Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Risperidone
Janssen-Cilag Ltd
N05AX08
Risperidone
50 milligram(s)
Powder and solvent for suspension for injection
Product subject to prescription which may not be renewed (A)
risperidone
Marketed
1996-12-13
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 Read the complete document
Health Products Regulatory Authority 20 September 2018 CRN008DNQ Page 1 of 35 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT RISPERDAL CONSTA 50 mg powder and solvent for prolonged-release suspension for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 vial contains 50 mg risperidone. 1 ml reconstituted suspension contains 25 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 injection (see Read the complete document