Letrovista film-coated tablets 2.5 mg blister No. 30

Letrovista film-coated tablets are indicated for:

Composition

Active ingredient: letrozole;

1 film-coated tablet contains letrozole 2.5 mg;

Excipients: lactose monohydrate, microcrystalline cellulose, corn starch, corn starch; sodium starch (type A); magnesium stearate, colloidal silicon dioxide;

Coating: hypromellose (E 464), talc (E 553b), macrogol 8000, titanium dioxide (E 171), iron oxide yellow (E172).

Contraindication

Method of application

The drug should be taken orally regardless of meals, as food does not affect the degree of absorption.

The missed dose should be taken as soon as the patient remembers. However, if the patient remembers shortly before the next dose (2-3 hours), the missed dose should be skipped and the next dose should be taken as scheduled. A double dose should not be taken, as systemic exposure above the recommended daily dose of 2.5 mg has been observed.

Application features

Pregnant women

Not applicable.

Children

Not applicable.

Drivers

Letrozole has little effect on the ability to drive and use machines. Since general weakness and dizziness, and in some cases drowsiness, have been observed in patients treated with the drug, patients should be warned that if these symptoms occur, they should refrain from driving or operating machinery.

Overdose

Isolated cases of drug overdose have been reported.

Specific treatment for overdose is unknown; treatment should be symptomatic and supportive.

Side effects

Fatigue (including asthenia, malaise), peripheral edema, chest pain, fever, dry mucous membranes, thirst, generalized edema.

Interaction

Inhibitors of CYP3A4 and CYP2A6 activity may reduce the metabolism of letrozole and thus increase the plasma concentration of letrozole. Concomitant use of medicinal products that strongly inhibit these enzymes (potent inhibitors of CYP3A4 include, but are not limited to: ketoconazole, itraconazole, voriconazole, ritonavir, clarithromycin and telithromycin; CYP2A6 (e.g. methoxsalen)) may increase exposure to letrozole. Therefore, caution is advised in patients who are indicated for use of potent inhibitors of CYP3A4 and CYP2A6.

Storage conditions

Store at a temperature not exceeding 30 °C in the original packaging to protect from moisture and out of the reach of children.

Shelf life - 3 years.