📌 COMPOSITION

Each dispersible tablet contains: Olanzapine 5 mg, 10 mg.

📌 DESCRIPTION

Olentab DT (Olanzapine) is an atypical antipsychotic drug with antipsychotic, antimanic and mood‑stabilising effects. It works by inhibiting a number of receptors such as 5-HT2A serotonin receptors and D1, D2, D4 dopamine receptors, and has an effect on histamine (H1) receptors. This group of antipsychotic medicines is characterised by higher affinity for serotonin receptors than dopamine receptors, so patients treated with olanzapine have a lower incidence of extrapyramidal side effects compared to patients treated with typical antipsychotic drugs.

📌 INDICATIONS

• Schizophrenia.
• Moderate to severe manic episodes.
• For the prevention of recurrence in patients with bipolar disorder.

📌 DOSAGE AND ADMINISTRATION

Dose should be according to doctor consultation.

• Schizophrenia in adults (≥ 18 years): Starting dose 5-10 mg/day, target dose 10 mg/day within several days.
• Schizophrenia in adolescents (13-17 years): Starting dose 2.5-5 mg once daily, target dose 10 mg/day.
• Manic or mixed episode in adults (≥ 18 years): The starting dose is 10 or 15 mg once daily.
• Manic or mixed episode in adolescents (13-17 years): The starting dose is 2.5-5 mg once daily, target dose 10 mg/day.
• Children under 13 years: Safety and efficacy not established.
• Preventing recurrence in bipolar disorder: The recommended starting dose is 10 mg/day.
• Patients with renal and/or hepatic impairment: A starting dose of 5 mg should be taken.
• Elderly patients over 65 years: A starting dose of 5 mg/day when clinical factors warrant.

The patient should consult the doctor if the symptoms return or to stop the medicine.

Note: The tablet dissolves directly in the mouth or place the tablet in a cup of water. Do not handle the tablet with wet hands.

📌 RESTRICTIONS ON USE

Contraindications

• Patients with known hypersensitivity to olanzapine.
• Patients with known risk for narrow‑angle glaucoma.

Precautions

• Antipsychotic drugs increase mortality in elderly patients with dementia‑related psychosis.
• Caution should be taken and the doctor consulted in the following cases: unusual movement mainly of the face and tongue, a blocked intestine, Parkinson's disease, Neuroleptic Malignant Syndrome (NMS), hyperglycaemia, high fat levels, weight gain, hyperprolactinaemia, family history of blood clots, stroke, prostate problems, liver or kidney disease, blood disorders, heart disease, seizures, low white blood cell counts.

Effects on the capacity to drive vehicles or use machines

Olentab DT may cause drowsiness; caution should be taken when driving and using machines.

Use in Pregnancy and Lactation

Consult the doctor if you become pregnant or intend to become pregnant. This medicine should not be given when breastfeeding, as small amounts of Olentab DT can pass into milk.

📌 DRUG INTERACTIONS

The patient should consult the doctor if taking one of the following drugs:

• Antidepressants or drugs for anxiety in combination with olanzapine may cause drowsiness.
• Drugs for Parkinson's disease.
• Carbamazepine, fluvoxamine or ciprofloxacin may make it necessary to change the olanzapine dose.
• Antihypertensive drugs: the antihypertensive effect may be enhanced.

📌 ADVERSE EFFECTS

Very common: Weight gain, sleepiness and increases in levels of prolactin in the blood. In the early stages of treatment, some patients may feel dizzy or faint (with a slow heart rate), especially when getting up or sitting.

Common: Changes in the levels of some blood cells, temporary increases in liver enzymes and increases in levels of creatine phosphokinase in the blood, increased appetite, dizziness, restlessness, tremor, unusual movements, constipation, dry mouth, rash, water retention, fever, joint pain.

📌 OVERDOSAGE

Symptoms of overdose: Rapid beating of the heart, aggressiveness, problems with speech, unusual movements especially of the face or tongue, reduced level of consciousness, confusion, seizures (epilepsy), coma, fever, faster breathing, sweating, muscle stiffness, drowsiness, sleepiness, slowing of the breathing rate, high blood pressure or low blood pressure and abnormal rhythms of the heart.

Treatment: There is no specific antidote to olanzapine. ECG monitoring should be undertaken. Gastric lavage within one hour of ingestion, as well as administration of activated charcoal and supportive treatment, should be given to the patient, and hypotension should be treated.

📌 STORAGE INSTRUCTIONS

Store below 30°C in a dry place.

📌 PHARMACEUTICAL FORMS

• Olentab 5 mg DT tablets: Pack of 30 tablets and hospital packs of different sizes.
• Olentab 10 mg DT tablets: Pack of 30 tablets and hospital packs of different sizes.