Concerta® - leaflet, price, method of use and contraindications of the medicine

Concerta®: composition and pharmaceutical form

Concerta® comes as prolonged-release tablets containing 18 mg, 36 mg or 54 mg of methylphenidate.

The prolonged-release form also dictates the rules of use: the tablet is swallowed whole with liquid and must not be chewed, split or crushed — otherwise the whole daily dose would be released at once. The medicine is taken once a day in the morning, with or without food.

Indications

Concerta® is indicated in children from 6 years as part of a comprehensive treatment programme for attention deficit hyperactivity disorder, when other approaches have proved insufficiently effective. Treatment is led by a doctor experienced in behavioural disorders in children.

The diagnosis must meet the current DSM criteria or the ICD recommendations and rest on a detailed history and thorough examination, not on one or several symptoms. There is no single test that confirms the diagnosis, so medical, psychological, educational and social criteria are all used. A full support programme includes psychological, educational and social measures alongside drug therapy; the medicine is not indicated for every child with this diagnosis, and the decision is taken after assessing the severity and persistence of the symptoms with the child's age in mind.

Method of use and dosage

Before treatment starts a cardiovascular assessment is mandatory: blood pressure and heart rate are measured. The records note the medicines being taken, past and current physical and mental disorders, cases of sudden cardiac or unexplained death in the family, and baseline height and weight.

Situation	Dose
Patients who have not taken methylphenidate before or who take other stimulants	18 mg once a day
Switching from methylphenidate 5 mg three times a day	18 mg once a day
Switching from methylphenidate 10 mg three times a day	36 mg once a day
Switching from methylphenidate 15 mg three times a day	54 mg once a day
Increasing the dose	in steps of 18 mg, roughly once a week; a maximum of 54 mg a day
No improvement after a month on the chosen dose	the medicine is withdrawn

During treatment, development, mental state and the cardiovascular system are monitored continuously: blood pressure and pulse are plotted on a centile chart after every dose change and thereafter at least once every 6 months, and height, weight and appetite at least once every six months. The appearance of new mental disturbances or the worsening of previous ones is checked at every dose change, every 6 months and at every visit. Separately, it is watched whether the patient only pretends to take the medicine and whether there is abuse.

Contraindications

The list is broad and falls into three parts: psychiatric, cardiovascular and endocrine.

• hypersensitivity to methylphenidate or to any excipient;
• glaucoma, phaeochromocytoma, hyperthyroidism or thyrotoxicosis;
• use of non-selective irreversible MAO inhibitors now or in the preceding 14 days — risk of hypertensive crisis;
• severe depression, anorexia, suicidal tendencies, psychotic symptoms, severe mood disorders, mania, schizophrenia, psychopathic disorders or borderline personality disorder, current or past;
• severe or episodic bipolar I disorder without good control;
• severe arterial hypertension, heart failure, ischaemic heart disease, obliterative arterial disease, cardiomyopathy, previous myocardial infarction;
• congenital haemodynamic disorders, potentially life-threatening arrhythmias, channelopathies;
• cerebral vascular disease, aneurysm, vascular anomalies, vasculitis or stroke in the history.

Special warnings and precautions

Methylphenidate is not suitable for every child with this diagnosis, and in treatment lasting more than 12 months monitoring becomes a mandatory part of therapy: the state of the heart and vessels, height, weight and appetite are watched, as is the appearance or worsening of mental disturbances — tics, aggression and hostility, agitation, restlessness, depression, psychosis, mania, delusions, irritability, withdrawal.

Heart and vessels

Before prescribing, a detailed history is taken, including family cases of sudden death and ventricular arrhythmias, and a physical examination is carried out with measurement of blood pressure and pulse; where heart disease is suspected the patient is referred to a cardiologist. The appearance of palpitations, chest pain on exertion, unexplained fainting or breathlessness calls for immediate cardiological assessment. Cases of sudden death on stimulants at usual doses have been described in children, some of whom had structural cardiac anomalies or serious heart disease, so stimulants are not recommended in children with known defects, cardiomyopathy and severe rhythm disorders. Caution is also needed in those for whom a rise in blood pressure or pulse would be dangerous.

Nervous system and psychiatric aspects

• with new neurological symptoms — severe headache, numbness, weakness, paralysis, disturbance of coordination, vision, speech or memory — cerebral vasculitis should be borne in mind: recognising it early allows the medicine to be withdrawn at once;
• the medicine is contraindicated in hemiparesis;
• if new mental symptoms appear or previous ones worsen, treatment continues only if the benefit outweighs the risk;
• mental state is assessed at every dose adjustment, then every 6 months and at every follow-up visit;
• in patients with heart and vascular disease who also take medicines that raise blood pressure, a neurological assessment is carried out at every visit;
• during treatment alcohol should be avoided;
• on the day of planned surgery the medicine is withdrawn: with halogenated anaesthetics a sharp rise in blood pressure is possible;
• in long-term therapy signs of abuse and of developing dependence are tracked.

