Risperidone 500microgram tablets

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Risperidone

Disponible depuis:

Accord-UK Ltd

Code ATC:

N05AX08

DCI (Dénomination commune internationale):

Risperidone

Dosage:

500microgram

forme pharmaceutique:

Oral tablet

Mode d'administration:

Oral

classe:

No Controlled Drug Status

Type d'ordonnance:

Valid as a prescribable product

Descriptif du produit:

BNF: 04020100; GTIN: 5060149311424

Notice patient

PACKAGE LEAFLET: INFORMATION FOR THE USER
RISPERIDONE 0.5 MG FILM-COATED TABLETS
RISPERIDONE 1 MG FILM-COATED TABLETS
RISPERIDONE 2 MG FILM-COATED TABLETS
RISPERIDONE 3 MG FILM-COATED TABLETS
RISPERIDONE 4 MG FILM-COATED TABLETS
RISPERIDONE 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, please 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.
WHAT IS IN THIS LEAFLET:
1.
What Risperidone is and what it is used for
2.
What you need to know before you take Risperidone
3.
How to take Risperidone
4.
Possible side effects
5.
How to store Risperidone
6.
Contents of the pack and other information
1. WHAT RISPERIDONE IS AND WHAT IT IS USED FOR
Risperidone belongs to a group of medicines called
‘anti-psychotics’.
Risperidone 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.
Risperidone can help alleviate the symptoms of your disease and stop
your symptoms from coming back.
2. WHAT YOU NEED TO KNOW BEFORE YOU T

Résumé des caractéristiques du produit

OBJECT 1
RISPERIDONE 0.5 MG FILM COATED TABLETS
Summary of Product Characteristics Updated 07-Jun-2016 | Accord
Healthcare Limited
1. Name of the medicinal product
Risperidone 0.5 mg Film-coated Tablets
Risperidone 1 mg Film-coated Tablets
Risperidone 2 mg Film-coated Tablets
Risperidone 3 mg Film-coated Tablets
Risperidone 4 mg Film-coated Tablets
Risperidone 6 mg Film-coated Tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 0.5 mg of risperidone.
Excipient with known effect: Each film-coated tablet contains 63.65 mg
lactose (as lactose monohydrate)
Each film-coated tablet contains 1 mg of risperidone.
Excipient with known effect: Each film-coated tablet contains 127.30
mg lactose (as lactose
monohydrate)
Each film-coated tablet contains 2 mg of risperidone.
Excipients with known effect: Each film-coated tablet contains 126.35
mg lactose (as lactose
monohydrate), and 0.02 mg of lake of sunset yellow (E 110)
Each film-coated tablet contains 3 mg of risperidone.
Excipient with known effect: Each film-coated tablet contains 189.53
mg lactose (as lactose
monohydrate)
Each film-coated tablet contains 4 mg of risperidone.
Excipient with known effect: Each film-coated tablet contains 124.45
mg lactose (as lactose
monohydrate)
Each film-coated tablet contains 6 mg of risperidone.
Excipients with known effect: Each film-coated tablet contains 122.55
mg lactose (as lactose
monohydrate) and 0.01 mg of lake of sunset yellow (E 110)
For a full list of excipients see section 6.1.
3. Pharmaceutical form
Film-coated tablet
Risperidone Accord 0.5 mg film-coated tablets are brick red coloured,
round, biconvex, film-coated
tablet, plain on both sides.
Risperidone Accord 1 mg film-coated tablets are white to off white,
capsule shaped, biconvex film-coated
tablet, plain on both sides.
Risperidone Accord 2 mg film-coated tablets are light orange coloured,
capsule shaped, biconvex film-
coated tablet, plain on both sides.
Risperidone Accord 3 mg film-coated tablets are light yellow coloured,
oval sha