anastrozole | Arimidex tablets 1 mg, 28 pcs.

Release form

film-coated tablets.

Packing

28 pcs

Indications

Adjuvant therapy for early hormone-positive breast cancer in postmenopausal women

treatment of common breast cancer in postmenopausal women

adjuvant therapy for early hormone-positive breast cancer in postmenopausal women for 2–3 years after therapy.

Contraindications

Severe renal failure (creatinine clearance less than 20 ml / min)

moderate to severe liver failure (safety and efficacy not established)

concomitant therapy with tamoxifen

childhood (safety and efficacy not established

lactation pregnancy

feeding)

hypersensitivity to anastrozole and other components of the drug

The drug is not prescribed for premenopausal women

Use during pregnancy and lactation

The drug is contraindicated in pregnancy and lactation (breastfeeding).

Composition

1 tablet contains:

Active substances: anastrozole 1 mg.

Excipients: lactose monohydrate, povidone, sodium carboxymethylene starch, magnesium stearate, purified water.

Shell composition: macrogol 300, hypromellose, titanium dioxide, purified water.

Dosage and administration of

Adults, including elderly patients, are prescribed 1 mg orally 1 time / day for a long time. If signs of disease progression appear, the drug should be discontinued. As adjuvant therapy, the recommended treatment duration is 5 years.

Patients with mild to moderate impaired renal function do not require dose adjustment.

Patients with mild hepatic impairment do not require dose adjustment.

The tablet should be swallowed whole and washed down with water. It is recommended to take the drug at the same time of day.

Side effects

Determination of the frequency of adverse reactions: very common (> 10%)

often (1-10%)

rare (0.1-1%)

very rare (<0.1%).

From the cardiovascular system: very often - hot flashes.

From the musculoskeletal system: often - arthralgia.

From the reproductive system: often - vaginal dryness rarely - vaginal bleeding (mainly during the first weeks after the cancellation or change of previous hormonal therapy to Arimidex).

From the digestive system: often - nausea, diarrhea rarely - anorexia, vomiting, increased activity of GGT and alkaline phosphatase.

From the nervous system: often - headache, carpal tunnel syndrome (mainly observed in patients with risk factors for this disease) rarely - drowsiness.

From the side of metabolism: rarely - hypercholesterolemia. Taking the drug can cause a decrease in bone mineral density due to a decrease in the level of circulating estradiol, thereby increasing the risk of osteoporosis and bone fractures.

Dermatological reactions: often - thinning of the hair, skin rash is very rare - erythema multiforme (Stevens-Johnson syndrome).

Allergic reactions: very rarely - angioedema, urticaria, anaphylactic shock.

Other: often - asthenia.



overdose Symptoms: single clinical cases of drug overdose have been reported. A single dose of Arimidex, which develops life-threatening symptoms, has not been established.

Treatment: No specific antidote exists. If necessary, conduct symptomatic therapy: induction of vomiting (if the patient is conscious), general supportive therapy, monitoring of the patient and control over the function of vital organs and systems. Dialysis is possible.

Storage conditions

Keep out of the reach of children at a temperature not exceeding 30 РC.

Expiration

5 years.

Deystvuyuschee substances

anastrozole

dosage form

dosage form

tablets

AstraZeneca, United Kingdom