Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Medice Arzneimittel Pütter GmbH & Co. KG, Kuhloweg 37, 58638 Iserlohn, Germany
Medikinet is indicated as part of a comprehensive treatment programme for attention-deficit/hyperactivity disorder (ADHD) in children aged 6 years of age and over when remedial measures alone prove insufficient. Treatment must be initiated under the supervision of a specialist in childhood behaviour disorders.
Diagnosis should be made according to current DSM criteria or the guidelines in ICD-10 and should be based on a complete history and evaluation of the patient. Diagnosis cannot be made solely on the presence of one or more symptoms.
The specific aetiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use of medical and specialised psychological, educational, and social resources.
A comprehensive treatment programme typically includes psychological, educational and social measures as well as pharmacotherapy and is aimed at stabilising children with a behavioural syndrome characterised by symptoms which may include chronic history of short attention span, distractibility, emotional lability, impulsivity, moderate to severe hyperactivity, minor neurological signs and abnormal EEG. Learning may or may not be impaired.
Methylphenidate treatment is not indicated in all children with ADHD and the decision to use the medicinal product must be based on a very thorough assessment of the severity and chronicity of the child’s symptoms in relation to the child’s age.
Appropriate educational placement is essential, and psychosocial intervention is generally necessary. Where remedial measures alone prove insufficient, the decision to prescribe a stimulant must be based on rigorous assessment of the severity of the child’s symptoms. The use of methylphenidate should always be used in this way according to the licensed indication and according to prescribing/diagnostic guidelines.
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).
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 methylphenidate.
The recommended starting daily dose is 5 mg once daily or twice daily (e.g. at breakfast and lunch), increasing if necessary by weekly increments of 5-10 mg in the daily dose according to tolerability and degree of efficacy observed.
The regimen that achieves satisfactory symptom control with the lowest total daily dose should be employed.
For doses not realisable/practicable with this strength, other strengths of this medicinal product and other methylphenidate containing products are available.
In the treatment of hyperkinetic disorders/ADHD, the times at which the doses of Medikinet are administered should be selected to provide the best effect when it is most needed to combat school and social behavioural difficulties.
The last doses should, in general, not be given within 4 hours before bedtime in order to prevent disturbances in falling asleep.
However, if the effect of the medicinal product wears off too early in the evening, disturbed behaviour may recur. A small evening dose may help to solve this problem.
The pros and cons of a small evening dose versus disturbances in falling asleep should be considered.
The maximum daily dose of methylphenidate hydrochloride is 60 mg.
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.
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.
Medikinet is not licensed for use in adults with ADHD. Safety and efficacy have not been established in this age group.
Methylphenidate should not be used in the elderly. Safety and efficacy has not been established in this age group.
Methylphenidate should not be used in children under the age of 6 years. Safety and efficacy in this age group has not been established.
Oral use.
The tablets should be swallowed whole or divided into halves with the aid of liquids, either with meals or after meals.
The effect of food on the absorption of methylphenidate from Medikinet tablets has not been studied; therefore, a possible effect of food on absorption cannot be excluded. Therefore it is recommended that Medikinet tablets should be taken in a standardised manner in relation to the timing of meals, i.e. that doses should be given at same times, relative to the time of meals, on each day, preferably with or immediately after meals.
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 arrhythmias, hypertension, mydriasis and dryness of mucous membranes.
There is no specific antidote to Medikinet overdose.
Treatment consists of appropriate supportive measures.
The patient must be protected against self-injury and against external stimuli that would aggravate overstimulation already present. If the signs and symptoms are not too severe and the patient is conscious, gastric contents may be evacuated by induction of vomiting or gastric lavage. Before performing gastric lavage, control agitation and seizures if present and protect the airway. Other measures to detoxify the gut include administration of activated charcoal and a cathartic. In the presence of severe intoxication, a carefully titrated dose of a benzodiazepine may be given before performing gastric lavage.
Intensive care must be provided to maintain adequate circulation and respiratory exchange; external cooling procedures may be required for hyperpyrexia.
Efficacy of peritoneal dialysis or extracorporeal haemodialysis for overdose of methylphenidate hydrochloride has not been established.
3 years.
Do not store above 25°C.
Store in the original package in order to protect from moisture.
Pack sizes 20, 30 or 50 tablets.
Boxes containing tablets packaged in PVC/PE/PVdC white opaque blisters heat sealed to aluminium foil.
Pack sizes: 20, 30, 50 or 100 tablets.
Boxes containing tablets packaged in PVC/PVdC blisters heat sealed to aluminium foil
Pack sizes: 30 or 50 tablets.
Boxes containing tablets packaged in PVC/PE/PVdC blisters heat sealed to aluminium foil
Not all pack sizes may be marketed.
No special requirements.
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