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RITALIN XL is a brand name for Methylphenidate. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Attention-deficit hyperactivity disorder (ADHD) Ritalin XL is indicated as a part of a comprehensive treatment programme for attention-deficit hyperactivity disorder (ADHD) in children and adolescents aged 6 years and over and in adults when remedial measures alone prove insufficient. Treatment must be initiated and…
Verbatim from this product's MHRA label. Tap a section to expand.
Treatment must be initiated and supervised by a doctor specialised in the treatment of ADHD such as an expert paediatrician, a child and adolescent psychiatrist or a psychiatrist. Formulation The specific galenics of Ritalin XL imitates the twice-daily administration of an immediate-release methylphenidate formulation.
2). 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. 4). 4). • Blood pressure and pulse should be recorded on a centile chart at each adjustment of dose and then at least every 6 months; • In children height, weight, and appetite should be recorded at least 6 monthly with maintenance of a growth chart; • In adults, weight should be recorded regularly; • 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. Dose titration should be started at the lowest dose deemed appropriate for the individual patient, with small increments at weekly intervals until a tolerable and sufficiently effective dose is reached (see further details below in the respective sub- sections for children and adolescents and adults).
The dose should be determined according to the patient’s age and severity of the symptoms, the clinical assessment and the patient's response and should be individualised according to the patient’s needs. The regimen that achieves satisfactory symptom control with the lowest total daily dose should be employed.
The effect occurs within an hour after ingestion if the dose is sufficiently high. Ritalin XL capsules should not be taken too late in the day in order to prevent sleep disturbances. In the treatment of ADHD, an attempt should be made to time administration to coincide with the periods of greatest academic/professional, behavioural, or social stress.
Other strengths of this medicinal product and other methylphenidate containing products may be available. Paediatric population Children and adolescents (6 years of age and over) Ritalin XL capsules are for oral administration once daily in the morning.
The list below shows all adverse drug reactions (ADRs) observed during clinical trials and post market spontaneous reports with Ritalin XL and those, which have been reported with other methylphenidate hydrochloride formulations. If ADRs with Ritalin XL and the methylphenidate formulation frequencies were different, the highest frequency of both databases was used.
The list applies to children, adolescents, and adults. 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 available data).
Infections and infestations Common: nasopharyngitis Uncommon: gastroenteritis3 Blood and lymphatic system disorders1 Very rare: anaemia, leucopenia, thrombocytopenia, thrombocytopenic purpura Not known: pancytopenia Immune system disorders Uncommon: hypersensitivity reactions such as angioneurotic oedema, anaphylactic reactions, auricular swelling, bullous conditions, exfoliative conditions, urticaria, pruritus, rashes, and eruptions Metabolism and nutrition disorders1 Very common: decreased appetite2 Common: anorexia, moderately reduced weight and height gain during prolonged use in children1, weight loss in adults1 Psychiatric disorders1 Very common: insomnia, nervousness Common: anorexia, affect lability, aggression1, agitation1, anxiety1, depression1, irritability, abnormal behaviour, restlessness2, sleep disorder2, libido decreased3, panic attack3, stress3, bruxism3 Uncommon: psychotic disorders1, auditory, visual, and tactile hallucinations1, anger, suicidal ideation1, mood altered, mood swings, tearfulness, tics1, worsening of pre-existing tics or Tourette’s syndrome1, hypervigilance, tension3 Rare: mania1, disorientation, libido disorder, obsessive-compulsive disorder (including trichotillomania and dermatillomania) Very rare: suicidal attempt (including completed suicide)1, transient depressed mood1, abnormal thinking, apathy Not known: delusions1, thought disturbances1, confusional state, dependence, logorrhoea.
Methylphenidate treatment is not indicated in all patients with ADHD and the decision to use the drug must be based on a very thorough assessment of the severity and chronicity of the symptoms (in children in relation to the child’s age).
4 for cardiovascular status, growth, appetite, development of de novo or worsening of pre-existing psychiatric disorders. 2). 2). 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.
Changes in diastolic and systolic blood pressure values were also observed in clinical trial data from adult ADHD patients. However, these changes were smaller compared to children and adolescents (around 2-3 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 advised in treating patients whose underlying medical conditions might be compromised by increases in blood pressure or heart rate. 3 for conditions in which methylphenidate treatment is contraindicated. 1 under subheading “Clinical studies in adults”.
Cardiovascular status should be carefully monitored. Blood pressure and pulse should be recorded on centile chart at each adjustment of dose and then at least every 6 months. 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.
1. 5) • 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, such as cerebral aneurysm, vascular abnormalities including vasculitis or stroke
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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, half a Ritalin 10 mg tablet, in the morning and at lunchtime). The dose may be increased, if necessary, by weekly increments of 5-10 mg in the daily dose. Alternatively, when the treating physician considers that 10 mg is the appropriate daily starting dose, Ritalin XL 10 mg capsules once daily can be used from the beginning of treatment in place of immediate-release methylphenidate 5 mg twice daily.
When, in the judgment of the clinician, a higher initial dose is appropriate, the patient may begin treatment with Ritalin XL 20 mg capsules. The maximum daily dose of methylphenidate in children and adolescents is 60 mg. If the effect of the drug wears off too early in the evening, disturbed behaviour and/or inability to go to sleep may recur.
A small evening dose of an immediate-release (short-acting) methylphenidate tablet (5 mg) may help to solve this problem. The pros and cons of a small evening dose of a short-acting methylphenidate tablet versus disturbances in falling asleep should be considered.
If additional dosing is necessary, it could be considered that adequate symptom control might be achieved with a twice daily immediate-release methylphenidate regimen. Treatment should not continue with Ritalin XL capsules if an additional late dose of a short-acting methylphenidate tablet is required, unless it is known that the same extra dose was also required for a conventional immediate-release regimen at equivalent breakfast/lunchtime dose.
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 have not been established. Adults Ritalin XL is for oral administration once daily usually in the morning.
The time of intake may be adapted according to the patient’s individual needs. The maximum daily dose of methylphenidate in adults is 80 mg. 1): The recommended starting dose of Ritalin XL in patients who are not currently taking methylphenidate is 20 mg once daily.
, in patients weighing less than 70 kg). The dose may be adjusted gradually at weekly intervals by a maximum of 20 mg per day. Ritalin XL 10 mg is available for smaller dosage increments.
Adult patients transitioning from childhood Ritalin treatment to adulthood:
Treatment may be continued with the same daily dose. If the patient was previously treated with an immediate-release formulation, a conversion to an appropriate recommended dose of Ritalin XL should be made (see below subsection “Switching […]
Cases of abuse and dependence have been described, more often with immediate release formulations Nervous system disorders Very common: headache Common: tremor2, dizziness, dyskinesia, psychomotor hyperactivity, somnolence Uncommon: sedation, akathisia3 Very rare: convulsions, choreo-athetoid 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).
4 “Special warnings and precautions for use” 2 ADRs from clinical trials in adult patients that were reported with a higher frequency than in children and adolescents 3 Based on the frequency calculated in adult ADHD studies (no cases were reported in the paediatric studies) 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 Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
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3).
Misuse and cardiovascular events:
Misuse of stimulants of the central nervous system, including methylphenidate, may be associated with sudden death and other serious cardiovascular adverse events. 3 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.
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 products. 2). 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 […]