandoz – side effects
While taking Tamoxifen Sandoz:
- Very common the following may occur: hot flushes, partly due to the anti-estrogenic effect of tamoxifen, vaginal discharge and itching, vaginal bleeding (in premenopausal patients very common cycle disturbances up to complete amenorrhea);
- common symptoms: in the initial period of treatment, bone pain and pain in the area of the affected tissue, fluid retention, increased serum triglyceride levels, somnolence, headache and depressed mood, visual disturbances, only partially reversible, often caused by cataracts, corneal opacity and / or retinopathy, deep vein thrombosis of the lower limbs, pulmonary embolism, especially in combination with chemotherapeutic drugs, nausea, alopecia;
- uncommon the following may occur: hypercalcaemia, especially at the beginning of treatment in patients with bone metastases, vomiting;
- rarely may occur: changes in blood cell counts such as transient anemia, leukopenia and transient thrombocytopenia, changes in liver enzymes and fatty liver, cholestasis, hepatitis and jaundice, hypersensitivity reactions including angioedema, rash, uterine fibroids, ovarian cysts;
- very rarely the following may occur: severe neutropenia and pancytopenia, severe hypertriglyceridaemia, partly with pancreatitis, interstitial pneumonia, agranulocytosis associated with hepatic necrosis, erythema multiforme, Stevens-Johnson syndrome or pemphigus.