RISPERDAL CONSTA 37.5 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:

Janssen-Cilag Ltd

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:

Marketed

Authorization date:

1996-12-13

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
RISPERDAL CONSTA 25, 37.5 AND 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.
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
‘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 USE RISPERDAL CONSTA
●
If you are allergic to risperidone or any of the other ingredients of
this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
●
If you have never taken any form of Risperdal, you should begin with
oral Risperdal before
beginning treatment with Risperdal Consta.
Talk to your doctor or pharmacist before using Risperdal Consta if:
●
You have a heart problem. Examples include an irregular heart rhythm
or if you are

Summary of Product characteristics

Health Products Regulatory Authority
20 September 2018
CRN008DNQ
Page 1 of 35
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
RISPERDAL CONSTA 37.5 mg powder and solvent for prolonged-release
suspension
for 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
1 ml reconstituted suspension contains 3 mg sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder and solvent for prolonged-release suspension for injection.
_Vial with powder_
White to off-white free flowing powder.
_Pre-filled syringe of solvent for reconstitution_
Clear, colourless aqueous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
RISPERDAL CONSTAis indicated for the maintenance treatment of
schizophrenia in
patients currently stabilised with oral antipsychotics.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
Starting dose
Health Products Regulatory Authority
20 September 2018
CRN008DNQ
Page 2 of 35
For most patients the recommended dose is 25 mg intramuscular every
two weeks.
For those patients on a fixed dose of oral risperidone for two weeks
or more, the
following conversion scheme should be considered. Patients treated
with a dosage of
4 mg or less oral risperidone should receive 25 mg RISPERDAL CONSTA,
while
patients treated with higher oral doses should be considered for the
higher
RISPERDAL CONSTA dose of 37.5 mg.
Where patients are not currently taking oral risperidone, the oral
pre‑treatment
dosage should be considered when choosing the I.M. starting dose. The
recommended starting dose is 25 mg RISPERDAL CONSTA every two weeks.
Patients
on higher dosages of the used oral antipsychotic should be considered
for the higher
RISPERDAL CONSTA dose of 37.5 mg.
Sufficient antipsychotic coverage with oral risperidone or the
previous antipsychotic
should be ensured during the three‑week lag period following the
first RISPERDAL
CONSTA injectio