Methylphenidate Teva

Methylphenidate hydrochloride.

18 mg tablet: Each prolonged-release tablet contains 18 mg of methylphenidate hydrochloride equivalent to 15.6 mg of methylphenidate.
27 mg tablet: Each prolonged-release tablet contains 27 mg of methylphenidate hydrochloride equivalent to 23.3 mg of methylphenidate.
36 mg tablet: Each prolonged-release tablet contains 36 mg of methylphenidate hydrochloride equivalent to 31.1 mg of methylphenidate.
54 mg tablet: Each prolonged-release tablet contains 54 mg of methylphenidate hydrochloride equivalent to 46.7 mg of methylphenidate.
Excipients/Inactive Ingredients: Tablet core: Lactose monohydrate (spray dried), hypromellose (K100 LV), colloidal anhydrous silica, magnesium stearate, methacrylic acid-methyl methacrylate copolymer (1:1), methacrylic acid-methyl methacrylate copolymer (1:2), triethyl citrate, talc, acetone, isopropyl alcohol, hypromellose (E5 LV), fumaric acid, water.
Tablet coating: 18 mg tablet: Polyvinyl alcohol-part. hydrolyzed, Macrogol/PEG (3350), talc, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172), water.
27 mg tablet: Polyvinyl alcohol-part. hydrolyzed, Macrogol/PEG (3350), talc, titanium dioxide (E171), FD&C Blue #2/Indigo carmine aluminium lake (E132), iron oxide black (E172), iron oxide yellow (E172), water.
36 mg tablet: Polyvinyl alcohol-part. hydrolyzed, Macrogol/PEG (3350), talc, titanium dioxide (E171), water.
54 mg tablet: Polyvinyl alcohol-part. hydrolyzed, Macrogol/PEG (3350), talc, titanium dioxide (E171), iron oxide red (E172), water.
Printing ink: Shellac glaze, isopropyl alcohol, iron oxide black (E172), N-butyl alcohol, propylene glycol, ammonium hydroxide 28%.

Attention-Deficit/Hyperactivity Disorder (ADHD): Methylphenidate Teva 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 the current DSM criteria or ICD guidelines and should be based on a complete history and evaluation of the patient. Diagnosis cannot be made solely on the presence of one or more symptom.
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 includes 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.
Methylphenidate Teva 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.

Treatment must be initiated under the supervision of a specialist in childhood and/or adolescent behavioural disorders.
Pre-treatment screening: Prior to prescribing, it is necessary to conduct a baseline evaluation of a patient's cardiovascular status including blood pressure and heart rate. A comprehensive history should document concomitant medications, past and present comorbid 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 (see Contraindications and Precautions).
Ongoing monitoring: Growth, psychiatric and cardiovascular status should be continuously monitored (see also Precautions): 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.
Posology: Dose titration: Careful dose titration is necessary at the start of treatment with Methylphenidate Teva. Dose titration should be started at the lowest possible dose. A 27 mg dosage strength is available for those who wish to prescribe between the 18 mg and 36 mg dosages.
Other strengths of this medicinal product and other methylphenidate-containing products may be available.
The dosage may be adjusted in 18 mg increments. In general, dosage adjustment may proceed at approximately weekly intervals.
The maximum daily dosage of Methylphenidate Teva is 54 mg.
Patients New to Methylphenidate: Clinical experience with Methylphenidate Teva is limited in these patients. Methylphenidate Teva 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 Methylphenidate Teva 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 Methylphenidate Teva 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. (See Table 1.)

