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Opatanol (olopatadine hydrochloride) – Labelling - S01GX09

Updated on site: 09-Oct-2017

Medication nameOpatanol
ATC CodeS01GX09
Substanceolopatadine hydrochloride
ManufacturerNovartis Europharm Limited

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOX OF 1 BOTTLE + BOX OF 3 BOTTLES

1.NAME OF THE MEDICINAL PRODUCT

OPATANOL 1 mg/mL eye drops, solution

Olopatadine

2.STATEMENT OF ACTIVE SUBSTANCE

1 mL of solution contains 1 mg olopatadine (as hydrochloride).

3.LIST OF EXCIPIENTS

Benzalkonium chloride, sodium chloride, disodium phosphate dodecahydrate, hydrochloric acid/sodium hydroxide (to adjust pH) and purified water.

4.PHARMACEUTICAL FORM AND CONTENTS

Eye drops, solution; 1 x 5 mL

3 x 5 mL

5.METHOD AND ROUTE OF ADMINISTRATION

For ocular 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

8.EXPIRY DATE

Exp: xx/xxxx

Discard four weeks after first opening.

Opened:

Opened (1):

Opened (2):

Opened (3):

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

Novartis Europharm Limited

Frimley Business Park

Camberley GU16 7SR

United Kingdom

12.MARKETING AUTHORISATION NUMBERS

EU/1/02/217/001 1 x 5 mL

EU/1/02/217/002 3 x 5 mL

13.BATCH NUMBER

Lot: xxxxx

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Opatanol

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

BOTTLE LABEL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION

OPATANOL 1 mg/mL eye drops.

Olopatadine.

For ocular use.

2.METHOD OF ADMINISTRATION

Read the package leaflet before use.

3.EXPIRY DATE

Exp: xx/xxxx

Discard four weeks after first opening.

Opened:

4.BATCH NUMBER

Lot:

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

5mL

6OTHER

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