Treatment must be initiated under the supervision of a specialist in childhood and/or adolescent behavioural disorders.
Prior to prescribing, it is necessary to conduct a baseline evaluation of a patient’s cardiovascular status including blood pressure and heart rate. A comprehensive history should document concomitant medications, past and present co-morbid medical and psychiatric disorders or symptoms, family history of sudden cardiac/unexplained death and accurate recording of pre-treatment height and weight on a growth chart (see sections 4.3 and 4.4).
Growth, psychiatric and cardiovascular status should be continuously monitored (see also section 4.4).
• Blood pressure and pulse should be recorded on a centile chart at each adjustment of dose and then at least every 6 months;
• Height, weight and appetite should be recorded at least 6 monthly with maintenance of a growth chart;
• Development of de novo or worsening of pre-existing psychiatric disorders should be monitored at every adjustment of dose and then at least every 6 months and at every visit.
Patients should be monitored for the risk of diversion, misuse and abuse of methylphenidate.
Careful dose titration is necessary at the start of treatment with Concerta XL. Dose titration should be started at the lowest possible dose. A 27 mg dosage strength is available for those who wish to prescribe between the 18 mg and 36 mg dosages.
Other strengths of this medicinal product and other methylphenidate-containing products may be available.
The dosage may be adjusted in 18 mg increments In general, dosage adjustment may proceed at approximately weekly intervals.
The maximum daily dosage of Concerta XL is 54 mg.
Patients New to Methylphenidate: Clinical experience with Concerta XL is limited in these patients (see section 5.1). Concerta XL may not be indicated in all children with ADHD syndrome. Lower doses of short-acting methylphenidate formulations may be considered sufficient to treat patients new to methylphenidate. Careful dose titration by the physician in charge is required in order to avoid unnecessarily high doses of methylphenidate. The recommended starting dose of Concerta XL for patients who are not currently taking methylphenidate, or for patients who are on stimulants other than methylphenidate, is 18 mg once daily.
Patients Currently Using Methylphenidate: The recommended dose of Concerta XL for patients who are currently taking methylphenidate three times daily at doses of 15 to 45 mg/day is provided in Table 1. Dosing recommendations are based on current dose regimen and clinical judgement.
Recommended Dose Conversion from Other Methylphenidate Hydrochloride Regimens, where available, to Concerta XL
Previous Methylphenidate Hydrochloride Daily Dose
Recommended Concerta XL Dose
5 mg Methylphenidate three times daily
18 mg once daily
10 mg Methylphenidate three times daily
36 mg once daily
15 mg Methylphenidate three times daily
54 mg once daily
If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.
Long-term (more than 12 months) use in children and adolescents
The safety and efficacy of long-term use of methylphenidate has not been systematically evaluated in controlled trials. Methylphenidate treatment should not and need not, be indefinite. Methylphenidate treatment is usually discontinued during or after puberty. The physician who elects to use methylphenidate for extended periods (over 12 months) in children and adolescents with ADHD should periodically re-evaluate the long-term usefulness of the medicinal product for the individual patient with trial periods off medication to assess the patient’s functioning without pharmacotherapy. It is recommended that methylphenidate is de-challenged at least once yearly to assess the child’s condition (preferable during times of school holidays). Improvement may be sustained when the medicinal product is either temporarily or permanently discontinued.
Dose reduction and discontinuation
Treatment must be stopped if the symptoms do not improve after appropriate dosage adjustment over a one-month period. If paradoxical aggravation of symptoms or other serious adverse events occur, the dosage should be reduced or discontinued.
In adolescents whose symptoms persist into adulthood and who have shown clear benefit from treatment, it may be appropriate to continue treatment into adulthood. However, start of treatment with Concerta XL in adults is not appropriate (see sections 4.4 and 5.1).
Methylphenidate should not be used in the elderly. Safety and efficacy has not been established in this age group.
Children under 6 years of age
Methylphenidate should not be used in children under the age of 6 years. Safety and efficacy in this age group has not been established.
Method of administration
Concerta XL must be swallowed whole with the aid of liquids, and must not be chewed, divided, or crushed (see section 4.4).
Concerta XL may be administered with or without food (see section 5.2).
Concerta XL is taken once daily in the morning.