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June 29, 2016


Company: Phoenix Healthcare Ltd.
Legal category: Prescription. GMS. Sport prohibited in competition.
Active ingredient: Tablets: Methylphenidate HCl 5mg, 10mg, 20mg. Capsules: Methylphenidate HCl 5mg, 10mg, 20mg, 30mg, 40mg.
Description: Tablets: White, round tablets marked S, M or L respectively. Capsules: Modified-release, hard capsules containing white and blue pellets. White, mauve/white, mauve, violet/light grey, violet/grey, respectively.
Presentation: Tablets: 5mg-30, €3.06; 10mg-30, €5.32; 20mg-30, €10.58. Capsules: 5mg-30, €15.39; 10mg-30, €16.58; 20mg-30, €28.07; 30mg-30, €36.52; 40mg-30, €48.15.
Indication: Attention-deficit hyperactivity disorder in children ≥6 years when remedial measures alone prove insufficient.
Pharmacology: The mechanism by which methylphenidate HCl exerts it’s mental and behavioural effects in children is not clearly established, but its effects are thought to be due to cortical stimulation and possibly to stimulation of the reticular activating system. It is thought to block the re-uptake of norepinephrine and dopamine into the presynaptic neurone and increase the release of these monoamines into the extraneuronal space.
Dosage: Adult: Not applicable. Elderly: Not applicable. Children: ≥6 years: Initially, 5mg once or twice daily, increasing if necessary by weekly increments of 5-10mg daily. Swallow whole in the morning with food. Maximum 60mg daily. <6 years, safety and efficacy not established. Contraindications: Known sensitivity to methylphenidate or any of the excipients. Glaucoma. Phaeochromocytoma. Hyperthyroidism or thyrotoxicosis. 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. Pre-existing cardiovascular disorders (including severe hypertension, heart failure, arterial occlusive disease, angina, haemodynamically significant congenital heart disease, cardiomyopathies, myocardial infarction, potentially life-threatening arrhythmias and channelopathies). Pre-existing cerebrovascular disorders, cerebral aneurysm, vascular abnormalities (including vasculitis or stroke). History of pronounced stomach anacidity with a pH value above 5.5. Pregnancy (unless clearly necessary), lactation.
Special precautions: Monitor blood pressure (BP), heart rate, growth, drug misuse, psychiatric and cardiovascular status continuously. Periodically re-evaluate long term usefulness of therapy. Caution: Emotionally unstable patients, epileptics. May exacerbate tics and Tourette’s syndrome. Do not use to prevent or treat normal fatigue states. Consider discontinuation if new manic or psychotic symptoms, suicidal ideation or behaviour occurs. Supervise drug withdrawal. Consider discontinuation if leukopenia, thrombocytopenia, anaemia or serious renal or hepatic disorders occur. Driving/using machines. Contains sucrose.
Drug interactions: Contra: MAOIs (or within 14 days), H2-receptor blockers, antacids. Caution: Coumarin anticoagulants, anticonvulsants (e.g. phenobarbital, phenytoin, primidone), some antidepressants (TCAs, SSRIs), antihypertensives, drugs that elevate BP, halogenated anaesthetics, centrally acting α-2 agonists (e.g. clonidine), dopaminergic drugs (including antipsychotics). Avoid: Alcohol. May induce false positive laboratory test for amphetamines.
Adverse drug reactions: Nasopharyngitis, anorexia, decreased appetite, growth retardation during prolonged use, insomnia, nervousness, affect lability, aggression, agitation, anxiety, depression, irritability, abnormal behaviour, headache, dizziness, dyskinesia, psychomotor hyperactivity, somnolence, arrhythmia, tachycardia, palpitations, hypertension, cough, pharyngolaryngeal pain, GI disorders, alopecia, pruritus, rash, urticaria, arthralgia, pyrexia, changes in BP and heart rate, decreased weight.
Full prescribing information and references available from Phoenix Healthcare Ltd. Telephone: (01) 4688917.