Tuzulby
Authorised
This medicine is authorised for use in the European Union
methylphenidate hydrochloride
Medicine
Human
Authorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Tuzulby is a medicine used to treat attention deficit hyperactivity disorder (ADHD) in children and adolescents aged 6 to 17 years.
It is used as part of a comprehensive treatment strategy that typically involves psychological, educational and other interventions and is used when these measures alone do not control their symptoms well enough.
Tuzulby contains the active substance methylphenidate hydrochloride and is a ‘hybrid’ medicine. This means that it is similar to a ‘reference medicine’ containing the same active substance, but there are differences between the two. Tuzulby tablets release the active substance over a longer period of time than the reference medicine does. The reference medicine is Ritalin.
Tuzulby treatment must be started by a doctor specialised in childhood or adolescent behavioural problems. Before starting treatment, the doctor should check the patient’s blood pressure and heart rate.
The recommended starting dose is 20 mg once a day taken in the morning. The dose may be increased weekly up to a maximum dose of 60 mg. Treatment should be stopped if symptoms do not improve, and doses may be reduced if the symptoms get worse or if the child has serious side effects.
The tablets are chewed and not swallowed whole or crushed. For more information about using Tuzulby, see the package leaflet or contact your doctor or pharmacist.
The medicine can only be obtained with a prescription.
The active substance in Tuzulby, methylphenidate hydrochloride, is thought to work by increasing the levels of the neurotransmitters noradrenaline and dopamine in some areas of the brain. By doing this, it enhances activity in areas of the brain that control attention, the ability to focus, concentration and impulsive behaviours.
After ingestion of the medicine, a small amount of the active substance is immediately available, with the remainder being slowly released over 8 hours, helping to prolong the action of the medicine.
Studies on the benefits and risks of the active substance have already been carried out with the reference medicine, Ritalin.
As for every medicine, the company provided studies on the quality of Tuzulby. The company also carried out a study that showed that giving Tuzulby produces similar levels of the active substance in the body as those seen with Ritalin. The company also presented results from a study which showed that children stabilised on Tuzulby for one week had better symptom scores for ADHD based on classroom observations than those taking placebo (a dummy treatment).
For the full list of side effects and restrictions with Tuzulby, see the package leaflet.
The most common side effects with methylphenidate treatment (which may affect more than 1 in 10 people) are decreased appetite, insomnia (difficulty sleeping), nervousness, headache, nausea and dry mouth.
Tuzulby must not be used in children who are allergic to the active substance or any of the other ingredients of the medicine. It must not be used in those with glaucoma (damage to the nerve in the eye, usually caused by high pressure in the eye), phaechromocytoma (a rare tumour in adrenal glands) or hyperthyroidism or thyrotoxicosis (conditions caused by excess thyroid hormones).
It must also not be used in children with a history of certain mental or psychiatric conditions, pre-existing heart disease and disorders affecting the circulation in the brain such as strokes. Finally, it should not be used in children taking antidepressants known as monoamine oxidase (MAO) inhibitors. For the full list of restrictions, see the package leaflet.
Studies show that Tuzulby produces similar levels of methylphenidate hydrochloride, the active substance, in the body Ritalin does. Methylphenidate hydrochloride is already widely used to treat ADHD and its safety is well known.
The European Medicines Agency therefore decided that Tuzulby’s benefits are greater than its risks and that it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tuzulby have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Tuzulby are continuously monitored. Suspected side effects reported with Tuzulby are carefully evaluated and any necessary action taken to protect patients.
Tuzulby received a marketing authorisation valid throughout the EU on 28 February 2025.
Product information
28/02/2025
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Tuzulby
- Active substance
- methylphenidate hydrochloride
- International non-proprietary name (INN) or common name
- methylphenidate hydrochloride
- Therapeutic area (MeSH)
- Attention Deficit Disorder with Hyperactivity
- Anatomical therapeutic chemical (ATC) code
- N06BA04
Pharmacotherapeutic group
PsychoanalepticsTherapeutic indication
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.
News on Tuzulby
This page was last updated on