Risperidone 1mg orodispersible tablets sugar free

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Osta kohe

Laadi alla Infovoldik (PIL)
15-06-2018
Laadi alla Toote omadused (SPC)
15-06-2018

Toimeaine:

Risperidone

Saadav alates:

Viatris UK Healthcare Ltd

ATC kood:

N05AX08

INN (Rahvusvaheline Nimetus):

Risperidone

Annus:

1mg

Ravimvorm:

Orodispersible tablet

Manustamisviis:

Oral

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 04020100; GTIN: 5016695002477

Infovoldik

                                PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RISPERIDONE 0.5 MG ORODISPERSIBLE TABLETS
RISPERIDONE 1 MG ORODISPERSIBLE TABLETS
RISPERIDONE 2 MG ORODISPERSIBLE TABLETS
risperidone
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 is and what it is used for
2.
What you need to know before you take Risperidone
3.
How to take Risperidone
4.
Possible side effects
5.
How to store Risperidone
6.
Contents of the pack and other information
1.
WHAT RISPERIDONE IS AND WHAT IT IS USED FOR
Risperidone belongs to a group of medicines called
‘anti-psychotics’.
Risperidone 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RISPERIDONE
DO NOT TAKE RISPERIDONE

if you are allergic to risperidone or any of the other ingredients of
this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or ph
                                
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Toote omadused

                                OBJECT 1
RISPERIDONE MYLAN 1 MG ORODISPERSIBLE TABLETS
Summary of Product Characteristics Updated 12-May-2017 | Generics UK
T/A Mylan
1. Name of the medicinal product
Risperidone Mylan 1 mg orodispersible tablets
2. Qualitative and quantitative composition
Each orodispersible tablet 1 mg contains 1 mg risperidone.
Excipients with known effect:
Each orodispersible tablet contains 0.80 mg aspartame and sorbitol.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Orodispersible tablet.
Round, slightly convex, pink marbled orodispersible tablets
4. Clinical particulars
4.1 Therapeutic indications
Risperidone Mylan is indicated for the treatment of schizophrenia.
Risperidone Mylan is indicated for the treatment of moderate to severe
manic episodes associated with
bipolar disorders.
Risperidone Mylan 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 Mylan 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 Mylan 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 
                                
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