MEDIKINET Tablet (2021)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Medikinet 5 mg tablets. Medikinet 10 mg tablets. Medikinet 20 mg tablets.

2. Qualitative and quantitative composition

Medikinet 5 mg tablets Each tablet contains 5 mg methylphenidate hydrochloride, equivalent to 4.35 mg methylphenidate. Excipient with known effect: 42.28 mg lactose/tablet. Medikinet 10 mg tablets ...

3. Pharmaceutical form

Tablet. Medikinet 5 mg tablets: White, round tablet with a break score on both sides and notches at the edges embossed with S on both halves. Medikinet 10 mg tablets: White, round tablets ...

4.1. Therapeutic indications

Attention-Deficit/Hyperactivity Disorder (ADHD) Medikinet 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

Posology 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 ...

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 medicinal product must be based on a very thorough assessment of the severity and chronicity of the child ...

4.5. Interaction with other medicinal products and other forms of interaction

Pharmacokinetic interaction It is not known how methylphenidate may affect plasma concentrations of concomitantly administered medicinal products. Therefore, caution is recommended at combining methylphenidate ...

4.6. 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. Medikinet may have a moderate influence on the ability to ...

4.8. Undesirable effects

The list below shows all adverse drug reactions (ADRs) observed during clinical trials and post-market spontaneous reports with Medikinet and those, which have been reported with other methylphenidate ...

4.9. Overdose

Signs and symptoms Acute overdose, mainly due to overstimulation of the central and sympathetic nervous systems, may result in vomiting, agitation, tremors, hyperreflexia, muscle twitching, convulsions ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: psychoanaleptics, psychostimulants, agents used for ADHD and nootropics; centrally acting sympathomimetics ATC Code: N06BA04 Mechanism of action Medikinet is a ...

5.2. Pharmacokinetic properties

Absorption Medikinet is rapidly and almost completely absorbed. Owing to its pronounced first-pass metabolism the absolute bioavailability is low at only 30% (11-51%) of the dose. Absorption is accelerated ...

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

Microcristalline cellulose Pregelatinised maize starch Calcium hydrogen phosphate dihydrate Lactose monohydrate Magnesium stearate

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Do not store above 25°C. Store in the original package in order to protect from moisture.

6.5. Nature and contents of container

Medikinet 5 mg tablets Pack sizes 20, 30 or 50 tablets. Boxes containing tablets packaged in PVC/PE/PVdC white opaque blisters heat sealed to aluminium foil. Medikinet 10 mg tablets Pack sizes: ...

6.6. Special precautions for disposal and other handling

No special requirements.

7. Marketing authorization holder

Medice Arzneimittel Pütter GmbH & Co. KG, Kuhloweg 37, 58638 Iserlohn, Germany

8. Marketing authorization number(s)

Medikinet 5 mg: PL 11243/0002 Medikinet 10 mg: PL 11243/0003 Medikinet 20 mg: PL 11243/0004

9. Date of first authorization / renewal of the authorization

11/12/2013

10. Date of revision of the text

29/01/2021

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