Anastrozole

Qualitative and quantitative composition

Anastrozole 1.00 mg per film-coated tablet.
List of excipients and excipients with a notable effect: see RCP.

Pharmaceutical form and presentation

Film-coated tablets, 1mg; box of 30.

Clinical information

  • Antitumour, antihormonal drug used in oncology; aromatase inhibitor.

  • Anastrozole 1.00 mg per film-coated tablet.
    List of excipients and excipients with a notable effect: see SPC.

    Film-coated tablets, 1mg; box of 30 pcs.

  • Anastrozole inhibits or inactivates the aromatase enzyme in peripheral tissues, thereby reducing the synthesis of estrogens from androgen precursors.

    Anastrozole is indicated for

    • the Treatment of hormone receptor-positive advanced breast cancer in postmenopausal women;
    • Adjuvant treatment of hormone receptor-positive early invasive breast cancer in postmenopausal women;
    • Adjuvant treatment of hormone-receptor-positive early invasive breast cancer in post-menopausal women who have received adjuvant tamoxifen therapy for 2 to 3 years.
    • Pregnancy and breast-feeding;
    • Premenopausal women.
  • This medicine is administered orally.
    Always take this medicine exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
    The recommended dose is one tablet a day.
    Try to take your tablets at the same time each day. Swallow the tablet whole with a glass of water. You can take Anastrozole before, during or after meals. Continue to take Anastrozole for as long as your doctor tells you to. This is a long-term treatment and you may need it for several years.

    If you forget to take Anastrozole :
    If you forget to take a dose, simply take your next dose at the usual time.
    Do not take a double dose (two doses at the same time) to make up for the dose you forgot to take.

    If you have any further questions about the use of this medicine, ask your doctor or pharmacist for more information.

  • Anastrazole is a substrate for CYP3A4. Inhibitors and inducers of this enzyme alter the plasma concentrations of anastrozole, leading to the risk of overdose in the case of inhibitors and therapeutic failure in the case of inducers.

  • Aggravation of perimenopausal hot flushes, vaginal dryness and dyspareunia.
    Joint complaints.
    Decreased bone density with increased risk of fractures.
    Increased risk of venous thromboembolism (less than with tamoxifen).

  • Pregnancy

    For most antitumour agents, there is evidence or suspicion of a harmful effect on the unborn child (teratogenic and mutagenic effects, embryotoxicity) or a reduction in fertility. In principle, therefore, all anti-tumour agents are contraindicated during pregnancy, and in any event, every attempt should be made to avoid administering them during the first trimester.
    If antitumour agents are used in women or men, strict contraception is recommended before the start of treatment, during treatment and generally a few weeks to a few months afterwards. Some SPCs specify the recommended contraceptive period before and after treatment. It should be borne in mind that some antitumour drugs can affect the contraceptive reliability of hormonal contraception, and in this case, dual contraception (hormonal and mechanical) is recommended.

    Breastfeeding

    In view of the many uncertainties as to the possible harmful effect of these drugs on infants, it seems justified to consider breast-feeding in women taking antitumour drugs as contraindicated.

  • If you swallow a large number of tablets at once, call your doctor, pharmacist or Poison Control Centre immediately.

Pharmaceutical information

  • The shelf life is 3 years. There are no special storage precautions.

  • Any unused medicine or waste must be disposed of in accordance with current regulations.