Conufen 18/27/36/54 18 mg, 27 mg, 36 mg, 54 mg Tablet

Attention - Deficit/Hyperactivity Disorder (ADHD) CONUFEN is indicated for the treatment of attention - deficit hyperactivity disorder (ADHD) in children and adolescents aged 6 to 17 and adults aged 18 to 65 who meet DSM - IV criteria for ADHD.

CONUFEN should not be used in patients under six years old. CONUFEN is administered orally once daily. As the effect has been shown to be present 12 hours after dosing, the product should be taken in the morning. CONUFEN must be swallowed whole with adequate amounts of liquids and must not be chewed, divided, or crushed. CONUFEN may be administered with or without food. Dosage should be individualised according to the need and response of each individual patient.

Patients New to Methylphenidate The recommended starting dose of CONUFEN prolonged release tablets for patients who are not currently taking methylphenidate, or for patients who are on stimulants other than methylphenidate, is 18 mg once daily for children and adolescents and 18 or 36 mg daily for adults. Patients Currently Using Methylphenidate The recommended dose of CONUFEN prolonged release tablets for patients who are currently taking methylphenidate three times daily at doses of 15 to 60 mg/day is provided in Table 1. Dosing recommendations are based on current dose regimen and clinical judgement.

TABLE 1: Recommended Dose Conversion from Other Methylphenidate Regimens to CONUFEN prolonged release tablets Previous methylphenidate daily dose Recommended CONUFEN prolonged release tablets dose 5 mg Methylphenidate twice daily or three times daily 18 mg once daily 10 mg Methylphenidate twice daily or three times daily 36 mg once daily 15 mg Methylphenidate twice daily or three times daily 54 mg once daily 20 mg Methylphenidate twice daily or three times daily 72 mg once daily

Clinical judgement should be used when selecting the dose for patients currently taking methylphenidate in other regimens. Dosage may be adjusted in 18 mg increments to a maximum of 54 mg/day for children aged between 6 to 12 years and to a maximum of 72 mg for adolescents aged between 13 to 18 years and 108 mg in adults. In general, dosage adjustments may proceed at approximately weekly intervals. Daily dosage above 54 mg is not recommended for children aged between 6 to 12 years. Daily dosage above 72 mg is not recommended for adolescents aged between 13 to 18 years. Daily dosage above 108 mg is not recommended in adults.

Maintenance/Extended Treatment The long - term use of CONUFEN has not been systematically evaluated in controlled clinical trials. The physician who elects to use CONUFEN for extended periods in patients with ADHD should periodically re - evaluate the long - term usefulness of the medicine for the individual patient with trials off medication to assess the patients functioning without pharmacotherapy. Dose reduction and discontinuation If paradoxical aggravation of symptoms or other adverse events occur, the dosage should be reduced, or, if necessary, CONUFEN should be discontinued. Elderly Safety and efficacy have not been established in patients over 60 years of age. Paediatric population Children under 6 years of age: CONUFEN should not be used in children under the age of 6 years. Hepatic impairment CONUFEN has not been studied in patients with hepatic impairment. Caution should be exercised in these patients. Renal impairment CONUFEN has not been studied in patients with renal impairment. Caution should be exercised in these patients. Method of administration General recommendations CONUFEN is for oral administration and can be taken with or without food.

• Known hypersensitivity to methylphenidate or to any of the excipients in CONUFEN (see section 6.1).
• Glaucoma.
• Pheochromocytoma.
• During treatment with non - selective, irreversible monoamine oxidase (MAO) inhibitors, or within a minimum of 14 days of discontinuing those medicines, due to risk of hypertensive crisis (see section 4.5).
• Hyperthyroidism.
• 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, channelopathies (disorders caused by the dysfunction of ion channels) and QT prolongation either congenital, familial or caused by medication (see section 4.4).
• Pre - existing cerebrovascular disorders, cerebral aneurysm, vascular abnormalities including vasculitis or stroke or known risk factors for cerebrovascular disorders.
• Anxiety, tension, agitation, a family history or diagnosis of Touretteu2019s syndrome.
• Pregnancy and lactation (see section 4.6).

Methylphenidate treatment is not indicated in all children with ADHD and the decision to use the medicine 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 adolescents 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. 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 medical practitioner 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 medicine for the individual patient with trial periods off medicine 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 medicine is either temporary or permanently discontinued.

Use in adults with ADHD Safety and efficacy have not been established for the initiation of treatment in adults or the routine continuation of treatment beyond 18 years of age. If treatment withdrawal has not been successful when an adolescent has reached 18 years of age, continued treatment into adulthood may be necessary. The need for further treatment of these adults should be reviewed regularly and undertaken annually.

Use in the elderly Methylphenidate should not be used in the elderly. Safety and efficacy have not been established in this age group.

Use in children under 6 years of age CONUFEN should not be used in patients under 6 years old. Sufficient data on the safety of long - term use of CONUFEN is not yet available.

Cardiovascular status Patients who are being considered for treatment with stimulant medicines should have a careful history (including assessment for a family history of sudden cardiac or unexplained death or malignant dysrhythmia) and physical exam to assess for the presence of cardiac disease, and should receive further specialist cardiac evaluation 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 evaluation.

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 mm Hg 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. See section 4.3 for conditions in which methylphenidate treatment is contraindicated. 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 advice has been obtained (see section 4.3).

Sudden death and pre - existing cardiac structural abnormalities or other serious cardiac disorders Sudden 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 medicines are not recommended in children or adolescents with known cardiac structural 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 events Misuse of stimulants of the central nervous system may be associated with sudden death and other serious cardiovascular adverse events.

Cerebrovascular disorders See section 4.3 for cerebrovascular conditions in which methylphenidate treatment is contraindicated. Patients with additional risk factors (such as a history of cardiovascular disease, concomitant medicines 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 disorders Co - morbidity of psychiatric disorders in ADHD is common and should be taken into account when prescribing stimulant medicines. 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 symptoms In psychotic patients, administration of methylphenidate may exacerbate symptoms of behavioural disturbance and thought disorder. Emergence of new psychotic or manic symptoms Treatment - 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 behaviour The 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. Medical practitioners should evaluate the need for adjustment of the treatment regimen in patients experiencing behavioural changes bearing in mind that upwards or downwards titration may be appropriate. Treatment interruption can be considered.

Suicidal tendency Patients with emergent suicidal ideation or behaviour during treatment for ADHD should be evaluated immediately by their medical practitioner. 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.

Tics Methylphenidate 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 evaluation 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 tension Methylphenidate is associated with the worsening of pre - existing anxiety, agitation or tension. Clinical evaluation 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 months and at every visit.

Forms of bipolar disorder Particular care should be taken in using methylphenidate to treat ADHD in patients with co - morbid bipolar disorder (including untreated type 1 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 co - morbid 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 (see above 'Psychiatric Disorders' and section 4.2). Patients should be monitored for symptoms at every adjustment of dose, then at least every 6 months and at every visit.

Growth Moderately reduced weight gain and growth retardation have been reported with 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 in patients without a history of convulsions and no EEG abnormalities. If seizure frequency increases or new onset seizures occur, methylphenidate should be discontinued.

Priapism Prolonged and painful erections have been reported in association with methylphenidate medicines, mainly in association with a change in the methylphenidate treatment regimen. Patients who develop abnormally sustained or frequent and painful erections should seek immediate medical attention.

Use with serotonergic medicinal products Serotonin syndrome has been reported following co - administration of methylphenidate with serotonergic medicinal products. If concomitant use of methylphenidate with a serotonergic medicinal product is warranted, prompt recognition of the symptoms of serotonin syndrome is important. These symptoms may include mental - status changes (e.g. agitation, hallucinations, coma), autonomic instability (e.g. tachycardia, labile blood pressure, hyperthermia), neuromuscular abnormalities (e.g. hyperreflexia, incoordination, rigidity), and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea). Methylphenidate must be discontinued as soon as possible if serotonin syndrome is suspected.

Abuse, misuse and diversion Patients 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 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.

Withdrawal Careful supervision is required during 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.

Fatigue Methylphenidate should not be used for the prevention or treatment of normal fatigue states.

Choice of methylphenidate formulation The 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 screening This product contains methylphenidate which may induce a false positive laboratory test for amphetamines, particularly with immunoassay screen test.

Renal or hepatic insufficiency There 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 obstruction Because CONUFEN prolonged release tablet is non - deformable 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 medicines in non - deformable prolonged release formulations. Due to the prolonged - release design of the tablet, CONUFEN prolonged release tablets should only be used in patients who are able to swallow the tablet whole. Patients should be informed that CONUFEN must be swallowed whole with the aid of liquids. Tablets should not be chewed, divided, or crushed. The medication is contained within a non - absorbable shell designed to release the medicines 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.

