Olfrex tablets 10 mg No. 28

Olfrex tablets are used for the indications listed below.

olanzapine:

Composition

The active substance is olanzapine (one film-coated tablet contains 10 mg of olanzapine).

Excipients: lactose monohydrate, hydroxypropylcellulose, crospovidone, microcrystalline cellulose, magnesium stearate, Opadry AMB White OY-B-28920 coating (polyvinyl alcohol, titanium dioxide (E 171), talc, lecithin, xanthan gum).

Contraindication

Method of application

The recommended starting dose of olanzapine is 10 mg once daily.

Application features

Pregnant women

Olanzapine should be used during pregnancy only if the expected benefits justify the potential risk to the fetus.

Patients are advised not to breastfeed their infants if they are taking olanzapine.

Children

Olanzapine is not recommended for use in children and adolescents (under 18 years of age) due to insufficient data on safety and efficacy. In short-term studies, adolescent patients experienced increased weight gain, changes in prolactin levels, and lipids compared with adults.

Drivers

Studies on the effect of olanzapine on the reaction rate when driving or operating other mechanisms have not been conducted. Since olanzapine may cause drowsiness and dizziness, patients should be warned about the dangers associated with the operation of mechanisms, including motor vehicles.

Overdose

Very common (> 10% of cases) - tachycardia, agitation/aggressiveness, dysarthria, various extrapyramidal symptoms and a reduced level of consciousness ranging from sedation to coma.

Other significant complications of overdose include delirium, seizures, coma, possible neuroleptic malignant syndrome, respiratory depression, aspiration, hypertension or hypotension, cardiac arrhythmia (<2% of overdoses), and cardiopulmonary shock. Fatalities have been reported with acute overdoses of 450 mg, but survival has been reported with acute overdoses of 2 g of olanzapine orally.

Side effects

The most common adverse reactions (occurring in ≥ 1% of patients) associated with the use of olanzapine in clinical studies were: drowsiness, weight gain, eosinophilia, increases in prolactin, cholesterol, glucose and triglycerides in the blood, glycosuria, increased appetite, dizziness, akathisia, parkinsonism, leukopenia, neutropenia, dyskinesia, orthostatic hypotension, anticholinergic effects, transient asymptomatic increases in hepatic transaminases, rash, asthenia, fatigue, hyperthermia, arthralgia, increases in alkaline phosphatase, gamma-glutamyltransferase, uric acid, creatine phosphokinase and edema.

Storage conditions

Store in the original packaging at a temperature not exceeding 25 °C, out of the reach of children.

Shelf life - 2 years.