DELMOSART Prolonged-release tablet (2020)
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Περιεχόμενα
1. Name of the medicinal product
Delmosart 18mg Prolonged-release Tablets.
2. Qualitative and quantitative composition
Each prolonged-release tablet contains 18 mg of methylphenidate hydrochloride equivalent to 15.6 mg of methylphenidate. <u>Excipient with known effect:</u> contains 183.8 mg of lactose (as monohydrate). ...
3. Pharmaceutical form
Prolonged-release tablet. <u>18 mg Tablet:</u> Capsule-shaped, biconvex, yellow tablet, 6.6 mm x 11.9 mm, with 2392 printed on one side in black ink.
4.1. Therapeutic indications
Attention-Deficit/Hyperactivity Disorder (ADHD) Delmosart 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
Treatment must be initiated under the supervision of a specialist in childhood and/or adolescent behavioural disorders. Pre-treatment screening Prior to prescribing, it is necessary to conduct a baseline ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Glaucoma. Phaeochromocytoma. During treatment with non-selective, irreversible monoamine oxidase (MAO) inhibitors, ...
4.4. Special warnings and precautions for use
Methylphenidate treatment is not indicated in all children with ADHD and the decision to use the drug must be based on a very thorough assessment of the severity and chronicity of the childs symptoms in ...
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 drugs. Therefore, caution is recommended at combining methylphenidate with ...
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 post-market spontaneous reports with Delmosart and those, which have been reported with ...
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> Psychoanaleptics; centrally acting sympathomimetics <b>ATC code:</b> N06BA04 Mechanism of action Methylphenidate HCl is a mild central nervous system (CNS) stimulant. ...
5.2. Pharmacokinetic properties
Absorption Methylphenidate is readily absorbed. Following oral administration of methylphenidate prolonged-release tablets in adults the tablet coating dissolves, providing an initial maximum methylphenidate ...
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>Tablet content:</u> Lactose monohydrate Hypromellose Silica, colloidal anhydrous Magnesium stearate Fumaric acid Methacrylic acid–methyl methacrylate copolymer Triethyl citrate Talc <u>Tablet coating: ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
24 months. Shelf life after first opening the bottle: 3 months.
6.4. Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5. Nature and contents of container
HDPE bottle with a child-resistant PP closure with silica gel desiccant integrated into the closure. <u>18 mg tablets:</u> 28, 30 or 90 prolonged-release tablets. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS
8. Marketing authorization number(s)
PL 0142/1220
9. Date of first authorization / renewal of the authorization
15/11/2019
10. Date of revision of the text
21/09/2020
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