Ridal

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Risperidone 1mg;  

Available from:

Douglas Pharmaceuticals Limited

INN (International Name):

Risperidone 1 mg

Dosage:

1 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Risperidone 1mg   Excipient: Colloidal silicon dioxide Hypromellose Lactose monohydrate Magnesium stearate Maize starch Microcrystalline cellulose Opadry white Y-1-7000

Units in package:

Blister pack, PVC/PVDC, 60 tablets, 60 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Jubilant Generics Limited

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC, 60 tablets - 60 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE, 60 tablets - 60 tablets - 36 months from date of manufacture stored at or below 25°C

Authorization date:

2004-01-16

Patient Information leaflet

Medsafe Logo
INFORMATION FOR
CONSUMERS
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Information
RIDAL
Risperidone 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, 6 mg film coated tablets
What is in this leaflet
This leaflet will answer some of the common questions about Ridal tablets. It does not contain all of the
information available on this medicine and does not take the place of talking to your doctor or
pharmacist.
If you have any concerns about using Ridal tablets, ask your doctor or pharmacist. Your doctor and
pharmacist have more information.
Keep this leaflet with your Ridal tablets. You may want to read it again.
What are Ridal tablets used for
Ridal is used to treat symptoms of schizophrenia and other types of related psychoses. These are
disorders related to thought, feeling and/or action.
This medicine is also used to treat behavioural problems in patients with a decline in mental ability
(dementia). These problems include:
aggression through words or action
agitation
morbid suspiciousness
wandering
Ridal tablets help to correct a chemical imbalance in the brain associated with these conditions.
This medicine can also be used to treat conduct and other disruptive behaviours such as aggression,
impulsiveness and self-injury in children (over 5 years old), adolescents and adults who are intellectually
disabled.
Ridal tablets may be taken for both sudden (acute) and long-lasting (chronic) schizophrenia.
Ridal can also be used for the treatment of autism in children and adolescents.
Ridal has been approved for the uses mentioned above. However, your doctor may prescribe this
medicine for another use. If you want more information, ask your doctor.
There is no evidence that Ridal tablets are ad

Summary of Product characteristics

1 | P a g e
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
RIDAL® 0.5 mg film coated tablets
RIDAL® 1 mg film coated tablets
RIDAL® 2 mg film coated tablets
RIDAL® 3 mg film coated tablets
RIDAL® 4 mg film coated tablets
RIDAL® 6 mg film coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 0.5 mg, 1mg, 2 mg, 3 mg or 4 mg of
risperidone.
EXCIPIENT(S) WITH KNOWN EFFECT
RIDAL tablets contain lactose monohydrate. For the full list of
excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
RIDAL 0.5 mg: A red, round tablet engraved with “R” on one face
and a breakline on the other
RIDAL 1 mg: A white oblong tablet engraved with “R”, a breakline
and “l” on one face and plain
on the other
RIDAL 2 mg: An orange, oblong tablet engraved with “R”, a
breakline and “2” on one face and
plain on the other
RIDAL 3 mg: A yellow, oblong tablet engraved with “R”, a breakline
and “3” on one face and
plain on the other
RIDAL 4 mg: A green, oblong tablet engraved with “R”, a breakline
and “4” on one face and plain
on the other
RIDAL 6 mg: A yellow, oblong tablet engraved with “R”, a breakline
and “6” on one face and
plain on the other.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
RIDAL is indicated for the treatment of schizophrenia and other
psychotic disorders. These
include first episode psychoses, acute schizophrenic exacerbations,
chronic schizophrenia and
other psychotic conditions, in which positive symptoms (such as
hallucinations, delusions,
thought disturbances, hostility, suspiciousness), and/or negative
symptoms (such as blunted
effect, emotional and social withdrawal, poverty of speech) are
prominent.
2 | P a g e
RIDAL is also indicated for the treatment and long term control of
mania in bipolar disorder.
These episodes are characterised by symptoms such as elevated,
expansive or irritable mood,
inflated self esteem, decreased need for sleep, pressured speech,
racing thoughts,
distractability, or poor judgement, including disruptive or ag