Zolafren film-coated tablets 5 mg blister No. 30

Zolafren tablets are indicated for:

Composition

Active ingredient: 1 tablet contains 5 mg or 10 mg of olanzapine;

Excipients: lactose, microcrystalline cellulose, sodium starch (type A), magnesium stearate;

Shell: hydroxypropylmethylcellulose (hypromellose), polyethylene glycol (Macrogol) 400, dye Yellow No.6 Al-Lake (E 110), titanium dioxide (E 171), iron oxide yellow (E172), lactose.

Contraindication

Hypersensitivity to the active substance or to the auxiliary components of the drug.

Known risk of glaucoma.

Method of application

Treatment of schizophrenia, manic episodes and prevention of relapse in bipolar disorder. The daily dose should be determined based on clinical status in the range of 5 to 20 mg per day. Increases in the recommended initial dose should be made at intervals of at least 24 hours only after clinical examination. Olanzapine should be used regardless of meals, since food intake does not affect the absorption of the drug. When discontinuing the drug, the end of therapy should be carried out gradually.

Application features

Pregnant women

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

Children

Olanzapine is not recommended for the treatment of children and adolescents.

Drivers

With caution, dizziness and drowsiness are possible.

Overdose

Symptoms: Very common (> 10%): tachycardia, agitation/aggressiveness, dysarthria, various extrapyramidal symptoms and decreased 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 there have been cases of survival after acute overdoses of 2 g of olanzapine orally.

Treatment. There is no specific antidote. Drugs that induce vomiting are not recommended. Standard overdose procedures are recommended (e.g. gastric lavage, administration of activated charcoal). Co-administration of activated charcoal has been shown to reduce the oral bioavailability of olanzapine by 50-60%.

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, CPK and edema.

Interaction

Caution should be exercised when prescribing olanzapine with other drugs with a known risk of prolonging the QTc interval.

Storage conditions

Store at a temperature not exceeding 25 °C, in the original packaging.

Keep out of reach of children.

Shelf life - 3 years.