Pharmacokinetic interaction It is not known how methylphenidate may affect plasma concentrations of concomitantly administered medicines. Therefore, caution is recommended at combining methylphenidate with other medicines, 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 I - enantiomers of methylphenidate do not relevantly inhibit cytochrome P450 1A2, 2C8, 2C9, 2C19, 2D6, 2E1 or 3A. However, there are reports indicating that methylphenidate may inhibit the metabolism of coumarin anticoagulants, anticonvulsants (e.g. phenobarbitone, phenytoin, primodone), and some antidepressants (tricyclic and selective serotonin reuptake inhibitors). When starting and stopping treatment with methylphenidate, it may be necessary to adjust the dosage of these medicines already being taken and establish drug plasma concentrations (or for coumarin, coagulation times).

Pharmacodynamic interactions Anti - hypertensive medicines Methylphenidate may decrease the effectiveness of medicines used to treat hypertension. Use with medicines that elevate blood pressure Caution is advised in patients being treated with methylphenidate with other medicines that can also elevate blood pressure (see also sections on cardiovascular and cerebrovascular conditions in section 4.4). 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 (see section 4.3).

Use with alcohol Alcohol may exacerbate the adverse CNS effects of psychoactive medicines, including methylphenidate. It is therefore advisable for patients to abstain from alcohol during treatment.

Use with halogenated anaesthetics There 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) The long - term safety of using methylphenidate in combination with clonidine or other centrally acting alpha - 2 agonists has not been systematically evaluated.

Use with dopaminergic medicines Caution is recommended when administering methylphenidate with dopaminergic medicines, including antipsychotics. Because a predominant action of methylphenidate is to increase extracellular 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.

Use with serotonergic medicines There have been reports of serotonin syndrome following co - administration of methylphenidate with serotonergic medicines. If concomitant use of CONUFEN with a serotonergic medicine is warranted, prompt recognition of the symptoms of serotonin syndrome is important. CONUFEN must be discontinued as soon as possible if serotonin syndrome is suspected.

Medicine/Laboratory test CONUFEN may induce false positive laboratory tests for amphetamines, particularly with immunoassays screen test.

Pregnancy CONUFEN is contraindicated in pregnancy, as safety has not been demonstrated. Cases of neonatal cardiorespiratory toxicity, specifically foetal tachycardia and respiratory distress have been reported in spontaneous reports. Studies in animals have only shown evidence of reproductive toxicity at maternally toxic doses. (See section 5.3.)

Lactation Methylphenidate has been found in breast - milk of women treated with methylphenidate. Mothers on CONUFEN should not breastfeed their infants.

Fertility There were no relevant effects observed in the non - clinical studies.

CONUFEN may cause dizziness, drowsiness and visual disturbances including difficulties with accommodation, diplopia and blurred vision. It may have a moderate influence on the ability to drive and use machines. Patients should be warned of these possible effects and advised that if affected, they should avoid potentially hazardous activities such as driving or operating machinery.

The table below shows all adverse reactions observed during clinical trials and post - market spontaneous reports with methylphenidate prolonged - release tablets and those which have been reported with other methylphenidate hydrochloride formulations. If the adverse reactions with methylphenidate prolonged - release tablet and the methylphenidate formulation frequencies were different, the highest frequency of both databases was used.

