Drug Class Description
Psychoanaleptics, psychostimulants and nootropics, centrally acting sympathomimetics.
Generic Name
Methylphenidate hydrochloride
Drug Description
Prolonged-release Tablet.18 mg Tablet: Capsule-shaped yellow tablet with “alza 18” printed on one side in black ink.27 mg Tablet: Capsule-shaped grey tablet with “alza 27” printed on one side in black ink.36 mg Tablet: Capsule-shaped white tablet with “alza 36” printed on one side in black ink.
Presentation
CONCERTA XL 18 mg prolonged-release tablets - One tablet contains 18 mg of methylphenidate hydrochlorideCONCERTA XL 27 mg prolonged-release tablet - One tablet contains 27 mg of methylphenidate hydrochlorideCONCERTA XL 36 mg prolonged-release tablets - One tablet contains 36 mg of methylphenidate hydrochloride
Indications
Attention-Deficit/Hyperactivity Disorder (ADHD)CONCERTA® XL 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 under the supervision of a specialist in childhood behavioural disorders. Diagnosis should be made according to DSM-IV criteria or the guidelines in ICD-10 and should be based on a complete history and eva luation 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 included 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.CONCERTA XL treatment is not indicated in all children with ADHD and the decision to use the drug 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.
Adult Dosage
Treatment must be initiated under the supervision of a specialist in childhood and/or adolescent behavioural disordersCONCERTA® XL must be swallowed whole with the aid of liquids, and must not be chewed, divided, or crushed.CONCERTA® XL may be administered with or without food.CONCERTA XL is taken once daily in the morning.Pre-treatment screening:Prior to prescribing, it is necessary to conduct a baseline eva luation 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.Ongoing monitoring:Growth, psychiatric and cardiovascular status should be continuously monitored.• Blood pressure and pulse should be recorded on a centile chart at each adjustment of dose and then at least every 6 months;• Height, 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 at least every 6 months and at every visit.Patients should be monitored for the risk of diversion, misuse and abuse of methylphenidate.Dose titrationCareful dose titration is necessary at the start of treatment with CONCERTA XL. Dose titration should be started at the lowest possible dose.Other strengths of this medicinal product and other methylphenidate-containing products may be available.Dosage may be adjusted in 18 mg increments. In general, dosage adjustment may proceed at approximately weekly intervals.The maximum daily dosage of CONCERTA XL is 54 mgPatients New to Methylphenidate: Clinical experience with CONCERTA XL is limited in these patients. CONCERTA XL may not be indicated in all children with ADHD syndrome. Lower doses of short-acting methylphenidate formulations may be considered sufficient to treat patients new to methylphenidate. Careful dose titration by the physician in charge is required in order to avoid unnecessarily high doses of methylphenidate. The recommended starting dose of CONCERTA XL for patients who are not currently taking methylphenidate, or for patients who are on stimulants other than methylphenidate, is 18 mg once daily.Patients Currently Using Methylphenidate: The recommended dose of CONCERTA XL for patients who are currently taking methylphenidate three times daily at doses of 15 to 45 mg/day is provided in Table 1. Dosing recommendations are based on current dose regimen and clinical judgement.TABLE 1Recommended Dose Conversion from Other Methylphenidate Regimens, where available, to CONCERTA® XLPrevious Methylphenidate Daily DoseRecommended CONCERTA® XL Dose5 mg Methylphenidate three times daily18 mg once daily10 mg Methylphenidate three times daily36 mg once daily15 mg Methylphenidate three times daily54 mg once dailyIf improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.Long-term (more than 12 months) use in children and adolescentsThe safety and efficacy of long-term use of methylphenidate has not been systematically eva luated 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-eva luate the long-term usefulness of the drug 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 drug is either temporarily or permanently discontinued.Dose reduction and discontinuation: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 discontinuedAdultsMethylphenidate is not licensed for use in adults in ADHD. Safety and efficacy have not been established in this age groupElderlyMethylphenidate should not be used in the elderly. Safety and efficacy has not been established in this age group.Children under 6 years of ageMethylphenidate should not be used in children under the age of 6 years. Safety and efficacy in this age group has not been established.
