Letrozole KRKA film-coated tablets are indicated for:
Active substance: letrozole;
1 coated tablet contains 2.5 mg letrozole;
Excipients: lactose, corn starch, hypromellose, microcrystalline cellulose, sodium starch (type A), colloidal silicon dioxide, magnesium stearate;
Film sheath: hypromellose, titanium dioxide (E 171), yellow iron oxide (E 172), polyethylene glycol 400, talc, purified water.
Hypersensitivity to the active substance or to any other component of the preparation.
Endocrine status characteristic of the premenopausal period.
Pregnancy, lactation period.
Women of reproductive age.
The preparation should be taken orally with or without food, since food does not affect absorption.
The missed dose should be taken as soon as the patient remembers it. However, if the patient remembers this shortly before taking the next dose (2-3 hours), the missed dose should be skipped and the next dose should be taken according to the schedule. You should not take a double dose, because when taking a daily dose higher than the recommended 2.5 mg, a systemic exposure higher than the proportional one was observed.
Pregnant
Not applicable.
Children
Not applicable.
Drivers
The effect of letrozole on the ability to drive vehicles and operate machinery is negligible. Since during the treatment with the preparation in patients, general weakness and dizziness were observed, in some cases - drowsiness, patients should be warned that when these symptoms occur, they should refuse to drive vehicles or work with mechanisms.
Reported isolated cases of preparation overdose.
The specific treatment for overdose is unknown; treatment should be symptomatic and supportive.
Fatigue (including asthenia, malaise), peripheral edema, chest pain, fever, dry mucous membranes, thirst, generalized edema.
Inhibitors of the activity of CYP3A4 and CYP2A6 can reduce the metabolism of letrozole and thus increase the concentration of letrozole in the blood plasma. Concomitant use of preparations that strongly inhibit these enzymes (powerful inhibitors of CYP3A4 include, but are not limited to: ketoconazole, itraconazole, voriconazole, ritonavir, clarithromycin, and telithromycin; CYP2A6 (eg, methoxalen)) may increase letrozole exposure. Therefore, patients who are shown potent inhibitors of CYP3A4 and CYP2A6 are advised to exercise caution when using them.
Store at a temperature not exceeding 25 ° C in its original packaging to protect against moisture.
Keep out of the reach of children.
Shelf life is 3 years.
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