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Prescribing Information and Adverse Events reporting can be found at the bottom of the page

Ritalin® XL is indicated as a 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 and in adults.1 Ritalin® XL prolonged-release capsule is for oral administration once daily in the morning.1

Children depicted in this image are above 6 years of age.

Prescribing Information can be found at the bottom of the page

Ritalin® XL: a flexible dosing approach focused on control1

Ritalin® XL offers a flexible treatment option that can be taken with or without food, not compromising the absorption of methylphenidate hydrochloride (MPH), unlike other 8- hour MPH formulations1-4

Plasma concentration-time profile of Ritalin® XL 40 mg following single-dose administration*5

Adapted and modified to combine two separate graphs from Haessler F. et al. 2008.5

Ritalin® XL PROVIDES SUSTAINED SYMPTOM CONTROL OVER ~ 8 HOURS6

Ritalin® XL reaches early peak MPH plasma concentration, with effects lasting for ~8 hours4-6

Average Swanson, Kotkin, Agler, M-Flynn and Pelham (SKAMP)-combined score over time: change from pre-dose rating to 8 hours post-dosing‡7

Adapted and modified to show two single graphs from Lopez F. et al. 2003.7
Please note: time intervals do not increase in regular increments (original axes have been maintained).

Ritalin® XL statistically outperformed placebo over an entire 8-hour analogue classroom day7

Ritalin® XL iS ALSO INDICATED FOR ADULTS1

RITALIN® XL HAS A FAMILIAR ADVERSE EVENT PROFILE AS PER OTHER 8-hour MPH FORMULATIONS1

To find out more, please contact us at
info.marketing@sandoz.com

ADHD=attention-deficit hyperactivity disorder; MPH=methylphenidate hydrochloride

* Data from an open-label, randomised, four-treatment, four-period, crossover study enrolling healthy male volunteers aged 18–30 years old (N=28). The primary objective was to investigate the bioequivalence of Ritalin® LA 40 mg compared to Medikinet® Retard 40 mg, under fasted and fed conditions. The study involved Ritalin® LA (approved under the brand name Ritalin® XL in the UK).5

† The Swanson, Kotkin, Agler, M-Flynn and Pelham (SKAMP) rating scale was designed to measure target classroom manifestations of ADHD. The version of the SKAMP scale used in this study consisted of 13 items.7 The scale generates scores on two subscales – ‘attention’ and ‘deportment’ – and a combined score that reflects both subscales.7

‡ Data from a four-way, randomised, single-blind crossover, analogue classroom study enrolling children aged 6–12 years old with ADHD (N=36). The study involved Ritalin® LA (approved under the brand name Ritalin® XL in the UK). The mean area under the curve [AUC(0–8)] change from pre-dose for Ritalin® XL 20 mg was –3.58 compared with 3.28 for placebo (p < 0.001).7