Child Dosage
Children (over 6 years of age) and Adolescents: CONCERTA® XL is administered orally once daily in the morning.CONCERTA® XL must be swallowed whole with the aid of liquids, and must not be chewed, divided, or crushed (See Special Precautions). CONCERTA® XL may be administered with or without food.Treatment must be initiated under the supervision of a specialist conversant with childhood and/or adolescence behavioural disorders.Dosage should be individualised according to the needs and responses of the patient.Dosage may be adjusted in 18 mg increments to a maximum of 54 mg/day taken once daily in the morning. A 27 mg dosage strength is available for those who wish to prescribe between the 18 mg and 36 mg dosages. In general, dosage adjustment may proceed at approximately weekly intervals.Patients New to Methylphenidate: Clinical experience with CONCERTA® XL is limited in these patients. CONCERTA® XL may not be indicated in all children with ADHD syndrome. Lower doses of short-acting methylphenidate formulations may be considered sufficient to treat patients new to methylphenidate. Careful dose titration by the physician in charge is required in order to avoid unnecessarily high doses of methylphenidate. The recommended starting dose of CONCERTA® XL for patients who are not currently taking methylphenidate, or for patients who are on stimulants other than methylphenidate, is 18 mg once daily.Patients Currently Using Methylphenidate: The recommended dose of CONCERTA® XL for patients who are currently taking methylphenidate three times daily at doses of 15 to 45 mg/day is provided in Table 1. Dosing recommendations are based on current dose regimen and clinical judgement.Recommended Dose Conversion from Other Methylphenidate Regimens, where available, to CONCERTA® XL Previous Methylphenidate Daily Dose = 5 mg methylphenidate three times daily - CONCERTA® XL Recommended Dose - 18 mg once daily Previous Methylphenidate Daily Dose = 10 mg methylphenidate three times daily - CONCERTA® XL Recommended Dose - 36 mg once daily Previous Methylphenidate Daily Dose = 15 mg methylphenidate three times daily - CONCERTA® XL Recommended Dose - 54 mg once daily Daily dosage above 54 mg is not recommended. If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.Maintenance/Extended Treatment: The long-term use of methylphenidate has not been systematically eva luated in controlled trials. The physician who elects to use CONCERTA® XL for extended periods in patients with ADHD should periodically re-eva luate the long-term usefulness of the drug for the individual patient with trial periods off medication to assess the patient's functioning without pharmacotherapy. Improvement may be sustained when the drug is either temporarily or permanently discontinued.Dose Reduction and Discontinuation: If paradoxical aggravation of symptoms or other adverse events occur, the dosage should be reduced, or, if necessary, the drug should be discontinued. Drug treatment is usually discontinued during or after puberty.Children (under 6 years): The safety and efficacy of CONCERTA® XL in children under 6 years of age have not been established. Therefore, CONCERTA® XL should not be used in children under 6 years of age.
Elderly Dosage
Not applicable.
Contra Indications
CONCERTA® XL is contraindicated:in patients known to be hypersensitive to methylphenidate or other components of the productin patients with marked anxiety and tension, since the drug may aggravate these symptomsin patients with glaucomain patients with a family history or diagnosis of Tourette's syndromein combination with non-selective, irreversible monoamine oxidase inhibitors (MAO), and also within a minimum of 14 days following discontinuation of a non-selective, irreversible MAO inhibitor (hypertensive crises may result) (See Interactions)in patients with hyperthyroidismin patients with severe angina pectorisin patients with cardiac arrhythmiasin patients with severe hypertensionin patients who currently exhibit severe depression, anorexia nervosa, psychotic symptoms or suicidal tendency, since the drug might worsen these conditionsin patients with known drug dependence or alcoholismin patients during pregnancy (See Interactions).
Special Precautions
Methylphenidate treatment is not indicated in all children with ADHD and the decision to use the drug 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.Long-term use (more than 12 months) in children and adolescentsThe safety and efficacy of long-term use of methylphenidate has not been systematically eva luated in controlled trials. Methylphenidate treatment should not and need not, be indefinite. Methylphenidate treatment is usually discontinued during or after puberty. Patients on long-term therapy (i.e. over 12 months) must have careful ongoing monitoring. for cardiovascular status, growth, appetite, development of de novo or worsening of pre-existing psychiatric disorders. Psychiatric disorders to monitor for are described below, and include (but are not limited to) motor or vocal tics, aggressive or hostile behaviour, agitation, anxiety, depression, psychosis, mania, delusions, irritability, lack of spontaneity, withdrawal and excessive perseveration.The physician who elects to use methylphenidate for extended periods (over 12 months) in children and adolescents with ADHD should periodically re-eva luate the long-term usefulness of the drug 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 (preferably during times of school holidays). Improvement may be sustained when the drug is either temporarily or permanently discontinued.Use in adultsMethylphenidate is not licensed for use in adults with ADHD. Safety and efficacy have not been established in this age group.Use in the elderlyMethylphenidate should not be used in the elderly. Safety and efficacy has not been established in this age group.Use in children under 6 years of ageMethylphenidate should not be used in children under the age of 6 years. Safety and efficacy in this age group has not been establishedCardiovascular statusPatients who are being considered for treatment with stimulant medications should have a careful history (including assessment for a family history of sudden cardiac or unexplained death or malignant arrhythmia) and physical exam to assess for the presence of cardiac disease, and should receive further specialist cardiac eva luation if initial findings suggest such history or disease. Patients who develop symptoms such as palpitations, exertional chest pain, unexplained syncope, dyspnoea or other symptoms suggestive of cardiac disease during methylphenidate treatment should undergo a prompt specialist cardiac eva luation.Analyses of data from clinical trials of methylphenidate in children and adolescents with ADHD showed that patients using methylphenidate may commonly experience changes in diastolic and systolic blood pressure of over 10 mmHg relative to controls. The short- and long-term clinical consequences of these cardiovascular effects in children and adolescents are not known, but the possibility of clinical complications cannot be excluded as a result of the effects observed in the clinical trial data. Caution is indicated in treating patients whose underlying medical conditions might be compromised by increases in blood pressure or heart rate.Cardiovascular status should be carefully monitored. Blood pressure and pulse should be recorded on a centile chart at each adjustment of dose and then at least every 6 months.The use of methylphenidate is contraindicated in certain pre-existing cardiovascular disorders unless specialist paediatric cardiac advice has been obtained.Sudden death and pre-existing structural cardiac abnormalities or other serious cardiac disordersSudden death has been reported in association with the use of stimulants of the central nervous system at usual doses in children, some of whom had structural cardiac abnormalities or other serious heart problems. Although some serious heart problems alone may carry an increased risk of sudden death, stimulant products are not recommended in children or adolescents with known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant medicine.Misuse and Cardiovascular EventsMisuse of stimulants of the central nervous system may be associated with sudden death and other serious cardiovascular adverse events.Cerebrovascular disordersPatients with additional risk factors (such as a history of cardiovascular disease, concomitant medications that elevate blood pressure) should be assessed at every visit for neurological signs and symptoms after initiating treatment with methylphenidate.Cerebral vasculitis appears to be a very rare idiosyncratic reaction to methylphenidate exposure. There is little evidence to suggest that patients at higher risk can be identified and the initial onset of symptoms may be the first indication of an underlying clinical problem. Early diagnosis, based on a high index of suspicion, may allow the prompt withdrawal of methylphenidate and early treatment. The diagnosis should therefore be considered in any patient who develops new neurological symptoms that are consistent with cerebral ischemia during methylphenidate therapy. These symptoms could include severe headache, numbness, weakness, paralysis, and impairment of coordination, vision, speech, language or memory.Treatment with methylphenidate is not contraindicated in patients with hemiplegic cerebral palsy.Psychiatric disordersCo-morbidity of psychiatric disorders in ADHD is common and should be taken into account when prescribing stimulant products. In the case of emergent psychiatric symptoms or exacerbation of pre-existing psychiatric disorders, methylphenidate should not be given unless the benefits outweigh the risks to the patient.Development or worsening of psychiatric disorders should be monitored at every adjustment of dose, then at least every 6 months, and at every visit; discontinuation of treatment may be appropriate.Exacerbation of pre-existing psychotic or manic symptomsIn psychotic patients, administration of methylphenidate may exacerbate symptoms of behavioural disturbance and thought disorder.Emergence of new psychotic or manic symptomsTreatment-emergent psychotic symptoms (visual/tactile/auditory hallucinations and delusions) or mania in children and adolescents without prior history of psychotic illness or mania can be caused by methylphenidate at usual doses. If manic or psychotic symptoms occur, consideration should be given to a possible causal role for methylphenidate, and discontinuation of treatment may be appropriate.Aggressive or hostile behaviourThe emergence or worsening of aggression or hostility can be caused by treatment with stimulants. Patients treated with methylphenidate should be closely monitored for the emergence or worsening of aggressive behaviour or hostility at treatment initiation, at every dose adjustment and then at least every 6 months and every visit. Physicians should eva luate the need for adjustment of the treatment regimen in patients experiencing behaviour changesSuicidal tendencyPatients with emergent suicidal ideation or behaviour during treatment for ADHD should be eva luated immediately by their physician. Consideration should be given to the exacerbation of an underlying psychiatric condition and to a possible causal role of methylphenidate treatment. Treatment of an underlying psychiatric condition may be necessary and consideration should be given to a possible discontinuation of methylphenidate.TicsMethylphenidate is associated with the onset or exacerbation of motor and verbal tics. Worsening of Tourette's syndrome has also been reported. Family history should be assessed and clinical eva luation for tics or Tourette's syndrome in children should precede use of methylphenidate. Patients should be regularly monitored for the emergence or worsening of tics during treatment with methylphenidate. Monitoring should be at every adjustment of dose and then at least every 6 months or every visit.Anxiety, agitation or tensionMethylphenidate is associated with the worsening of pre-existing anxiety, agitation or tension. Clinical eva luation for anxiety, agitation or tension should precede use of methylphenidate and patients should be regularly monitored for the emergence or worsening of these symptoms during treatment, at every adjustment of dose and then at least every 6 month or every visit.Forms of bipolar disorderParticular care should be taken in using methylphenidate to treat ADHD in patients with comorbid bipolar disorder (including untreated Type I Bipolar Disorder or other forms of bipolar disorder) because of concern for possible precipitation of a mixed/manic episode in such patients. Prior to initiating treatment with methylphenidate, patients with comorbid depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression. Close ongoing monitoring is essential in these patients. Patients should be monitored for symptoms at every adjustment of dose, then at least every 6 months and at every visit.GrowthModerately reduced weight gain and growth retardation have been reported with the long-term use of methylphenidate in children.The effects of methylphenidate on final height and final weight are currently unknown and being studied.Growth should be monitored during methylphenidate treatment: height, weight and appetite should be recorded at least 6 monthly with maintenance of a growth chart. Patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted.Seizures Methylphenidate should be used with caution in patients with epilepsy. Methylphenidate may lower the convulsive threshold in patients with prior history of seizures, in patients with prior EEG abnormalities in absence of seizures, and rarely in patients without a history of convulsions and no EEG abnormalities. If seizure frequency increases or new-onset seizures occur, methylphenidate should be discontinued.Abuse, misuse and diversionPatients should be carefully monitored for the risk of diversion, misuse and abuse of methylphenidate.Methylphenidate should be used with caution in patients with known drug or alcohol dependency because of a potential for abuse, misuse or diversion.Chronic abuse of methylphenidate can lead to marked tolerance and psychological dependence with varying degrees of abnormal behaviour. Frank psychotic episodes can occur, especially in response to parenteral abuse.Patient age, the presence of risk factors for substance use disorder (such as co-morbid oppositional-defiant or conduct disorder and bipolar disorder), previous or current substance abuse should all be taken into account when deciding on a course of treatment for ADHD. Caution is called