Страна: Нидерландия
Език: нидерландски
Източник: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
RISPERIDON 1 mg/stuk
Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)
N05AX08
RISPERIDON 1 mg/stuk
Orodispergeerbare tablet
ASPARTAAM (E 951) ; BASISCH GEBUTYLEERD METHACRYLAAT COPOLYMEER (E 1205) ; CALCIUMSILICAAT (E 552) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; COMPOSITION UNKNOWN (RI) ; CROSPOVIDON (E 1202) ; HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463a) ; IJZEROXIDE ROOD (E 172) ; KRUISMUNTSMAAKSTOF ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; PEPPERMINT FLAVOR, NATURAL & ARTIFICIAL ; POVIDON (E 1201), ASPARTAAM (E 951) ; BASISCH GEBUTYLEERD METHACRYLAAT COPOLYMEER ; CALCIUMSILICAAT (E 552) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; COMPOSITION UNKNOWN (RI) ; CROSPOVIDON (E 1202) ; HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463) ; IJZEROXIDE ROOD (E 172) ; KRUISMUNTSMAAKSTOF ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; PEPPERMINT FLAVOR, NATURAL & ARTIFICIAL ; POVIDON (E 1201),
Oraal gebruik
Risperidone
Hulpstoffen: ASPARTAAM (E 951); BASISCH GEBUTYLEERD METHACRYLAAT COPOLYMEER; CALCIUMSILICAAT (E 552); CELLULOSE, MICROKRISTALLIJN (E 460); COMPOSITION UNKNOWN (RI); CROSPOVIDON (E 1202); HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463); IJZEROXIDE ROOD (E 172); KRUISMUNTSMAAKSTOF; MAGNESIUMSTEARAAT (E 470b); MANNITOL (D-) (E 421); PEPPERMINT FLAVOR, NATURAL & ARTIFICIAL; POVIDON (E 1201);
2006-11-03
PACKAGE LEAFLET: INFORMATION FOR THE USER RISPERIDON DISPER STADA 0.5, 1 AND 2 MG ORODISPERGEERBARE TABLETTEN 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 DISPER STADA is and what it is used for 2. What you need to know before you take RISPERIDON DISPER STADA 3. How to take RISPERIDON DISPER STADA 4. Possible side effects 5. How to store RISPERIDON DISPER STADA 6. Contents of the pack and other information 1. WHAT RISPERIDON DISPER STADA IS AND WHAT IT IS USED FOR RISPERIDON DISPER STADA belongs to a group of medicines called ‘anti-psychotics’. RISPERIDON DISPER STADA 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. RISPERIDON DISPER STADA can help alleviate the symptoms of your disease and stop your symptoms from coming back. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RISPERIDON DISPER STADA DO NOT TAKE RISPERIDON DISPER STADA • If you ar Прочетете целия документ
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Risperidon disper STADA 0.5 mg orodispergeerbare tabletten Risperidon disper STADA 1 mg orodispergeerbare Risperidon disper STADA 2 mg orodispergeerbare tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One orodispersible tablet contains 0.5 mg, 1 mg or 2 mg risperidone Excipient with known effect Each 0.5 mg orodispersible tablet contains 0.40 mg aspartame. Each 1 mg orodispersible tablet contains 0.80 mg aspartame. Each 2 mg orodispersible tablet contains 1.60 mg aspartame. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Orodispersible tablet 0.5 mg orodispersible tablets: round, slightly biconvex tablets, pink marbled. 1 mg orodispersible tablets: round, slightly biconvex tablets, pink marbled. 2 mg orodispersible tablets: round, slightly biconvex tablets, pink marbled. The tablet must not be divided. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONSis indicated for the treatment of schizophrenia. Прочетете целия документis indicated for the treatment of moderate to severe manic episodes associated with bipolar disorders. 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. 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 sub average 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 psychosocial and educational intervention. It is recommended that risperidone be prescribed by a specialist in child neurology and child and adolescen