Prescribing Information

NAME AND ACTIVE INGREDIENTS: Ritalin ® XL 10/20/30/40mg modified-release hard capsules. Each capsule contains 10 mg, 20 mg, 30 mg or 40mg of methylphenidate hydrochloride. INDICATIONS: Ritalin XL is indicated as part of a comprehensive treatment programme for attention-deficit hyperactivity disorder (ADHD) in children aged 6 years and over when remedial measures alone prove insufficient and in adults. DOSAGE AND ADMINISTRATION: Treatment must be initiation under the supervision of a specialist in childhood and/or adolescent behavioural disorders in children, and a specialist in treatment on behavioural disorders in adults. Pre-treatment screening: Baseline evaluation of cardiovascular status including blood pressure and heart rate must be conducted. Document a comprehensive history of concomitant medications, past and present co-morbid medical and psychiatric disorders or symptoms, family history of sudden cardiac/unexplained death and, in children, accurate recording of pre-treatment height and weight on a growth chart. Dose titration: Careful dose titration is necessary at the start of treatment with methylphenidate. Ritalin XL capsules are for oral administration. Children (over 6 years): Dose titration should be started at the lowest possible dose. Recommended starting dose is 20 mg once daily in the morning, a lower initial dose of 10 mg can be used if considered appropriate. Short acting Ritalin can be used to initiate treatment and titrated upwards as per the recommendations listed in the SmPC. Maximum daily dose for children is 60 mg. Adults: Recommended starting dose is 20 mg once daily in the morning. Intake and titration should be personalised according to individual needs but should not be too late to prevent sleep disturbances. The regimen that achieves satisfactory symptom control with the lowest total daily dose should be employed. Maximum daily dose for adults is 80 mg. Adult patients new to methylphenidate: Recommended starting dose is 20 mg once daily. Dose may be adjusted at weekly intervals in 20 mg increments. Patients transitioning from childhood Ritalin treatment to adulthood: Treatment may be continued with the same daily dose. If previously treated with immediate release formulation, conversion to appropriate recommended dose of Ritalin XL should be made (see full SmPC for full details). Switching patients: Patients taking immediate-release methylphenidate twice daily can be switched to mg equivalent daily dose of Ritalin XL (see full SmPC for full details). Method of administration: Ritalin XL is for oral administration once daily in the morning. Capsules may be administered with or without food. They may be swallowed whole or by sprinkling the contents on a small amount of soft food. Ritalin XL capsules and/or their contents should not be crushed, chewed, or divided. Administration by sprinkling capsule contents on food: The capsules may be carefully opened and the beads sprinkled over soft food (e.g. apple sauce, jam, spread or yoghurt). The food should not be warm as this could affect the prolonged-release properties of the formulation. The mixture of drug and food should be consumed immediately in its entirety. The drug and food mixture should not be stored for future use. CONTRAINDICATIONS: Sensitivity to methylphenidate or excipients, glaucoma, phaeochromocytoma, during treatment with non-selective, irreversible monoamine oxidase inhibitors, or discontinuation within 14 days, 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 1) Bipolar disorder, pre-existing cardiovascular disorders including severe hypertension, heart failure, arterial occlusive disease, angina, haemodynamically significant congenital heart disease, cardiomyopathies, myocardial infarction, potentially life-threatening arrhythmias and channelopathies and pre-existing cerebrovascular disorders cerebral aneurysm, vascular abnormalities including vasculitis, strokes, or known risk factors for cerebrovascular disorders. SPECIAL WARNINGS AND PRECAUTIONS: Methylphenidate treatment is not indicated in all patients with ADHD, the decision to treat must be based on a very thorough assessment of the severity and chronicity of the symptoms (in children related to age). Long-term use (more than 12 months): Long-term safety and efficacy of treatment with methylphenidate has not been systematically evaluated in controlled trials. Careful ongoing monitoring for cardiovascular status, growth, appetite, development of de novo or worsening of pre-existing psychiatric disorders. Periodically re-evaluate usefulness and de-challenge at least once yearly. Use in patients over the age of 60 years: Should not be used. Safety and efficacy have not been established. Use in children under 6 years: Should not be used. Safety and efficacy have not been established. Cardiovascular status: Careful history (including family history of sudden cardiac or unexplained death or malignant arrhythmia) and physical exam to assess presence of cardiac disease. Seek prompt specialist cardiac evaluation