MEDIKINET MR CAPSULES 30MG [SIN14839P]

Product Info

MEDIKINET MR CAPSULES 30MG

[SIN14839P]

4.1 Therapeutic indications

Attention-Deficit/Hyperactivity Disorder (ADHD)

MEDIKINET MR is indicated as part of a comprehensive treatment programme for attention-deficit/hyperactivity disorder (ADHD) when remedial measures alone prove insufficient. Treatment must be initiated under the supervision of a specialist in behavioural disorders.

Diagnosis should be made considering DSM-IV criteria or the guidelines in ICD-10 and should be based on a complete history and evaluation of the patient. For adults, this includes a structured interview of the patient to determine current symptoms, also comprising scales for self-assessment as well as a retrospective determination of the preexistence of ADHD during childhood, which has to be conducted using validated instruments. Diagnosis cannot be made solely on the presence of one or more symptoms.

The specific aetiology of this syndrome is unknown. There is no single diagnostic test. Adequate diagnosis requires the use of medical, specialised psychological, and (for children and adolescents) educational, as well as social resources.

A comprehensive treatment programme typically includes psychological, social, and (for children and adolescents) educational measures, as well as pharmacotherapy and is aimed at stabilising patients with a behavioural syndrome characterised by symptoms which may include chronic history of short attention span, distractibility, emotional lability, impulsivity, moderate to severe hyperactivity, minor neurological signs, and abnormal EEG. Learning may or may not be impaired.

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 symptoms.

Appropriate psychopathological or (for children and adolescents) educational placement is essential, and psychosocial intervention is generally necessary. Where remedial measures alone prove insufficient, the decision to prescribe a stimulant must be based on rigorous assessment of the severity of the symptoms. The use of methylphenidate should always follow the licensed indication and prescribing/diagnostic guidelines.

4.2 Posology and method of administration

Treatment must be initiated under the supervision of a specialist in behavioural disorders.

Pre-treatment screening:

Prior to a prescription, the cardiovascular status of the patient, including blood pressure and pulse rate, has to be evaluated. A comprehensive anamnesis should comprise concomitant medication, past and present physical and psychiatric comorbidities or symptoms, family history of sudden cardiac/unexplained death and accurate recording of pre-treatment body weight (see sections 4.3 and 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

For children and adolescents, also body height should be documented using a growth chart.

Ongoing monitoring

Body weight, (for children and adolescents also body height) psychiatric and cardiovascular status should be continuously monitored (see also section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• blood pressure and pulse should be recorded on a centile chart at each adjustment of dose and then at least every 6 months;

• body weight and appetite should be recorded at least 6 monthly with maintenance of a 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;

• in children and adolescents, body height should be recorded at least 6 monthly with maintenance of a growth chart

Patients should be monitored for the risk of diversion, misuse and abuse of methylphenidate.

Dose titration

Treatment with methylphenidate requires individual dosing according to the observed degree of efficacy and tolerability, as the individual response may vary broadly. Hence, careful dose titration is necessary at the start of treatment with MEDIKINET MR. Dose titration should be started at a dose as low as possible. The effect occurs within an hour after ingestion if the dose is sufficiently high.

Initiation of treatment with MEDIKINET MR in children and adolescents

This is normally achieved using an immediate-release formulation taken in divided doses. The recommended starting daily dose is 5 mg once daily or twice daily (e.g. at breakfast and lunch), increasing if necessary by weekly increments of 5–10 mg in the daily dose according to tolerability and degree of efficacy observed. MEDIKINET MR 10 mg once daily may be used in place of immediate-release methylphenidate hydrochloride 5 mg twice daily from the beginning of treatment where the treating physician considers that twice daily dosing is appropriate from the outset and twice daily treatment administration is impracticable.

Children and adolescents currently using methylphenidate hydrochloride

Patients established on an immediate-release methylphenidate hydrochloride formulation may be switched to the milligram equivalent daily dose of MEDIKINET MR.

MEDIKINET MR should not be taken too late in the morning as it may cause disturbances in sleep.

However, if the effect of the medicinal product wears off too early in the evening, disturbed behaviour may recur.

A small dose (5 mg) of an immediate-release methylphenidate hydrochloride tablet 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 MEDIKINET MR 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 maximum daily dose of methylphenidate hydrochloride is 60 mg.

