국가: 영국
언어: 영어
출처: MHRA (Medicines & Healthcare Products Regulatory Agency)
Methylphenidate hydrochloride
Janssen-Cilag Ltd
N06BA04
Methylphenidate hydrochloride
27mg
Modified-release tablet
Oral
Schedule 2 (CD)
Caution - AMP level prescribing advised
BNF: 04040000; GTIN: 5012674901212
This info is to help you learn the main things about your medicine called Concerta XL. If you don’t enjoy reading, someone like your mum, dad or carer (sometimes called ‘your guardian’) can read it to you and answer any questions. It may help if you read small bits at a time. WHY HAVE I BEEN GIVEN THIS MEDICINE? This medicine can help children and young people with ‘ADHD’. • ADHD can make you: - run about too much - not be able to pay attention - act quickly without thinking about what will happen next (impulsive). • It affects learning, making friends and how you think about yourself. It is not your fault. WHILE YOU ARE TAKING THIS MEDICINE • as well as taking this medicine you will also get help with ways to cope with your ADHD such as talking to ADHD specialists. • this medicine should help you. But it does not cure ADHD. • you will need to go to your doctor several times a year for check ups. This is to make sure the medicine is working and that you are growing and developing OK. • if you take the medicine for more than one year, your doctor may stop your medicine to see if it is still needed. This will probably happen in a school holiday. • do not drink alcohol. Alcohol may make the side effects of this medicine worse. • if you are having sex, please talk to your doctor about contraception. Girls must tell their doctor straight away if they think they may be pregnant. We do not know how this medicine affects unborn babies. SOME PEOPLE CANNOT HAVE THIS MEDICINE You cannot have this medicine if: • you have a problem with your heart • you feel very unhappy, depressed or have a mental illness. PACKAGE LEAFLET: INFORMATION FOR THE USER CONCERTA ® XL 27 MG PROLONGED RELEASE TABLETS Methylphenidate hydrochloride The name of your medicine is Concerta XL 27mg Prolonged release tablets. However they will be referred to as Concerta XL throughout this leaflet. Concerta XL contains the active substance ‘methylphenidate hydrochloride’. The name ‘methylphenidate’ will also be used 전체 문서 읽기
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Concerta XL 27 mg prolonged-release tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One prolonged-release tablet contains 27 mg of methylphenidate hydrochloride. Excipients with known effect: contains 4.94 mg of lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release tablet. Capsule-shaped grey tablet with “alza 27” printed on one side in black ink. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Attention-Deficit/Hyperactivity Disorder (ADHD) Concerta XL is indicated as part of a comprehensive treatment programme for Attention Deficit Hyperactivity Disorder (ADHD) in children aged 6 years of age and over when remedial measures alone prove insufficient. Treatment must be under the supervision of a specialist in childhood behavioural disorders. Diagnosis should be made according to the current DSM criteria or ICD guidelines and should be based on a complete history and evaluation of the patient . Diagnosis cannot be made solely on the presence of one or more symptom. The specific aetiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use of medical and specialised psychological, educational, and social resources. A comprehensive treatment programme typically includes psychological, educational and social measures as well as pharmacotherapy and is aimed at stabilising children with a behavioural syndrome characterised by symptoms which may include chronic history of short attention span, distractibility, emotional lability, impulsivity, moderate to severe hyperactivity, minor neurological signs and abnormal EEG. Learning may or may not be impaired. Concerta XL treatment is not indicated in all children with ADHD and the decision to use the drug must be based on a very thorough assessment of the severity and chronicity of the child’s symptoms in relation to the child’s age. Appropriate educational placement is essential, and psychosocial 전체 문서 읽기