Risperidone 4mg tablets

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Risperidone

Dostępny od:

Relonchem Ltd

Kod ATC:

N05AX08

INN (International Nazwa):

Risperidone

Dawkowanie:

4mg

Forma farmaceutyczna:

Oral tablet

Droga podania:

Oral

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 04020100; GTIN: 05055144200606

Ulotka dla pacjenta

Risperidone contains the active substance risperidone.
It 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.
Risperidone can help alleviate the symptoms of your
disease and stop your symptoms from coming back.
DO NOT TAKE RISPERIDONE:
•
if you are allergic to risperidone or any of the other
ingredients of this medicine (listed in section 6).
If you are not sure if the above applies to you, talk to
your doctor or pharmacist before using Risperidone.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking
Risperidone if:
•
You have a heart problem. Examples include an
irregular heart rhythm or if you are prone to low blood
pressure or if you are using medicines for your blood
pressure. Risperidone may cause low blood pressure.
Your dose may need to be adjusted.
•
You know of any factors which would favour you having
a stroke, such as high blood pressure, cardiovascular
disorder or blood vessel problems in the brain.
•
You have ever experienced involuntary movements
of the tongue, mouth and face.
•
You have ever had a condition whose symptoms
include high temperature, muscle stiffness, sweating
or a lowered level of consciousness (also known as
Neuroleptic Malignant Syndrome).
•
You have Parkinson’s disease or dementia.
•
You know that you have had low levels of white bl

Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Risperidone 4 mg Orodispersible Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orodispersible tablet contains 4 mg of risperidone.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Orodispersible tablet
Mottled light pink, flat, round tablets, plain on both sides, rough on
borders an
face
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
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 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 will benefit from daily doses between 4 and 6
mg. In some
patients, a slower titration phase an