ELVANSE Capsule, hard Ref.[7642] Active ingredients: Lisdexamfetamine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Shire Pharmaceutical Contracts Limited, 1 Kingdom Street, London, W2 6BD, UNITED KINGDOM

Product name and form

Elvanse 20 mg capsules, hard.
Elvanse 30 mg capsules, hard.
Elvanse 40 mg capsules, hard.
Elvanse 50 mg capsules, hard.
Elvanse 60 mg capsules, hard.
Elvanse 70 mg capsules, hard.

Pharmaceutical Form

Capsule, hard.

Elvanse 20 mg capsule: ivory opaque body and ivory opaque cap, printed ‘S489’ and ‘20 mg’ in black ink.

Elvanse 30 mg capsule: white opaque body and pink opaque cap, printed ‘S489’ and ‘30 mg’ in black ink.

Elvanse 40 mg capsule: white opaque body and blue/green opaque cap, printed ‘S489’ and ‘40 mg’ in black ink.

Elvanse 50 mg capsule: white opaque body and blue opaque cap, printed ‘S489’ and ‘50 mg’ in black ink.

Elvanse 60 mg capsule: aqua blue opaque body and aqua blue opaque cap, printed ‘S489’ and ‘60 mg’ in black ink.

Elvanse 70 mg capsule: blue opaque body and pink opaque cap, printed ‘S489’ and ‘70 mg’ in black ink.

Each capsule measures approximately 16 mm long and 6 mm wide.

Qualitative and quantitative composition

20 mg Capsules: Each capsule contains 20 mg lisdexamfetamine dimesylate, equivalent to 5.9 mg of dexamfetamine.

30 mg Capsules: Each capsule contains 30 mg lisdexamfetamine dimesylate, equivalent to 8.9 mg of dexamfetamine.

40 mg Capsules: Each capsule contains 40 mg lisdexamfetamine dimesylate, equivalent to 11.9 mg of dexamfetamine.

50 mg Capsules: Each capsule contains 50 mg lisdexamfetamine dimesylate, equivalent to 14.8 mg of dexamfetamine.

60 mg Capsules: Each capsule contains 60 mg lisdexamfetamine dimesylate, equivalent to 17.8 mg of dexamfetamine.

70 mg Capsules: Each capsule contains 70 mg lisdexamfetamine dimesylate, equivalent to 20.8 mg of dexamfetamine.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Lisdexamfetamine

Lisdexamfetamine is rapidly absorbed from the gastrointestinal tract and hydrolysed primarily by red blood cells to dexamfetamine, which is responsible for the drug’s activity. Amfetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity.

List of Excipients

Microcrystalline cellulose
Croscarmellose sodium
Magnesium stearate
Capsule shells
Gelatin
Black ink (shellac and black iron oxide E172)

Capsule shell colourants:

20 mg: titanium dioxide (E171) and yellow iron oxide (E172)
30 mg: titanium dioxide (E171) and erythrosine (E127)
40 mg: titanium dioxide (E171), brilliant blue FCF (E133), black iron oxide (E172) and yellow iron oxide (E172)
50 mg: titanium dioxide (E171) and brilliant blue FCF (E133)
60 mg: titanium dioxide (E171) and brilliant blue FCF (E133)
70 mg: titanium dioxide (E171), brilliant blue FCF (E133) and erythrosine (E127)

Pack sizes and marketing

High density polyethylene bottle and a polypropylene child resistant cap with a foil inner seal.

Pack sizes: 28 or 30.

Not all pack sizes may be marketed.

Marketing authorization holder

Shire Pharmaceutical Contracts Limited, 1 Kingdom Street, London, W2 6BD, UNITED KINGDOM

Marketing authorization dates and numbers

30mg: PL 08081/0050
50mg: PL 08081/0051
70mg: PL 08081/0052
20mg: PL 08081/0062
40mg: PL 08081/0063
60mg: PL 08081/0064

01/02/2013

Drugs

Drug Countries
ELVANSE Austria, Estonia, Spain, Finland, Netherlands, Poland, United Kingdom

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