Nolvadex 10mg tablets Astrazeneca treat breast cancer (3 blisters x 10 tablets)

Common (≥1/100 to

benign, malignant and non -specific (including cysts and polips): uterine fibroids.

Blood disorders and lymphatic systems: Anemia.

immune system disorders: Hypersensitivity reaction.

Nervous system disorders:

Bone and bond muscle disorders:

Many systems of organs: vasodilation thrombosis (including deep vein thrombosis, microelectric thrombosis and pulmonary embolism).

rarely (≥1/1000 to

benign, malignant and nonspecific (including cysts and polips): endometrial cancer.

Blood disorders and lymphatic systems:

Eye disorders: visual disorders .

Respiratory, chest and mediastinum disorders: interstitial pneumonia.

Gastrointestinal disorders: pancreatitis .

Liver disorders: cirrhosis.

rare (≥1/10000 to

Healthy, malignant and non -specific (including cysts and polips):

Skin and subcutaneous tissue disorders: Lupus skin erythematosus b.

gene disorders, family -style; congenital: Porphyrin metabolic disorders b.

Complications due to narrative, damage, toxicity: Serious skin reactions due to radiation therapy b.

A: The side effect is not reported in the Tamoxifen branch of the aforementioned study (n = 3094); However, this reaction has been reported in engraving tests or from other sources. The frequency is calculated according to the upper limit of the 95% confidence in the estimates (based on 3/x, x is the sum size, as 3094). The frequency is calculated as 3/3094 equivalent to the rare frequency classification.

B: Not observing events in other main clinical studies. The frequency is calculated according to the upper limit of 95% confidence in the estimates (based on 3/x, x is the total sample size of 13,357 patients in the main clinical studies). The frequency is calculated as 3/13.357, equivalent to the very rare frequency classification.

Nolvadex side effects can be classified according to the pharmacological effects of the drug such as hot face, vaginal bleeding, vaginal discharge, vulva itching and tumor outbreak or general adverse effects such as digestive disorders, headache, dizziness and less common body fluid fluid and hair loss.

When these side effects are severe, it can be treated by reducing the dose (to the extent that not less than 20 mg/day) without affecting the control of the disease. If the side effects do not decrease when reducing the dose, may need to stop therapy.

Skin rash (including dangerous cases such as diverse erythema, Stevens-Johnson syndrome, skin capillary inflammation, pemphigut pemphigut form) and hypersensitivity reactions, even angiema are often recorded.

few cases of patients with bone metastasis have hypercalcium in the blood at the beginning of treatment.

Cases of visual disorders, including rare changes in the cornea and common reports on retinopathy have been recorded in nolvadex treatment patients. Bonus cataracts are recorded related to the use of nolvadex.

Cases of visual neuritis and optic neuritis have been recorded in patients using tamoxifen, and a few cases of blindness occur.

Sensory disorders (including abnormalities and taste disorders) are commonly recorded in patients using Nolvadex.

uterine fibroids, endometriosis and other endothelial changes including hyperplasia and polips are also recorded.

The phenomenon of thrombocytopenia, usually reduced to 80,000 to 90,000/mm3, sometimes lower, recorded in cancer patients dance treatment with Tamoxifen.

Observatory for observation, after using nolvadex, sometimes it is related to anemia and/or platelet reduction. Neutral leukemia is recorded in some rare cases; Sometimes it can become serious and rare cases of granulocytes.

Stroke due to ischemia and blood vessels due to thrombosis including deep vein thrombosis, microscopic thrombosis and pulmonary obstruction often occur when treated with nolvadex. Sharing Nolvadex with cytotoxic substances may increase the risk of blood tolerance.

cramped and muscle pain that has been reported is often occurring in patients using Nolvadex.

few cases of pneumonia have been recorded.

Nolvadex is associated with changing the level of liver enzyme and some abnormalities in the liver worse, which in some cases can lead to death, including fatty liver, bile and hepatitis, liver failure, cirrhosis, liver cell damage (including liver necrosis).

