Prescribing information For Healthcare Professionals Only

ACTIVE INGREDIENT: Methylphenidate hydrochloride.

Please refer to Summary of Product Characteristics (SmPC) before prescribing.

INDICATION(S): Indicated as part of a comprehensive treatment programme for Attention Deficit Hyperactivity Disorder (ADHD) in children aged 6 years of age and over and adults, when remedial measures alone prove insufficient. Treatment must be initiated and supervised by a physician specialised in the treatment of ADHD such as an expert paediatrician, a child and adolescent psychiatrist or an adult psychiatrist.

DOSAGE & ADMINISTRATION: Children under 6 years: Do not use. Children over 6 years and adolescents: Once daily in the morning, increase weekly by 18 mg to max. 54 mg daily. Adults: Once daily in the morning, increase weekly by 18 mg to max. 72 mg daily. In adults new to Concerta XL, and if required by national practice, cardiologist advice is needed prior to treatment initiation in order to check the absence of cardiovascular contraindications. A 27 mg tablet is available for dosing between 18 mg and 36 mg.  New patients (children and adults): Start 18 mg daily.  Patients taking 3 times daily formulations: 18 mg Concerta XL ≡ 5 mg methylphenidate tds; 36 mg Concerta XL ≡ 10 mg tds; 54 mg Concerta XL ≡ 15 mg tds; 72 mg Concerta XL ≡ 20 mg tds.. Swallow whole with liquid.  Pre-treatment screening: conduct baseline evaluation of patient’s cardiovascular status including blood pressure and heart rate, record pre-treatment height/weight on growth chart. Elderly: Should not be used in the elderly. Renal & Hepatic impairment: no data available.

CONTRAINDICATIONS: Known sensitivity to methylphenidate or any excipients. Glaucoma, phaeochromocytoma, during treatment with non-selective, irreversible, monoamine oxidase inhibitors (MAOIs) or discontinuation within 14 days.  Hyperthyroidism or thyrotoxicosis, pre-existing cardiovascular disorders including angina, heart failure, severe hypertension, occlusive disease, haemodynamically significant congenital heart disease, cardiomyopathies, myocardial infarction, potentially life threatening arrhythmias and channelopathies, diagnosis/history of severe depression, anorexia nervosa, psychotic symptoms, suicidal tendency, severe mood disorders, mania, schizophrenia, psychopathic/borderline personality disorder, diagnosis/history of severe and episodic (Type I) Bipolar Disorder, pre-existing cerebrovascular disorders, cerebral aneurysm, vascular abnormalities including vasculitis/stroke.

SPECIAL WARNINGS & PRECAUTIONS:  Discontinue treatment at least once yearly to assess patient's condition.  Not recommended in patients with known structural cardiac abnormalities, cardiomyopathy, serious, heart rhythm abnormalities or other serious cardiac problems.  Caution with underlying medical condition that might be compromised by increases in blood pressure or heart rate, known drug/alcohol dependency.  Evaluate patients with suicidal ideation or behaviour immediately.  Carefully monitor at every adjustment of dose, then at least every 6 months: cardiovascular status, blood pressure and pulse, development/worsening of psychiatric disorders, emergence worsening of psychotic or manic symptoms, aggressive behaviour, hostility, emergence/worsening of tics, anxiety, agitation, tension, symptoms of Bipolar Disorder in patients with co-morbid depressive symptoms.  Record height, weight, appetite on growth chart. Assess neurological signs/symptoms in patients at risk of cerebrovascular disease.  
Discontinue if seizure frequency increases or new-onset seizures occur. Discontinue if repeated measures of tachycardia, arrhythmia or increased systolic blood pressure (>95th percentile) occur and referral to a cardiologist should be considered. Withdrawal: careful supervision required.  When withdrawal is unsuccessful at 18 years old, treatment can continue into adulthood but should be reviewed annually. Avoid use in GI narrowing, dysphagia, difficulty swallowing. Priapism reported mainly with change in methylphenidate treatment regimen; immediate medical attention required. Use in renal or hepatic insufficiency: no experience.  Haematological effects: long term safety not known.  Drug screening: possible false positive result for amphetamines during drug testing.  Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption: do not take.

