Anazole Tablets (Generic Anastrozole Tablets)

1. Anazole Tablets (Generic Anastrozole Tablets) © The Swiss Pharmacy

2. Anazole Tablets (Generic Anastrozole Tablets) Anazole (Generic Anastrozole Tablets) is an aromatase inhibitor indicated for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer. They are also used for first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer and for the treatment of advanced breast cancer in postmenopausal women with disease progression following Tamoxifen therapy. © The Swiss Pharmacy

3. Anazole Tablets (Generic Anastrozole Tablets) Anazole Tablets are manufactured by Alpha Pharma Healthcare Private limited, India in the strength of 1 mg. © The Swiss Pharmacy

4. Anazole Tablets (Generic Anastrozole Tablets) Chemical Structure © The Swiss Pharmacy

5. Anazole Tablets (Generic Anastrozole Tablets) The active ingredient contained in Anazole tablets is Anastrozole. Each Anazole tablet contains 1 mg of Anastrozole. © The Swiss Pharmacy

6. Anazole Tablets (Generic Anastrozole Tablets) Uses of Anazole 1 mg Tablets: Anazole Tablets (Generic Anastrozole Tablets) are used to treat early hormone receptor-positive breast cancer. It is also used for first-line treatment of hormone receptor-positive or hormone receptor- unknown advanced or metastatic (cancer that has spread) breast cancer. Anastrozole is also used to treat advanced breast cancer that has grown or spread after Tamoxifen treatment. This medicine is used only in women who have already stopped menstruating (postmenopausal). Many breast cancer tumors grow in response to estrogen. This medicine interferes with the production of estrogen in the body. As a result, the amount of estrogen that the tumor is exposed to is reduced, limiting the growth of the tumor. © The Swiss Pharmacy

7. Anazole Tablets (Generic Anastrozole Tablets) Recommended Adult Dosage The dose of Anazole tablets Anazole tablets (Anastrozole tablets) is one 1 mg tablet taken once a day. For patients with advanced breast cancer, Anazole should be continued until tumor progression. Anazole can be taken with or without food. For adjuvant treatment of early breast cancer in postmenopausal women, the optimal duration of therapy is unknown. In the ATAC trial, Anastrozole tablets were administered for five years. No dosage adjustment is necessary for patients with renal impairment or for elderly patients. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9949_Anazole-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9949_Anazole-Tablets.html © The Swiss Pharmacy

8. Anazole Tablets (Generic Anastrozole Tablets) Contraindications ➔Anazole tablets are contraindicated in patients with a known hypersensitivity to Anastrozole or any component of the tablet. ➔Administration of Anazole is contrindicated in women of premenopausal endocrine status, including pregnant women. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9949_Anazole-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9949_Anazole-Tablets.html © The Swiss Pharmacy

9. Anazole Tablets (Generic Anastrozole Tablets) Storage Instructions Anazole Tablets (Generic Anastrozole Tablets) have to be stored at controlled room temperature i.e. from 20°C to 25°C (68°F to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). Keep this as well as all other medicines away from children and pets. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9949_Anazole-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9949_Anazole-Tablets.html © The Swiss Pharmacy

10. Anazole Tablets (Generic Anastrozole Tablets) Warnings In women with pre-existing ischemic heart disease, an increased incidence of ischemic cardiovascular events occurred with Anastrozole Tablets (Anazole) use compared to Tamoxifen use. Consider risks and benefits. Decreases in bone mineral density may occur. As Anastrozole lowers circulating estrogen levels it may cause a reduction in bone mineral density with a possible consequent increased risk of fracture. Consider bone mineral density monitoring. Increases in total cholesterol may occur. Consider cholesterol monitoring. Anastrozole should not be used in premenopausal women. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9949_Anazole-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9949_Anazole-Tablets.html © The Swiss Pharmacy

