PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton box

1. NAME OF THE MEDICINAL PRODUCT

Levocetirizine dihydrochloride 5 mg film-coated tablets

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 5 mg levocetirizine dihydrochloride

3. LIST OF EXCIPIENTS

Contains lactose: see leaflet for further information

4. PHARMACEUTICAL FORM AND CONTENTS

film-coated tablet

7 film-coated tablets 10 film-coated tablets

14    film-coated tablets

15    film-coated tablets

20    film-coated tablets

21    film-coated tablets 28 film-coated tablets 30 film-coated tablets 40 film-coated tablets 50 film-coated tablets 56 film-coated tablets 60 film-coated tablets 70 film-coated tablets 90 film-coated tablets 100 film-coated tablets 112 film-coated tablets 120 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.: {mm/yyyy}

9. SPECIAL STORAGE CONDITIONS

Store in the original package to protect from moisture

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

Ratiopharm GmbH, Graf-Arco-Strasse 3, 89079 Ulm, Germany.

12. MARKETING AUTHORISATION NUMBER(S)

PL 15773/0862

13. BATCH NUMBER

Batch No.:

14. GENERAL CLASSIFICATION FOR SUPPLY

POM

15. INSTRUCTIONS ON USE

Use as directed by your doctor.

16. INFORMATION IN BRAILLE

17.    UNIQUE IDENTIFIER - 2D BARCODE

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA