Company: Rowex Ltd.
Legal category: Prescription. GMS. Sport prohibited in competition.
Active ingredient: Methylphenidate hydrochloride 18mg, 27mg, 36mg.
Description: Round, yellow, grey or white, film-coated prolonged-release tablets with a delivery orifice, respectively.
Presentation: 18mg-30, €14.97; 27mg-30, €16.49; 36mg-30, €20.37.
Indication: As part of a comprehensive treatment programme for Attention Deficit Hyperactivity Disorder when remedial measures alone insufficient. See SPC.
Pharmacology: Methylphenidate HCl is a mild central nervous system stimulant thought to block the reuptake of noradrenaline and dopamine into the presynaptic neurone and increase their release into the extraneuronal space.
Dosage: Children: Initiate under specialist supervision. Swallow whole once daily in morning. 6 years and older: Start at lowest dose, adjust in 18mg weekly increments. Maximum 54mg daily. Methylphenidate-naïve patients: 18 mg once daily (limited experience). Methylphenidate-experienced patients: If previous dose 5mg, 10mg or 15mg three times daily, take 18mg, 36mg or 54mg Metidate XL once daily, respectively. Under 6 years, not recommended.
Contraindications: Hypersensitivity to the active substance or to any of the excipients. Glaucoma, phaeochromocytoma, hyperthyroidism, thyrotoxicosis, severe depression (or history), anorexia nervosa/anorexic disorders, suicidal tendencies, psychotic symptoms, severe mood disorders, mania, schizophrenia, psychopathic/borderline personality disorder, severe and episodic (Type I) Bipolar (affective) Disorder (not well-controlled, or history), cardiovascular disorders (see SPC), cerebrovascular disorders cerebral aneurysm, vascular abnormalities (including vasculitis, stroke). Pregnancy, lactation.
Special precautions: Not for normal fatigue (or prevention). Not recommended: Structural cardiac abnormalities. Caution: Emotionally unstable patients, epileptics. Regularly monitor growth, drug misuse, weight, appetite, psychiatric and cardiovascular status. Monitor long-term use. Seizures (discontinue). Reduce or discontinue if paradoxical symptom aggravation or other serious adverse events occur. Consider discontinuation if leukopenia, thrombocytopenia, anaemia, serious renal or hepatic disorders, psychotic/ manic symptoms (including exacerbation), suicidal ideation or behaviour occurs. May exacerbate tics and Tourette’s syndrome. Cerebrovascular disorders. Supervise drug withdrawal. Over 18 years; safety and efficacy not established. Sudden death reported with CNS stimulants. Gastrointestinal obstruction potential. Driving/using machines. Contains lactose.
Drug interactions: Contraindicated: Non-selective, irreversible monoamine oxidase inhibitors (within 14 days). Caution: Halogenated anaesthetics, other drugs (especially with narrow therapeutic window), other drugs elevating blood pressure, dopaminergic drugs (including antipsychotics). Coumarin anticoagulants, anticonvulsants, some antidepressants, anti-hypertensives. Avoid alcohol. Positive test for amphetamines (especially with immunoassay).
Adverse drug reactions: Insomnia, nervousness, headache, nasopharyngitis, anorexia, decreased appetite, decreased weight, moderately reduced weight and height gain/ growth retardation (prolonged use), lability affect, aggression, agitation, anxiety, depression, irritability, abnormal behaviour, mood swings, tics, dizziness, dyskinesia, psychomotor hyperactivity, somnolence, arrhythmia, tachycardia, palpitations, hypertension, cough, oropharyngeal pain, gastrointestinal disorders, alopecia, pruritis, rash, urticaria, arthralgia, pyrexia, fatigue, blood pressure and heart rate changes.
Full prescribing information and references available from Rowex Ltd. Telephone: 1800 304400. Fax: (027) 50417.
E-mail: rowex@rowa-pharma.ie