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STRATTERA Hard capsules (2015)

Active ingredients: Atomoxetine

Product Name and Form

STRATTERA* 10mg, 18mg, 25mg, 40mg, 60mg, 80mg or 100mg hard capsules.

Pharmaceutical form

Capsule, hard.

STRATTERA 10 mg capsules: hard capsule, opaque white, imprinted with “Lilly 3227” and “10 mg” in black ink, approximately 15.5-16.1 mm length.

STRATTERA 18 mg capsules: hard capsule, gold (cap) and opaque white (body), imprinted with “Lilly 3238” and “18 mg” in black ink, approximately 15.5-16.1 mm length.

STRATTERA 25 mg capsules: hard capsule, opaque blue (cap) and opaque white (body), imprinted with “Lilly 3228” and “25 mg” in black ink, approximately 15.5-16.1 mm length.

STRATTERA 40 mg capsules: hard capsule, opaque blue, imprinted with “Lilly 3229” and “40 mg” in black ink, approximately 15.5-16.1 mm length.

STRATTERA 60 mg capsules: hard capsule, opaque blue (cap) and gold (body), imprinted with “Lilly 3239” and “60 mg” in black ink, approximately 17.5-18.1 mm length.

STRATTERA 80 mg capsules: hard capsule, opaque brown (cap) and opaque white (body), imprinted with “Lilly 3250” and “80 mg” in black ink, approximately 17.5-18.1 mm length.

STRATTERA 100 mg capsules: hard capsule, opaque brown, imprinted with “Lilly 3251” and “100 mg” in black ink, approximately 19.2-19.8 mm length.

Qualitative and Quantitative Composition

Each hard capsule contains atomoxetine hydrochloride equivalent to 10mg, 18mg, 25mg, 40mg, 60mg, 80mg or 100mg of atomoxetine.

For the full list of excipients, see Section 6.1.

Chemical substance
Description
Atomoxetine

Atomoxetine is a highly selective and potent inhibitor of the pre-synaptic noradrenaline transporter, its presumed mechanism of action, without directly affecting the serotonin or dopamine transporters.

List of excipients

The capsules contain:

Starch, pregelatinised (Maize)
Dimeticone

Capsule shell:

Sodium laurilsulfate
Gelatin

Capsule shell cap colourants:

10 mg: Titanium dioxide E171

18 mg: Yellow iron oxide E172

25 mg, 40 mg, and 60 mg: FD&C Blue 2 (Indigo Carmine) E132 and Titanium dioxide E171

80 mg and 100 mg: Yellow iron oxide E172, Red iron oxide E172, Titanium dioxide E171

Capsule Shell Body colourants:

60 mg: Yellow iron oxide E172

10 mg, 18 mg, 25 mg and 80 mg: Titanium dioxide E171

40 mg: FD&C Blue 2 (Indigo Carmine) E132 and Titanium dioxide E171

100 mg: Yellow iron oxide E172, Red iron oxide E172, Titanium dioxide E171

Edible Black Ink SW-9008 (containing Shellac and Black Iron Oxide E172) or Edible Black Ink SW-9010 (containing Shellac and Black Iron Oxide E172).

Pack sizes and Marketing

Capsules: Polyvinyl chloride (PVC)/polyethylene (PE)/polychlorotrifluoroethylene (PCTFE) blister sealed with aluminium foil lid.

Available in pack sizes of 7, 14, 28 and 56 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

Eli Lilly and Company Limited, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom

Capsules

Date of first authorisation: 27 May 2004

Date of last renewal: 27 May 2014

Marketing authorization number:

STRATTERA 10mg hard capsules: PL 00006/0375
STRATTERA 18mg hard capsules: PL 00006/0376
STRATTERA 25mg hard capsules: PL 00006/0377
STRATTERA 40mg hard capsules: PL 00006/0378
STRATTERA 60mg hard capsules: PL 00006/0379
STRATTERA 80mg hard capsules: PL 00006/0615
STRATTERA 100 mg hard capsules: PL 00006/0616