System Organ Class Adverse reaction Frequency Frequent Less frequent Frequency unknown Infections and infestations Nasopharyngitis, upper respiratory tract infection # , sinusitis # Blood and lymphatic system disorders Anaemia u2020 , leukopenia u2020 , thrombocytopenia, thrombocytopenic purpura Pancytopenia Immune system disorders Hypersensitivity reactions such as angioedema, anaphylactic reactions, auricular swelling, bullous conditions, exfoliative conditions, urticaria, pruritus, rashes, and eruptions Metabolism and nutrition disorders* Anorexia, decreased appetite u2020 , moderately reduced weight and height gain during prolonged use in children* Psychiatric disorders* Insomnia, nervousness, affect lability, aggression*, agitation*, anxiety* u2020 , depression* # , irritability, Psychotic disorders*, auditory, visual and tactile hallucination*, anger, suicidal ideation*, mood altered, restlessness u2020 , tearfulness, Delusions* u2020 , thought disturbances*, dependence; cases of abuse and dependence have been described more often with abnormal behaviour, mood swings, tics*, initial insomnia # , depressed mood # , libido decreased # , tension # , bruxism # , panic attack # worsening of pre - existing tics of Tourette's syndrome*, logorrhoea, hypervigilance, sleep disorder, mania* u2020 , disorientation, libido disorder, confusional state u2020 , suicidal attempt (including completed suicide)* u2020 , transient depressed mood*, abnormal thinking, apathy u2020 , repetitive behaviours, over - focusing immediate release formulations Nervous system disorders Headache, dizziness, dyskinesia, psychomotor hyperactivity, somnolence, paraesthesia # , tension headache # Sedation, tremor u2020 , lethargy # , convulsion, choreoathetoid movements, Cerebrovascular disorders* u2020 (including vasculitis, cerebral haemorrhages, cerebrovascular accidents, cerebral reversible ischaemic neurological deficit, neuroleptic malignant syndrome (NMS; reports were poorly documented and in most cases patients were also receiving other medicines, so the role of methylphenidate is unclear). arteritis, cerebral occlusion), grand mal convulsion*, migraine u2020 , dysphemia Eye disorders Accommodation disorder # Blurred vision u2020 , dry eye # , difficulties in visual accommodation, visual impairment, diplopia Mydriasis Ear and labyrinth disorders Vertigo # Cardiac disorders Dysrhythmia, tachycardia, palpitations Chest pain, angina pectoris, cardiac arrest; myocardial infarction Supraventricular tachycardia, bradycardia, ventricular extrasystoles u2020 , extrasystoles u2020 Vascular disorders Hypertension Hot flush # , cerebral arteritis and/or occlusion, peripheral coldness u2020 , Raynaud's phenomenon Respiratory, Thoracic and mediastinal disorders Cough, oropharyngeal pain Dyspnoea u2020 Gastrointestinal disorders Upper abdominal pain, diarrhoea, nausea u2020 , abdominal discomfort, vomiting, dry mouth u2020 , dyspepsia # Constipation u2020 Hepatobiliary disorders Alanine aminotransferase increased # Hepatic enzyme increased, abnormal liver function, including acute hepatic failure and hepatic coma, blood alkaline phosphatase increased, blood bilirubin increased u2020 Skin and subcutaneous tissue disorders Alopecia, pruritus, rash, urticaria Angioedema, bullous conditions, exfoliative conditions, hyperhidrosis u2020 , macular rash, erythema, erythema multiforme, exfoliative dermatitis, fixed drug eruption Musculoskeletal and connective tissue disorders Arthralgia, muscle tightness # , muscle spasms # Myalgia u2020 , muscle twitching, muscle cramps, Trismus^ Renal and urinary disorders Haematuria, pollakiuria Incontinence Reproductive system and breast disorders Erectile dysfunction # Gynaecomastia Priapism*, erection increased* and prolonged erection* General disorders and administration site conditions Pyrexia, growth retardation during prolonged use in children*, fatigue u2020 , irritability # , feeling jittery # , asthenia # , thirst # Chest pain, sudden cardiac death* Chest discomfort u2020 , hyperpyrexia Investigations Changes in blood pressure and heart rate (usually an increase)*, weight decreased* Cardiac murmur*, platelet count decreased, abnormal white blood cell count * See section 4.4 # Frequency derived from adult clinical trials and not on data from trials in children and adolescents; may also be relevant for children and adolescents. u2020 Frequency derived from clinical trials in children and adolescents and reported at a higher frequency in clinical trials in adult patients.

When treating patients with overdose, allowances must be made for the delayed release of methylphenidate from formulations with extended durations of action. 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 dysrhythmias, hypertension, mydriasis, dryness of mucous membranes and rhabdomyolysis.

Treatment There is no specific antidote to methylphenidate overdosage. Treatment consists of appropriate supportive measures and symptomatic treatment of life - threatening events e.g. hypertensive crisis, cardiac dysrhythmias, convulsions. For the most current guidance for treatment of symptoms of overdose, the medical practitioner should consult a certified Poison Control Centre or current toxicological publication. The patient must be protected against self - injury and against external stimuli that would aggravate over - stimulation already present. If the patient is conscious, administration of activated charcoal and a laxative is recommended. In the presence of severe intoxication, a carefully titrated dose of a benzodiazepine should be given. Intensive care must be provided to maintain adequate circulation and respiratory exchange; external cooling procedures may be required to reduce hyperpyrexia. Efficacy of peritoneal dialysis or extracorporeal haemodialysis for overdose of methylphenidate has not been established.