Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
Paliperidone
Krka d.d., Novo mesto
N05AX; N05AX13
Paliperidone
9 milligram(s)
Prolonged-release tablet
Product subject to prescription which may not be renewed (A)
Other antipsychotics; paliperidone
Not marketed
2018-06-22
Navodila prepognjena na sredini z vidno prvo stranjo (naslovom); pharma kodi, ki izhajata iz sredine navodila, morata biti vidni! smer vlaken smer branja kode 70 mm ± 0,5 mm 70 mm ± 0,5 mm smer branja kode Šifra: XXXXXX Emb. mat.: NA.Paliperidone Krka tbl IE Dimenzije: 148 ± 0,5 mm x 594 ± 0,8 mm Material: papir tip B PhC št.: 1234 Merilo: 1:1 Datum: 29.05.2018 Izdelal: A. Mohorič Pregledal: N. Regina _Oddelek za oblikovanje_ _ - PMS-433U-KRKA_ _NA.Paliperidone Krka tbl IE _ prva stran PACKAGE LEAFLET: INFORMATION FOR THE PATIENT Paliperidone Krka 3 mg prolonged-release tablets Paliperidone Krka 6 mg prolonged-release tablets Paliperidone Krka 9 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 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 Paliperidone Krka is and what it is used for 2. What you need to know before you take Paliperidone Krka 3. How to take Paliperidone Krka 4. Possible side effects 5. How to store Paliperidone Krka 6. Contents of the pack and other information 1. What Paliperidone Krka is and what it is used for Paliperidone Krka contains the active substance paliperidone which belongs to the class of antipsychotic medicines. Paliperidone Krka 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such as hearing things, seeing or sensing things that are not there, mistaken beliefs, unusual suspiciousness, becoming withdrawn, incoherent speech, and behaviour and emotional flatness.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 Baca dokumen lengkapnya
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Paliperidone Krka 9 mg prolonged-release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release tablet contains 9 mg paliperidone. Excipient with known effect Each tablet contains 15.7 mg sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release tablet Off-pink, round, biconvex, film-coated tablets with possible uneven surface and imprinted with mark P9 on one side of the tablet. Diameter: approximately 9 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Paliperidone Krka is indicated for the treatment of schizophrenia in adults and in adolescents 15 years and older. Paliperidone Krka is indicated for the treatment of schizoaffective disorder in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Schizophrenia (adults)_ The recommended dose of Paliperidone Krka 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 Paliperidone Krka for the treatment of schizoaffective disorder in adults is 6 mg once daily, administered in the morning. Initial dose titration is not required. Some patients may benefit from higher doses within the recommended range of 6 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 4 days. _Switching to other antipsychotic medicinal products_ There are no systematically collected data to specifically address switching patien Baca dokumen lengkapnya