Risperidone 1mg/ml oral solution sugar free

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Risperidone

Prieinama:

Wockhardt UK Ltd

ATC kodas:

N05AX08

INN (Tarptautinis Pavadinimas):

Risperidone

Dozė:

1mg/1ml

Vaisto forma:

Oral solution

Vartojimo būdas:

Oral

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 04020100; GTIN: 5012727905686

Pakuotės lapelis

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NEUTRAL CODE NOT REQUIRED ON THE LEAFLET ARTWORKS
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RISPERIDONE 1MG/ML ORAL SOLUTION
RISPERIDONE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING
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, nurse
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, pharmacist or
nurse. This includes any possible side effects not listed in
this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Risperidone Oral Solution is and what it is used for
2. What you need to know before you take Risperidone Oral
Solution
3. How to take Risperidone Oral Solution
4. Possible side effects
5. How to store Risperidone Oral Solution
6. Contents of the pack and other information
1. WHAT RISPERIDONE ORAL SOLUTION IS AND
WHAT IT IS USED FOR
Risperidone Oral Solution belongs to a group of medicines
called ‘anti-psychotics’.
Risperidone Oral Solution 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 six 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 six weeks) of long-term aggression in
intellectually disabled children (at
least five years of

Prekės savybės

OBJECT 1
RISPERIDONE 1MG/ML ORAL SOLUTION
Summary of Product Characteristics Updated 31-Aug-2017 | Wockhardt UK
Ltd
1. Name of the medicinal product
Risperidone 1mg/ml Oral Solution
2. Qualitative and quantitative composition
Each ml of solution contains 1mg of risperidone.
Excipient with known effect: sodium methylparaben (E219) 1.8mg/ml.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral solution
The solution is clear and colourless.
4. Clinical particulars
4.1 Therapeutic indications
Risperidone is indicated for the treatment of schizophrenia.
Risperidone is indicated for the treatment of moderate to severe manic
episodes associated with bipolar
disorders.
Risperidone 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 is indicated for the short-term symptomatic treatment (up
to 6 weeks) of persistent
aggression in conduct disorder in children from the age of five 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 Oral Solution 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, if needed. Most patients
w