MATORIDE XR Prolonged-release tablet (2023)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Matoride XL 18 mg prolonged-release tablets.
2. Qualitative and quantitative composition
Each prolonged-release tablet contains 18 mg of methylphenidate hydrochloride. <u>Excipient(s) with known effect:</u> Each prolonged-release tablet contains 5.99 mg of lactose (as monohydrate) and 0.34 ...
3. Pharmaceutical form
Prolonged-release tablet. Light yellow film-coated tablet of round shape (diameter 8 mm) with a delivery orifice (visible round small hole) on one side.
4.1. Therapeutic indications
Attention-Deficit/Hyperactivity Disorder (ADHD) Matoride XL is indicated as part of a comprehensive treatment programme for Attention Deficit Hyperactivity Disorder (ADHD) in children aged 6 years of age ...
4.2. Posology and method of administration
<b>Treatment must be initiated under the supervision of a specialist in childhood and/or adolescent behavioural disorders.</b> Pre-treatment screening Prior to prescribing, it is necessary to conduct a ...
4.3. Contraindications
Hypersensitivity to methylphenidate or to any of the excipients listed in section 6.1. Glaucoma Phaeochromocytoma During treatment with non-selective, irreversible monoamine oxidase (MAO) inhibitors, or ...
4.4. Special warnings and precautions for use
Methylphenidate treatment is not indicated in all patients with ADHD and the decision to use the medicinal product must be based on a very thorough assessment of the severity and chronicity of the patient ...
4.5. Interaction with other medicinal products and other forms of interaction
Pharmacokinetic interaction It is not known how methylphenidate may effect plasma concentrations of concomitantly administered medicinal products. Therefore, caution is recommended at combining methylphenidate ...
4.6. Fertility, pregnancy and lactation
Pregnancy Data from a cohort study of in total approximately 3,400 pregnancies exposed in the first trimester do not suggest an increased risk of overall birth defects. There was a small increased occurrence ...
4.7. Effects on ability to drive and use machines
Methylphenidate can cause dizziness, drowsiness and visual disturbances including difficulties with accommodation, diplopia and blurred vision. It may have a moderate influence on the ability to drive ...
4.8. Undesirable effects
The table below shows all adverse reactions observed during clinical trials of children, adolescents, and adults and postmarket spontaneous reports with methylphenidate prolonged-release tablet and those, ...
4.9. Overdose
When treating patients with overdose, allowances must be made for the delayed release of methylphenidate from formulations with extended durations of action. Signs and Symptoms Acute overdose, mainly due ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> centrally acting sympathomimetics <b>ATC code:</b> N06BA04 Mechanism of action Methylphenidate HCl is a mild central nervous system (CNS) stimulant. The mode of therapeutic ...
5.2. Pharmacokinetic properties
Absorption Methylphenidate is readily absorbed. Following oral administration of methylphenidate prolonged-release tablet to adults the drug overcoat dissolves, providing an initial maximum drug concentration ...
5.3. Preclinical safety data
Carcinogenicity In life-time rat and mouse carcinogenicity studies, increased numbers of malignant liver tumours were noted in male mice only. The significance of this finding to humans is unknown. Methylphenidate ...
6.1. List of excipients
<u>Drug layer:</u> Polyethylene oxide Succinic acid Povidone (K 25) Butylhydroxytoluene Stearic acid <u>Push layer:</u> Polyethylene oxide Sodium chloride Povidone (K 25) Butylhydroxytoluene Iron oxide ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years. Shelf life after first opening of the bottle: 6 months. Storage conditions after first opening of the bottle: Store below 25°C.
6.4. Special precautions for storage
This medicinal product does not require any special storage conditions. For storage condition after first opening of the medicinal product, see section 6.3.
6.5. Nature and contents of container
The prolonged-release tablets are packed in high-density polyethylene (HDPE) bottles with a child-resistant polypropylene closure (PP screw cap) with drying plug. <u>Pack size:</u> 28 or 30 prolonged-release ...
6.6. Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
Sandoz Limited, Park View, Riverside Way, Watchmoor Park, Camberley, Surrey, GU15 3YL, United Kingdom
8. Marketing authorization number(s)
PL 04416/1346
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 08 November 2013 Date of latest renewal: 23 July 2016
10. Date of revision of the text
10/02/2023
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