The information provided on this website is intended for Healthcare Professionals in the UK only.
If you are a parent or caregiver of a child who has been prescribed Methylphenidate Hydrochloride 2mg/ml oral solution for ADHD, please click here.
If you are interested in finding out more about ADHD, please click here.
Adverse event reporting information can be found at the bottom of the page.

Safety Considerations

Christopher, 9 years old

The above illustration has been created to depict choice.

Safety in Practice

Methylphenidate Hydrochloride 2mg/ml oral solution is bioequivalent to Ritalin®
(methylphenidate hydrochloride) 10mg tablets.1,2 This section presents safety considerations
for prescribers, including pre-treatment screening and ongoing monitoring.

Safety icon 1

A baseline evaluation of cardiovascular status is required prior to prescribing methylphenidate, including blood pressure and heart rate.1

A comprehensive history should document:1

  • Concomitant medications
  • Past and present co-morbid medical and psychiatric disorders or symptoms
  • Family history of sudden cardiac/unexplained death
  • Accurate recording of pre-treatment height and weight on a growth chart
Safety icon monitoring

Growth, psychiatric and cardiovascular status should be continuously monitored in children receiving methylphenidate:1

  • 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 also be monitored for the risk of diversion, misuse and abuse of methylphenidate.1

Treatment must be stopped if the symptoms do not improve after appropriate dosage adjustment over a one-month period.1

If paradoxical aggravation of symptoms or other serious adverse events occur, the dosage should be reduced or discontinued.1

Safety icon precautions

Please refer to the Special Warnings and Precautions for use (section 4.4) of the Summary of Product Characteristics for full information.

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.1

Methylphenidate treatment is usually discontinued during or after puberty.1

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.1

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.1

Indications and Patient Selection
Methylphenidate is not for all children with ADHD. Treatment decisions should consider symptom severity and chronicity. Long-term use (over 12 months) lacks sufficient controlled trial data and requires periodic reassessment, especially during puberty. Discontinuation during school holidays is recommended to evaluate the child’s progress without medication.

Usage in Specific Age Groups
Adults: Not approved for adult ADHD treatment; safety and efficacy are unconfirmed.
Elderly: Not recommended; safety and efficacy data are lacking.
Children under 6: Should not be used due to a lack of safety and efficacy data.

Cardiovascular Considerations
A detailed cardiac history and assessment are mandatory, especially for those with personal or family history of heart issues. Patients should be monitored for blood pressure and pulse changes at each dose adjustment and every six months thereafter. Methylphenidate is contraindicated for individuals with specific cardiovascular conditions due to risks like sudden death and adverse cardiac events.

Please refer to the Contraindications section below for further information. For Cerebrovascular disorders, please refer to the Summary of Product Characteristics and the Contraindications section below.

Psychiatric Precautions
Psychiatric disorders are common in ADHD and may worsen with methylphenidate. Development or worsening or psychiatric disorders should be monitored at every dose adjustment, then at least every 6 months, and at every visit: discontinuation of treatment may be appropriate. Patients should be closely monitored for:
Psychosis or mania: Can worsen; discontinuation may be necessary.
Aggression and hostility: May emerge or worsen; regular monitoring advised.
Suicidal ideation: Any emergence should prompt immediate evaluation.
Tics and Tourette’s syndrome: May worsen; family history should be evaluated.
Anxiety, agitation, and bipolar disorder: Can worsen; detailed psychiatric history is required.

Other Risks
Growth and Weight: Growth retardation has been reported. Monitor height, weight, and appetite every six months.
Seizures: Caution in epilepsy patients; discontinue if seizure frequency increases.
Abuse Potential: Methylphenidate has a risk of misuse and dependency. Monitor especially those with past substance abuse or co-morbid behavioural disorders.
Withdrawal: May reveal underlying depression or chronic hyperactivity; careful supervision is advised.
Fatigue: Should not be used for general fatigue prevention or in cases with a risk of misuse.

Please refer to the Special Warnings and Precautions for use (section 4.4) of the Summary of Product Characteristics  for full information.

