Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Neuraxpharm Pharmaceuticals, S.L., Avda. Barcelona 69, 08970 Sant Joan Despí - Barcelona, Spain
Tuzulby is indicated as part of a comprehensive treatment programme for attention-deficit/hyperactivity disorder (ADHD) in children and adolescents 6-17 years old when remedial measures alone prove insufficient.
Treatment must be under the supervision of a specialist in childhood behavioural disorders. Diagnosis should be made according to Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria or the guidelines in International Classification of Diseases, Tenth Revision (ICD-10) and should be based on a complete history and evaluation of the patient. Diagnosis cannot be made solely on the presence of one or more symptoms.
Treatment must be initiated under the supervision of a specialist in childhood and/or adolescent behavioural disorders.
Tuzulbi prolonged-release chewable tablets consists of an immediate release component (30% of the dose, which ensures rapid onset of action) and a prolonged-release component (70% of the dose, which is designed to maintain therapeutic plasma levels over an extended period). This medicinal product is designed to deliver therapeutic plasma levels for a period of approximately 8 hours following administration (see also section 5.2).
Careful dose titration is necessary at the start of treatment with methylphenidate. Dose titration should be started at the lowest possible dose.
Other methylphenidate-containing medicinal products with different strengths may be available. Switching from immediate-release methylphenidate-containing medicinal products to Tuzulby prolonged-release chewable tablets, administered as a single dose, provides comparable overall exposure of methylphenidate compared to the same total dose of the immediate release formulation administered twice daily.
The recommended dose of Tuzulby should be equal to the total daily dose of the immediate-release methylphenidate-containing formulation not exceeding a total dose of 60 mg. Examples are provided in the table below.
| Immediate-release methylphenidate dose | Tuzulby dose |
|---|---|
| 10 mg methylphenidate twice daily | 20 mg once daily |
| 15 mg methylphenidate twice daily | 30 mg once daily |
| 20 mg methylphenidate twice daily | 40 mg once daily |
| 30 mg methylphenidate twice daily | 60 mg once daily |
For patients from 6 years to less than 18 years of age, the recommended starting dose is 20 mg given orally once daily in the morning. The dose may be titrated up or down weekly in increments of 10 mg, 15 mg or 20 mg. The 10 mg and 15 mg doses can each be achieved by breaking in half the functionally scored 20 mg and 30 mg tablets, respectively. The dose should be individualised according to the treatment needs and responses of the patient.
The maximum daily dose of methylphenidate is 60 mg for treatment of children and adolescents (from 6 years to less than 18 years of age) with ADHD.
The safety and efficacy of long-term use of methylphenidate has not been systematically evaluated in controlled trials. Methylphenidate treatment should not and need not, be indefinite. Methylphenidate treatment is usually discontinued during or after puberty. The physician who elects to use methylphenidate for extended periods (more than 12 months) in children and adolescents (from 6 years to less than 18 years of age) with ADHD should periodically re-evaluate the long-term usefulness of the medicinal product 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 child's condition (preferable during school holidays). Improvement may be sustained when the medicinal product is either temporarily or permanently discontinued.
Treatment must be stopped if the symptoms do not improve after appropriate dose adjustment over a one-month period. If paradoxical aggravation of symptoms or other serious adverse reactions occur, the dosage should be reduced or discontinued.
Methylphenidate is not indicated for use in adults in ADHD. Safety and efficacy have not been established in this age group.
Methylphenidate should not be used in the elderly. Safety and efficacy have not been established in this age group.
Methylphenidate has not been studied in patients with hepatic impairment. Caution should be exercised in these patients.
Methylphenidate has not been studied in patients with renal impairment. Caution should be exercised in these patients.
Methylphenidate should not be used in children under the age of 6 years. The safety and efficacy of methylphenidate in this age group have not been established.
Tuzulby is for oral use.
Tuzulby should be administered orally once daily in the morning with or without food (see section 5.2).
Tuzulby must be chewed and not swallowed whole or crushed.
When treating patients with overdose, allowances must be made for the delayed release of methylphenidate from formulations with extended durations of action.
Acute overdose, mainly due to overstimulation of the central and sympathetic nervous system, may result in vomiting, agitation, tremours, hyperreflexia, muscle twitching, convulsions (may be followed by coma), euphoria, confusion, hallucinations, delirium, sweating, flushing, headache, hyperpyrexia, tachycardia, palpitations, cardiac arrhythmias, hypertension, mydriasis, dryness of mucous membranes, and rhabdomyolysis.
There is no specific antidote to methylphenidate overdose. Treatment consists of appropriate supportive measures.
The patient must be protected against self-injury and against external stimuli that would aggravate overstimulation already present. If the signs and symptoms are not too severe and the patient is conscious, gastric contents may be evacuated by induction of vomiting or gastric lavage. Before performing gastric lavage, control agitation and seizures if present and protect the airway. Other measures for gastrointestinal detoxification include administration of activated charcoal and a cathartic. In the presence of severe intoxication, a carefully titrated dose of a benzodiazepine should be given before performing gastric lavage.
Intensive care must be provided to maintain adequate circulation and respiratory exchange; external cooling procedures may be required to reduce hyperpyrexia.
Efficacy of peritoneal dialysis or extracorporeal haemodialysis for overdose of methylphenidate has not been established.
3 years.
This medicinal product does not require any special temperature storage conditions.
Keep the bottle tightly closed in order to protect from moisture.
Pack size: 30 prolonged-release chewable tablets in a 60 mL HDPE bottle including a 2 g desiccant canister with a child-resistant cap (PP).
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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