Country: Olanda
Lingwa: Olandiż
Sors: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
RISPERIDON
Sandoz B.V. Veluwezoom 22 1327 AH ALMERE
N05AX08
RISPERIDONE
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460) ; CHINOLINEGEEL ALUMINIUMLAK (E 104) ; HYPROMELLOSE (E 464) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; LACTOSE 1-WATER ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Risperidone
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CHINOLINEGEEL ALUMINIUMLAK (E 104); HYPROMELLOSE (E 464); INDIGOKARMIJN ALUMINIUMLAK (E 132); LACTOSE 1-WATER; MACROGOL 4000; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL, GEPREGELATINEERD; SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);
2004-08-31
Sandoz B.V. Page 1 of 13 Risperidon Sandoz ® 1/2/3/4, filmomhulde tabletten 1/2/3/4 mg RVG 28914-7 1313-V16 1.3.1.3. Bijsluiter November 2019 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT RISPERIDON SANDOZ® 1, FILMOMHULDE TABLETTEN 1 MG RISPERIDON SANDOZ® 2, FILMOMHULDE TABLETTEN 2 MG RISPERIDON SANDOZ® 3, FILMOMHULDE TABLETTEN 3 MG RISPERIDON SANDOZ® 4, FILMOMHULDE TABLETTEN 4 MG 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 [nationally completed name ] is and what it is used for 2. What you need to know before you take [nationally completed name] 3. How to take [nationally completed name] 4. Possible side effects 5. How to store [nationally completed name] 6. Contents of the pack and other information 1. WHAT [INVENTED NAME] IS AND WHAT IT IS USED FOR [invented name] contains the active substance risperidone. It belongs to a group of medicines called ‘ANTI-PSYCHOTICS’. [invented name] 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, a Aqra d-dokument sħiħ
Sandoz B.V. Page 1 of 24 Risperidon Sandoz ® 1/2/3/4, filmomhulde tabletten 1/2/3/4 mg RVG 28914-5-6-7 1311-V14 1.3.1 Summary of Product Characteristics November 2019 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Risperidon Sandoz 1, filmomhulde tabletten 1 mg Risperidon Sandoz 2, filmomhulde tabletten 2 mg Risperidon Sandoz 3, filmomhulde tabletten 3 mg Risperidon Sandoz 4, filmomhulde tabletten 4 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 1 mg risperidone. Excipients with known effect: Each film-coated tablet contains 51.25 mg lactose (as lactose monohydrate). Each film-coated tablet contains 2 mg risperidone. Excipients with known effect: Each film-coated tablet contains 101.45 mg lactose (as lactose monohydrate). Each film-coated tablet contains 3 mg risperidone. Excipients with known effect: Each film-coated tablet contains 151.94 mg lactose (as lactose monohydrate). Each film-coated tablet contains 4 mg risperidone. Excipients with known effect: Each film-coated tablet contains 202.49 mg lactose (as lactose monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. white, oval film-coated tablet with breaking notch, one sided debossment “1” apricot, oval film-coated tablet with breaking notch, one sided debossment “2” yellow, oval film-coated tablet with breaking notch, one sided debossment “3” green, oval film-coated tablets with breaking notch, one sided debossment “4” Sandoz B.V. Page 2 of 24 Risperidon Sandoz ® 1/2/3/4, filmomhulde tabletten 1/2/3/4 mg RVG 28914-5-6-7 1311-V14 1.3.1 Summary of Product Characteristics November 2019 The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Risperidone is indicated for the treatment of schizophrenia. Risperidone is indicated for the treatment of moderate to severe manic episodes associated with bipolar disorders. Risperidone is indicated for the short-term treatment (up to 6 weeks) of persistent Aqra d-dokument sħiħ