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If 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 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. The physician 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 medicinal product 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 medicinal product 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 discontinued.
Adults: In adolescents whose symptoms persist into adulthood and who have shown clear benefit from treatment, it may be appropriate to continue treatment into adulthood. However, start of treatment with Methylphenidate Teva in adults is not appropriate (see Precautions).
Elderly: Methylphenidate should not be used in the elderly. Safety and efficacy has not been established in this age group.
Children under 6 years of age: Methylphenidate should not be used in children under the age of 6 years. Safety and efficacy in this age group has not been established.
Method of administration: Methylphenidate Teva must be swallowed whole with the aid of liquids, and must not be chewed, divided, or crushed (see Precautions).
Methylphenidate Teva may be administered with or without food.
Methylphenidate Teva is taken once daily in the morning.

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 arrhythmias, hypertension, mydriasis, and dryness of mucous membranes.
Treatment: There is no specific antidote to methylphenidate overdosage.
Treatment consists of appropriate supportive measures.
The patient must be protected against self-injury and against external stimuli that would aggravate overstimulation already present. The efficacy of activated charcoal has not been established.
Intensive care must be provided to maintain adequate circulation and respiratory exchange; external cooling procedures may be required for hyperpyrexia.
Efficacy of peritoneal dialysis or extracorporeal haemodialysis for overdose of methylphenidate has not been established.

Hypersensitivity to methylphenidate or to any of the excipients listed in Description.
Glaucoma.
Phaeochromocytoma.
During treatment with non-selective irreversible monoamine oxidase (MAO) inhibitors, or within a minimum of 14 days of discontinuing those drugs, due to the risk of hypertensive crisis (see Interactions).
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 arrhythmias and channelopathies (disorders caused by the dysfunction of ion channels).
Pre-existing cerebrovascular disorders, cerebral aneurysm, vascular abnormalities including vasculitis or stroke.

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 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 according to the guidance as follows and in Dosage & Administration for cardiovascular status, growth, appetite, development of de novo or worsening of pre-existing psychiatric disorders. Psychiatric disorders to monitor for are described as follows, 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-evaluate the long-term usefulness of the medicinal product 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 medicinal product is either temporarily or permanently discontinued.
Use in adults: 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.
Cardiovascular status: Patients 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 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 mmHg relative to controls. The short- and long-term clinical consequences of these cardiovascular effects in children and adolescents are not known. The possibility of clinical complications cannot be excluded as a result of the effects observed in the clinical trial data especially when treatment during childhood/adolescence is continued into adulthood. Caution is indicated in treating patients whose underlying medical conditions might be compromised by increases in blood pressure or heart rate. See Contraindications 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 cardiac advice has been obtained (see Contraindications).
Sudden death and pre-existing structural cardiac 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 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 events: Misuse of stimulants of the central nervous system may be associated with sudden death and other serious cardiovascular adverse events.
Cerebrovascular disorders: See Contraindications for cerebrovascular conditions in which methylphenidate treatment is contraindicated. Patients 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. Theses 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: Comorbidity 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 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. Aggression has been reported in patients treated with methylphenidate (see Adverse Reactions). 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 evaluate the need for adjustment of the treatment regimen in patients experiencing behaviour changes bearing in mind that upwards or downwards titration may be appropriate. Treatment interruption can be considered.
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: Anxiety, agitation and tension have been reported in patients treated with methylphenidate (see Adverse Reactions). Methylphenidate is also associated with the worsening of pre-existing anxiety, agitation or tension, and anxiety led to discontinuation of methylphenidate in some patients. 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 or every visit.
Forms of bipolar disorder: Particular 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 (see as previously mentioned and Dosage & Administration). 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 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 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.
Priapism: Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with methylphenidate products in both paediatric and adult patients. Priapism was not reported with drug initiation but developed after some time on the drug, often subsequent to an increase in dose. Priapism has also appeared during a period of drug withdrawal (drug holidays or during discontinuation). Patients who develop abnormally sustained or frequent and painful erections should seek immediate medical attention.
Suicidal behaviour and ideation: There have been post-marketing reports of suicide-related events in patients treated with ADHD drugs, including cases of ideation, attempts, and very rarely, completed suicide. The mechanism of this risk is not known. ADHD and its related comorbidities may be associated with increased risk of suicidal ideation and/or behaviour. Therefore, it is recommended for patients treated with ADHD drugs that caregivers and physicians monitor for signs of suicide-related behaviour, including at dose initiation/optimization and drug discontinuation. The physician should initiate appropriate treatment of the underlying psychiatric condition and consider a possible change in the ADHD treatment regimen.
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 comorbid 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.
Withdrawal: Careful 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.
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 the Methylphenidate Teva 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, Methylphenidate Teva should only be used in patients who are able to swallow the tablet whole. Patients should be informed that Methylphenidate Teva 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.
Effects on ability to drive and use machines: Methylphenidate can 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.
This medicine can impair cognitive function and can affect a patient's ability to drive safely. When prescribing this medicine, patients should be told: that the medicine is likely to affect the ability to drive; to not drive until it is known how the medicine affects them; that it is an offence to drive while under the influence of this medicine.
Use in the Elderly: Methylphenidate should not be used in the elderly. Safety and efficacy has not been established in this age group.
Use in Children: Methylphenidate should not be used in children under the age of 6 years. Safety and efficacy in this age group has not been established.

