Risperdal 500microgram tablets

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Risperidone

זמין מ:

Janssen-Cilag Ltd

קוד ATC:

N05AX08

INN (שם בינלאומי):

Risperidone

כמות:

500microgram

טופס פרצבטיות:

Oral tablet

מסלול נתינה (של תרופות):

Oral

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 04020100; GTIN: 5012674055823

עלון מידע

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

מאפייני מוצר

OBJECT 1
RISPERDAL 6MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 15-Mar-2018 | Janssen-Cilag
Ltd
1. Name of the medicinal product
RISPERDAL 0.5 mg film-coated tablets
RISPERDAL 1 mg film-coated tablets
RISPERDAL 2 mg film-coated tablets
RISPERDAL 3 mg film-coated tablets
RISPERDAL 4 mg film-coated tablets
RISPERDAL 6 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 0.5 mg of risperidone
Each film-coated tablet contains 1 mg of risperidone
Each film-coated tablet contains 2 mg of risperidone
Each film-coated tablet contains 3 mg of risperidone
Each film-coated tablet contains 4 mg of risperidone
Each film-coated tablet contains 6 mg of risperidone
Excipients with known effect:
Each 0.5 mg film-coated tablet contains 91 mg lactose monohydrate
Each 1 mg film-coated tablet contains 131 mg lactose monohydrate
Each 2 mg film-coated tablet contains 130 mg lactose monohydrate and
0.05 mg orange yellow S
aluminium lake (sunset yellow) E110
Each 3 mg film-coated tablet contains 195 mg lactose monohydrate
Each 4 mg film-coated tablet contains 260 mg lactose monohydrate
Each 6 mg film-coated tablet contains 115 mg lactose monohydrate and
0.01 mg orange yellow S
aluminium lake (sunset yellow) E110
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
_Film-coated tablets_
● 0.5 mg risperidone as brownish-red, half-scored, oblong, biconvex
tablets of 9 mm x 5 mm
● 1 mg risperidone as white, half-scored, oblong, biconvex tablets
of 10.5 mm x 5 mm
● 2 mg risperidone as orange, half-scored, oblong, biconvex tablets
of 10.5 mm x 5 mm
● 3 mg risperidone as yellow, half-scored, oblong, biconvex tablets
of 13.5 mm x 5 mm
● 4 mg risperidone as green, half-scored, oblong, biconvex tablets
of 15 mm x 6.5 mm
● 6 mg risperidone as yellow, circular, biconvex tablets of 8 mm.
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 0.5, RIS