Risperdal Quicklet 3mg orodispersible tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Risperidone

Available from:

Janssen-Cilag Ltd

ATC code:

N05AX08

INN (International Name):

Risperidone

Dosage:

3mg

Pharmaceutical form:

Orodispersible tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04020100; GTIN: 5012674901274

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
RISPERDAL 0.5, 1, 2, 3, 4 AND 6 MG FILM-COATED TABLETS
RISPERDAL QUICKLET 0.5, 1, 2, 3 AND 4 MG ORODISPERSIBLE TABLETS
Risperidone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINEBECAUSE 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 Risperdalis 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 ingredie

Summary of Product characteristics

OBJECT 1
RISPERDAL QUICKLET 0.5MG ORO-DISPERSIBLE TABLETS
Summary of Product Characteristics Updated 15-Mar-2018 | Janssen-Cilag
Ltd
1. Name of the medicinal product
RISPERDAL Quicklet 0.5 mg orodispersible tablets
RISPERDAL Quicklet 1 mg orodispersible tablets
RISPERDAL Quicklet 2 mg orodispersible tablets
RISPERDAL Quicklet 3 mg orodispersible tablets
RISPERDAL Quicklet 4 mg orodispersible tablets
2. Qualitative and quantitative composition
Each orodispersible tablet contains 0.5 mg of risperidone
Each orodispersible tablet contains 1 mg of risperidone
Each orodispersible tablet contains 2 mg of risperidone [reformulated,
square]
Each orodispersible tablet contains 3 mg of risperidone
Each orodispersible tablet contains 4 mg of risperidone
Excipients with known effect:
Each 0.5 mg orodispersible tablet contains 0.25 mg aspartame (E951)
Each 1 mg orodispersible tablet contains 0.5 mg aspartame (E951)
Each 2 mg orodispersible tablet contains 0.75 mg aspartame (E951)
[reformulated, square]
Each 3 mg orodispersible tablet contains 1.125 mg aspartame (E951)
Each 4 mg orodispersible tablet contains 1.5 mg aspartame (E951)
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
_Orodispersible tablets_
● 0.5 mg risperidone as light coral, round, biconvex tablets of 10
mm
● 1 mg risperidone as light coral, square, biconvex tablets of 11 mm
● 2 mg risperidone as coral, square, biconvex tablets of 11 mm
● 3 mg risperidone as coral, round, biconvex tablets of 14 mm
● 4 mg risperidone as coral, round, biconvex tablets of 16 mm
Orodispersible tablets are etched on one side with R0.5, R1, R2, R3,
and R4 respectively.
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 t