ADDEPTA XL

Posology Addepta XL consists of an immediate release component (30% of the dose) and a modified release component (70% of the dose). Hence Addepta XL 10 mg yields an immediate-release dose of 3 mg and an extended release dose of 7 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). For example, 20 mg of Addepta XL 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 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 usually accomplished by using an immediate-release formulation divided into multiple doses. The recommended initial dose is 5 mg once or twice daily (for example for breakfast and lunch). If necessary, the daily dose may be increased weekly in increments of 5 - 10 mg, depending on the tolerability and the observed degree of effectiveness.

Instead of twice daily administration of an immediate release methylphenidate hydrochloride 5 mg formulation, Addepta XL 10 mg may be used from the beginning of treatment if the treating physician determines that twice daily dosing is appropriate at baseline but twice daily dosing is not feasible.

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 Addepta XL.

Addepta XL should be given in the morning before breakfast. Addepta XL 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 immediate-release methylphenidate 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 long-acting methylphenidate 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. Long-term (more than 12 months) use in children (>6 years of age) and adolescents (<18 years of age) The safety and efficacy of long-term use of methylphenidate has not been systematically evaluated in controlled trials in children and adolescents.

Methylphenidate treatment should not and need not, be indefinite. ADHD methylphenidate treatment is usually discontinued during or after puberty. The physician who elects to use methylphenidate for extended periods (over 12 months) in patients with ADHD should periodically re-evaluate the long-term usefulness of the medicinal product 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 medicinal product is either temporarily or permanently discontinued.

Dose reduction and discontinuation Treatment must be stopped if the symptoms do not improve after appropriate dose adjustment over a one-month period. If paradoxical aggravation of symptoms or other serious adverse events occur, the dose should be reduced or discontinued.

Adults Addepta XL is not approved for the treatment of adults with ADHD. Safety and efficacy have not been demonstrated in this age group. Special populations Elderly Addepta XL should not be used in the elderly. Safety and efficacy in this age group has not been established.

Children under 6 years of age Addepta XL should not be used in children under the age of 6 years. Safety and efficacy in this […]

The table below shows all adverse drug reactions (ADRs) observed during clinical trials and post-market spontaneous reports with methylphenidate. If the ADRs with (Invented name) and the other methylphenidate formulations frequencies were different, the highest frequency of both databases was used.

4. 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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme.

uk/yellowcard or search for MHRA Yellow Card in the Google Play and Apple App store.

Addepta XL treatment is not indicated in all patients with ADHD and the decision to use the medicinal product 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) The safety and efficacy of long-term use of methylphenidate has not been systematically evaluated in controlled trials in children and adolescents. Methylphenidate treatment should not and need not, be indefinite.

Methylphenidate treatment is usually discontinued during or after puberty. e. 4 for cardiovascular status, growth (children), weight, appetite, development of de novo or worsening of pre-existing 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 patients with ADHD should periodically re-evaluate the long-term usefulness of the medicinal product 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 patient’s condition (for children preferably during times of school holidays). Improvement may be sustained when the medicinal product is either temporarily or permanently discontinued.

Use in adults Addepta XL is not licensed for the treatment of adults with ADHD. Safety and efficacy of Addepta XL has not been demonstrated in this age group. Use in the elderly Addepta XL must not be used in elderly patients. Safety and efficacy have not been established in this age group.

Use in children under 6 years of age Addepta XL should not be used in children under the age of 6 years. Safety and efficacy of methylphenidate 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 a 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 cardiac structural 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 patients 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 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 ischaemia 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 […]

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 pectoris, 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.