Leaflet LEPONEX 100mg tablets

Indicated for: schizophrenia; bipolar disorder

Route of administration: oral

Substance: clozapine (antipsychotic)

ATC: N05AH02 (Nervous system | Antipsychotics | Diazepines, oxazepines, thiazepines and oxepines)

Precautions:
Driving impairment
Driving impairment

This medicine may affect your ability to drive or use machines.

Dizziness / vertigo
Dizziness / vertigo

This medicine may cause dizziness or vertigo.

Hyperglycemia
Hyperglycemia

This medicine may increase blood sugar.

Myelosuppression / agranulocytosis
Myelosuppression / agranulocytosis

This medicine may lower blood cell counts.

Cardiac risk / QT prolongation / arrhythmias
Cardiac risk / QT prolongation / arrhythmias

This medicine may increase the risk of heart rhythm disturbances.

Seizure risk
Seizure risk

This medicine may increase the risk of seizures.

Drowsiness / sedation
Drowsiness / sedation

This medicine may cause drowsiness or reduced alertness.

Clozapine is an atypical antipsychotic used for the treatment of schizophrenia resistant to other therapies and for reducing the risk of suicidal behavior in patients with psychotic disorders. It works by modulating the activity of neurotransmitters in the brain.

The medication is taken orally, as directed by a doctor, usually once or twice daily. It is important for patients to undergo regular blood tests to monitor white blood cell counts due to the risk of agranulocytosis.

Patients should be aware of potential side effects, such as drowsiness, dizziness, or weight gain. It is important to inform the doctor of any unusual symptoms.

Common side effects include drowsiness, dizziness, and weight gain. In rare cases, severe reactions such as agranulocytosis, seizures, or myocarditis may occur. Patients should be informed of these risks before use.

General data about LEPONEX 100mg

  • Substance: clozapine
  • Date of latest medicines list: 01-06-2026
  • Product code: W63177002
  • Concentration: 100mg
  • Pharmaceutical form: tablets
  • Quantity: 50
  • Product type: Original
  • Price: 72.28 RON
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: MYLAN HUNGARY KFT. - UNGARIA
  • Holder: MYLAN HEALTHCARE GMBH - GERMANIA
  • Number: 12019/2019/02
  • Shelf life: 3 years

Concentrations available for clozapine

  • 100mg
  • 25mg
  • 50mg

Compensation lists for LEPONEX 100mg Mylan

G12 (C1) - Parkinson's disease

Price

Copayment

Patient

72.28 RON

72.28 RON

0.00 RON

G15 (C1) - Mental disorders

Price

Copayment

Patient

72.28 RON

72.28 RON

0.00 RON

GX (C1) - GENERIC (used in compensation list, C1, for another diagnosis)

Price

Copayment

Patient

72.28 RON

72.28 RON

0.00 RON