Leaflet RISPOLEPT CONSTA 50mg powder and solvent for prolonged-release suspension for injection

Indicated for: schizophrenia; bipolar disorder

Route of administration: injectable

Substance: risperidone (antipsychotic)

ATC: N05AX08 (Nervous system | Antipsychotics | Other antipsychotics)

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.

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.

Risperidone is an atypical antipsychotic medication used to treat schizophrenia, bipolar disorder, and irritability associated with autism spectrum disorder. It works by blocking dopamine (D2) and serotonin (5-HT2A) receptors in the brain, helping to reduce psychotic symptoms and stabilize mood.

In schizophrenia, risperidone is effective in reducing positive symptoms (such as hallucinations and delusions) and negative symptoms (such as social withdrawal and lack of motivation). In bipolar disorder, it is used to treat acute manic or mixed episodes. It is also indicated for managing irritability and aggressive behaviors in children and adolescents with autism spectrum disorders.

Risperidone is available in the form of tablets, oral solution, or long-acting injectable formulations. The dose is gradually adjusted based on the patient’s response and tolerance. Common side effects include drowsiness, weight gain, dizziness, increased appetite, and extrapyramidal symptoms (such as tremors or muscle stiffness).

Treatment with risperidone should be administered under the supervision of a doctor, and patients should be regularly monitored to assess effectiveness and manage potential side effects. It is important for patients to follow the prescribed dosage and not discontinue treatment without consulting their doctor.

General data about RISPOLEPT CONSTA 50mg

  • Substance: risperidone
  • Date of latest medicines list: 01-06-2026
  • Product code: W13833002
  • Concentration: 50mg
  • Pharmaceutical form: powder and solvent for prolonged-release suspension for injection
  • Quantity: 1
  • Product type: Original
  • Price: 602.72 RON
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: JANSSEN PHARMACEUTICA N.V. - BELGIA
  • Holder: JANSSEN PHARMACEUTICA N.V. - BELGIA
  • Number: 10492/2018/01
  • Shelf life: 3 years la 2-8°C-after packing for marketing;a se utiliza in maxim 6h

Concentrations available for risperidone

  • 0.5mg
  • 100mg
  • 1mg
  • 1mg/ml
  • 25mg
  • 2mg
  • 37.5mg
  • 3mg
  • 4mg
  • 50mg
  • 6mg
  • 75mg
  • 8mg

Compensation lists for RISPOLEPT CONSTA 50mg Janssen

G15 (C1) - Mental disorders

Price

Copayment

Patient

602.72 RON

550.40 RON

52.32 RON

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

Price

Copayment

Patient

602.72 RON

550.40 RON

52.32 RON