for in emotionally unstable patients, such as those with a history of drug or alcohol dependence, because such patients may increase the dosage on their own initiative.For some high-risk substance abuse patients, methylphenidate or other stimulants may not be suitable and non-stimulant treatment should be considered.WithdrawalCareful supervision is required during drug withdrawal, since this may unmask depression as well as chronic over-activity. Some patients may require long-term follow up.Careful supervision is required during withdrawal from abusive use since severe depression may occur.FatigueMethylphenidate should not be used for the prevention or treatment of normal fatigue states.Excipients: galactose intoleranceThis medicinal product contains lactose: patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.Choice of methylphenidate formulationThe choice of formulation of methylphenidate-containing product will have to be decided by the treating specialist on an individual basis and depends on the intended duration of effect.Drug screeningThis product contains methylphenidate which may induce a false positive laboratory test for amphetamines, particularly with immunoassay screen test.Renal or hepatic insufficiencyThere is no experience with the use of methylphenidate in patients with renal or hepatic insufficiency.Haematological effects The long-term safety of treatment with methylphenidate is not fully known. In the event of leukopenia, thrombocytopenia, anaemia or other alterations, including those indicative of serious renal or hepatic disorders, discontinuation of treatment should be considered.Potential for gastrointestinal obstructionBecause the CONCERTA XL tablet is nondeformable and does not appreciably change in shape in the gastrointestinal (GI) tract, it should not ordinarily be administered to patients with pre-existing severe GI narrowing (pathologic or iatrogenic) or in patients with dysphagia or significant difficulty in swallowing tablets. There have been rare reports of obstructive symptoms in patients with known strictures in association with the ingestion of drugs in nondeformable prolonged-release formulations.Due to the prolonged-release design of the tablet, CONCERTA XL should only be used in patients who are able to swallow the tablet whole. Patients should be informed that CONCERTA XL must be swallowed whole with the aid of liquids. Tablets should not be chewed, divided, or crushed. The medication is contained within a nonabsorbable shell designed to release the drug at a controlled rate. The tablet shell is eliminated from the body; patients should not be concerned if they occasionally notice in their stool something that looks like a tablet.
Interactions
Pharmacokinetic interactionIt is not known how methylphenidate may effect plasma concentrations of concomitantly administered drugs. Therefore, caution is recommended at combining methylphenidate with other drugs, 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. Conversely, the d- and l- enantiomers of methylphenidate do not relevantly inhibit cytochrome P450 1A2, 2C8, 2C9, 2C19, 2D6, 2E1 or 3A.However, there are reports indication that methylphenidate may inhibit the metabolism of coumarin anticoagulants, anticonvulsants (eg, phenobarbital, phenytoin, primidone), and some antidepressants (tricyclics and selective serotonin reuptake inhibitors). When starting or stopping treatment with methylphenidate, it may be necessary to adjust the dosage of these drugs already being taken and establish drug plasma concentrations (or for coumarin, coagulation times).Pharmacodynamic interactionsAnti-hypertensive drugsMethylphenidate may decrease the effectiveness of drugs used to treat hypertensionUse with drugs that elevate blood pressure blood pressureCaution is advised in patients being treated with methylphenidate with any other drug that can also elevate blood pressure.Because of possible hypertensive crisis, methylphenidate is contraindicated in patients being treated (currently or within the preceding 2 weeks) with non-selective, irreversible MAO-inhibitors.Use with alcoholAlcohol may exacerbate the adverse CNS effect of psychoactive drugs, including methylphenidate It is therefore advisable for patients to abstain from alcohol during treatment.Use with halogenated anaestheticsThere is a risk of sudden blood pressure increase during surgery. If surgery is planned, methylphenidate treatment should not be used on the day of surgery.Use with centrally acting alpha-2 agonists (e.g. clonidine)Serious adverse events, including sudden death, have been reported in concomitant use with clonidine. The safety of using methylphenidate in combination with clonidine or other centrally acting alpha-2 agonists has not been systematically eva luated.Use with domapinergic drugsCaution is recommended when administering methylphenidate with dopaminergic drugs, including antipsychotics. Because a predominant action of methylphenidate is to increase extracelluar dopamine levels, methylphenidate may be associated with pharmacodynamic interactions when co-administered with direct and indirect dopamine agonists (including DOPA and tricyclic antidepressants) or with dopamine antagonists including antipsychotics.
