RISPOLEPT CONSTA 50mg powder+solvent for suspension injection with prolonged release medication leaflet

N05AX08 risperidone • Nervous system | Antipsychotics | Other antipsychotics

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 last drug list: 10-04-2026

Commercial code: W13833002

Concentration: 50mg

Pharmaceutical form: powder+solvent for suspension injection with prolonged release

Quantity: 1

Product type: original

Price: 602.72 RON

Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

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