The phenomenon of increased serum triglyceride concentration, in some cases, pancreatitis may occur, due to Nolvadex.

Ovarian cysts rarely observe in patients using Nolvadex.

Vaginal polyps rarely observe in patients using Nolvadex. Lupus erythematitis rarely observed in patients using Nolvadex.

Porphyrin metabolic disorders are very dangerous when observing in patients using nolvadex.

Fatigue has been recorded very common in patients using Nolvadex.

Very rarely observed a serious skin reaction due to radiation therapy in patients using Nolvadex.

Few and endometrial cancer and dangerous cancer encounter the case of uterine sacomy (mostly in the form of malignant mixed mullarian tumors) related to Nolvadex treatment.

Precautions when used

While treating breast cancer with Nolvadex, some cases of premenopausal patients may lose menstruation.

The increase in the frequency of endometrial disorders includes hyperplasia, polyps, endometrial cancer and uterine sacoma (mostly in the form of mullarians of the evil mixed form of the province) have been recognized as related to Nolvadex treatment. The mechanism has not been known but may be related to the similarity of Nolvadex's estrogen.

Need to immediately survey patients who have been taking Nolvadex with abnormal gynecological symptoms, especially vaginal bleeding, or menstrual disorders, vaginal disorders and symptoms such as pain or severe pelvis.

Some of the second primary primary tumors appear in the endometrium and the opposite breast that has been recorded in clinical trials in breast cancer patients after treatment with tamoxifen. The causal relationship has not been established and the clinical importance of these observations is still unclear.

venous venous embolism (VTE)

Increased 2-3 times the risk of VTE was recorded in healthy women using Tamoxifen.

Doctors need to carefully consider the history of the patient and the patient's family that has been VTE. If there is a risk of thrombosis, patients need to be tested for blood thrombosis. Patients with positive results need to be guided on the risk of thrombosis. The decision to use Tamoxifen for these patients should be based on the overall risk of rings.

In some selective patients, the use of Tamoxifen along with preventive anticoagulant drugs may be useful (see "interactions of drugs with other drugs and other types of interactions").

The risk of VTE increases when the patient is severe, when the patient's age increases and when there are other VTE risk factors. All patients should be carefully considered for risks and benefits before treatment with Tamoxifen. This risk also increases when there is a coordinated chemotherapy. The long -lasting use of anti -dynamic drugs can be helpful for some patients with many VTE risk factors.

Surgery and motionless should only stop therapeutic with Tamoxifen when the risk of thrombosis due to Tamoxifen surpasses the risks due to stopping treatment. All patients should take appropriate prevention measures, and should be instructed on how to use with pressure during hospitalization, early walking, if possible, and treatment with anticoagulant drugs.

If the patient shows VTE, should stop immediately Tamoxifen and take appropriate anticoagulant measures. The decision to reuse Tamoxifen should be assessed based on the patient's overall risk. In some selective patients, the use of Tamoxifen along with preventive anticoagulant may be helpful.

All patients should contact the doctor immediately if the patient has any VTE symptoms.

In breast regeneration surgery, delayed by micro -surgical techniques, Nolvadex may increase the risk of complications on micro -transplant flap.

In a non-control study over 28 women from 2-10 years old suffered from McCune Albright (MAS) using 20 mg of Tamoxifen once a day for 12 months, the average volume of uterus increased after 6 months of treatment and doubled at the end of the test lasting 1 year. Although these records are consistent with Tamoxifen's pharmacological properties, the cause and effect relationship has not been set.

In the literature, patients with poor metabolic CYP2D6 have an endoxifen concentration in lower plasma, which is one of the most important active metabolites of Tamoxifen.