SIDE EFFECTS:  Very common (≥ 1/10); Insomnia, nervousness, headache.
Common (≥ 1/100 to <1/10); anorexia, decreased appetite, reduced weight and height gain (prolonged use in children), affect lability, aggression, depression, depressed mood, libido decreased, tension, bruxism, panic attack, agitation, anxiety, irritability, abnormal behaviour, dizziness, vertigo, dyskinesia, psychomotor hyperactivity, paraesthesia, tension headache, somnolence, initial insomnia, arrhythmia, tachycardia, changes in heart rate, palpitations, hypertension/changes in blood pressure, accommodation disorder, cough, oropharyngeal pain, abdominal discomfort and pain (upper), diarrhoea, nausea, vomiting, dry mouth, dyspepsia, alopecia, pruritus, rash, urticaria, hyperhidrosis, arthralgia, muscle tightness/spasms, pyrexia, growth retardation during prolonged use in children, mood swings, tics, fatigue, nasopharyngitis, upper respiratory tract infection, sinusitis, erectile dysfunction, feeling jittery, asthenia, thirst, weight decreased, alanine aminotransferase increased. 
Other side-effects: hypersensitivity reactions; suicidal ideation, attempt, completion; neuroleptic malignant syndrome (NMS); cerebrovascular disorders: cerebral vasculitis/arteritis, cerebral occlusion/haemorrhage, cerebrovascular accidents; myocardial infarction, chest pain, angina pectoris, cardiac arrhythmias, cardiac arrest, sudden cardiac death; convulsions including grand mal; psychotic disorders; abnormal liver function, acute hepatic failure, hepatic coma; dependence, abuse; priapism; trismus; incontinence. Refer to SmPC for other side effects

PREGNANCY:  Not recommended. Data from a cohort study of in total approximately 3,400 pregnancies exposed in the first trimester do not suggest an increased risk of overall birth defects. There was a small increased occurrence of cardiac malformations (pooled adjusted relative risk, 1.3; 95 % CI, 1.0 1.6) corresponding to 3 additional infants born with congenital cardiac malformations for every 1000 women who receive methylphenidate during the first trimester of pregnancy, compared with non exposed pregnancies.

LACTATION: Methylphenidate is excreted in human milk.

INTERACTIONS: Inducers/inhibitors of cytochrome P450 not expected to impact methylphenidate pharmacokinetics, conversely methylphenidate does not relevantly impact Cytochrome P450, 1A2, 2C8, 2C9, 2C19, 2D6, 2E1 or 3A.  May decrease effectiveness of anti-hypertensive drugs. Non-selective, irreversible MAOIs (currently or within 2 weeks).  Caution with drugs that elevate blood pressure. May inhibit metabolism of coumarin anticoagulants, anticonvulsants (eg. phenobarbital, phenytoin, primidone), antidepressants (tricyclics/SSRIs).  If starting/stopping Concerta XL, re-evaluate dose of these medicines.  Halogenated anaesthetics: risk of sudden BP and heart rate increase; do not use on day of surgery.  Avoid alcohol.  When co-administration with serotonergic drugs is warranted: prompt recognition of serotonin syndrome is important, and methylphenidate must be discontinued as soon as possible if serotonin syndrome is suspected. Serious, adverse events, including sudden death, have been reported in concomitant use of methylphenidate and clonidine. Long-term safety of combination with clonidine/other centrally acting alpha-2-antagonists not been systematically evaluated. Caution with dopaminergic drugs, including antipsychotics. Refer to SmPC for full details of interactions.

LEGAL CATEGORY: POM (CD) Schedule 2.

FURTHER INFORMATION IS AVAILABLE FROM THE MARKETING AUTHORISATION HOLDER: Janssen-Cilag Limited, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK.

Prescribing information last revised: June 2022