if cardiac disease symptoms present during treatment. Caution in patients with underlying medical conditions might be compromised by increases in blood pressure or heart rate. Sudden death has been reported in association with use of stimulants. Assess neurological symptoms at every visit in patients at risk of cerebrovascular disorders. At least every 6 months and at every visit: Monitor cardiovascular status, blood pressure and pulse, development or worsening of psychiatric disorders, emergence or worsening of; pre-existing psychotic or manic symptoms, aggressive or hostile behaviour, tics and Tourette’s syndrome, anxiety, agitation and tension. Comorbid bipolar disorder and those with comorbid depressive symptoms at risk for bipolar disorder. In children, height, weight and appetite on a growth chart. Evaluate/seek medical attention immediately: Patients with emergent suicidal ideation or behaviour, develop abnormally sustained or frequent and painful erections. Precautions: Caution in patients with epilepsy and prior EEG abnormalities, discontinue treatment if seizure frequency increases or new-onset seizures occur. Monitor for risk of diversion, misuse and abuse of methylphenidate. Consider patient age, risk factors for substance use disorder, previous or current substance abuse. Should not be used for prevention or treatment of normal fatigue states. Should not be used in patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltose insufficiency. May indicate false positive laboratory test for amphetamines. Caution should be exercised in patients with hepatic and/or renal impairment. In the event of leucopoenia, thrombocytopenia, anaemia or other alterations discontinuation of treatment should be considered. It is not known how methylphenidate may affect plasma concentrations of concomitantly administered drugs. May decrease effectiveness of drugs used to treat hypertension. Caution is advised in patients being treated with other drugs which can elevate blood pressure. Patients should abstain from alcohol during treatment. INTERACTIONS (SEE SMPC FOR FULL DETAILS): Coumarin anticoagulants, anticonvulsants (e.g. phenobarbital, phenytoin, primidone), some antidepressants (tricyclic antidepressants and selective serotonin reuptake inhibitors), anti-hypertensives, drugs that elevate blood pressure, alcohol, halogenated anaesthetics, alpha-2 agonists, dopamine agonists (including DOPA and tricyclic antidepressants) or dopamine antagonists (including antipsychotics). Fertility, pregnancy and lactation: Methylphenidate is not recommended for use during pregnancy. In breast-feeding mothers, a decision must be made which considers the benefit of breast feeding for the child and benefit of therapy for the woman. No human data available on the effect of methylphenidate on fertility. Driving and use of machines: If patient is affected by dizziness, drowsiness and visual disturbances they should avoid driving and operating hazardous machinery. UNDESIRABLE EFFECTS (SEE SMPC FOR FULL DETAILS): Very common (≤1/10): Decreased appetite, Insomnia, nervousness, headache, nausea and dry mouth. Common (≥ 1/100 to <1/10): Nasopharyngitis, Anorexia, moderately reduced weight and height gain during prolonged use in children, Anorexia, affect lability, aggression, agitation, anxiety, depression, irritability, abnormal behaviour, restlessness, sleep disorder, libido decreased, panic attack, stress, bruxism, tremor, dizziness, dyskinesia, psychomotor hyperactivity, somnolence, arrhythmia, tachycardia palpitations, hypertension, peripheral coldness, cough, pharyngolaryngeal pain, dyspnoea, abdominal pain, diarrhoea, stomach discomfort and vomiting, dyspepsia, toothache, hyperhidrosis, alopecia, pruritus, rash, urticaria, arthralgia, pyrexia, growth retardation during prolonged use in children, feeling jittery, fatigue, thirst, changes in blood pressure and heart rate (usually an increase) and weight decreased. Serious: hypersensitivity reactions, erythema multiforme, psychotic disorders, delusions, suicidal ideation/ attempt/ completion, neuroleptic malignant syndrome, cerebrovascular disorders, cerebrovascular accidents, convulsions, angina pectoris, cardiac arrest, myocardial infarction, sudden cardiac death, abnormal liver function including hepatic coma, anaemia, leukopenia, thrombocytopenia, pancytopenia, priapism, hyperpyrexia. LEGAL CLASSIFICATION: CD (Sch 2) POM COST (NHS cost for 30 pack) and MARKETING AUTHORISATION NUMBER: Ritalin XL 10mg Modified-release Capsules £17.00 PL 15011/0034, Ritalin XL 20mg Modified-release Capsules £20.43 PL 15011/0035, Ritalin XL 30mg Modified-release Capsules £23.91 PL 15011/0037 and Ritalin XL 40mg Modified-release Capsules £39.88 PL 15011/0038. MARKETING AUTHORISATION HOLDER: INFECTOPHARM Arzneimittel und Consilium GmbH, Von-Humboldt-Straße 1, 64646 Heppenheim, Germany. Additional information available on request. Adverse reactions should be reported. Ritalin is a registered trademark of Novartis AG. September 2024 PP/RIT/2024/001v2.

PP/RIT/2024/006 October 2024