Janssen-Cilag Ltd

Change to section 4.4 - Special warnings and precautions for Use

Addition of class labelling text for VTE. Update of class labelling text re increased mortality in elderly patients with dementia and CVAE.

Change to section 4.8 - Undesirable Effects

Addition of class labelling text for VTE. Addition of urinary retention as an uncommon ADR.

Change to section 10 - Date of revision of the text

04.06.10

Change to section 1 –Name of the medicinal product

Inclusion of statement approved by MHRA clarifying black triangle indications

Addition of Black Triangle                                                                                                                                                                                                                                     

Following receipt of MHRA letter dated 17/02/09

Change to section 4.1 – Therapeutic Indications

RISPERDAL is indicated for the short-term treatment (up to 6 weeks) of persistent aggression in patients with moderate to

severe Alzheimer’s dementia unresponsive to non-pharmacological approaches and when there is a risk of harm to self or others.

RISPERDAL is indicated for the short-term symptomatic treatment (up to 6 weeks) of persistent aggression in conduct disorder in children from the age of 5 years and adolescents with subaverage intellectual functioning or mental retardation diagnosed according to DSM-IV criteria, in whom the severity of aggressive or other disruptive behaviours require pharmacologic treatment.

Change to section 4.2 – Posology and |Method of Administration

Persistent aggression in patients with moderate to severe Alzheimer’s dementia

A starting dose of 0.25 mg twice daily is recommended. This dosage can be individually adjusted by increments of 0.25 mg twice daily, not more frequently than every other day, if needed. The optimum dose is 0.5 mg twice daily for most patients. Some patients, however, may benefit from doses up to 1 mg twice daily.

RISPERDAL should not be used more than 6 weeks in patients with persistent aggression in Alzheimer’s dementia. During treatment, patients must be evaluated frequently and regularly, and the need for continuing treatment reassessed.

Conduct disorder

Children and adolescents from 5 to 18 years of age

For subjects ³50 kg, a starting dose of 0.5 mg once daily is recommended. This dosage can be individually adjusted by increments of 0.5 mg once daily not more frequently than every other day, if needed. The optimum dose is 1 mg once daily for most patients. Some patients, however, may benefit from 0.5 mg once daily while others may require 1.5 mg once daily. For subjects <50 kg, a starting dose of 0.25 mg once daily is recommended. This dosage can be individually adjusted by increments of 0.25 mg once daily not more frequently than every other day, if needed. The optimum dose is 0.5 mg once daily for most patients. Some patients, however, may benefit from 0.25 mg once daily while others may require 0.75 mg once daily.

As with all symptomatic treatments, the continued use of RISPERDAL must be evaluated and justified on an ongoing basis.

RISPERDAL is not recommended in children less than 5 years of age, as there is no experience in children less than 5 years of age with this disorder.

Change to section 4.4 – Special Warnings and Precautions for Use

QT prolongation

QT prolongation has very rarely been reported postmarketing. As with other antipsychotics, caution should be exercised when risperidone is prescribed in patients with known cardiovascular disease, family history of QT prolongation, bradycardia, or electrolyte disturbances (hypokalaemia, hypomagnesaemia), as it may increase the risk of arrhythmogenic effects, and in concomitant use with medicines known to prolong the QT interval.

Change to section 4.8 – Undesirable effects

Class effects

As with other antipsychotics, very rare cases of QT prolongation have been reported postmarketing with risperidone. Other class-related cardiac effects reported with antipsychotics which prolong QT interval include ventricular arrhythmia, ventricular fibrillation, ventricular tachycardia, sudden death, cardiac arrest and Torsades de Pointes.

Change to section 10 – Date of revision of the text

Changed to 08.12.08

Change to section 2 – quantitative and qualitative composition

Addition of information re aspartame content of 2 mg Quicklet

Change to section 3 – pharmaceutical form

Change in description of Risperdal Quciklet 2 mg to “Coral, square” from “Round, light coral”

Change to section 6.3 – Shelf Life

Change in shelf life of 2 mg Quicklet to 24 months

Change to section 10 – Date of revision of the text

29.08.08

Change to MA holder contact details

Change of company address

Change to section 4.8 – Undesirable effects

Addition of warning for angioedema and benign pituitary adenoma

Change to section 4.5 –Interaction with other medicinal products and other forms of interaction

Topiramate extra paragraph

Change to section 5.2 - Pharmacokinetic properties

Topiramate extra paragraph

Change to section 10 – Date of revision of the text

16^th july 2007

4.6

Pregnancy and Lactation

Updated with CCDS Oct-2005 wording: “Reversible extrapyramidal symptoms in the neonate were observed following postmarketing use of risperidone during the last trimester of pregnancy.”

4.8

Undesirable effects

Updated with Oculogyric crisis wording

10.

DATE OF REVISION OF THE TEXT

06-09-2006