Tamoxifen Creative Pharma Solutions 20 mg compr.

Adjuvant therapy after the first line of breast cancer – metastatic breast cancer.

In adult men, Tamoxifen Creative Pharma Solutions is indicated for the prevention of gynecomastia and masalgia caused by the administration of antiandrogens in monotherapy in the treatment of advanced prostate cancer.

In general, the dose is between 20 and 40 mg tamoxifen, daily. Usually a dose of 20 mg tamoxifen is sufficiently effective.

In the prophylaxis of gynecomastia and masalgia caused by the administration of antiandrogens in monotherapy in the treatment of advanced prostate cancer: 20 mg once a day.

In the adjuvant treatment of breast cancer with positive hormonal receiver, the therapy is currently recommended for a period of at least 5 years. The optimum duration of Tamoxifen therapy remains to be evaluated.

Children and teenagers

It is not recommended to use Tamoxifen Creative Pharma Solutions in children and adolescents, because effectiveness and safety have not yet been established (see PCT. 4.3)

Administration method

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The Tamoxifen Creative Pharma Solutions tablet must be swallowed up whole, unmixed, with a sufficient amount of liquid (eg, 1 glass of water) during the meal.

Tamoxifen Creative Pharma Solutions therapy is usually a long -term one and should only be performed by experienced oncologists.

When adverse reactions are severe, they may be controlled by a simple dose reduction, without influencing the response to treatment. It is necessary to request specialized tips to properly assess the need to continue or suspend treatment or any changes in treatment.

• Hypersensitivity to Tamoxifen or any of the excipients listed to the pt. 6.1
• Children should not be treated with Tamoxifen Creative Pharma Solutions
• Tamoxifen Creative Pharma Solutions should not be given during pregnancy and breastfeeding (see PCT. 4.6).

In case of severe thrombocytopenia, leukopenia or hypercalcemia, careful evaluation of the therapeutic benefit/potential risk for each patient is required and, in case of prescription, careful medical supervision is required. Periodic monitoring of the number of blood cells, including platelets is recommended.

In women in premenopausal period, suppression of menstruation may occur, but this does not affect the antimalign activity of the drug.

During the administration of Tamoxifen Creative Pharma Solutions, the number of blood cells, serum calcium and liver functions should be monitored regularly. It is also necessary to evaluate the serum value of triglycerides.

During treatment with Tamoxifen, an increased incidence of endometrial changes, including hyperplasia, polyps, carcinoma and uterine sarcomas (usually Müllerian tumors) has been reported. Causes of vaginal bleeding in the postmenopausal period and irregular premenopausal bleeding should be investigated immediately. The incidence and spectrum of these changes suggest a basic mechanism related to properties similar to estrogen of tamoxifen. Patients who are not hysterectomized should undergo an annual gynecological examination for observing endometrial changes. In patients with tumor metastases, the doctor must decide on the frequency of examinations.

In clinical trials, after treatment with Tamoxifen, isolated cases of other secondary tumors have been reported, in areas other than the endometrium and in the contralateral breast. A causal relationship has not been established, and the clinical significance of these observations is not clear.

Thromboembolism venous / pulmonary thromboembolism (TEV / EP)

• In healthy women treated with Tamoxifen, a 2-3 times increase in TEV risk (see PCT. 4.8). The 5 -year risk of EP was 1.2% for women treated with Tamoxifen and 0.50% for women not treated with Tamoxifen.
• • In patients with breast cancer, prescribing doctors must obtain the detailed history of the personal and family history of the patient. If a protrombotic risk is suggested, patients should be under investigations for thrombophilic factors. Patients with positive test for thrombophilic factors should be advised on thrombotic risk. The decision to use tamoxifen in these patients should be based on the overall risk of the patient. In selected patients, the use of tamoxifen together with prophylactic anticoagulant treatment may be justified (see also. 4.5). The use of tamoxifen is not recommended for the adjuvant treatment of in situ ductal carcinoma in women who require concomitant anticoagulant therapy or who have a deep venous thrombosis or pulmonary embolism.
• Severe obesity, old age and other risk factors for TEV increase the risk of TEV. Risks and benefits should be carefully considered for all patients before starting treatment with tamoxifen. In patients with breast cancer, the risk is increased by concomitant chemotherapy (see PCT. 4.5). Long-term anti-coagulant prophylaxis may be justified for some breast cancer patients who have multiple risk factors for TEV.
• Ciurgical intervention and immobilization: for breast cancer patients and for patients who are given Tamoxifen to prevent gynecomastia, Tamoxifen treatment should only be discontinued if the risk of Tamoxifen induced thrombosis clearly exceeds the risks associated with treatment. All patients should benefit from appropriate prophylactic measures against thrombosis, which should include graded compression stockings for the hospitalization period, early mobilization, if possible anti-coagulant treatment.
• If any patient presents TEV, the administration of Tamoxifen should be stopped immediately and the appropriate anti -rombose measures should be initiated. In patients treated with tamoxifen for breast cancer and in patients using tamoxifen to prevent gynecomastia, the decision to start again treatment with Tamoxifen should be taken into account taking into account the general risk for the patient. In patients with selected breast cancer, the continuation of the use of tamoxifen may be justified, along with the prophylactic administration of anticoagulant.
• All patients should be advised to contact the attending physician immediately, if they find any of the following symptoms: facial numbness or weakness in the arms or legs and speech or vision difficulties, which could indicate a stroke. Similarly, patients should be advised to contact the doctor in case of chest pain or dyspnoea, which could be symptoms of pulmonary embolism or in case of abdominal pain or abnormal bleeding, which may indicate uterine cancer. Also, in case of cough and dyspnoea, which could be symptoms of interstitial pneumonia, patients should be trained to inform their doctor. Patients should be asked if they have a history of stroke, events similar to stroke, thromboembolic events or uterine cancer.

At the beginning of Tamoxifen treatment an ophthalmological examination should be performed.

If vision changes occur during Tamoxifen therapy, an ophthalmological examination should be performed immediately, as some changes that are detected in the early stages will be remitted after cessation of therapy.

In the case of a late microsurgical mammary reconstruction, tamoxifen may increase the risk of microvascular complications.

In the literature it has been shown that slow metabolizers through CYP2D6 (cytochrome P450) have a lower plasma concentration of endoxofen, one of the most important active metabolites of tamoxifen (see.5.2).

Concomitant administration with CYP2D6 inhibition drugs may decrease the plasma concentrations of the active metabolite, endoxifen. Therefore, concomitant administration of potent inhibitors of CYP2D6 (eg paroxetine, fluoxetine, quinacin, cinquery or bupropion) should be avoided when possible during treatment with tamoxifen (see PCT.4.5 and 5.2).

The decision to initiate Tamoxifen treatment in patients with in situ carcinoma should be discussed with patients, to evaluate with them potential risks and benefits.

Using Tamoxifen Creative Pharma Solutions can cause positive results in anti -doping tests.

Patients with rare hereditary disorders of galactose intolerance (total lactase deficiency or glucose-galactose malabsorption) should not use this medicine.

Children and teenagers

In an uncontrolled study, conducted in 28 little girls, between the ages of 2 and 10 years with McCune Albright syndrome, the daily administration of Tamoxifen 20 mg, for up to 12 months, has increased the average uterine volume after 6 months of treatment and it doubled at the end of a year of treatment. While these determinations are in accordance with the pharmacodynamic properties of Tamoxifen, a causal relationship could not be identified (see PCT. 5.1).