Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Methylphenidate hydrochloride
CST Pharma Ltd
N06BA04
Methylphenidate hydrochloride
10mg
Oral tablet
Oral
Schedule 2 (CD)
Valid as a prescribable product
BNF: 04040000; GTIN: 5055946805801
INFORMATION FOR CHILDREN AND YOUNG PEOPLE WITH ADHD This info is to help you learn the main things about your medicine called Ritalin. 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. • If you take this medicine more than once a day, you may have to remember to take it AT SCHOOL OR COLLEGE. You or your mum, dad or carer will need to find out what the school rules are about this. • Do not drink alcohol. Alcohol may make the side effects of this medicine worse. • Girls must tell their doctor straight away if they think they may be pregnant. We do not know how this medicine affects unborn babies. If you are having sex, please talk to your doctor about contraception. 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. SOME PEOPLE NEED TO TALK TO THEIR DOCTOR BEFORE THEY START HAVING THIS MEDICINE You need to talk to your doctor if: • you have epilepsy (fits) Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ritalin ® 10mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The active ingredient is Methylphenidate (INN for α -Phenyl-2-piperidineacetic acid methyl ester hydrochloride). One tablet contains 10mg methylphenidate hydrochloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets. 4.1. THERAPEUTIC INDICATIONS _ _ Ritalin is indicated as a 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 DSM criteria or the guidelines in ICD 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. Methylphenidate treatment is not indicated in all children with this syndrome and the decision to use the drug must be based on a very thorough assessment of the severity and the chronicity of the child’s symptoms in relation to the child’s age. Appropriate educational placement is essential, and psychosocial intervention is generally necessary. Where remedial measures alone prove insufficient, the decision to prescribe a stimulant must be based on Read the complete document