11. Anazole Tablets (Generic Anastrozole Tablets) Warnings Anastrozole has not been investigated in breast cancer patients with moderate or severe hepatic impairment. Exposure to Anastrozole can be increased in subjects with hepatic impairment. Administration of Anazole in patients with moderate and severe hepatic impairment should be performed with caution. Anastrozole has not been investigated in breast cancer patients with severe renal impairment. In patients with severe renal impairment, administration of Anazole should be performed with caution. Based on findings from animal studies and its mechanism of action, Anastrozole can cause fetal harm when administered to a pregnant woman. Anastrozole caused embryo-fetal toxicities in rats at maternal exposure that were 9 times the human clinical exposure, based on area under the curve (AUC). © The Swiss Pharmacy

12. Anazole Tablets (Generic Anastrozole Tablets) Warnings Anazole is not recommended for use in children and adolescents as safety and efficacy have not been established in this group of patients. This product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9949_Anazole-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9949_Anazole-Tablets.html © The Swiss Pharmacy

13. Anazole Tablets (Generic Anastrozole Tablets) Possible Side Effects In the early breast cancer (ATAC) study, the most common side effects occurring with an incidence of more than 10% in women taking Anastrozole tablets (Anazole) included: hot flashes, asthenia, arthritis, pain, arthralgia, pharyngitis, hypertension, depression, nausea and vomiting, rash, osteoporosis, fractures, back pain, insomnia, headache, peripheral edema and lymphedema, regardless of causality. In the advanced breast cancer studies, the most common side effects occurring with an incidence of more than 10% in women taking Anastrozole tablets (Anazole) included: hot flashes, nausea, asthenia, pain, headache, back pain, bone pain, increased cough, dyspnea, pharyngitis and peripheral edema. © The Swiss Pharmacy

14. Anazole Tablets (Generic Anastrozole Tablets) Overdosage Clinical trials have been conducted with Anastrozole tablets, up to 60 mg in a single dose given to healthy male volunteers and up to 10 mg daily given to postmenopausal women with advanced breast cancer; these dosages were tolerated. A single dose of Anastrozole that results in life-threatening symptoms has not been established. There is no specific antidote to Anazole overdosage and treatment must be symptomatic. In the management of an overdose, consider that multiple agents may have been taken. Vomiting may be induced if the patient is alert. Dialysis may be helpful because Anastrozole is not highly protein bound. General supportive care, including frequent monitoring of vital signs and close observation of the patient, is indicated. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9949_Anazole-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9949_Anazole-Tablets.html © The Swiss Pharmacy

15. Anazole Tablets (Generic Anastrozole Tablets) Anazole Tablets During Pregnancy Anastrozole (Anazole tablets) has been classified by the US FDA as Pregnancy Category X. Anastrozole (Anazole tablets) may cause fetal harm when administered to a pregnant woman and offers no clinical benefit to premenopausal women with breast cancer. Anastrozole is contraindicated in women who are or may become pregnant. In animal studies, Anastrozole caused pregnancy failure, increased pregnancy loss, and signs of delayed fetal development. There are no studies of Anastrozole use in pregnant women. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9949_Anazole-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9949_Anazole-Tablets.html © The Swiss Pharmacy

16. Anazole Tablets (Generic Anastrozole Tablets) Anazole Tablets During Pregnancy Anastrozole (Anazole tablets) has been classified by the US FDA as Pregnancy Category X. In case Anastrozole (Anazole tablets) is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus and potential risk for pregnancy loss. In animal reproduction studies, pregnant rats and rabbits received Anastrozole during organogenesis at doses equal to or greater than 1 (rats) and 1/3 (rabbits) the recommended human dose on a mg/m2 basis. In both species, Anastrozole crossed the placenta, and there was increased pregnancy loss. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9949_Anazole-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9949_Anazole-Tablets.html © The Swiss Pharmacy

17. Anazole Tablets (Generic Anastrozole Tablets) Anazole Tablets Anazole Tablets (Anastrozole 1 mg Tablets) are manufactured by Alpha Pharma Healthcare Private limited, India. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9949_Anazole-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9949_Anazole-Tablets.html © The Swiss Pharmacy