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.
Christopher, 9 years old
The above illustration has been created to depict choice.
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.
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
Growth, psychiatric and cardiovascular status should be continuously monitored in children receiving methylphenidate:1
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
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.
Contraindications of methylphenidate are:1
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 infestations | Nasopharyngitis |
Metabolism and nutritional disorders | Anorexia, decreased appetite, moderately reduced weight and height gain during prolonged use in children |
Psychiatric disorders | Anorexia, affect lability, aggression, agitation, anxiety, depression, irritability, abnormal behaviour, bruxism |
Nervous system disorders | Dizziness, dyskinesia, psychomotor hyperactivity, somnolence |
Cardiac disorders | Arrhythmia, tachycardia palpitations |
Vascular disorders | Hypertension |
Respiratory, thoracic and mediastinal disorders | Cough, pharyngolaryngeal pain |
Gastro-intestinal disorders | Abdominal 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 disorders | Alopecia, pruritis, rash, urticaria |
Musculoskeletal, connective tissue and bone disorders | Arthralgia |
General disorders and administration site conditions | Pyrexia, growth retardation during prolonged use in children |
Investigations | Changes in blood pressure and heart rate (usually an increase), weight decreased |
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.
A short animation giving step-by-step instructions on administering methylphenidate oral solution.
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.
A quick reference guide to ADHD and its treatment with methylphenidate oral solution.
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.
A fun, interactive way to help children with ADHD find out more about their condition and its treatment.
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.
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.
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.
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.
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.
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.