Patient information leaflet
Trade name: Anastrozole-Belmed
International nonproprietary name: Anastrozole
Description: White or off-white round, biconvex coated tablets. Coating roughness on tablets surface is permissible.
Each tablet contains:active substance– anastrozole –1 mg;
excipients– sodium starch glycolate (A type), povidone K-25, calcium stearate, sodium lauryl sulfate, lactose monohydrate, opadry II white (85 F);
Composition of coating substance (opadry II white (85 F)): partially hydrolyzed polyvinyl alcohol, macrogol/polyethyleneglycol, talc (E553b); titanium dioxide (E171).
Pharmaceutical form:film-coated tablets.
Pharmacotherapeutic group: antineoplastic agent, estrogen synthesis inhibitor
ATC code: L02BG03.
Anastrozole is a high selective non-steroid inhibitor of aromatase enzyme which converts androstendione in peripheral tissues into estron and further into estradiol in organism of a postmenopausal woman. Therapeutic effect in women suffering from breast cancer is reached through reduction of circulating estradiol level. In postmenopausal women anastrozole in daily dose of 1 mg causes reduction of estradiol level by 80%.
Adjuvant therapy of early hormone-positive breast cancer in postmenopausal period.
Advanced breast cancer in postmenopausal women.
Adjuvant therapy of early hormone-positive breast cancer in postmenopausal period after taking tamoxifen during 2-3 years.
Mode of administration and doses
Tablet is administrated orally and washed down. It is recommended to administrate the drug at one and the same time.
Daily dose for adults, including aged persons, is 1 mg once a day. In case of progressive disease manifestation, administration of the drug should be ceased.
In adjuvant therapy recommended duration of treatment is 5 years.
In case of light and moderate renal function impairment, it is not required to correct the dose.
In case of light liver function impairment, it is not required to correct the dose.
Frequency of side effects is given in the following gradation: very frequent (≥1/10), frequent (≥1/100 to <1/10), infrequent (≥1/1,000 to <1/100), rarely (≥1/10,000 to <1/1,000), very rarely (<1/10,000), including separate reports.
Vascular system disorders: very frequent – flushes.
Musculoskeletal system disorders: very frequent – arthralgia, joint stiffness, arthritis; frequent – bone ache; infrequent – trigger finger.
Reproductive system disorders: frequent – dry vestibular mucous coat, vaginal hemorrhage (mainly, during first weeks after withdrawal of the drug product or transfer from prior therapy to Anastrozole-Belmed).
Skin and skin appendage disorders: very frequent – skin rash, frequent – alopecia, allergic reactions; infrequent – urticarial fever; rarely – multiform erythema, anaphylactoid reaction, cutaneous vasculitis (including separate cases of purpura (Henoch-Schonlein syndrome)); very rarely - Stevens-Johnson syndrome, angioneurotic edema.
Digestion disorders: very frequent – nausea; frequent – diarrhea, vomiting.
Hepatobiliary system disorders: - frequent – increase of potency of alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase; infrequent – increase of gamma glutamyltransferase potency and bilirubin concentration, hepatitis.
Nervous system disorders: very frequent – headache, frequent – drowsiness, carpal tunnel syndrome (observed predominantly in patients with this disease factor risks).
Metabolism disorders: frequent – anorexia, hypercholesterolemia. Drug administration may cause reduced bone density due to reduction of circulating estradiol concentration, enhancing thereby the risk of osteoporosis and bone fractures.
Others:very frequent – light and moderate asthenia.
Hypersensibility to anastrozole or other components of the drug; perimenopause in women; heavy renal failure (creatinine clearance less than 20 ml/min); moderate or heavy liver failure (safety and effectiveness are nor determined); concomitant therapy of tamoxifen or estrogen containing drugs.
Pregnancy and lactation; pediatric age (safety and effectiveness in children are not determined).
With caution: osteoporosis, hypercholesterolemia, ischemic heart disease, liver function impairment, lactase deficiency, glucose-galactose malabsorption.
Overdosage cases are single and occasional. Single dose of the drug which could cause life threatening symptoms is not determined.
Treatment: there is no specific antidote. Symptomatic treatment. Induced vomiting (if patient is in consciousness). Dialysis. Common supporting treatment, supervision over the patient and control of vital organ and systems.
Interaction with other drug products
No clinically significant interaction with phenazone (antipyrine), cimetidine and other frequently prescribed drugs. There are no data on combined administration with other antineoplastic drugs.
Estrogen containing drugs reduce pharmacological action of anastrozole, therefore, they should not be prescribed together with the drug product.
Concomitant administration of tamoxifen and anastrozole may reduce pharmacologic action of the latter.
Safety and effectiveness in children are not determined.
In women with estrogen receptor negative oedema, effectiveness of Anastrozole-Belmed was not established, except for the cases when preceding positive clinical response to tamoxifen was observed. In case of doubts about hormone state of the patient, menopause should be confirmed by determination of sex hormones in blood serum. There are no data on application of the drug product in patients with moderate or heavy liver failure and in patients with heavy renal failure (creatinine clearance not less than 20 ml/min).
In case of vaginal hemorrhage persistence on the top of Anastrozole-Belmed therapy, consultation and surveillance of gynecologist is required.
Estrogen containing drugs should not be prescribed at the same time.
Reduced circulating estradiol level may cause reduction of mineral bone density followed by fracture risk increase. Patients with such high risk are subject to treatment according to the therapy manual for such complications. Concomitant administration of bisphosphonates in patients with moderate and high risk of fractures facilitates prevention of bone system changes. Supporting treatment with vitamin D and calcium in patient with low risk prevents bone structure changes.
In patients suffering from osteoporosis or under risk of osteoporosis, mineral bone density should be evaluated by densitometry, for example, by DEXA scanning (Dual-Energy X-ray Absorptiometry) at the beginning of the treatment and over time. If necessary, osteoporosis treatment or prevention treatment should be started under careful surveillance of the doctor.
There are no data on concomitant administration of Anastrozole-Belmed and analogue drug products of luteinising hormone releasing hormone. It is unknown whether Anastrozole-Belmed improves the treatment results in case of concomitant application with chemotherapy. There are no data on safety in long-lasting Anastrozole-Belmed treatment.
In cases when Anastrozole-Belmed was administrated more frequent than in case of tamoxifen therapy, ischemic diseases were observed, however no statistical significance was determined.
Effectiveness and safety of Anastrozole-Belmed and tamoxifen in concomitant administration thereof irrespective of hormone receptors status are comparable to that in single tamoxifen administration. Exact mechanism of this event is still unknown.
Effect on ability to drive a car or potentially dangerous mechanisms: one should be careful while driving a car or potentially dangerous mechanisms, since Anastrozole-Belmed may cause asthenia and drowsiness.
Store in protected from light place and moisture at temperature below 25 ºС.
Keep out of reach of children.
Do not use after expiry of shelf life indicated on the package.
10 tablets in a blister made of polyvinylchloride film and aluminum foil. Three blisters together with instruction are placed into cardboard box.
30 Fabritsius Str.,
220007 Minsk, Republic of Belarus.