Država: Evropska unija
Jezik: angleščina
Source: EMA (European Medicines Agency)
paliperidone
Janssen-Cilag International NV
N05AX13
paliperidone
Psycholeptics
Schizophrenia; Psychotic Disorders
Invega is indicated for the treatment of schizophrenia in adults and in adolescents 15 years and older.Invega is indicated for the treatment of schizoaffective disorder in adults.
Revision: 18
Authorised
2007-06-24
43 B. PACKAGE LEAFLET 44 PACKAGE LEAFLET: INFORMATION FOR THE USER INVEGA 3 MG PROLONGED-RELEASE TABLETS INVEGA 6 MG PROLONGED-RELEASE TABLETS INVEGA 9 MG PROLONGED-RELEASE TABLETS INVEGA 12 MG PROLONGED-RELEASE TABLETS Paliperidone 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What INVEGA is and what it is used for 2. What you need to know before you take INVEGA 3. How to take INVEGA 4. Possible side effects 5. How to store INVEGA 6. Contents of the pack and other information 1. WHAT INVEGA IS AND WHAT IT IS USED FOR INVEGA contains the active substance paliperidone which belongs to the class of antipsychotic medicines. INVEGA is used to treat schizophrenia in adults and in adolescents aged 15 years and older. Schizophrenia is a disorder with symptoms such as hearing things, seeing or sensing things that are not there, mistaken beliefs, unusual suspiciousness, becoming withdrawn, incoherent speech, and behaviour and emotional flatness. People with this disorder may also feel depressed, anxious, guilty, or tense. INVEGA is also used to treat schizoaffective disorder in adults. Schizoaffective disorder is a mental condition in which a person experiences a combination of schizophrenia symptoms (as listed above) in addition to mood disorder symptoms (feeling very high, feeling sad, feeling agitated, distracted, sleeplessness, talkativeness, losing interest in everyday activities, sleeping too much or too little, eating too much or too little, and recurrent thoughts of suicide). INVEGA c Preberite celoten dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT INVEGA 3 mg prolonged-release tablets INVEGA 6 mg prolonged-release tablets INVEGA 9 mg prolonged-release tablets INVEGA 12 mg prolonged-release tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release tablet contains 3 mg of paliperidone. Each prolonged-release tablet contains 6 mg of paliperidone. Each prolonged-release tablet contains 9 mg of paliperidone. Each prolonged-release tablet contains 12 mg of paliperidone. Excipient with known effect Each 3 mg tablet contains 13.2 mg lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Prolonged-release tablet Trilayer capsule-shaped white tablets of 11 mm in length and 5 mm in diameter printed with “PAL 3” Trilayer capsule-shaped beige tablets of 11 mm in length and 5 mm in diameter printed with “PAL 6” Trilayer capsule-shaped pink tablets of 11 mm in length and 5 mm in diameter printed with “PAL 9” Trilayer capsule-shaped yellow tablets of 11 mm in length and 5 mm in diameter printed with “PAL 12” 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS INVEGA is indicated for the treatment of schizophrenia in adults and in adolescents 15 years and older. INVEGA is indicated for the treatment of schizoaffective disorder in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Schizophrenia (adults)_ The recommended dose of INVEGA for the treatment of schizophrenia in adults is 6 mg once daily, administered in the morning. Initial dose titration is not required. Some patients may benefit from lower or higher doses within the recommended range of 3 mg to 12 mg once daily. Dosage adjustment, if indicated, should occur only after clinical reassessment. When dose increases are indicated, increments of 3 mg/day are recommended and generally should occur at intervals of more than 5 days. _Schizoaffective disorder (adults)_ The recommended dose of INVEGA for the treatment of schizoaffective disorder in adults is 6 mg once daily, a Preberite celoten dokument