Continuation of treatment into adulthood

In adults who had unambiguously profited from treatment with MEDIKINET MR during childhood or adolescence, treatment with MEDIKINET MR may initially be continued at the same daily dose (mg/day). It has to be regularly checked if an adjustment of the dose is necessary or feasible, depending on efficacy and tolerability. Adult patients may require a higher daily dose, as compared to children and adolescents. The maximum daily dose should be based on the body weight of the patient and must not exceed 1 mg/kg body weight. However, the maximum daily dose should not exceed 80 mg, independent of the body weight of the patient, as only limited experience with total daily doses higher than 80 mg are available from clinical studies.

Initiation of treatment with MEDIKINET MR in adults

The recommended starting daily dose is 10 mg. If necessary, the daily dose may be increased by weekly increments of 10 mg according to tolerability and degree of efficacy observed.

The total daily dose should be divided into two administrations, in the morning and at noon. The target of the individual dose titration should be the lowest total daily dose that achieves satisfactory symptom control. The maximum daily dose should be based on body weight of the patient and must not exceed 1 mg/kg body weight. However, the maximum daily dose should not exceed 80 mg, independent of the body weight of the patient, as only limited experience with total daily doses higher than 80 mg are available from clinical studies.

MEDIKINET MR consists of an immediate-release component (50% of the dose) and a modified-release component (50% of the dose). Hence, MEDIKINET MR 10 mg contains an immediate-release dose of 5 mg and an extended-release dose of 5 mg methylphenidate hydrochloride.

Thus, MEDIKINET MR is designed to deliver therapeutic plasma levels for a time period of approximately 8 hours.

Therefore, children and adolescents shall take a single dose of MEDIKINET MR in the morning with or after breakfast in order to obtain a sufficiently prolonged throughout the school day.

Adults shall usually divide their total daily dose of MEDIKINET MR into two equal doses and shall take one dose in the morning and one at lunchtime, each with or after a meal in order to obtain a sufficiently prolonged action throughout the day (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

If other formulations of methylphenidate should be substituted, it should be kept in mind that MEDIKINET MR has to be administered with food. Conditions leading to increased gastric pH have to be avoided. In this case, release may not be adequately sustained.

MEDIKINET MR has to be taken with or after the meal in order to obtain sufficiently prolonged action and to avoid high plasma peaks. Methylphenidate is absorbed much faster from MEDIKINET MR when the medicinal product is taken on an empty stomach. In this case, release may not be adequately sustained. Therefore, MEDIKINET MR should not be administered without food.

The regimen that achieves satisfactory symptom control with the lowest total daily dose should be employed.

For doses not realisable/practicable with this strength, other strengths of this medicinal product and other methylphenidate-containing products are available.

The capsules may be swallowed whole with the aid of liquids, or alternatively, the capsule may be opened and the capsule contents sprinkled onto a small amount (tablespoon) of applesauce or yoghurt and given immediately, and not stored for future use. Drinking some fluids, e.g. water, should follow the intake of the sprinkles with applesauce or yoghurt. In this case food should be eaten as well, of course. The capsules and the capsule contents must not be crushed or chewed.

Long-term (more than 12 months)

The safety and efficacy of long-term use of MEDIKINET MR for more than 6 months has not been systematically evaluated in controlled trials. Methylphenidate treatment should not and needs not to be indefinite. 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 drug 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 and adolescent preferably during times of school holidays). Improvement may be sustained when the drug 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 shall be reduced or discontinued.

Elderly

Methylphenidate should not be used in the elderly. Safety and efficacy has not been established in this age group.

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.

Hepatic impairment

Medikinet has not been studied in patients with hepatic impairment. Caution should be exercised in these patients.

Renal impairment

Medikinet has not been studied in patients with renal impairment. Caution should be exercised in these patients.

4.3 Contraindications

• known sensitivity to methylphenidate or any of the excipients

• anxiety, tension

• agitation

• glaucoma

• phaeochromocytoma

• during treatment with non-selective, irreversible monoamine oxidase (MAO) inhibitors, or within a minimum of 14 days of discontinuing those drugs, due to risk of hypertensive crisis (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

• 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

• diagnosis of pronounced anacidity of the stomach with a pH value above 5.5, in therapy with H₂ receptor blockers or in antacid therapy or proton pump inhibitors

• Diagnosis or family history of Tourette’s syndrome