Risperidone Grindeks 3 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Risperidone

Available from:

AS Grindeks

ATC code:

N05AX08

INN (International Name):

Risperidone

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

risperidone

Authorization status:

Not marketed

Authorization date:

2023-09-15

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
RISPERIDONE GRINDEKS 0.5 MG FILM-COATED TABLETS
RISPERIDONE GRINDEKS 1 MG FILM-COATED TABLETS
RISPERIDONE GRINDEKS 2 MG FILM-COATED TABLETS
RISPERIDONE GRINDEKS 3 MG FILM-COATED TABLETS
RISPERIDONE GRINDEKS 4 MG FILM-COATED TABLETS
RISPERIDONE GRINDEKS 6 MG FILM-COATED 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 Grindeks is and what it is used for
2.
What you need to know before you take Risperidone Grindeks
3.
How to take Risperidone Grindeks
4.
Possible side effects
5.
How to store Risperidone Grindeks
6.
Contents of the pack and other information
1.
WHAT RISPERIDONE GRINDEKS IS AND WHAT IT IS USED FOR
Risperidone Grindeks belongs to a group of medicines called
‘antipsychotics’.
Risperidone Grindeks 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 treatment
(non-medication) 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 disorders.
Risperidone Grindeks can

Summary of Product characteristics

Health Products Regulatory Authority
15 September 2023
CRN00CQSS
Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Risperidone Grindeks 3 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 3 mg risperidone.
Excipients with known effect:
Each film-coated tablet contains 219 mg lactose.
For a full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Beige, round biconvex film-coated tablet. Size of tablet:
approximately 9 mm x 5 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Risperidone Grindeks is indicated for the treatment of schizophrenia.
Risperidone Grindeks is indicated for the treatment of moderate to
severe manic episodes associated with bipolar disorders.
Risperidone Grindeks 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 Grindeks 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
pharmacological 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 Grindeks may be given once or twice daily.
Patients should start with 2 mg/day risperidone. The dosage may be
increased on the second day to 4 mg. Subsequent