RISPERDAL CONSTA 50 mg powder and solvent for prolonged-release suspension for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Risperidone

Available from:

PCO Manufacturing Ltd.

ATC code:

N05AX; N05AX08

INN (International Name):

Risperidone

Dosage:

50 milligram(s)

Pharmaceutical form:

Suspension for injection

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Other antipsychotics; risperidone

Authorization status:

Authorised

Authorization date:

2011-08-05

Patient Information leaflet

1
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
RISPERDAL CONSTA 25 MG POWDER AND SOLVENT FOR PROLONGED-RELEASE
SUSPENSION
FOR INJECTION
RISPERDAL CONSTA 37.5 MG POWDER AND SOLVENT FOR PROLONGED-RELEASE
SUSPENSION
FOR INJECTION
RISPERDAL CONSTA 50 MG POWDER AND SOLVENT FOR PROLONGED-RELEASE
SUSPENSION
FOR INJECTION
risperidone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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.
_RISPERDAL CONSTA IS KNOWN AS RISPOLEPT CONSTA IN POLAND AND ROMANIA.
DISCARD THE ROMANIAN OR THE _
_POLISH LANGUAGE LEAFLET (IF PRESENT) _
WHAT IS IN THIS LEAFLET
1.
What Risperdal Consta is and what it is used for
2.
What you need to know before you use Risperdal Consta
3.
How to use Risperdal Consta
4.
Possible side effects
2
_ _
5.
How to store Risperdal Consta
6.
Contents of the pack and other information
1.
WHAT RISPERDAL CONSTA IS AND WHAT IT IS USED FOR
Risperdal Consta belongs to a group of medicines called
‘antipsychotics’.
Risperdal Consta is used to maintain the treatment of 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.
Risperdal Consta is intended for patients who are currently treated
with oral (e.g. tablets, capsules)
antipsychotics.
Risperdal Consta can help alleviate the symptoms of your disease and
stop your symptoms from coming
back.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE RISPERDAL CONSTA
DO NOT TAKE RISPERDAL CONSTA

If you are allergic to risperidone or any of the other ingredients of
this medicine (listed in section 6)

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Risperdal Consta 50mg Powder and Solvent for Prolonged-Release
Suspension for Intramuscular Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 vial contains 50 mg risperidone.
1 ml reconstituted suspension contains 25 mg of risperidone.
Excipients: 1 ml reconstituted suspension contains 3 mg sodium.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder and Solvent for Prolonged-Release Suspension for Injection
_Product imported from Greece, UK, Romania and Poland:_
Vial with powder: white to off-white free-flowing powder
Pre-filled syringe of solvent for reconstitution: clear, colourless
aqueous solution
4 CLINICAL PARTICULARS
As per PA0748/003/012
5 PHARMACOLOGICAL PROPERTIES
As per PA0748/003/012
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
_Microspheres_
(Poly-(d, l-lactide-co-glycolide))
_Solvent_
Polysorbate 20
Carmellose sodium
Disodium hydrogen phosphate dihydrate
Citric acid anhydrous
Sodium chloride
Sodium hydroxide
Water for injection
6.2 INCOMPATIBILITIES
This medicinal product must not be mixed with other medicinal products
except those mentioned in section 6.6.
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6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the inner and outer package of the produc