Country: মাল্টা
ভাষা: ইংরেজি
সূত্র: Medicines Authority
RISPERIDONE
Mylan Pharmaceuticals Limited Damastown Industrial Park Mulhuddart Dublin15 Dublin, Ireland
N05AX08
RISPERIDONE 0.5 mg
ORODISPERSIBLE TABLET
RISPERIDONE 0.5 mg
POM
PSYCHOLEPTICS
Authorised
2012-07-13
Page 1 of 16 PACKAGE LEAFLET Page 2 of 16 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT RISPERIDONE MYLAN 0.5 MG ORODISPERSIBLE TABLETS RISPERIDONE MYLAN 1 MG ORODISPERSIBLE TABLETS RISPERIDONE MYLAN 2 MG ORODISPERSIBLE TABLETS RISPERIDONE MYLAN 3MG ORODISPERSIBLE TABLETS RISPERIDONE 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 Risperidone Mylan is and what it is used for 2. What you need to know before you take Risperidone Mylan 3. How to take Risperidone Mylan 4. Possible side effects 5. How to store Risperidone Mylan 6. Contents of the pack and other information. 1. WHAT RISPERIDONE MYLAN IS AND WHAT IT IS USED FOR This medicine belongs to a group of medicines called ‘anti-psychotics’. Risperidone 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. Risperidone Mylan can help alleviate the sy সম্পূর্ণ নথি পড়ুন
Page 1 of 26 SUMMARY OF PRODUCT CHARACTERISTICS Page 2 of 26 1. NAME OF THE MEDICINAL PRODUCT Risperidone Mylan 0.5 mg orodispersible tablets Risperidone Mylan 1 mg orodispersible tablets Risperidone Mylan 2 mg orodispersible tablets Risperidone Mylan 3 mg orodispersible tablets Risperidone Mylan 4 mg orodispersible tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 0.5 mg orodispersible tablet contains 0.5 mg of risperidone Each 1 mg orodispersible tablet contains 1 mg of risperidone Each 2 mg orodispersible tablet contains 2 mg of risperidone Each 3 mg orodispersible tablet contains 3 mg of risperidone Each 4 mg orodispersible tablet contains 4 mg of risperidone Excipient with known effect Each 0.5 mg orodispersible tablet contains 2.5 mg aspartame (E951) Each 1 mg orodispersible tablet contains 5 mg aspartame (E951) Each 2 mg orodispersible tablet contains 10 mg aspartame (E951) Each 3 mg orodispersible tablet contains 15 mg aspartame (E951) Each 4 mg orodispersible tablet contains 20 mg aspartame (E951) For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Orodispersible tablet. Risperidone 0.5 mg orodispersible tablet: Light pink coloured, plain to mottled, round, flat faced, bevelled edged tablets debossed with ‘M’ on one side and ‘R05’ on the other side. Risperidone 1 mg orodispersible tablet: Light pink coloured, plain to mottled, round, flat faced, bevelled edged tablets debossed with ‘M’ on one side and ‘R1’ on the other side. Risperidone 2 mg orodispersible tablet: Light pink coloured, plain to mottled, round, flat faced, bevelled edged tablets debossed with ‘M’ on one side and ‘R2’ on the other side. Risperidone 3 mg orodispersible tablet: Light pink coloured, plain to mottled, round, flat faced, bevelled edged tablets debossed with ‘M’ on one side and ‘R3’ on the other side. Risperidone 4 mg orodispersible tablet: Light pink coloured, plain to mottled, round, flat faced, bevelled edged tablets debossed with ‘M’ on one side and ‘R4’ on th সম্পূর্ণ নথি পড়ুন