Risperdal 2mg tablets

Negara: Inggris

Bahasa: Inggris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Risperidone

Tersedia dari:

DE Pharmaceuticals

Kode ATC:

N05AX08

INN (Nama Internasional):

Risperidone

Dosis:

2mg

Bentuk farmasi:

Oral tablet

Rute administrasi :

Oral

Kelas:

No Controlled Drug Status

Jenis Resep:

Valid as a prescribable product

Ringkasan produk:

BNF: 04020100

Selebaran informasi

RISPERDAL
® 2MG TABLETS
(risperidone)
PATIENT INFORMATION LEAFLET
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.
Risperdal Tablets are also available in the following strengths:
0.5mg,
1mg, 3mg, 4mg and 6mg.
WHAT IS IN THIS LEAFLET:
1. What Risperdal is and what it is used for
2. What you need to know before you take Risperdal
3. How to take Risperdal
4. Possible side effects
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

Karakteristik produk

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
RISPERDAL 2 mg film-coated tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2 mg of risperidone
Excipients with known effect
Each 2 mg film-coated tablet contains 130 mg lactose monohydrate and
0.05 mg
orange yellow S aluminium lake (sunset yellow) E110
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
_Film-coated tablet _
•
2 mg risperidone as orange half-scored oblong biconvex tablets
_ _
The score line is only to facilitate breaking for ease of swallowing
and not to divide
into equal doses.
Film-coated tablets are etched on one side with RIS 2. Additionally
JANSSEN may
be etched on the other side.
_ _
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
_Schizophrenia _
_Adults_
RISPERDAL may be give