Drug interactions

Methylphenidate is not metabolised by the cytochrome P450 system, but there are reports that it can inhibit the metabolism of coumarin anticoagulants, of anticonvulsants — phenobarbital, phenytoin, primidone — and of some antidepressants: tricyclics and selective serotonin reuptake inhibitors. At the start and on stopping therapy the doses of those medicines may need adjusting with monitoring of their plasma concentrations and, for coumarins, of clotting parameters. With medicines of narrow therapeutic range caution is required.

Methylphenidate may reduce the efficacy of antihypertensives and, conversely, calls for caution when combined with any medicines that raise blood pressure. It is contraindicated with non-selective irreversible MAO inhibitors now or in the preceding 2 weeks because of the risk of hypertensive crisis. Alcohol intensifies the undesirable effects of psychoactive agents. With halogenated anaesthetics a sharp rise in blood pressure during surgery is possible. The safety of combination with clonidine and other centrally acting agonists has not been studied — serious adverse events, including sudden death, have been reported. Dopamine agonists, including levodopa and tricyclic antidepressants, and its antagonists, including antipsychotics, also call for caution.

Pregnancy and breastfeeding

During pregnancy the medicine is not recommended. Spontaneous reports have been received of signs of cardiopulmonary toxicity in newborns, above all foetal tachycardia and respiratory distress syndrome. An exception is possible only if, on clinical assessment, stopping therapy would pose a greater threat to the pregnancy than continuing it.

Methylphenidate is excreted in breast milk; one case of unexplained weight loss in a child during exposure to the medicine has been described. The decision whether to stop breastfeeding or treatment is taken by weighing the benefit of breastfeeding for the child against the benefit of therapy for the mother.

Adverse effects

Very often the medicine causes insomnia, nervousness and headache — these three reactions occur in most patients and usually determine how well treatment is tolerated.

• common in the psychic sphere: emotional lability, aggression, agitation, anxiety, depression and low mood, irritability, atypical behaviour, mood swings, tics, tension, bruxism, panic attacks, reduced libido;
• common in the nervous system: dizziness, dyskinesias, psychomotor hyperactivity, drowsiness, paraesthesia, tension headache, disturbance of accommodation;
• common in the heart and vessels: arrhythmias, tachycardia, palpitations, arterial hypertension, changes in blood pressure and pulse;
• common, other: anorexia and reduced appetite, moderate slowing of weight gain and growth with prolonged use in children, upper respiratory tract infections and sinusitis, abdominal pain, nausea, vomiting, diarrhoea, dry mouth, rash, itching, urticaria, hair loss, muscle spasms, joint pain, erectile dysfunction, fatigue, increased ALT activity;
• uncommon: hypersensitivity reactions up to angioedema and anaphylaxis, auditory, visual and tactile hallucinations, suicidal thoughts, anger, tearfulness, worsening of tics in Tourette's syndrome, tremor, lethargy, blurred vision, chest pain, breathlessness, constipation, increased liver enzyme activity;
• rare: disorientation, mania, confusion, double vision, angina pectoris, gynaecomastia;
• very rare: suicide attempts, including completed ones, seizures, choreoathetoid movements, reversible ischaemic neurological disturbances, neuroleptic malignant syndrome, cardiac arrest, myocardial infarction, sudden cardiac death, impaired liver function up to hepatic coma, erythema multiforme, exfoliative dermatitis;
• frequency not known: delusions, thought disorders, dependence and abuse (described more often for immediate-release forms), cerebrovascular disturbances including vasculitis and haemorrhage, generalised convulsive seizures, migraine, supraventricular tachycardia, bradycardia, extrasystoles, very high fever.

Slowing of growth and weight gain with prolonged use is not rare, which is why these parameters are entered on the development chart every six months: a fall in the rate of growth may be grounds for reviewing the treatment plan.

How to get a prescription for Concerta® online

Concerta® is a prescription-only medicine and belongs to the strictly controlled group: it is prescribed by a specialist in behavioural disorders in children and adolescents, and a cardiovascular assessment is needed before starting. During the online consultation the doctor will go through the diagnosis, the medical history and the medicines being taken.

If the medicine is indicated, the doctor will issue an electronic prescription, set the dose and the size of each increase and explain which parameters to monitor during treatment and with which symptoms to contact a doctor immediately.