Concentrated with CYP2D6 enzyme inhibitors may reduce the concentration of endogen -active metabolites. Therefore, avoid using strong CYP2D6 inhibitors (such as paroxetin, fluoxetin, quinidine, cinacalcet or bupropion) while treatment with tamoxifen.

Nolvadex contains lactose: Patients with genetic problems encountered in galactose tolerance, Lapp Lactose deficiency or absorbent glucose-galactose should not be used.

Serious skin reactions due to radiation therapy are rarely reported in patients using Nolvadex that have been radiation previously. Reward reactions after temporary stop treatment and if repeated radiation therapy reaction also decreases slightly. In most cases, it is possible to continue using Nolvadex.

Use drugs for women during pregnancy and lactation

Pregnant women: Nolvadex must not be used during pregnancy. A few cases such as natural miscarriage, fetal defects and fetuses have been recorded in women using Nolvadex, although the causal relationship has not been established.

Toxic studies on the reproductive system in mice, rabbits and monkeys show that Nolvadex has no teratogenicity potential.

For the development of the fetal reproductive system in the rodent species, Tamoxifen is related to similar changes to changes caused by oestradiol, ethynyl-oestradiol, clomiphen and diethylstilboestrol (DES). Although the clinical relationship of these changes is not known, a few changes, especially the abnormal development of the vaginal epithelium similar to the changes in young women using DES in the uterus and patients with 1/1000 risk of light cell cancer in the vagina or cervix. Only a small number of patients who are pregnant women use Tamoxifen. In young female patients using this tamoxifen, do not record any abnormal development of gland epithelium in the vagina or light cell cancer in the vagina or in the cervix.

Women's patients should not be pregnant while being treated with nolvadex and should use hormonal contraception or partition form. Premenopausal patients need to be carefully examined to eliminate the possibility of pregnancy before treatment. The patient should be informed about the potential risk to the fetus if pregnant during nolvadex treatment or within 2 months after the treatment.

Lactating women: Although Nolvadex has not been clearly defined whether or not they are excreted through breast milk or not, people still recommend not using nolvadex during breastfeeding. The decision to stop breastfeeding or stop taking the drug should depend on the importance of the drug to the mother.

The effect on driving and operating machinery

Nolvadex does not seem to affect the ability to drive and operate machinery.

However, fatigue has been recorded when using Nolvadex, so cautious while driving and operating machinery while still this symptom.

Medicine interaction

Nolvadex sharing with coagulant anticoagulants can significantly increase anticoagulant effects. When starting to use such a combination of drugs should monitor patients carefully.

Nolvadex sharing with cytotoxic substances, to treat breast cancer, may increase the risk of blood tolerance due to thrombosis. Due to this increased risk of VTE, the prevention of thrombosis should be considered in patients in the period of chemotherapy.

Using Tamoxifen in combination with Anastrozol as a complementary treatment does not show improvement in effectiveness compared to monomers of Tamoxifen.

Because Nolvadex is metabolized through the Cytochrom P450 3A4 enzyme system, when used with drugs like rifampicin, it is known to cause this enzyme, be careful because the tamoxifen level may be reduced. Clinically related relationships of this concentration decrease is still unclear.

Interactive pharmacokinetics with CYP2D6 enzyme inhibitors shows a reduction in plasma concentrations of the activity of Tamoxifen, 4-Hydroxy-N-Desmethylamoxifen (Endoxifen) that has been reported in literature.

Mobile pharmacokinetic interaction with CYP2D6 enzyme inhibitors shows a decrease of 65-75% of plasma concentrations of one of the active metabolites of the drug (such as endoxifen) that has been reported in literature. The effectiveness of tamoxifen has been recorded when used simultaneously with some antidepressants inhibitors inhibiting Serotonin (as paroxetin) in some studies. Because it is not possible to rule out the possibility of reducing the effects of tamoxifen, avoid simultaneous use with CYP2D6 inhibitors (such as paroxetin, fluoxetin, quinidine, cinacalcet or bupropion).