Krajina: Spojené kráľovstvo
Jazyk: angličtina
Zdroj: myHealthbox
Methylphenidate hydrochloride
Janssen-Cilag Ltd
N06BA04
Methylphenidate hydrochloride
18 mg
Prolonged-release tablet
Oral use
28 or 30 prolonged-release tablets
POM - Prescription Only Medicine
Janssen Pharmaceutica NV
Centrally acting sympathomimetics
It 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.
Authorised
2002-02-19
TO P PACK AGE L EA FL ET: INF ORMATION F OR THE USER CONCER TA ® XL 18 MG PR OLONGED R ELEASE TABLETS CONCER TA ® XL 36 MG PR OLONGED R ELEASE TABLETS CONCER TA ® XL 54 MG PR OLONGED R ELEASE TABLETS Meth ylphenidate h ydr ochloride The name of y our medicine is Concer ta XL, it contains the activ e substance ‘meth ylphenidate h ydr ochloride’. The name ‘meth ylphenidate’ will also be used in this lea fl et. IMPORTANT THINGS YOU NEED TO KNOW ABOUT YOUR MEDICINE THIS MEDICINE IS USED TO TR EAT ADHD • The full name f or ADHD is ‘A ttention De fi cit Hyper activity Disor der’. • The medicine helps with y our br ain activity . It can help impr ov e y our attention, help y ou concentr ate , and mak e y ou less impulsiv e. • Y ou need to ha ve other tr eatments f or ADHD as w ell as this medicine . R ead Section 1 f or mor e inf ormation. BE FOR E Y OU TAK E THIS MEDICINE , TALK TO Y OUR DOCTOR IF: • Y ou ha ve hear t, cir culation, or mental health pr oblems - y ou ma y not be able to tak e this medicine . • Y ou ar e taking an y other medicines - this is because meth ylphenidate can aff ect ho w other medicines w ork. R ead Section 2 f or mor e inf ormation. WHILE TAKING THIS MEDICINE: • See y our doctor r egularly . This is because y our doctor will w ant to check ho w the medicine is w orking. • Do not stop taking the medicine without fi rst talking to y our doctor . • Y our doctor ma y stop y our medicine to see if it is still needed, if y ou tak e it f or mor e than a y ear . • The most common side e ff ects ar e f eeling ner vous , not being able to sleep or ha ving a headache . R ead Sections 3 and 4 f or mor e inf ormation. TALK TO Y OUR DOCTOR STR AIGHT A W AY IF AN Y OF THE F OLLO WING HAPPEN: • Y our mood and ho w y ou f eel changes . • Y ou f eel an y pr oblems with y our hear t. R ead Section 4 f or mor e inf ormation. THE R EST OF THIS LEA FL ET INCLUDES MOR E DETAIL AND OTHER IMPOR Prečítajte si celý dokument
Concerta XL 18 mg prolongedrelease tablets. Summary of Product Characteristics Updated 16Jun2015 | JanssenCilag Ltd 1. Name of the medicinal product Concerta XL 18 mg prolongedrelease tablets. 2. Qualitative and quantitative composition One prolongedrelease 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 Prolongedrelease tablet. Capsuleshaped yellow tablet with “alza 18” printed on one side in black ink. 4. Clinical particulars 4.1 Therapeutic indications AttentionDeficit/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 Prečítajte si celý dokument