Tamoxifen, tablets – updated prospectus

Tamoxifen citrate tablets USP 20mg Taj Pharma scaled

Tamoxifen, tablets

Metastatic breast carcinoma; breast carcinoma therapy.

Doses and method of administration
The following indications will be respected, if your doctor. will not recommend otherwise. Please respect the use information, for the action of the Tamoxifen 10 hexal drug to be the one expected. Generally the dose is between 2-4 film-coated tablets (20-40 mg Tamoxifen). In the long -term therapy, 3 film -coated tablets (30 mg Tamoxifen) are recommended as usual dose. Filmed tablets will be taken with a little liquid in the morning and in the evening during the meal. Treatment with tamoxifen 10 hexal is long lasting. Its duration is deciding the attending physician.

One film-coated tablet contains 15.2 mg tamoxifen-dihydrogencite, corresponding to 10 mg or 20 mg tamoxifen. Other components: cellulose, hyromelosis, lactose, magnesium stearate, manitol, pole starch (o-carboxy-methyl) sodium, polyptionon, dye E 171.

Therapeutic action
Estrogens can favor the appearance and development of breast cancer. Some types of breast cancer are classified as having estrogen receiver, thus being sensitive hormone. These types of cancers need estrogen to develop. Tamoxifen also called selective modulator of estrogen receptor acts by binding this receiver by blocking the action of estrogen. It is useful only on cancer cells that have this receptor type, so it is necessary to determine the receiver before starting treatment. If in the cancer cells it acts as an antagonist in the other types of cells in the body acts as an estrogen agonist, and can be used as an antiososoporotic treatment.

Is contraindicated to administer tamoxifen 10 hexal during pregnancy. Below the situations are described when, under certain conditions and only with great care can be given Tamoxifen 10 hexal. That’s why you need to consult your doctor. This is true even if you used this medicine before. At a massive reduction of platelets (thrombocytopenia) and leukocytes (leukopenia) as well as the case of serum calcium increase will be given tamoxifen 10 hexal only subject to the assessment of the benefit/risk relationship. If Tamoxifen 10 hexal is prescribed under these conditions, special medical supervision is required.

Pregnancy and breastfeeding: Tamoxifen 10 hexal is not given during pregnancy. Therefore, before starting treatment with Tamoxifen 10 hexal, the possibility of a task should be excluded. During treatment, non -tormonal contraceptive methods will be used to avoid pregnancy. Dependent on risk/benefit assessment for mother, breastfeeding or treatment with tamoxifen 10 hexal. Precautionary measures during treatment: periodic control of calcium level, number of platelets and leukocytes as well as liver function is absolutely necessary.

Side effects
During the use of tamoxifen 10 hexal, dizziness, nausea, vomiting, uterine bleeding, leukorrhea, calves, erythema (erythema multiform, stevens-johnson syndrome, pemphigus, hyperthermia, edema, vulvar pruritus, changes in hepatic enzymes, as well as heparous, Passenger reduction in the number of platelets and leukocytes. In patients who are going to enter menopause, menstrual cycle disorders may occur until it stops. Occasionally the inflammations of the ovaries (ovarian cysts) were observed. Rarely, at the beginning of treatment, joint pain and pain in the sick tissue may occur. Very rarely observed in patients with tumors in bone an increase in serum calcium. Also, in isolated cases, serious disorders of liver functions are observed (eg. biliary dyskinesia, liver inflammation, hepatitis, liver steatosis). Inflammation of the veins, the onset of venous or arterial thrombosis and thrombo-eombols, especially in the case of association with antibiotics have also been observed. It is known that in patients with malignant diseases thrombombolus appears. Since, in isolated cases uterine inflammation, uterine polyps and uterine tumors are discovered on the occasion of Tamoxifen treatment, the cause of post-humanopausal bleeding or menstrual bleeding should be well established before menuPause. In few cases, vision disorders (opacification, corneal tissue changes, retinal disorders, optical nerve inflammation) appear in patients with long -term treatment, sometimes they occur at normal doses after a few weeks of treatment. In one case, an exaggerated decrease in leukocytes with massive hepatic cells has been reported. If you notice side effects that are not mentioned in the prospect, please communicate to your doctor or pharmacist. In case of side effects mentioned above, treatment is interrupted. Please inform your doctor so that he can decide on their severity and take the necessary measures.


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