Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Risperidone
Laboratorios Farmacéuticos Rovi, S.A.
N05AX08
risperidone
Psycholeptics
Schizophrenia
Treatment of schizophrenia in adults for whom tolerability and effectiveness has been established with oral risperidone.
Revision: 2
Authorised
2022-02-14
41 B. PACKAGE LEAFLET 42 PACKAGE LEAFLET: INFORMATION FOR THE USER OKEDI 75 MG POWDER AND SOLVENT FOR PROLONGED-RELEASE SUSPENSION FOR INJECTION 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, 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 OKEDI is and what it is used for 2. What you need to know before you use OKEDI 3. How to use OKEDI 4. Possible side effects 5. How to store OKEDI 6. Contents of the pack and other information 1. WHAT OKEDI IS AND WHAT IT IS USED FOR OKEDI contains the active substance risperidone which belongs to the group of medicines called ‘antipsychotics’. OKEDI is used in adult patients to treat 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. OKEDI is intended for patients who show tolerability and effectiveness to oral (e.g. tablets) risperidone. OKEDI can help alleviate the symptoms of your disease and stop your symptoms from coming back. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE OKEDI DO NOT USE OKEDI: • If you are allergic (hypersensitive) to risperidone or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking OKEDI if: • You have a heart problem. Examples include an irregular heart rhythm or if you are prone to low blood pressure or if you are using medicines for your blood pressure. OKEDI may cause low blood pressure. Your dose may need to be adjusted • You know of any factors which would favour yo Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT OKEDI 75 mg powder and solvent for prolonged-release suspension for injection OKEDI 100 mg powder and solvent for prolonged-release suspension for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION OKEDI 75 mg powder and solvent for prolonged-release suspension for injection 1 pre-filled syringe contains 75 mg of risperidone. OKEDI 100 mg powder and solvent for prolonged-release suspension for injection 1 pre-filled syringe contains 100 mg risperidone. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for prolonged-release suspension for injection. _Pre-filled syringe of powder _ White to white-yellowish non-aggregated powder. _Pre-filled syringe of solvent for reconstitution _ Clear solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS OKEDI is indicated for the treatment of schizophrenia in adults for whom tolerability and effectiveness have been established with oral risperidone. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ _ OKEDI should be administered every 28 days by intramuscular (IM) injection. OKEDI should be initiated according to the patient’s clinical context: _Patients with history of previous response to Risperidone who are currently stabilised with oral _ _antipsychotics (mild to moderate psychotic symptoms) _ Patients stabilised with oral risperidone can be switched to OKEDI without previous titration. Patients stabilised on other oral antipsychotics (different from risperidone) should be titrated with oral risperidone before initiating treatment with OKEDI. The duration of the titration period should be sufficiently long (at least 6 days) to confirm the tolerability and responsiveness to risperidone. _Patients never treated before with oral Risperidone _ Patients who are candidates to receive OKEDI and have NOT been previously treated with risperidone, the tolerability and responsiveness to risperidone must be confirmed with a period of oral risperidone t Aqra d-dokument sħiħ