Land: Zweden
Taal: Zweeds
Bron: Läkemedelsverket (Medical Products Agency)
risperidon
Mylan S.A.S.
N05AX08
risperidone
0,5 mg
Munsönderfallande tablett
aspartam Hjälpämne; mannitol Hjälpämne; risperidon 0,5 mg Aktiv substans
Apotek
Receptbelagt
Risperidon
Förpacknings: Blister, 30 tabletter; Blister, 28 tabletter; Blister, 56 tabletter; Blister, 60 tabletter; Blister, 10 tabletter; Blister, 14 tabletter
Avregistrerad
2006-10-13
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT RISPERIDON MYLAN 0.5 MG ORODISPERSIBLE TABLETS RISPERIDON MYLAN 1 MG ORODISPERSIBLE TABLETS RISPERIDON MYLAN 2 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 se Lees het volledige document
1 Produktinformationen för Risperidon Mylan 0,5 mg, 1 mg, 2 mg munsönderfallande tablett, MTnr 21767, 21768, 21769, 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 när Sverige är referensland i proceduren. Om läkemedelsnamnet i följande produktinformation inte stämmer med namnet på dokumentet, beror det på att läkemedlet i Sverige är godkänt under ett annat namn. 2 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT RISPERIDON MYLAN 0.5 mg orodispersible tablets RISPERIDON MYLAN 1 mg orodispersible tablets RISPERIDON MYLAN 2 mg orodispersible tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet 0.5 mg contains 0.5 mg risperidone. Each orodispersible tablet 1 mg contains 1 mg risperidone. Each orodispersible tablet 2 mg contains 2 mg risperidone. EXCIPIENTS: aspartame (E951), sorbitol (E420). 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 Risperidone is indicated for the treatment of schizophrenia. Risperidone is indicated for the maintenance treatment in order to prevent relapse in chronic schizophrenia in patients having shown a response to initial treatment. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Risperidon Mylan orodispersible tablets should not be divided. When administration of 0.25 mg or dose increments of 0.25 mg is necessary another preparation containing risperidone should be used. _Acute and chronic treatment of schizophrenia_ _Adults and adolescents ≥ 15 years_ The daily dose of risperidone may be taken once daily or twice daily. For some patients, taking into account the risk of orthostatic hypotension of risperidone, a twice daily administration is preferable, partic Lees het volledige document