Letrozole KRKA 2.5mg 90 tablets — Made in Slovenia — Free Delivery

Product description

Letrozole KRKA film-coated tablets are indicated for:

• Adjuvant therapy for hormone-positive invasive breast cancer in early stages in postmenopausal women.
• Advanced adjuvant therapy for early invasive breast cancer in postmenopausal women who have received standard adjuvant tamoxifen therapy for 5 years.
• First-line therapy for hormone-dependent advanced breast cancer in postmenopausal women.
• Treatment of common forms of breast cancer in postmenopausal women (natural or induced) after relapse or progression of the disease, who received previous antiestrogen therapy.
• Neoadjuvant therapy in postmenopausal women with hormone-positive, HER-2-negative breast cancer who are unsuitable for chemotherapy and are not indicated for urgent surgery.

Compound

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.

Contraindications

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.

Mode of application

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.

Application features

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.

Overdose

Reported isolated cases of preparation overdose.

The 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 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.

Storage conditions

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.