Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Methylphenidate hydrochloride
Janssen-Cilag Ltd
N06BA; N06BA04
Methylphenidate hydrochloride
18 milligram(s)
Prolonged-release tablet
Product subject to prescription which may not be renewed (A)
Centrally acting sympathomimetics; methylphenidate
Marketed
2002-11-22
TOP _ _ _ _ _ _ _ _ PACKAGE LEAFLET: INFORMATION FOR THE USER CONCERTA ® XL 18 MG PROLONGED RELEASE T ABLETS CONCERTA ® XL 36 MG PROLONGED RELEASE T ABLETS CONCERTA ® XL 54 MG PROLONGED RELEASE T ABLETS Methylphenidate hydrochloride The name of your medicine is Concerta XL, it contains the active substance ‘methylphenidate hydrochloride’. The name ‘methylphenidate’ will also be used in this leaflet. IMPORTANT THINGS YOU NEED TO KNOW ABOUT YOUR MEDICINE THIS MEDICINE IS USED TO TREAT ADHD • The full name for ADHD is ‘Attention Deficit Hyperactivity Disorder’. • The medicine helps with your brain activity. It can help improve your attention, help you concentrate, and make you less impulsive. • You need to have other treatments for ADHD as well as this medicine. Read Section 1 for more information. BEFORE YOU TAKE THIS MEDICINE, TALK TO YOUR DOCTOR IF: • You have heart, circulation, or mental health problems - you may not be able to take this medicine. • You are taking any other medicines - this is because methylphenidate can a ff ect how other medicines work. Read Section 2 for more information. WHILE TAKING THIS MEDICINE: • See your doctor regularly. This is because your doctor will want to check how the medicine is working. • Do not stop taking the medicine without first talking to your doctor. • Your doctor may stop your medicine to see if it is still needed, if you take it for more than a year. • The most common side e ff ects are feeling nervous, not being able to sleep or having a headache. Read Sections 3 and 4 for more information. TALK TO YOUR DOCTOR STRAIGHT AWAY IF ANY OF THE F OLLOWING HAPPEN: • Your mood and how you feel changes. • You feel any problems with your heart. Read Section 4 for more information. THE REST OF THIS LEAFLET INCLUDES MORE DETAIL AND OTHER IMPORTANT INFORMATION ON THE SAFE AND E ff ECTIVE USE OF THIS MEDICINE. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This Citiți documentul complet
Health Products Regulatory Authority 27 February 2019 CRN008LF8 Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Concerta XL 18 mg prolonged-release tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One prolonged-release tablet contains 18 mg of methylphenidate hydrochloride. Excipients with known effect: contains 6.49 mg of lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release tablet. Capsule-shaped, yellow tablets with “alza 18” 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 Citiți documentul complet