RISPERDAL QUICKLET 2 Milligram Orodispersible Tablet

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

RISPERIDONE

Inapatikana kutoka:

Janssen-Cilag Ltd

ATC kanuni:

N05AX08

INN (Jina la Kimataifa):

RISPERIDONE

Kipimo:

2 Milligram

Dawa fomu:

Orodispersible Tablet

Dawa ya aina:

Product subject to prescription which may not be renewed (A)

Eneo la matibabu:

Other antipsychotics

Idhini hali ya:

Authorised

Idhini ya tarehe:

2004-03-05

Taarifa za kipeperushi

PACKAGE LEAFL ET: INFORMATION FOR THE USER 0.5, 1, 2, 3, 4 AND 6 MG
FILM-COATED TABLETS QUICKLET 0.5, 1, 2, 3 AND 4 MG
ORODISPERSIBLE TABLETS
Risperidone
READ ALL OF THIS LEAFL ET CAREFULLY BEFORE
YOU START TAKING THIS MEDICINEBECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
• Keep this leafl et. 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 eff ects, talk to your doctor or
pharmacist.This includes any possible side eff ects
not listed in this leafl et.See section 4.
WHAT IS IN THIS LEAFL ET
1
WHAT RISPERDALIS AND WHAT IT IS USED FOR
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
RISPERDAL
3
HOW TO TAKE RISPERDAL
4
POSSIBLE SIDE EFF ECTS
5
HOW TO STORE RISPERDAL
6
CONTENTS OF THE PACK AND OTHER INFORMATION
1 WHAT RISPERDAL IS AND WHAT IT IS USED FOR
Risperdal belongs to a group of medicines called
‘antipsychotics’.
Risperdal is 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 suspicious, or confused
• Mania, where you may feel very excited, elated,
agitated, enthusiastic or hyperactive. Mania occurs
in an illness called “bipolar disorder”
• Short-term treatment (up to 6 weeks) of long-term
aggression in people with Alzheimer’s dementia,
who harm themselves or others. Alternative (non-drug)
treatments should have been used previously
• Short-term treatment (up to 6 weeks) of long-term
aggression in intellectually disabled children
(at least 5 years of age) and adolescents with
conduct disorder.
Risperdal can help alleviate the symptoms of your
disease and stop your symptoms from coming back.
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE RISPERDAL
DO NOT TAKE RISPERDAL
• If you are allergic (hypersensitive) to risperidone
or any of the other ingredients of this medicine

Tabia za bidhaa

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
RISPERDAL Quicklet 2 mg orodispersible tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orodispersible tablet contains 2 mg of risperidone
Excipients with known effect:
Each 2 mg orodispersible tablet contains 0.75 mg aspartame (E951)
[reformulated, square]
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Orodispersible tablet
2 mg risperidone as coral, square, biconvex tablets of 11 mm.
Orodispersible tablets are etched on one side with R2.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
RISPERDAL is indicated for the treatment of schizophrenia.
RISPERDAL is indicated for the treatment of moderate to severe manic
episodes associated with bipolar disorders.
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. 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
_Adults_
RISPERDAL 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, the dosage can be maintained unchanged, or further
individualised,