SCHEDULES

SCHEDULE 15Requirements for specific products subject to general sale

Regulation 221

1

A medicinal product that contains aloxiprin, aspirin or paracetamol (or, where appropriate, any combination of those substances) and that is in the form specified in column 1 of the following table must be presented for sale in a separate and individual package containing not more than the amount of the product specified in the corresponding entry in column 2—

Column 1

Column 2

Effervescent tablets—

(a) that do not contain aspirin, or

(b) that do not contain more than 325 milligrams of aspirin per tablet.

30 tablets

Effervescent tablets—

(a) that contain more than 325 milligrams of aspirin per tablet, but

(b) that do not contain more than 500 milligrams per tablet.

20 tablets

Non-effervescent tablets—

(a) that are enteric-coated,

(b) that contain aspirin only, and

(c) that do not contain more than 75 milligrams per tablet.

28 tablets

Other non-effervescent tablets

16 tablets

Powder or granules

10 sachets

Capsules

16 capsules

Liquid preparations of paracetamol intended for persons aged 12 years and over

160 millilitres

Liquid preparations of paracetamol intended for persons aged less than 12 years

Individual unit doses of not more than 5 millilitres each, to a maximum of 20 unit doses

2

A medicinal product that contains ibuprofen and that is in the form specified in column 1 of the following table must be presented for sale in a separate and individual package containing not more than the amount of the product specified in the corresponding entry in column 2—

Form of product

Maximum amount

Tablets

16 tablets

Capsules

16 capsules

Powder or granules

12 sachets

Liquid preparations of ibuprofen

Individual unit doses of not more than 5 millilitres each, to a maximum of 20 unit doses