MEDIKINET MR CAPSULES 30MG

CAPSULE, DELAYED RELEASE PELLETS

**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. _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 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.