Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Medice Arzneimittel Pütter GmbH & Co. KG, Kuhloweg 37, 58638 Iserlohn, Germany
Medikinet 5 mg tablets.
Medikinet 10 mg tablets.
Medikinet 20 mg tablets.
| Pharmaceutical Form |
|---|
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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 embossed with “M”. To enable dividing, the tablets have a score line with notches. Medikinet 20 mg tablets: White, round tablets embossed with “L”. To enable dividing, the tablets have a score line with notches. The tablet can be divided into equal halves. |
Each tablet contains 5 mg methylphenidate hydrochloride, equivalent to 4.35 mg methylphenidate.
Excipient with known effect: 42.28 mg lactose/tablet.
Each tablet contains 10 mg methylphenidate hydrochloride, corresponding to 8.65 mg methylphenidate.
Excipients: 40.85 mg lactose/tablet.
Each tablet contains 20 mg methylphenidate hydrochloride, corresponding to 17.30 mg methylphenidate.
Excipients: 38.48 mg lactose/tablet.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Methylphenidate |
Methylphenidate HCl is a mild central nervous system (CNS) stimulant. The mode of therapeutic action in Attention Deficit Hyperactivity Disorder (ADHD) is not known. Methylphenidate is thought to block the reuptake of noradrenaline and dopamine into the presynaptic neurone and increase the release of these monoamines into the extraneuronal space. |
| List of Excipients |
|---|
|
Microcristalline cellulose |
Pack sizes 20, 30 or 50 tablets.
Boxes containing tablets packaged in PVC/PE/PVdC white opaque blisters heat sealed to aluminium foil.
Pack sizes: 20, 30, 50 or 100 tablets.
Boxes containing tablets packaged in PVC/PVdC blisters heat sealed to aluminium foil
Pack sizes: 30 or 50 tablets.
Boxes containing tablets packaged in PVC/PE/PVdC blisters heat sealed to aluminium foil
Not all pack sizes may be marketed.
Medice Arzneimittel Pütter GmbH & Co. KG, Kuhloweg 37, 58638 Iserlohn, Germany
Medikinet 5 mg: PL 11243/0002
Medikinet 10 mg: PL 11243/0003
Medikinet 20 mg: PL 11243/0004
11/12/2013
| Drug | Countries | |
|---|---|---|
| MEDIKINET | Austria, Germany, Estonia, Spain, Finland, France, Hong Kong, Ireland, Lithuania, Netherlands, Poland, Singapore, Turkey, United Kingdom |
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