Ülke: Ermenistan
Dil: İngilizce
Kaynak: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
risperidone
Remedica Ltd
N05AX08
risperidone
1mg
tablets film-coated
(60/6x10/) blisters
Prescription
Registered
2015-05-29
P18-0689RPILECY2 000058 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT RISPERIDONE-REMEDICA, 1 MG, FILM-COATED TABLETS RISPERIDONE-REMEDICA, 2 MG, FILM-COATED TABLETS RISPERIDONE-REMEDICA, 3 MG, FILM-COATED TABLETS RISPERIDONE-REMEDICA, 4 MG, FILM-COATED TABLETS RISPERIDONE-REMEDICA, 6 MG, FILM-COATED TABLETS 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, 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 symptoms 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 RISPERIDONE-REMEDICA is and what it is used for 2. What you need to know before you take RISPERIDONE-REMEDICA 3. How to take RISPERIDONE-REMEDICA 4. Possible side effects 5. How to store RISPERIDONE-REMEDICA 6. Contents of the pack and other information 1. WHAT RISPERIDONE-REMEDICA IS AND WHAT IT IS USED FOR Risperidone-Remedica belongs to a group of medicines called ‘anti-psychotics’. Risperidone-Remedica is used to treat the following: • 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. • Mania, where you may feel very excited, elated, agitated, enthusiastic or hyperactive. Mania occurs in an illness called ‘bipolar disorder’. • Short-term treatment (up to 6 weeks) of long-term aggression in people with Alzheimer’s dementia, who harm themselves or others. Alternative (non – drug) treatments should have been used previously. • Short-term treatment (up to 6 weeks) of long-term, aggression in intellectually disabled children (at least 5 years of age) and adolescents with conduct disorder. Risperidone-Re Belgenin tamamını okuyun
SmPC RISPERIDONE - REMEDICA TABLETS Remedica Risperidone Cyprus RISPERIDONE - REMEDICA TABS-M1.3-V4-00 Section 1.3 p 1 SUMMARY OF PRODUCT CHARACTERISTICS _1. NAME OF THE MEDICINAL PRODUCT _ Risperidone – Remedica, 6 mg, Film-Coated Tablets Risperidone – Remedica, 4 mg, Film-Coated Tablets Risperidone – Remedica, 3 mg, Film-Coated Tablets Risperidone – Remedica, 2 mg, Film-Coated Tablets Risperidone – Remedica, 1 mg, Film-Coated Tablets _2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ Each Risperidone – Remedica 6 mg film-coated tablet contains Risperidone EP 6 mg. Each Risperidone – Remedica 4 mg film-coated tablet contains Risperidone EP 4 mg. Each Risperidone – Remedica 3 mg film-coated tablet contains Risperidone EP 3 mg. Each Risperidone – Remedica 2 mg film-coated tablet contains Risperidone EP 2 mg. Each Risperidone – Remedica 1 mg film-coated tablet contains Risperidone EP 1 mg. For the full list of excipients, see section 6.1. _3. PHARMACEUTICAL FORM _ Tablets for oral use. _4. CLINICAL PARTICULARS _ _ _ _4.1. Therapeutic Indications _ Risperidone – Remedica is indicated for the treatment of schizophrenia. Risperidone – Remedica is indicated for the treatment of moderate to severe manic episodes associated with bipolar disorders. Risperidone – Remedica is indicated for the short-term treatment (up to 6 weeks) of persistent aggression in patients with moderate to severe Alzheimer’s dementia unresponsive to non-pharmacological approaches and when there is a risk of harm to self or others. Risperidone – Remedica is indicated for the short-term symptomatic treatment (up to 6 weeks) of persistent aggression in conduct disorder in children from the age of 5 years and adolescents with subaverage intellectual functioning or mental retardation diagnosed according to DSM-IV criteria, in whom the severity of aggressive or other disruptive behaviours require pharmacologic treatment. Pharmacological treatment should be an integral part of a more comprehensive treatment programme, including Belgenin tamamını okuyun