EXATTENT XL

This medicinal product consists of an immediate release component (30% of the dose) and a modified release component (70% of the dose). Hence it 30 mg yields an immediate-release dose of 9 mg and an extended release dose of 21 mg methylphenidate hydrochloride.

The extended-release portion of each dose is designed to maintain a treatment response through the afternoon without the need for a midday dose. 2 “Pharmacokinetic properties”). For example, 20 mg of this medicinal product is intended to take the place of 10 mg at breakfast and 10 mg at lunchtime of immediate release methylphenidate hydrochloride.

Paediatric population (Children (aged 6 years and over) and adolescents):

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.

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; • Height, weight and appetite should be recorded in children 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. Dose titration Careful dose titration is necessary at the start of treatment with methylphenidate. Dose titration should be started at the lowest possible dose.

This is normally achieved using an immediate release formulation taken in divided doses. , at breakfast and lunch), increasing if necessary, by weekly increments of 5-10 mg in the daily dose according to tolerability and degree of efficacy observed.

Exattent XL 10 mg once daily may be used in place of immediate release methylphenidate hydrochloride 5 mg twice daily from the beginning of treatment where the treating physician considers that once daily dosing is appropriate from the outset and twice daily treatment administration is impracticable.

The maximum daily dose of methylphenidate hydrochloride is 60 mg. For doses not realisable/practicable with this strength, other strengths of this medicinal product and other methylphenidate containing products are available.

Patients currently using methylphenidate:

Patients established on an immediate release methylphenidate hydrochloride formulation may be switched to the milligram equivalent daily dose of this medicinal product. Treatment should not be taken too late in the morning as it may cause disturbances in sleep.

If the effect of the medicinal product wears off too early in the late afternoon or evening, disturbed behaviour and/or inability to go to sleep may recur. A small dose of an immediate-release methylphenidate hydrochloride tablet late in the day may help to solve this problem.

In that case, it could be considered that adequate symptom control might be achieved with a twice daily immediate release methylphenidate regimen. The pros and cons of a small evening dose of immediate-release methylphenidate versus disturbances in falling asleep should be considered.

Treatment should not continue with this medicinal product if an additional late dose of immediate-release methylphenidate 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.

The regimen that achieves satisfactory symptom control with the lowest total daily dose should be employed. This medicinal product should be given in the morning before breakfast. The capsules may be swallowed whole with the aid of liquids, or alternatively, the capsule may be opened, and the capsule contents sprinkled onto a small amount (tablespoon) of apple sauce and given immediately, and not stored for future use.

, water, should follow the intake of the sprinkles with apple sauce. The capsules and the capsule contents must not be crushed or chewed. 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 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 drug 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 drug 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 Exattent XL […]

The table below shows all adverse drug reactions (ADRs) observed during clinical trials and post market spontaneous reports with methylphenidate and those, which have been reported with other methylphenidate hydrochloride formulations.

If ADRs with methylphenidate and the methylphenidate formulation frequencies were different, the highest frequency of both databases was used. 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).

4 'Special Warnings and precautions for use' ** Based on the frequency calculated in adult ADHD studies (no cases were reported in the paediatric studies) † 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.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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.

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. 4 for cardiovascular status, growth, appetite, development of de novo or worsening of preexisting psychiatric disorders. Psychiatric disorders to monitor for are described below, 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 drug 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 drug is either temporarily or permanently discontinued.

Use in adults Exattent XL is not approved for the treatment of adults with ADHD. Safety and efficacy have not been demonstrated in this age group. Use in the elderly Methylphenidate should not be used in the elderly. Safety and efficacy have not been established in this age group.

Use in 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. 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, but the possibility of clinical complications cannot be excluded as a result of the effects observed in the clinical trial data.

Caution is indicated 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. 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 Contraindications). 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.

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 cardiac structural 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. 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 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 Comorbidity of psychiatric […]

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 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.