Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Shire Pharmaceuticals Ireland Limited, Block 2 & 3, Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, Ireland
Equasym XL 10 mg modified-release capsules, hard.
Equasym XL 20 mg modified-release capsules, hard.
Equasym XL 30 mg modified-release capsules, hard.
| Pharmaceutical Form |
|---|
|
Modified release capsule, hard. Equasym XL 10 mg capsule: The capsule has a dark green opaque cap imprinted with “S544” in white and a white opaque body imprinted with “10 mg” in black. Equasym XL 20 mg capsule: The capsule has a blue opaque cap imprinted with “S544” in white and a white opaque body imprinted with “20 mg” in black. Equasym XL 30 mg capsule: The capsule has a reddish-brown opaque cap imprinted with “S544” in white and a white opaque body imprinted with “30 mg” in black. |
Each capsule contains 10 mg methylphenidate hydrochloride corresponding to 8.65 mg methylphenidate.
Excipient: 45 mg sucrose/capsule for Equasym XL 10 mg.
Each capsule contains 20 mg methylphenidate hydrochloride corresponding to 17.30 mg methylphenidate.
Excipient: 90 mg sucrose/capsule for Equasym XL 20 mg.
Each capsule contains 30 mg methylphenidate hydrochloride corresponding to 25.94 mg methylphenidate.
Excipient: 135 mg sucrose/capsule for Equasym XL 30 mg.
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 |
|---|
|
Capsule content: Sugar Spheres (Sucrose, Maize starch) Capsule shell: Gelatin 10 mg capsules only: Indigo carmine (E132), Yellow iron oxide (E172) 20 mg capsules only: Indigo carmine (E132) 30 mg capsules only: Indigo carmine (E132), Red iron oxide (E172) White printing ink: Shellac Black printing ink: Shellac glaze 45% (20% esterified) in ethanol |
Clear or opaque PVC/Aclar blister with aluminum foil backing and vinyl seal coating.
Pack sizes:
10 modified-release capsules, hard.
28 modified-release capsules, hard.
30 modified-release capsules, hard.
60 modified-release capsules, hard.
100 modified-release capsules, hard (10 mg and 20 mg capsules only).
Not all pack sizes may be marketed.
Shire Pharmaceuticals Ireland Limited, Block 2 & 3, Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, Ireland
Equasym XL 10 mg: PL 27303/0004
Equasym XL 20 mg: PL 27303/0005
Equasym XL 30 mg: PL 27303/0006
Date of first authorisation: 11 February 2005
Renewal of the authorisation: 10 February 2010
| Drug | Countries | |
|---|---|---|
| EQUASYM | Germany, Spain, Finland, Ireland, Netherlands, United Kingdom |
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