NEUCON Extended-release tablet Ref.[115224] Active ingredients: Methylphenidate

Posology

Patients New to NEUCON

The recommended starting dose of NEUCON for patients who are not currently taking methylphenidate, or for patients who are on stimulants other than methylphenidate, is 18 mg once daily for children and adolescents and 18 or 36 mg once daily for adults.

Patients currently using NEUCON

The recommended dose of NEUCON for patients who are currently taking methylphenidate three times daily at doses of 15 to 60 mg/day is provided in Table 1. Dosing recommendations are based on current dose regimen and clinical judgement.

Table 1. Recommended Dose Conversion from Other Methylphenidate Regimens to NEUCON:

Clinical judgment should be used when selecting the dose for patients currently taking methylphenidate in other regimens.

Dosage may be adjusted in 18 mg increments to a maximum of 54 mg/day for children aged between 6–12 years and to a maximum of 72 mg for adolescents aged between 13–18 years and 108 mg in adults. In general, dosage adjustment may proceed at approximately weekly intervals.

Daily dosage above 54 mg is not recommended for children aged between 6–12 years. Daily dosage above 72 mg is not recommended for adolescents aged between 13–18 years.

Daily dosage above 108 mg is not recommended in adults.

Maintenance/Extended Treatment

The long-term use of NEUCON has not been systematically evaluated in controlled clinical trials.

The medical practitioner who elects to use NEUCON for extended periods in patients with ADHD should periodically re-evaluate the long-term usefulness of the medicine for the individual patient with trials off medication to assess the patient’s functioning without pharmacotherapy.

Changing from one extended-release methylphenidate product to another

The efficacy and tolerability profile of NEUCON over the dosing period is determined by the specific release profile of the product. Other extended-release methylphenidate formulations with different release profiles may have different efficacy and tolerability profiles. If changing from one extended-release methylphenidate product to another, it is recommended that this be carried out only with additional medical supervision.

Dose reduction and Discontinuation

If paradoxical aggravation of symptoms or other adverse events occur, the dosage should be reduced, or, if necessary, NEUCON should be discontinued.

Elderly

Use of NEUCON in elderly patients over 65 years has not been studied in controlled trials.

Method of administration

NEUCON must be swallowed whole with adequate amounts of liquids, and must not be chewed, divided, or crushed.

NEUCON may be administered with or without food.

Dosage should be individualised according to the need and response of each individual patient.

NEUCON should not be used in patients under six years old.

NEUCON is administered orally once daily. As the effect has been shown to be present 12 hours after dosing, the product should be taken in the morning.

Signs and symptoms of NEUCON in overdosage, resulting principally from overstimulation of the CNS and excessive sympathomimetic stimulations. They may include the following: vomiting, agitation, tremors, hyperreflexia, muscle twitching, convulsions, coma, grand mal convulsion, euphoria, confusional state, confusion, hallucinations (auditory and/or visual), hyperhidrosis, flushing, headache, pyrexia, tachycardia, palpitations, heart rate increased, sinus dysrhythmias, hypertension, mydriasis, and dry mouth.

Treatment consists of appropriate supportive measures. The patients must be protected against self-injury and against external stimuli that would aggravate overstimulation already present. The efficacy of activated charcoal has not been established.

Intensive care must be provided to maintain adequate circulation and respiratory exchange; external cooling procedures may be required for pyrexia. Efficacy of peritoneal dialysis or extracorporeal haemodialysis for NEUCON overdosage has not been established.

The prolonged release of methylphenidate from NEUCON should be considered when treating patients with overdose.

2 years.

Store at or below 25°C.

KEEP OUT OF REACH OF CHILDREN.

NEUCON is available in a square, white, opaque high-density polyethylene (HDPE) bottle with a white polypropylene child resistant closure, with induction sealed tamper-evident membrane. Each HDPE bottle contains one or two desiccants and will hold 30 tablets. The HDPE bottle is packed into an outer carton until required for use.

No special requirements.