References

Ritalin XL (methylphenidate hydrochloride) Prescribing Information Please refer to the Summary of Product Characteristics (SmPC) before prescribing. Presentation: Modified-release hard capsules containing 10 milligrams (mg), 20mg, 30mg, 40mg or 60mg of methylphenidate (MPH) hydrochloride. Indication: Indicated as a 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 and in adults. Treatment must be initiated and be under the supervision of a specialist in (childhood) behavioural disorders. Diagnosis should be made according to DSM criteria or the guidelines in ICD 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 symptoms. Dosage and Method of Use: Oral administration once daily in the morning. Capsules may be administered with or without food. They may be swallowed as whole capsules or alternatively may be administered by sprinkling the capsule contents on a small amount of food. Capsules should not be crushed, chewed or divided. Prior to prescribing, pre-treatment cardiovascular screening is necessary and a comprehensive history should be documented. Growth, psychiatric and cardiovascular status should be continuously monitored. Careful dose titration is necessary at the start of treatment with MPH. Dose titration in children should be started at the lowest possible dose. Dose titration in adults can be started at 20mg. The maximum daily dose is 60mg for treatment of ADHD in children, and 80mg for treatment of ADHD in adults. If symptoms do not improve after dose titration over a period of one month, the drug should be discontinued. If symptoms worsen or other adverse effects occur, the dosage should be reduced or, if necessary, the drug discontinued. The regimen that achieves satisfactory symptom control with the lowest total daily dose should be employed. Ritalin XL capsules should not be taken too late in the morning as it may cause disturbances in sleep. If the effect of the drug wears off too early in the evening, a small evening dose of the standard Ritalin tablet may help to solve the problem. Ritalin XL should be discontinued periodically to assess the patient’s condition. Improvement may continue when the drug is temporarily or permanently discontinued. Treatment may be restarted as appropriate to control the symptoms of ADHD. In children with ADHD, treatment can usually be discontinued during or after puberty. The recommended dose of Ritalin XL should be equal to the total daily dose of Ritalin immediate–release formulation. Contraindications: Known sensitivity to MPH or to any of the excipients in Ritalin XL. Glaucoma. Phaechromocytoma. During treatment with non-selective, irreversible 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. Warnings and Precautions: MPH 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 the chronicity of the child’s symptoms in relation to the child’s age. MPH treatment should not and need not be indefinite. MPH 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 for cardiovascular status, growth, appetite, development of de novo or worsening of pre-existing psychiatric disorders. MPH should not be used in children under 6 years of age and the elderly. MPH is contraindicated in certain pre-existing cardiovascular disorders unless specialist cardiac advice has been obtained. 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. Cerebral vasculitis appears to be very rare idiosyncratic reaction to MPH exposure. MPH is not contraindicated in patients with hemiplegic cerebral palsy. In the case of emergent psychiatric symptoms or exacerbation of pre-existing psychiatric disorders, MPH should not be given unless the benefits outweigh the risks to the patient. In psychotic patients, administration of MPH may exacerbate symptoms of behavioural disturbance and thought disorder. Treatment-emergent psychotic symptoms or mania can be caused by MPH at usual doses. The emergence or worsening of aggression or hostility can be caused by treatment with stimulants. Patients with emergent suicidal ideation or behaviour during treatment for ADHD should be evaluated immediately. MPH is associated with the onset or exacerbation of motor and verbal tics. MPH is associated with worsening of pre-existing anxiety, agitation or tension. Particular care should be taken when using MPH in ADHD patients with comorbid bipolar disorder because of concerns for possible precipitation of a mixed/manic episode. Prolonged and painful erections have been reported in association with MPH products. MPH should be discontinued if seizure frequency increases or new-onset seizures occur. Patients should be carefully monitored for the risk of diversion, misuse and abuse of MPH. Chronic abuse of MPH can lead to marked tolerance and psychological dependence with varying degrees of abnormal behaviour. 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. Patients with rare hereditary problems of galactose/sucrose intolerance should not take the medicine. MPH should not be used for the prevention or treatment of normal fatigue states. Caution should be exercised in patients with hepatic or renal impairment. In the event of leucopenia, thrombocytopenia, anaemia or other alterations, discontinuation of treatment should be considered. MPH may induce a false positive laboratory test for amphetamines. Interactions: Caution is recommended at combining MPH with other drugs, especially those with narrow therapeutic window. MPH is not metabolised by cytochrome P450 to a clinically relevant extent. MPH may inhibit the metabolism of coumarin anticoaugulants, anticonvulsants and some antidepressants, and so it may be necessary to adjust the dosage of these drugs and establish drug plasma concentrations when taken with MPH. MPH may decrease the effectiveness of drugs used to treat hypertension and caution is advised when taken with other drugs that can also elevate blood pressure. Patients should abstain from alcohol during treatment. MPH treatment should not be used on the day of surgery due to risk of sudden blood pressure increase. Caution is recommended when administering MPH with dopaminergic drugs, including antipsychotics. Pregnancy, Lactation and Fertility: Pregnancy: MPH is not recommended for use during pregnancy unless a clinical decision is made that postponing treatment may pose a greater risk to the pregnancy. Lactation: MPH has been found in breast-milk of women treated. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from MPH therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman. Fertility: No human data are available. Effects on Ability to Drive and Use Machines: Ritalin XL may cause dizziness, drowsiness and visual disturbances. 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. Adverse Reactions: Very common (≥1/10): decreased appetite, insomnia, nervousness, headache, nausea, dry mouth. Common (≥ 1/100 to &lt; 1/10): nasopharyngitis, anorexia, moderately reduced weight and height gain during prolonged use in children, affect lability, aggression, agitation, anxiety, depression, irritability, abnormal behaviour, restlessness, sleep disorder, libido decreased, panic attack, stress, bruxism, tremor, dizziness, dyskinesia, psychomotor hyperactivity, somnolence, arrhythmia, tachycardia palpitations, hypertension, peripheral coldness, cough, pharyngolaryngeal pain, dyspnoea, abdominal pain, diarrhoea, stomach discomfort and vomiting, dyspepsia, toothache, hyperhidrosis, alopecia, pruritus, rash, urticaria, arthralgia, pyrexia, growth retardation during prolonged use in children, feeling jittery, fatigue, thirst, changes in blood pressure and heart rate (usually an increase), weight decreased. Serious: sudden death, serious cardiac disorders, serious renal or hepatic disorders. Prescribers should consult the SmPC in relation to other adverse reactions. Legal Category: POM (Prescription Only Medicine).
Basic NHS List Price (per 30 capsules): Ritalin XL 10 mg: £23.92, Ritalin XL 20 mg: £28.72, Ritalin XL 30 mg: £33.49, Ritalin XL 40 mg: £57.43, Ritalin XL 60 mg: £66.98
Marketing Authorisation (MA) Number: Ritalin XL 10 mg: PL 00101/0973, Ritalin XL 20 mg: PL 00101/0974, Ritalin XL 30 mg: PL 00101/0975, Ritalin XL 40 mg: PL 00101/0976, Ritalin XL 60 mg: PL 00101/0977
MA Holder: Novartis Pharmaceuticals UK Limited, 2nd floor, The Westworks, White City Place, 195 Wood Lane, London, W12 7FQ, UK.
Local Representative: Sandoz Limited, Park View, Riverside Way, Watchmoor Park, Camberley, Surrey, GU15 3YL, UK.
Last Date of Revision: February 2020.
Approval Code: UK/MKT/RXL/20-0003

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Sandoz Limited on uk.patientsafety@novartis.com