Pregnancy: 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 a small 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, compare with non-exposed pregnancies.
Cases of neonatal cardiorespiratory toxicity, specifically foetal tachycardia and respiratory distress have been reported in spontaneous case reports.
Studies in animals have shown evidence of reproductive toxicity at maternally toxic doses.
Methylphenidate is not recommended for use during pregnancy unless a clinical decision is made that postponing treatment may pose a greater risk to the pregnancy.
Breast-feeding: Methylphenidate is excreted in human milk. Based on reports of breast milk sampling from five mothers, methylphenidate concentrations in human milk resulted in infant doses of 0.16% to 0.7% of the maternal weight-adjusted dosage, and a milk to maternal plasma ratio ranging between 1.1 and 2.7.
There is one case report of an infant who experienced an unspecified decrease in weight during the period of exposure but recovered and gained weight after the mother discontinued treatment with methylphenidate. A risk to the suckling child cannot be excluded.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from methylphenidate therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility: There were no relevant effects observed in the non-clinical studies.

The following table shows all adverse reactions observed during clinical trials of children, adolescents, and adults and post-market spontaneous reports with Methylphenidate Teva and those which have been reported with other methylphenidate hydrochloride formulations. If the adverse reactions with Methylphenidate Teva and the methylphenidate formulation frequencies were different, the highest frequency of both databases was used. (See Tables 2a and 2b.)
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).

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Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Pharmacokinetic interactions: It is not known how methylphenidate may affect 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 indicating that methylphenidate may inhibit the metabolism of coumarin anticoagulants, anticonvulsants (e.g. 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 interactions: Anti-hypertensive drugs: Methylphenidate may decrease the effectiveness of drugs used to treat hypertension.
Use with drugs that elevate blood pressure: Caution is advised in patients being treated with methylphenidate with any other drug that can also elevate blood pressure (see also Precautions for cardiovascular and cerebrovascular conditions).
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 Contraindications).
Use with alcohol: Alcohol may exacerbate the adverse CNS effects of psychoactive medicinal products, including methylphenidate. It is therefore advisable for patients to abstain from alcohol during treatment.
Use with serotonergic medicinal products: There have been reports of serotonin syndrome 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 (see Precautions). Methylphenidate must be discontinued as soon as possible if serotonin syndrome is suspected.
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 drugs: Caution is recommended when administering methylphenidate with dopaminergic drugs, 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.

Store below 30°C.
Shelf life after first opening the bottle: 18 mg tablet: 3 months.
27 mg tablet: 6 months.
36 mg tablet: 6 months.
54 mg tablet: 6 months.

Other CNS Drugs & Agents for ADHD

N06BA04 - methylphenidate ; Belongs to the class of centrally-acting sympathomimetics. Used as CNS stimulant.

DD, P₁S₁S₃