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 |
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Methylphenidate is a CNS stimulant (psychostimulant) with more pronounced effects on central than on motor activities. The mechanism of action in humans is not fully understood; however, it is thought that the effect is due to inhibition of dopamine reuptake in the striatum without triggering a release of dopamine. |
| List of Excipients |
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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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