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FOCUSIM 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) Methylphenidate is indicated as part of a comprehensive treatment programme for attention-deficit/hyperactivity disorder (ADHD) in children aged 6 years of age and over and adults when remedial measures alone prove insufficient. Treatment must be initiated and supervised…
Verbatim from this product's MHRA label. Tap a section to expand.
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 a psychiatrist. 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 (children), 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.
Posology The specific galenics of Focusim XL simulate twice daily administration of an immediate-release methylphenidate formulation. About 50% of the total amount of the active substance is available in unretarded, immediate-release form, while the remaining 50% are released after approximately 4 hours.
Dose titration Careful dose titration is necessary at the start of treatment with methylphenidate. Dose titration should be started at the lowest possible dose If symptoms do not improve after dose titration over a period of one month, the medicinal product should be discontinued.
If symptoms worsen or other adverse effects occur, the dose should be reduced or, if necessary, the medicinal product discontinued. The regimen that achieves satisfactory symptom control with the lowest total daily dose should be employed.
Long-acting methylphenidate should not be taken too late in the morning as it may cause disturbances in sleep. For the treatment of hyperkinetic disorders/ADHD the time of methylphenidate intake should be chosen in such a way that the effect concurs with the time of the largest school (in children) and social problems as well as behavioural abnormalities of the patient.
Other strengths of this medicinal product and other methylphenidate-containing products may be available. Children (6 years and over) Focusim XL is taken once daily in the morning. The recommended starting dose is 20 mg. When in the judgment of the clinician a lower initial dose is appropriate, the patient may begin treatment with 10 mg, alternatively it is recommended to start with conventional short-acting methylphenidate 10 mg and continuously increase according to the recommendation for this formulation..
The table below shows all adverse drug reactions (ADRs) observed during clinical trials and post-market spontaneous reports with methylphenidate. If the ADRs with Focusim XL and the other methylphenidate formulations frequencies were different, the highest frequency of both databases was used.
The table is based on data collected in children, adolescents and adults. 4. ** ADRs from clinical trials in adult patients that were reported with a higher frequency than in children and adolescents. *** ADRs from clinical trials in adult patients that were not reported in 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.
Focusim 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 symptoms (for children in relation to the 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. The long term safety of methylphenidate has not been systematically evaluated in controlled clinical trials in adults.
Methylphenidate treatment should not and need not, be indefinite. In children and adolescents with ADHD 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 the elderly Focusim XL must not be used in elderly patients. Safety and efficacy of Focusim XL has not been evaluated in ADHD in patients older than 60 years. Use in children under 6 years of age Focusim XL should not be used in children under the age of 6 years.
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 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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The maximum daily dose of methylphenidate is 60 mg. 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.
Adults Focusim XL is taken once daily usually in the morning. The time of the intake may be adapted according to the patient’s individual needs, but intake should not be too late in the morning in order to prevent sleep disturbances.
The dose should be titrated individually. The regimen that achieves satisfactory symptom control with the lowest total daily dose should be employed. Only the modified-release formulation of methylphenidate should be used for the treatment of ADHD in adults.
A maximum daily dose of 80 mg should not be exceeded. 1) The recommended starting dose of Focusim XL in patients who are not currently taking methylphenidate is 20 mg once daily. Focusim XL dose may be adjusted at weekly intervals in 20 mg increments for adults.
For lower doses or smaller increments, other strengths of Focusim XL or other methylphenidate-containing medicinal products are available. Patients transitioning from childhood methylphenidate 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 Focusim XL should be made (see below “Switching patient’s treatment to Focusim XL”). Periodic assessment of the treatment in ADHD Focusim XL should be discontinued periodically to assess the patient’s condition.
Improvement may continue when the medicinal product is temporarily or permanently discontinued. Treatment may be restarted as appropriate to control the symptoms of ADHD. Medicinal product treatment should not, and need not, be indefinite.
When used in children with ADHD, treatment can usually be discontinued during or after puberty. Special populations Elderly Focusim XL should not be used in the elderly. Safety and efficacy has not been established in ADHD patients older than 60 years.
Hepatic impairment Focusim XL has not been studied in patients with hepatic impairment. Caution should be exercised in these patients. Renal impairment Focusim […]
Safety and efficacy of methylphenidate 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.
Changes in diastolic and systolic blood pressure values were also observed in clinical trial data from adults 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 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. 1 under subheading “ADHD in adults”.
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 […]