DuoResp Spiromax (budesonide / formoterol fumarate dihydrate) – Labelling - R03AK07

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1.NAME OF THE MEDICINAL PRODUCT

DuoResp Spiromax 160 micrograms /4.5 micrograms inhalation powder

budesonide / formoterol fumarate dihydrate

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Side panel: Each delivered dose contains 160 micrograms of budesonide and 4.5 micrograms of formoterol fumarate dihydrate.

This is equivalent to a metered dose of 200 micrograms of budesonide and 6 micrograms of formoterol fumarate dihydrate.

Front panel: This delivered dose is equivalent to a metered dose of 200 micrograms of budesonide and 6 micrograms of formoterol fumarate dihydrate.

3.LIST OF EXCIPIENTS

Contains lactose. See leaflet for further information

4.PHARMACEUTICAL FORM AND CONTENTS

Inhalation powder

1 inhaler containing 120 doses.

2 inhalers each containing 120 doses.

3 inhalers each containing 120 doses.

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Inhalation use.

Read the package leaflet before 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

Front panel: Not for use in children and adolescents.

Side panel: For use in adults 18 years of age and older only.

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

FOIL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

DuoResp Spiromax 160 micrograms / 4.5 micrograms inhalation powder

budesonide/ formoterol fumarate dihydrate

Inhalation use.

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

Contains 1 inhaler.

6.OTHER

Keep the mouthpiece cover closed and use within 6 months of removing from foil wrapping.

Teva Pharma B.V.

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

INHALER

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

DuoResp Spiromax 160 mcg/4.5 mcg inhalation powder

budesonide/formoterol fumarate dihydrate

Inhalation use.

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

120 doses

6. OTHER

Start

Teva Pharma B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

DuoResp Spiromax 320 micrograms/9 micrograms inhalation powder

budesonide/formoterol fumarate dihydrate

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Side panel: Each delivered dose contains 320 micrograms of budesonide and 9 micrograms of formoterol fumarate dihydrate.

This is equivalent to a metered dose of 400 micrograms of budesonide and 12 micrograms of formoterol fumarate dihydrate.

Front panel: This delivered dose is equivalent to a metered dose of 400 micrograms of budesonide and 12 micrograms of formoterol fumarate dihydrate.

3. LIST OF EXCIPIENTS

Contains lactose. See leaflet for further information

4. PHARMACEUTICAL FORM AND CONTENTS

Inhalation powder

1 inhaler containing 60 doses.

2 inhalers each containing 60 doses.

3 inhalers each containing 60 doses.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Inhalation use.

Read the package leaflet before 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

Front panel: Not for use in children and adolescents.

Side panel: For use in adults 18 years of age and older only.

Not for use in children or adolescents under 18 years of age.

8. EXPIRY DATE

EXP

Use the product within 6 months of removing from foil wrapping.

9. SPECIAL STORAGE CONDITIONS

Do not store above 25°C. Keep the mouthpiece cover closed after the removal of foil wrap.

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

Teva Pharma B.V., Swensweg 5, 2031GA Haarlem, The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/14/920/004

EU/1/14/920/005

EU/1/14/920/006

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

DuoResp Spiromax 320 mcg/9 mcg

17. UNIQUE IDENTIFIER – 2D BARCODE

<2D barcode carrying the unique identifier included.>]

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC:

SN:

NN:

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

FOIL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

DuoResp Spiromax 320 micrograms/9 micrograms inhalation powder

budesonide/formoterol fumarate dihydrate

Inhalation use.

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

Contains 1 inhaler.

6. OTHER

Keep the mouthpiece cover closed and use within 6 months of removing from foil wrapping.

Teva Pharma B.V.

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

INHALER

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

DuoResp Spiromax 320 mcg/9 mcg inhalation powder

budesonide/formoterol fumarate dihydrate

Inhalation use.

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

60 doses

6. OTHER

Start

Teva Pharma B.V.