Daliresp (roflumilast) – Labelling - R03DX07

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON FOR BLISTER

1.NAME OF THE MEDICINAL PRODUCT

Daliresp 500 micrograms film-coated tablets roflumilast

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 500 micrograms roflumilast.

3.LIST OF EXCIPIENTS

Contains lactose. See package leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

10 film-coated tablets

30 film-coated tablets

90 film-coated tablets

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7.OTHER SPECIAL WARNING(S), IF NECESSARY

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

AstraZeneca AB

SE-151 85 Södertälje

Sweden

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/11/668/001

EU/1/11/668/002

EU/1/11/668/003

13.BATCH NUMBER

Batch

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Daliresp 500 micrograms

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

Daliresp 500 micrograms tablets roflumilast

2.NAME OF THE MARKETING AUTHORISATION HOLDER

AstraZeneca AB

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Batch

5.OTHER