Risperidone 500microgram tablets

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Risperidone

Disponible depuis:

Actavis UK Ltd

Code ATC:

N05AX08

DCI (Dénomination commune internationale):

Risperidone

Dosage:

500microgram

forme pharmaceutique:

Oral tablet

Mode d'administration:

Oral

classe:

No Controlled Drug Status

Type d'ordonnance:

Valid as a prescribable product

Descriptif du produit:

BNF: 04020100; GTIN: 5012617015723

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Details
RISPERIDONE 0.5MG, 1MG, 2MG, 3MG & 4MG TABLETS PIL - UK
Black
BBBA1810
S.Anson
15.03.18
19.03.18
S.Anson
190 x 380
7pt
Actavis Bulgaria
Dupnitsa
15.03.18
16.03.18
2
Version 2
01.11.2017
PACKAGE LEAFLET: INFORMATION FOR THE USER
RISPERIDONE 0.5MG, 1MG, 2MG, 3MG,
AND 4MG FILM-COATED TABLETS
BBBA1810
_Continued over page_
_Continued top of next column_
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same
as
yours.
•
If you get any side effects talk to your doctor or pharmacist. This
includes
any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1
WHAT RISPERIDONE TABLETS ARE AND WHAT THEY ARE USED FOR
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RISPERIDONE
TABLETS
3
HOW TO TAKE RISPERIDONE TABLETS
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE RISPERIDONE TABLETS
6
CONTENTS OF THE PACK AND OTHER INFORMATION
1
WHAT RISPERIDONE TABLETS ARE AND WHAT THEY ARE USED FOR
Risperidone Tablets belong to a group of medicines called
‘anti-psychotics’.
Risperidone Tablets are used to treat the following:
• Schizophrenia, where you may see, hear or feel things that are not
there, believe
things that are not true or feel unusually susp

Résumé des caractéristiques du produit

OBJECT 1
RISPERIDONE 0.5MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 16-Apr-2018 | Accord-UK Ltd
1. Name of the medicinal product
Risperidone 0.5mg Film-coated Tablets
2. Qualitative and quantitative composition
Each tablet contains 0.5mg of the active substance risperidone.
Excipient with known effect: 61.70mg lactose monohydrate per tablet.
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Film coated Tablet
Light yellow, 8 x 5mm, oval, biconvex, scored, coated tablets, marking
“T“.
4. Clinical particulars
4.1 Therapeutic indications
Risperidone tablets is indicated for the treatment of schizophrenia.
Risperidone tablets is indicated for the treatment of moderate to
severe manic episodes associated with
bipolar disorders.
Risperidone tablets 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.
Risperidone tablets 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. Pharmacological
treatment should be an integral part of a more comprehensive treatment
programme, including
psychosocial and educational intervention. It is recommended that
risperidone be prescribed by a
specialist in child neurology and child and adolescent psychiatry or
physicians well familiar with the
treatment of conduct disorder of children and adolescents.
4.2 Posology and method of administration
Posology
Schizophrenia
_Adults_
Risperidone tablets may be given once daily or twice daily.
Patients should start with 2 mg/day risperidone. The dosage may be
increased on the second day to 4 mg.
Subsequently, th