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MEFLYNATE 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; - Weight should be recorded in 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.
Adult titration may be initiated with 20 mg. Other strengths of this medicinal product and other methylphenidate- containing products may be available. The specific galenics of Meflynate 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. 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.
Meflynate XL should not be taken too late in the morning as it may cause disturbances in sleep. The dose should be titrated individually, in accordance with the clinical needs and patient’s responses. For the treatment of 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.
The table below shows all adverse drug reactions (ADRs) observed during clinical trials and post-market spontaneous reports with Meflynate XL and those, which have been reported with other methylphenidate hydrochloride formulations.
If the ADRs with Meflynate 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.
Frequencies:
Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000) Not known (cannot be estimated from the available data) Undesirable effects Frequency System Organ Class Very common Common Uncommon Rare Very rare Not known Infections and infestations Nasophar yngitis Gastroenter itis Blood and lymphatic system disorders Anaemia, leukopenia, thrombocyt openia, thrombocyt openic purpura Pancytopen ia Immune system disorders Hypersensit ivity reactions such as angioneurot ic oedema, anaphylacti c reactions, auricular swelling, bullous conditions, exfoliative conditions, urticaria, pruritus (1), rashes, and eruptions (1) Metabolism and nutrition disorders (1) Decreased appetite (2) Anorexia, moderatel y reduced weight and height gain during prolonged Undesirable effects Frequency System Organ Class Very common Common Uncommon Rare Very rare Not known use in children (1), weight decrease in adults (2) Psychiatric disorders (1) Insomnia, nervousnes s Affect lability, aggressio n (1), agitation (1), anxiety (1), depressio n (1), irritability , abnormal behaviour , restlessne ss (2), sleep disorder (2), libido decreased (3), panic attack (3), stress (3), bruxism (3) Psychotic disorders (1), auditory, visual, and tactile hallucinatio ns (1), anger, suicidal ideation (1), mood altered, mood swings, tearfulness, tics (1), worsening of pre- existing tics or Tourette’s syndrome (1), hypervigila nce, tension (3) Mania (1), disorienta tion, libido disorder, obsessive- compulsiv e disorder (including trichotillo mania and dermatillo mania) Suicidal attempt (including completed suicide) (1), transient depressed mood (1), abnormal thinking, apathy Delusions (1), thought disturbance s (1), confusional state, dependence , logorrhoea.
) Long-term use (more than 12 months) in children, adolescents and adults 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, and 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 drug is either temporarily or permanently discontinued.
Use in the elderly Methylphenidate must not be used in the elderly. Safety and efficacy of Meflynate XL has not been evaluated in ADHD in patients older than 60 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 stimulants 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.
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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Children (6 years and over) Meflynate XL should be taken once daily in the morning. The recommended starting dose of Meflynate XL is 20 mg. When in the judgment of the clinician a lower initial dose is appropriate, the patient should 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 maximum daily dosage of methylphenidate is 60 mg. If the effect of the medicinal product wears off too early in the late afternoon, disturbed behaviour and/or inability to go to sleep may recur. A small dose of an 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 breakfast/lunchtime. Adults Meflynate XL should be 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. Dose titration in adults can be started at 20 mg.
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 Meflynate XL in patients who are not currently taking methylphenidate is 20 mg once daily.
Meflynate XL dose may be adjusted at weekly intervals in 20 mg increments for adults. For lower doses or smaller increments, other strengths of Meflynate 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 Meflynate XL should be made (see below “Switching patient’s treatment to Meflynate XL”). Periodic assessment of the treatment in ADHD Meflynate 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. Switching patient’s treatment to Meflynate XL Meflynate XL, administered as a single dose, provides comparable overall exposure (AUC) of methylphenidate compared to the same total dose of immediate-release methylphenidate administered […]
4. (2) ADR from clinical trials in adult patients that were reported with a higher frequency than in children and adolescents. (3) Based on the frequency calculated in adult ADHD studies (no cases were reported in the paediatric studies.
(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. 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 […]
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, stimulants 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.
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 […]