MEFEDINEL Prolonged release tablet Ref.[115335] Active ingredients: Methylphenidate

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

MEFEDINEL 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.

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

MEFEDINEL may be administered with or without food. Dosage should be individualised according to the need and response of each individual patient.

Patients New to Methylphenidate

The recommended starting dose of MEFEDINEL prolonged release tablets 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 daily for adults.

Patients Currently Using Methylphenidate

The recommended dose of MEFEDINEL prolonged release tablets 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 MEFEDINEL prolonged release tablets:

Clinical judgement 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 to 12 years and to a maximum of 72 mg for adolescents aged between 13 to 18 years and 108 mg in adults. In general, dosage adjustments may proceed at approximately weekly intervals.

Daily dosage above 54 mg is not recommended for children aged between 6 to 12 years. Daily dosage above 72 mg is not recommended for adolescents aged between 13 to 18 years. Daily dosage above 108 mg is not recommended in adults.

Maintenance/Extended Treatment

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

The physician who elects to use MEFEDINEL 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 patients functioning without pharmacotherapy.

Dose reduction and discontinuation

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

Elderly

Safety and efficacy have not been established in patients over 60 years of age.

Paediatric population

Children under 6 years of age

MEFEDINEL should not be used in children under the age of 6 years.

Hepatic impairment

MEFEDINEL has not been studied in patients with hepatic impairment. Caution should be exercised in these patients.

Renal impairment

MEFEDINEL has not been studied in patients with renal impairment. Caution should be exercised in these patients.

Method of administration

General recommendations

MEFEDINEL is for oral administration and can be taken with or without food.

When treating patients with overdose, allowances must be made for the delayed release of methylphenidate from formulations with extended durations of action.

Signs and symptoms

Acute overdose, mainly due to overstimulation of the central and sympathetic nervous systems, may result in vomiting, agitation, tremors, hyperreflexia, muscle twitching, convulsions (may be followed by coma), euphoria, confusion, hallucinations, delirium, sweating, flushing, headache, hyperpyrexia, tachycardia, palpitations, cardiac dysrhythmias, hypertension, mydriasis, dryness of mucous membranes and rhabdomyolysis.

Treatment

There is no specific antidote to methylphenidate overdosage. Treatment consists of appropriate supportive measures and symptomatic treatment of life-threatening events e.g. hypertensive crisis, cardiac dysrhythmias, convulsions. For the most current guidance for treatment of symptoms of overdose, the medical practitioner should consult a certified Poison Control Centre or current toxicological publication.

The patient must be protected against self-injury and against external stimuli that would aggravate over-stimulation already present. If the patient is conscious, administration of activated charcoal and a laxative is recommended. In the presence of severe intoxication, a carefully titrated dose of a benzodiazepine should be given.

Intensive care must be provided to maintain adequate circulation and respiratory exchange; external cooling procedures may be required to reduce hyperpyrexia.

Efficacy of peritoneal dialysis or extracorporeal haemodialysis for overdose of methylphenidate has not been established.

24 months.

Store at or below 25°C.

MEFEDINEL 18, 27, 36, 54: HDPE bottles closed with a child-resistant, tamper evident PP screw cap with drying plug.

Pack sizes of 28, 30, 50, 56, 60, 98, 100 or 120 prolonged-release tablets.

Not all pack sizes may be marketed.

No special requirements.