Prescribing Information

NAME AND ACTIVE INGREDIENTS: Ritalin ® 10mg Tablets. Each tablet contains 10 mg of methylphenidate hydrochloride.

INDICATIONS: Ritalin is indicated as part of a comprehensive treatment programme for attention-deficit hyperactivity disorder (ADHD) in children and adolescents aged 6 years and over, and in adults, when remedial measures alone prove insufficient.

DOSAGE AND ADMINISTRATION: Treatment must be initiated and supervised by a specialist in the treatment of ADHD. 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, accurate recording of body weight, and in children, accurate recording of pre-treatment height on a growth. Dose titration: Careful dose titration is necessary at the start of treatment. The regimen that achieves satisfactory symptom control with the lowest total daily dose should be employed. The total daily dose should be administered in divided doses. Children (6 years and over): Begin with 5 mg once or twice daily (e.g. at breakfast and lunch), increasing if necessary by weekly increments of 5-10 mg. The total daily dose is usually administered in 2-3 divided doses. Maximum daily dose for children is 60 mg. Adults: Recommended starting dose is 10 mg twice daily. This may be started at 5 mg twice daily as per clinician’s judgement. The dose may be adjusted at weekly intervals by a maximum of 20 mg per day, administered in 2-3 divided doses. Maximum daily dose for adults is 80 mg. Method of administration: For oral use. Tablets may be administered with or without food. The tablet can be divided into equal doses. The last dose should generally not be given within 4 hours of bedtime to prevent sleep disturbances.

CONTRAINDICATIONS: Hypersensitivity to methylphenidate or excipients, glaucoma, phaeochromocytoma, during treatment with non-selective, irreversible monoamine oxidase (MAO) inhibitors or within 14 days of discontinuation, 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 (not well-controlled), 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 such as cerebral aneurysm, vascular abnormalities including vasculitis or stroke.

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, in relation to age). Long-term use (more than 12 months): in controlled clinical trials. Careful ongoing monitoring for cardiovascular status, growth, appetite, and development of de novo or worsening of pre-existing psychiatric disorders is required. 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: A careful history (including family history of sudden cardiac or unexplained death or malignant arrhythmia) and physical exam are required to assess for the presence of cardiac disease. Seek prompt specialist cardiac evaluation if cardiac disease symptoms present during treatment. Caution in patients whose 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 for neurological signs and symptoms at every visit. At least every 6 months and at every visit: Monitor cardiovascular status (blood pressure and pulse recorded on a centile chart), 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. Monitor for co-morbid bipolar disorder. In children, monitor height, weight and appetite on a growth chart. In adults, monitor weight regularly. Evaluate/seek medical attention immediately: For patients with emergent suicidal ideation or behaviour, or who develop abnormally sustained or frequent and painful erections. Precautions: Caution in patients with epilepsy; discontinue treatment if seizure frequency increases or new-onset seizures occur. Monitor for risk of diversion, misuse and abuse. Should not be used for prevention or treatment of normal fatigue states. Contains lactose and wheat starch; should not be used in patients with rare hereditary problems of galactose intolerance, total lactase deficiency, glucose-galactose malabsorption, or wheat allergy. May induce a false positive laboratory test for amphetamines. Caution in patients with hepatic and/or renal impairment. Consider discontinuation if leucopenia, thrombocytopenia, anaemia or other alterations occur. 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, anaesthetics, centrally acting alpha-2 agonists (e.g. clonidine), and dopaminergic drugs (including antipsychotics).

Fertility, pregnancy and lactation: Methylphenidate is not recommended for use during pregnancy  unless a clinical decision is made that postponing treatment may pose a greater risk to the pregnancy. In breast-feeding mothers, a decision must be made which considers the benefit of breast feeding for the child and the 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, dry mouth. Common (≥1/100 to <1/10): Nasopharyngitis, anorexia, moderately reduced weight and height gain during prolonged use in children, weight loss in adults, 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), weight decreased. Serious: Hypersensitivity reactions, erythema multiforme, psychotic disorders, delusions, suicidal attempt (including completed suicide), neuroleptic malignant syndrome, cerebrovascular disorders (including vasculitis, cerebral haemorrhages, cerebrovascular accidents), convulsions, angina pectoris, cardiac arrest, myocardial infarction, sudden cardiac death, abnormal liver function including hepatic coma, anaemia, leucopenia, thrombocytopenia, pancytopenia, priapism, hyperpyrexia.

LEGAL CLASSIFICATION: CD (Sch 2) POM

COST (NHS cost for 30 pack) and MARKETING AUTHORISATION NUMBER: Ritalin 10mg Tablets £6.68, PL 15011/0033.

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. January 2026

PP/RIT/2026/025 January 2026