Safety icon contradictions

Contraindications of methylphenidate are:1

  • Known sensitivity to methylphenidate or to any of the excipients in its formulation
  • Glaucoma
  • Phaechromocytoma
  • During treatment with monoamine oxidase (MAO) inhibitors, or within a minimum of 14 days of discontinuing those drugs (due to risk of hypertensive crisis)
  • 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 1) 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 or known risk factors for cerebrovascular disorders
Safety icon tolerability

Methylphenidate Hydrochloride 2mg/ml oral solution is bioequivalent to Ritalin® (methylphenidate hydrochloride) 10mg tablets.1,2

Headache, insomnia and nervousness are very common (>1/10) adverse drug reactions with methylphenidate.1

Please see the SmPC for Methylphenidate Hydrochloride 2mg/ml oral solution for full details of potential adverse drug reactions before prescribing.1

Common (>1/100 to <1/10) adverse events in the Summary of Product Characteristics for Methylphenidate Hydrochloride 2mg/ml oral solution1

Infections and infestationsNasopharyngitis
Metabolism and nutritional disordersAnorexia, decreased appetite, moderately reduced weight and height gain during prolonged use in children
Psychiatric disordersAnorexia, affect lability, aggression, agitation, anxiety, depression, irritability, abnormal behaviour, bruxism
Nervous system disordersDizziness, dyskinesia, psychomotor hyperactivity, somnolence
Cardiac disordersArrhythmia, tachycardia palpitations
Vascular disordersHypertension
Respiratory, thoracic and mediastinal disordersCough, pharyngolaryngeal pain
Gastro-intestinal disordersAbdominal pain, diarrhoea, nausea, stomach discomfort and vomiting. These usually occur at the beginning of treatment and may be alleviated by concomitant food intake. Dry mouth
Skin and subcutaneous tissue disordersAlopecia, pruritis, rash, urticaria
Musculoskeletal, connective tissue and bone disordersArthralgia
General disorders and administration site conditionsPyrexia, growth retardation during prolonged use in children
InvestigationsChanges in blood pressure and heart rate (usually an increase), weight decreased

 

Related resources

UK-MPH-45g | December 2024
References

1. Methylphenidate Hydrochloride 2mg/ml oral solution Summary of Product Characteristics. Consilient Health Ltd. 2. Data on file, Module 2.5 – MPH OS bioequivalence to Ritalin 10mg tablets. Consilient Health Ltd – UK-MPH-83 June 2024.

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Administration video

This two minute animation gives simple step-by-step instructions on how to administer your child’s doses of methylphenidate oral solution exactly as prescribed by their doctor. Following these simple steps helps to ensure that your child gets the very most from therapy.

ADHD leaflet for parents and guardians

This quick reference guide gives you easily accessible information about ADHD and its treatment with methylphenidate oral solution. This includes simple step-by-step instructions on administering this medicine, as well as answers to frequently asked questions, such as possible side effects to look out for and how to store methylphenidate oral solution.

ADHD booklet for children

This comic-style booklet helps children with ADHD to explore their condition and its treatment in a fun, interactive way. 
The booklet explains how treatment helps kids to make friends with their ADHD, so that they can do lots of things together. There’s easy to understand information about methylphenidate oral solution too, helping your child to understand their treatment and get the very most from it.

You are now leaving this webpage. Any information derived from an external link is not owned by Consilient Health and is not subject to any Consilient Health policy.

This link does not constitute endorsement by Consilient Health.

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UK-MPH-44 | November 2024

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Product Information Pack

This information pack has been developed to provide a central resource that may be used for activities such as completion of a formulary request for Methylphenidate Hydrochloride 2mg/ml oral solution. It contains a wealth of information about this medicine and its place in therapy, from guidelines and recommendations to bioequivalence data and financial considerations vs. immediate-release methylphenidate tablets.

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Administration Video

This two minute animation for parents and caregivers of children with ADHD gives simple step-by-step instructions on how to administer doses of Methylphenidate Hydrochloride 2mg/ml oral solution exactly as prescribed. This includes important information to help ensure that treatment is delivered as safely and effectively as possible.

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Parent and Carer Leaflet

This quick reference guide for parents and caregivers of children with ADHD combines background information on the condition with practical guidance on helping their child to get the very most from treatment with Methylphenidate Hydrochloride 2mg/ml oral solution. This includes step-by-step administration instructions and answers to frequently asked questions.

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HCP Leaflet

This quick reference guide provides key information on Methylphenidate Hydrochloride 2mg/ml oral solution, including prescribing considerations, dosage and administration. The guide also includes useful information to share with parents and caregivers of children receiving this medicine, to help ensure that treatment is delivered as safely and effectively as possible.

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Patient Leaflet

This highly visual resource takes a fun, interactive approach to helping children with ADHD explore their condition and how it affects them. It presents ADHD as being like a really great friend who can help them to do things when they take the medicine that you have prescribed. Specific child-friendly information about Methylphenidate Hydrochloride 2mg/ml oral solution is included to help patients get the very most from treatment.