ATENZA XL

Treatment must be initiated and supervised by a physician specialised in the treatment of ADHD such as an expert paediatrician, a child and adolescent psychiatrist or an adult psychiatrist. Pre-treatment screening In adults new to Atenza XL, and if required by national practice, cardiologist advice is needed prior to treatment initiation in order to check the absence of cardiovascular contraindications.

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 in children should be recorded at least 6 monthly with maintenance of a growth chart; Weight should be recorded for adults 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. Dose titration Careful dose titration is necessary at the start of treatment with methylphenidate. Dose titration should be started at the lowest possible dose.

A 27 mg dosage strength is available for those who wish to prescribe between the 18 mg and 36 mg dosages. Other strengths of this medicinal product and other methylphenidate-containing products may be available. Dosage may be adjusted in 18 mg increments In general, dosage adjustment may proceed at approximately weekly intervals.

The maximum daily dosage of Atenza XL is 54 mg in children. The maximum daily dosage of Atenza XL is 72 mg in adults.

Posology Children Children New to Methylphenidate:

Atenza XL may not be indicated in all children with ADHD syndrome. Lower doses of short-acting methylphenidate formulations may be considered sufficient to treat children new to methylphenidate. Careful dose titration by the physician in charge is required in order to avoid unnecessarily high doses of methylphenidate.

The recommended starting dose of Atenza XL for children who are not currently taking methylphenidate, or for children who are on stimulants other than methylphenidate, is 18 mg once daily.

Adults Adults New to Methylphenidate:

Atenza XL may not be indicated in all adults with ADHD syndrome. Lower doses of short-acting methylphenidate formulations may be considered sufficient to treat adults new to methylphenidate. Careful dose titration by the physician in charge is required in order to avoid unnecessarily high doses of methylphenidate.

The recommended starting dose of Atenza XL for adults who are not currently taking methylphenidate, or for adults who are on stimulants other than methylphenidate, is 18 mg once daily.

Patients Currently Using Methylphenidate:

The recommended dose of Atenza XL for patients who are currently taking methylphenidate three times daily at doses of 15 to 60 mg/day is provided in Table 1. Dosing recommendations are based on current dose regimen and clinical judgement.

TABLE 1 Recommended Dose Conversion from Other methylphenidate Hydrochloride Regimens, where available, to Atenza XL Previous methylphenidate Hydrochloride Daily Dose Recommended Atenza XL Dose 5 mg methylphenidate three times daily 18 mg once daily 10 mg methylphenidate three times daily 36 mg once daily 15 mg methylphenidate three times daily 54 mg once daily 20 mg methylphenidate three times daily 72 mg once daily If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.

Long-term (more than 12 months) use 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. In children and adolescents 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 patient's condition (for children preferable 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 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.

Special populations Elderly Methylphenidate should not be used in the elderly. Safety and efficacy has not been established in this age group. Methylphenidate has not been studied in ADHD in patients older than 65 years. Hepatic impairment Methylphenidate has not been studied in patients with hepatic impairment.

Renal impairment Methylphenidate has not been studied in patients with renal impairment. 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 has not been established.

4). This medicinal product may […]

The table below shows all adverse reactions observed during clinical trials of children, adolescents, and adults and post-market spontaneous reports with methylphenidate and those, which have been reported with other methylphenidate hydrochloride formulations.

If the adverse reactions with Atenza XL 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 the available data).

Adverse ReactionSystem Organ Class Frequency Very common Common Uncommon Rare Very rare Not known Infections and infestations Nasopharyngitis, Upper respiratory tract infection#, Sinusitis# Blood and lymphatic system disorders Anaemia†, Leucopenia†, Thrombo- cytopenia, Thrombo- cytopenic purpura Pancytopenia Immune system disorders Hypersensitivity reactions such as Angioneurotic oedema, Anaphylactic reactions, Auricular swelling, Bullous conditions, Exfoliative conditions, Urticarias, Pruritus, Rashes, and Eruptions Metabolism and nutritional disorders* Anorexia, Decreased appetite†, Moderately reduced weight and height gain during prolonged use in children* Psychiatric disorders* Insomnia, Nervousness Affect lability, Aggression*, Agitation*, Anxiety*†, Depression*#, Irritability, Abnormal behaviour, Mood swings, Tics*, Initial insomnia#, Depressed mood#, Libido decreased#, Tension#, Bruxism ˆ, Panic attack# Psychotic disorders*, Auditory, visual and tactile hallucination*, Anger, Suicidal ideation*, Mood altered, Restlessness†, Tearfulness, Worsening of pre- existing tics of Tourette's syndrome*, Logorrhoea, Hypervigilance, Sleep disorder Mania*†, Disorientatio n, Libido disorder, Confusional state†, Obsessive- compulsive disorder (including trichotilloma nia and dermatilloma nia) Suicidal attempt (including completed suicide)* †, Transient depressed mood*, Abnormal thinking, Apathy† Delusions*†, Thought disturbances*, dependence.

Cases of abuse and dependence have been described, more often with immediate release formulations Nervous system disorders Headache Dizziness, Dyskinesia, Psychomotor hyperactivity, Somnolence, Paresthaesia#, Tension headache# Sedation, Tremor†, Lethargy# Convulsion, Choreo- athetoid movements, Reversible ischaemic neurological deficit, Cerebrovascul ar disorders*†(in cluding vasculitis, cerebral haemorrhages, cerebrovascula Adverse Reaction Frequency System Organ Class Very common Common Uncommon Rare Very rare Not known Neuroleptic malignant syndrome (NMS; Reports were poorly documented and in most cases, patients were also receiving other drugs, so the role of methylphenida te is unclear).

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. † Adverse drug reaction from clinical trials in adult patients that were reported with a higher frequency than in children and adolescents.

^ Based on the frequency calculated in adult ADHD studies (no cases were reported in the paediatric studies) 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 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 patient's symptoms. When treatment of children is considered, assessment of the severity and chronicity of the child's symptoms should be related to the child's age (6-18 years).

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. Methylphenidate treatment should not and need not, be indefinite. In children and adolescents, 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) 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 the elderly Methylphenidate should not be used in the elderly. Safety and efficacy has not been established in this age group. Methylphenidate has not been studied in ADHD in patients older than 65 years. 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 has 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.

Increases in diastolic and systolic blood pressure values were also observed in clinical trial data from adult ADHD patients. The short- and long-term clinical consequences of these cardiovascular effects in children and adolescents are not known.

The possibility of clinical complications cannot be excluded as a result of the effects observed in the clinical trial data especially when treatment during childhood/adolescence is continued into adulthood. 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.

Methylphenidate should be discontinued in patients undertreatment with repeated measures of tachycardia, arrhythmia or increased systolic blood pressure (>95th percentile) and referral to a cardiologist should be considered. 3). Sudden death and pre-existing structural cardiac 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 patients, 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 patients or adolescents with known structural cardiac 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.

Adults Sudden deaths, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses for ADHD. Although the role of stimulants in these adult cases is unknown, adults have a greater likelihood than children of having serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems.

Adults with such abnormalities should also generally not be treated with stimulant drugs. 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 […]

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