Prescribing information For Healthcare Professionals Only

RISPERDAL® Film-Coated Tablets, and Oral Solution

Tablets, Oral Solution and Risperdal® Quicklet® Orodispersible Tablets

PRESCRIBING INFORMATION

ACTIVE INGREDIENT:

Risperidone

Please refer to Summary of Product Characteristics (SmPC) before prescribing.

INDICATIONS: 

Schizophrenia. Moderate to severe manic episodes in bipolar disorder. Short-term treatment of persistent aggression in moderate to severe Alzheimer’s dementia and conduct disorder in children.

DOSAGE & ADMINISTRATION: 

Oral. 
Adults: Schizophrenia: 2 mg on day 1; 4 mg possible from day 2. Adjust if needed.  Most benefit from 4 - 6 mg/day. Maximum 16 mg/day. 
Mania in bipolar disorder: start: 2 mg once daily; adjust by 1 mg per day if needed; recommended range 1-6 mg/day. 
Elderly: schizophrenia or bipolar mania: start 0.5 mg twice daily.  Adjust by 0.5 mg twice daily to 1 - 2 mg twice daily. Caution in mania as limited experience in the elderly. 
Persistent aggression in Alzheimer’s dementia: 0.25 mg twice daily. Adjust if needed by increments of 0.25 mg twice daily not more often than every other day. Optimum for most patients: 0.5 mg twice daily. Up to 6 weeks treatment. Children: Not recommended below 18 years old with schizophrenia or bipolar mania. 
Conduct disorder: from 5 to 18 years of age; 0.25 mg (if <50 kg) or 0.5 mg (if ≥50 kg) once daily. Adjust if needed by same amount not more often than every other day. Optimum for most patients: 0.5 mg (if <50 kg) or 1 mg (if ≥50 kg) once daily.
Upon discontinuation/switching, gradually withdraw Risperdal®/other antipsychotic.

Renal impairment, Hepatic impairment: Half starting dose, slower dose titration, half consecutive doses. Caution in renal and liver disease.

CONTRAINDICATIONS: 

Hypersensitivity to active substance or any excipient.

SPECIAL WARNINGS & PRECAUTIONS:

Increased mortality in elderly with dementia. Three-fold increased risk of cerebrovascular adverse events (CVAE) in patients with dementia; consider carefully if at risk of stroke (particularly in the elderly). Patients with non-Alzheimer’s dementia should not be treated with risperidone. Short term use only for persistent aggression in moderate to severe Alzheimer's dementia. Caution in patients with risk factors for VTE, orthostatic hypotension, cardiovascular disease and drugs prolonging QT interval. Reduce dose for hypotension. If signs of tardive dyskinesia appear, consider discontinuing all antipsychotic drugs. Caution is warranted in patients receiving both, psychostimulants (e.g., methylphenidate) and paliperidone concomitantly, as extrapyramidal symptoms could emerge when adjusting one or both medications. Gradual withdrawal of stimulant treatment is recommended. Monitor during first few months if history of significant low WBC or drug-induced leucopenia/neutropenia; discontinue if clinically significant decline in WBC or severe neutropenia. May worsen Parkinson’s disease/dementia with Lewy Bodies. Caution if history of/potential for seizures. If neuroleptic malignant syndrome (NMS) develops, stop all antipsychotics. Monitoring in diabetics and those with risk factors for diabetes. Advise of potential for weight gain and monitor regularly. Caution in patients with pre-existing hyperprolactinaemia/possible prolactin-dependent tumours. Evaluate prolactin plasma levels if signs of possible prolactin-related side effects. Advise not to drive or operate machinery if alertness affected. Care when using Risperdal® and furosemide and avoid dehydration in elderly patients with dementia. Potential disruption of body temperature regulation.  Caution if at risk of elevation in core body temperature.  Antiemetic effects observed which may mask symptoms of overdosage or conditions such as intestinal obstruction, Reye’s syndrome and brain tumour Intraoperative Floppy Iris Syndrome (IFIS) observed during cataract surgery in patients treated with medicines with alpha1a-adrenergic antagonist effect, including Risperdal®. Film-coated tablets contain lactose: do not use in patients with galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. 2 & 6 mg film-coated tablets contain sunset yellow (E110): may cause allergic reactions. Oral solution contains benzoic acid (E 210), increase in bilirubinaemia from albumin displacement may increase neonatal jaundice which may develop into kernicterus.

