CONTRAMYL Prolonged release tablet Ref.[51190] Active ingredients: Methylphenidate

Posology

• CONTRAMYL XR is administered orally once daily.
• As the effect has been shown to be present 12 hours after dosing, it should be taken in the morning.
• CONTRAMYL XR must be swallowed whole with adequate amounts of liquids and must not be chewed, divided or crushed.
• Even though the tablets have a score line, it is not intended as a break line and the tablets should not be divided and taken at different intervals.
• CONTRAMYL XR may be administered with or without food.
• Dosage should be individualised according to the needs and responses of the patients.

Patients new to methylphenidate:

• The recommended starting dose of CONTRAMYL XR 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 (6 years and older) and adolescents and 18 or 36 mg once daily for adults.

Patients currently using methylphenidate:

• The recommended dose of CONTRAMYL XR for patients who are currently taking methylphenidate three times daily at doses of 15 to 60 mg/day is provided in the table included.
• Dosing recommendations are based on current dose regimen and clinical judgement.

Table 2. Recommended dose conversion from other methylphenidate regimens to CONTRAMYL XR:

• 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 6–12 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 CONTRAMYL XR has not been systemically evaluated in controlled clinical trials.
• The medical practitioner who elects to use CONTRAMYL XR for extended periods in patients with ADHD should periodically re-evaluate the long-term usefulness for the individual patient with trials off medicine to assess the patient’s 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, CONTRAMYL XR should be discontinued (see section 4.4).

Special population

Elderly population

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

Paediatric population

CONTRAMYL XR should not be used in patients under six years old.

Method of administration

For oral use.

In overdose, side effects can be precipitated and/or be of increased severity (see section 4.8).

Signs and symptoms of acute methylphenidate overdosage, as contained in CONTRAMYL XR, resulting principally from overstimulation of the CNS (central nervous system) and excessive sympathomimetic effects, may include the following: vomiting, agitation, tremors, hyper reflexia, 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. Measures to detoxify the gut include administration of activated charcoal and a cathartic.

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 methylphenidate, as in CONTRAMYL XR, overdosage has not been established.

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

3 years.

Store at or below 25°C.

Keep the container tightly closed.

CONTRAMYL XR tablets are available in white high-density polyethylene (HDPE) bottles with round white, child-resistant, tamper-evident screw caps with three break-points on the tamper-evident ring made of polypropylene and aperture for desiccant insert.

Packs of 30’s.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.