Medikinet MR Capsules

Attention-Deficit/Hyperactivity Disorder (ADHD) in Children 6 years or older and in adults with ADHD onset in childhood

Medikinet MR is indicated as part of a comprehensive treatment programme for attention-deficit/hyperactivity disorder (ADHD) in children aged 6 years of age and over and in adults with ADHD onset in childhood when remedial measures alone prove insufficient. Treatment must be initiated and supervised by a doctor specialised in the treatment of ADHD such as an expert paediatrician, a child and adolescent psychiatrist or a psychiatrist.

Posology

Treatment must be initiated and supervised by a doctor specialised in the treatment of ADHD such as an expert paediatrician, a child and adolescent psychiatrist or a psychiatrist.

Pre-treatment screening: Prior to prescribing, it is necessary to conduct a baseline evaluation of a patientu2019s 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. In case of adults, only weight should be recorded (see sections 4.3 and 4.4).

Ongoing monitoring: Growth (children), weight, 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 (children), 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 least every 6 months and at every visit. Patients should be monitored for the risk of diversion, misuse and abuse of methylphenidate.

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• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
• Glaucoma
• Phaeochromocytoma
• During treatment with non-selective, irreversible monoamine oxidase (MAO) inhibitors, or within a minimum of 14 days of discontinuing those medicinal products, due to risk of hypertensive crisis (see section 4.5)
• Hyperthyroidism or Thyrotoxicosis
• Diagnosis or history of severe depression, anorexia nervosa/anorexic disorders, suicidal tendencies, psychotic symptoms, severe mood disorders, mania, schizophrenia, psychopathic/borderline personality disorder
• Diagnosis or history of severe and episodic (Type I) Bipolar (affective) Disorder (that is not well-controlled)
• Pre-existing cardiovascular disorders including severe hypertension, heart failure, arterial occlusive disease, angina, haemodynamically significant congenital heart disease, cardiomyopathies, myocardial infarction, potentially life-threatening dysrhythmias and channelopathies (disorders caused by the dysfunction of ion channels) and OT prolongation either congenital, familial or caused by medication. (See Section 4.4)
• Pre-existing cerebrovascular disorders, cerebral aneurysm, vascular abnormalities including vasculitis or stroke
• A history of pronounced anacidity of the stomach with a pH value above 5.5, in therapy with H2 receptor blockers, proton pump inhibitors or in antacid therapy.
• Pregnancy and lactation (see Section 4.6)

Medikinet MR treatment is not indicated in all patients 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 patientu2019s symptoms. When treatment of children is considered, assessment of the severity and chronicity of the childu2019s symptoms should be related to the childu2019s age (6 - 18 years). This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially u2018sodium freeu2019.

Long-term use (more than 12 months) The safety and efficacy of long term use of Medikinet MR has not been systematically evaluated in controlled trials. Medikinet MR treatment should not and need not, be indefinite. Patients on long-term therapy (i.e. over 12 months) must have careful ongoing monitoring according to the guidance in sections 4.2 for cardiovascular status, growth (children), weight, appetite, development of de novo or worsening of pre-existing psychiatric disorders.

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Pharmacokinetic interaction

It is not known how Medikinet MR may affect plasma concentrations of concomitantly administered medicinal products. Therefore, caution is recommended at combining Medikinet MR with other medicinal products, especially those with a narrow therapeutic window. Methylphenidate is not metabolised by cytochrome P450 to a clinically relevant extent. Inducers or inhibitors of cytochrome P450 are not expected to have any relevant impact on methylphenidate pharmacokinetics.

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Pregnancy

Medikinet MR is contraindicated in pregnancy (see Section 4.3). Data from a cohort study of in total approximately 3,400 pregnancies exposed in the first trimester do not suggest an increased risk of overall birth defects. There was an increased occurrence of cardiac malformations (pooled adjusted relative risk, 1.3; 95 % CI, 1.0-1.6) corresponding to 3 additional infants born with congenital cardiac malformations for every 1000 women who receive methylphenidate during the first trimester of pregnancy, compared with non-exposed pregnancies.

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Medikinet MR can cause dizziness, drowsiness and visual disturbances including difficulties with accommodation, diplopia and blurred vision. Patients on Medikinet MR experiencing these adverse effects should not drive and use machines.

The table below shows all adverse drug reactions (ADRs) observed during clinical trials and post-market spontaneous reports with Medikinet MR and those, which have been reported with other methylphenidate hydrochloride formulations.

Frequency estimate : very common (u2265 1/10) common (u2265 1/100 to < 1/10) uncommon (u2265 1/1,000 to <1/100)

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When treating patients with overdose, allowances must be made for the delayed release of methylphenidate from Medikinet MR. 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 dysrhymias, hypertension, mydriasis and dryness of mucous membranes.

Treatment There is no specific antidote to Medikinet MR overdose. Treatment consists of appropriate symptomatic and supportive measures.