SIDE EFFECTS:  

Very common: Parkinsonism, headache sedation/somnolence, insomnia. 
Common: hyperprolactinaemia, weight increased, increased/decreased appetite, tachycardia, akathisia, dizziness, tremor, dystonia, dyskinesia, vision blurred, conjunctivitis, dyspnoea, epistaxis, cough, nasal congestion, pharyngolaryngeal pain, vomiting, diarrhoea, constipation, nausea, abdominal pain/discomfort, dyspepsia, dry mouth, toothache, urinary incontinence, rash, erythema, arthralgia, back pain, muscle spasms, musculoskeletal pain, pneumonia, influenza, bronchitis, upper respiratory tract infection, sinusitis, urinary tract infection, ear infection, pyrexia, fatigue, oedema, asthenia, chest pain, pain, anxiety, agitation, depression, sleep disorder, hypertension, fall.  
Other side effects include: thrombocytopenia, agranulocytosis, neutropenia, WBC count decreased, depressed/loss of consciousness, convulsion, cerebrovascular disorder/cerebral ischaemia, tardive dyskinesia, neuroleptic malignant syndrome, diabetic coma, atrial fibrillation, atrioventricular block, electrocardiogram QT prolonged, electrocardiogram abnormal, glaucoma, retinal artery occlusion, intestinal obstruction, ileus, faecaloma, pancreatitis, angioedema, rhabdomyolysis, diabetic ketoacidosis, diabetes mellitus, face oedema, hypothermia, anaphylactic reaction, mania, inappropriate antidiuretic hormone secretion, water intoxication, pulmonary embolism, venous thrombosis, pneumonia aspiration, pulmonary congestion, sleep apnoea syndrome, urinary retention, drug withdrawal syndrome (including neonates), jaundice, priapism.
Class effects: As with other antipsychotics, very rare cases of QT prolongation (postmarketing with risperidone). Other cardiac effects reported with antipsychotics which prolong QT interval: ventricular arrhythmia, ventricular fibrillation, ventricular tachycardia, sudden death, cardiac arrest and Torsade de Pointes. Postural orthostatic tachycardia syndrome and venous thromboembolism.

Refer to SmPC for other side effects.

PREGNANCY: 

Should only be used if clearly necessary. Monitor newborns if treatment continues in third trimester of pregnancy.

LACTATION: 

Use should be weighed against potential risks for the child.

INTERACTIONS: 

Caution with medicinal products known to prolong QT interval: antiarrhythmics; tricyclic antidepressants; tetracyclic antidepressants; certain antihistamines and antimalarials; other antipsychotics; medicines causing electrolyte imbalance, bradycardia or those which inhibit hepatic metabolism of risperidone. Caution with centrally acting drugs (including alcohol).  May antagonise dopamine agonists, adjust dose accordingly. Hypotension observed when used with antihypertensives. Concomitant use of CYP3A4 and/or P-gp inducers (e.g. carbamazepine, rifampicin, phenytoin and phenobarbital) may decrease risperidone plasma levels, adjust dose accordingly. CYP2D6 inhibitors (e.g. fluoxetine, paroxetine, quinidine, verapamil) CYP3A4 and/or P-gp inhibitors (e.g. itraconazole, ketoconazole), ritonavir may increase risperidone plasma levels; adjust dose accordingly. Doses of sertraline and fluvoxamine above 100 mg/day may increase plasma concentrations of active antipsychotic fraction. Phenothiazines, tricyclic antidepressants, and some beta-blockers may increase the plasma concentrations of risperidone but not those of the active antipsychotic fraction. Concomitant use with paliperidone not recommended. The combined use of psychostimulants (e.g. methylphenidate) with paliperidone can lead to extrapyramidal symptoms upon change of either/both treatments.

Refer to SmPC for full details of interactions.

LEGAL CATEGORY: Prescription Only Medicine.

PRESENTATIONS, PACK SIZES, MARKETING AUTHORISATION NUMBER(S) & BASIC NHS COSTS

PRESENTATIONS PACK SIZES MARKETING AUTHORISATION NUMBER(S) BASIC NHS COSTS
0.5 mg tablets 20 tablets PL 00242/0347 £5.08
1 mg tablets 20 tablets
60 tablets
PL 00242/0186

£8.36
£17.56

2 mg tablets 60 tablets PL 00242/0187 £34.62
3 mg tablets 60 tablets PL 00242/0188 £50.91
4 mg tablets 60 tablets PL 00242/0189 £67.20
6 mg tablets 28 tablets PL 00242/0317 £67.88
1 mg per ml solution 100 ml PL 00242/0199 £37.01

FURTHER INFORMATION IS AVAILABLE FROM THE MARKETING AUTHORISATION HOLDER: Janssen-Cilag Limited, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK.

Prescribing information last revised: September 2018

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