Risperidone 1mg tablets

Land: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Risperidone

Fáanlegur frá:

Milpharm Ltd

ATC númer:

N05AX08

INN (Alþjóðlegt nafn):

Risperidone

Skammtar:

1mg

Lyfjaform:

Oral tablet

Stjórnsýsluleið:

Oral

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 04020100; GTIN: 8901175006694 08901175006694

Upplýsingar fylgiseðill

RISPERIDONE 0.5 MG FILM-COATED TABLETS
RISPERIDONE 1 MG FILM-COATED TABLETS
RISPERIDONE 2 MG FILM-COATED TABLETS
RISPERIDONE 3 MG FILM-COATED TABLETS
RISPERIDONE 4 MG FILM-COATED TABLETS
RISPERIDONE 6 MG FILM-COATED TABLETS
Risperidone
PACKAGE LEAFLET: INFORMATION FOR THE USER
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
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.
Risperidone can help alleviate the symptoms of your disease and stop
your symptoms from
coming back.
DO NOT TAKE RISPERIDONE IF:
•
You are allergic (hypersensitive) to risperidone or a

Vara einkenni

OBJECT 1
RISPERIDONE 1MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 16-Sep-2015 | Aurobindo
Pharma - Milpharm Ltd.
1. Name of the medicinal product
Risperidone 1 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 1 mg risperidone.
Excipient with known effect: Each 1 mg film-coated tablet contains
59.00 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
1 mg film-coated tablets are white, biconvex, capsule-shaped tablets
inscribed with 'A' on one side and
'51' on the other side. Scored between '5' and '1'. The tablet can be
divided into equal doses.
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
Schizophrenia
_Adults_
Risperidone may be given once daily or twice daily.
Patients shoul