RISPERDAL CONSTA 37.5 mg powder and solvent for prolonged-release suspension for intramuscular injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Risperidone

Available from:

Imbat Limited

ATC code:

N05AX; N05AX08

INN (International Name):

Risperidone

Dosage:

37.5 milligram(s)

Pharmaceutical form:

Powder and solvent for 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:

2015-07-24

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
RISPERDAL
® CONSTA™ 37.5MG POWDER AND
SOLVENT FOR PROLONGED-RELEASE SUSPENSION FOR
INTRAMUSCULAR INJECTION
(risperidone)
Your medicine is available using the name above, but will be
referred to as Risperdal Consta throughout this leaflet.
The vial and solvent syringe in this pack are labelled as
'Rispolept Consta'. 'Rispolept Consta' is the trademark of this
product as marketed in Romania. This product is equivalent
to the product marked in Ireland as 'Risperdal Consta'.
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.
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
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 ‘anti-
psychotics’.
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 USE RISPERDAL CONSTA

If you are allergic to risperidone or any of the other
in

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
RISPERDAL CONSTA 37.5 mg powder and solvent for prolonged-release
suspension for intramuscular injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 vial contains 37.5 mg risperidone.
1 ml reconstituted suspension contains 18.75 mg of risperidone.
Excipients with known effect: 1ml reconstituted suspension contains
3mg sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder and solvent for prolonged-release suspension for injection.
_Product imported from Poland & Romania_
_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 PA0748/003/011
5 PHARMACOLOGICAL PROPERTIES
As per PA0748/003/011
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Imported from Poland - 7525 DL polymer JN1 poly
(d,l-lactide-co-glycolide).
Imported from Romania - Powder for suspension for injection poly
(d,l-lactide-co-glycolide).
Imported from Poland & Romania
Solvent (solution):
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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