देश: स्वीडन
भाषा: स्वीडिश
स्रोत: Läkemedelsverket (Medical Products Agency)
risperidon
Mylan S.A.S.
N05AX08
risperidone
4 mg
Munsönderfallande tablett
mannitol Hjälpämne; aspartam Hjälpämne; risperidon 4 mg Aktiv substans
Apotek
Receptbelagt
Risperidon
Förpacknings: Blister, 10 tabletter; Blister, 14 tabletter; Blister, 20 tabletter; Blister, 28 tabletter; Blister, 30 tabletter; Blister, 56 tabletter; Blister, 60 tabletter; Blister, 84 tabletter; Blister, 90 tabletter; Blister, 100 tabletter; Blister, 180 tabletter; Blister, 200 tabletter
Avregistrerad
2010-06-11
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT RISPERIDON MYLAN 3 MG ORODISPERSIBLE TABLETS RISPERIDON MYLAN 4 MG ORODISPERSIBLE 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 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 Risperidon Mylan is and what it is used for 2. What you need to know before you take Risperidon Mylan 3. How to take Risperidon Mylan 4. Possible side effects 5. How to store Risperidon Mylan 6. Contents of the pack and other information 1. WHAT RISPERIDON MYLAN IS AND WHAT IT IS USED FOR Risperidon Mylan belongs to a group of medicines called ‘anti-psychotics’. Risperidon Mylan 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. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RISPERIDON MYLAN DO NOT TAKE RISPERIDON MYLAN if you are allergic to risperidone or any of the other ingredients of this medicine (listed in section 6 ). WARNINGS AND PRECAUTIONS Talk to you पूरा दस्तावेज़ पढ़ें
Produktinformationen för Risperidon Mylan 3, 4 mg munsönderfallande tablett, MTnr 42086, 42087, gäller vid det tillfälle då läkemedlet godkändes. Informationen kommer inte att uppdateras eftersom läkemedlet inte marknadsförs i Sverige. Av samma anledning finns inte någon svensk produktinformation. Den engelska produktinformationen kommer dock att uppdateras för de produkter där Sverige är referensland. Om läkemedelsnamnet i följande produktinformation inte stämmer med namnet på dokumentet, beror det på att läkemedlet i Sverige är godkänt under ett annat namn. 1. NAME OF THE MEDICINAL PRODUCT Risperidon Mylan 3 mg orodispersible tablets Risperidon Mylan 4 mg orodispersible tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains 3 mg risperidone. Each orodispersible tablet contains 4 mg risperidone. Excipients: Each orodispersible tablet contains 2.40 mg aspartame and 0.021 mg sorbitol. Each orodispersible tablet contains 3.20 mg aspartame and 0.028 mg sorbitol. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Orodispersible tablet. Round, slightly convex, pink marbled orodispersible tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Risperidon Mylan is indicated for the treatment of schizophrenia. Risperidon Mylan is indicated for the treatment of moderate to severe manic episodes associated with bipolar disorders. Risperidon Mylan 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. Risperidon Mylan 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 pharmaco पूरा दस्तावेज़ पढ़ें