Adverse Reactions
The table below shows all adverse drug reactions (ADRs) observed during clinical trials and post-market spontaneous reports with CONCERTA XL and those, which have been reported with other methylphenidate hydrochloride formulations. If the ADRs with CONCERTA XL and the methylphenidate formulation frequencies were different, the highest frequency of both databases was used.Frequency estimate:very common ( 1/10)common ( 1/100 to < 1/10)uncommon ( 1/1000 to < 1/100);rare ( 1/10,000 to <1/1000);very rare (<1/10,000),not known (cannot be estimated from the available data).System Organ ClassAdverse Drug ReactionFrequencyVery commonCommonUncommonRareVery rareNot knownInfections and infestationsNasopharyngitisBlood and lymphatic system disordersAnaemia, Leucopenia, Thrombocyt-openia, Thrombo-cytopenic purpuraPancytopeniaImmune system disordersHypersensitivity reactions such as Angioneurotic oedema, Anaphylactic reactions, Auricular swelling, Bullous conditions, Exfoliative conditions, Urticarias, Pruritus, Rashes, and EruptionsMetabolism and nutritional disordersAnorexia, Decreased appetite, Moderately reduced weight and height gain during prolonged use in childrenPsychiatric disordersInsomnia, NervousnessAnorexia, Affect lability, Aggression, Agitation, Anxiety, Depression, Irritability, Abnormal behaviourPsychotic disorders, Auditory, visual and tactile hallucinations, Anger, Suicidal ideation, Mood altered, Mood swings, Restlessness, Tearfulness, Tics, Worsening of pre-existing tics of Tourette's syndrome, Hypervigilance, Sleep disorderMania, Disorientation, Libido disorderSuicidal attempt (including completed suicide), Transient depressed mood, Abnormal thinking, Apathy, Repetitive behaviours, Over-focussingDelusions, Thought disturbances, Confusional state, dependence. Cases of abuse and dependence have been described, more often with immediate release formulationsNervous system disordersHeadacheDizziness, Dyskinesia, Psychomotor hyperactivity, SomnolenceSedation, TremorConvulsions, Choreoathetoid movements, Reversible ischaemic neurological deficit, Neuroleptic malignant syndrome (NMS; Reports were poorly documented and in most cases, patients were also receiving other drugs, so the role of methylphenidate is unclear).Cerebrovascular disorders(including vasculitis, cerebral haemorrhages, cerebrovascular accidents, cerebral arteritis, cerebral occlusion), Grand mal convulsions, MigraineEye disordersDiplopia, Blurred visionDifficulties in visual accommo-dation, Mydriasis, Visual disturbanceCardiac disordersArrhythmia, Tachycardia, PalpitationsChest painAngina pectorisCardiac arrest; Myocardial infarctionSupraventricular tachycardiaa, Bradycardia, Ventricular extrasystoles, ExtrasystolesVascular disordersHypertensionCerebral arteritis and/or occlusion, Peripheral coldness, Raynaud's phenomenonRespiratory, thoracic and mediastinal disordersCough, Pharyngol-aryngeal painDyspnoeaGastrointestinal disordersAbdominal pain, Diarrhoea, Nausea, Stomach discomfort, Vomiting, Dry mouthConstipationHepatobiliary disordersHepatic enzyme elevationsAbnormal liver function, including hepatic comaSkin and subcutaneous tissue disordersAlopecia, Pruritis, Rash, UrticariaAngioneurotic oedema, Bullous conditions, Exfoliative conditionsHyperhidrosis, Macular rash; ErythemaErythema multiforme, Exfoliative dermatitis, Fixed drug eruptionMusculoskeletal, connective tissue and bone disordersArthralgiaMyalgia, Muscle twitchingMuscle crampsRenal and urinary disordersHaematuriaReproductive system and breast disordersGynaeco-mastiaGeneral disorders and administration site conditions Pyrexia, Growth retardation during prolonged use in childrenChest pain, FatigueSudden cardiac deathChest discomfort, HyperpyrexiaInvestigationsChanges in blood pressure and heart rate (usually an increase), Weight decreasedCardiac murmur, Hepatic enzyme increasedBlood alkaline phosphatase increased, Blood bilirubin increased, Platelet count decreased, White blood cell count abnormal
Manufacturer
Janssen-Cilag Ltd
Drug Availability
(POM)
Updated
31 August 2010
