Brinzolamide and timolol Mylan

INFORMATION TO BE INCLUDED ON THE SECONDARY PACKAGING
BOX FOR SINGLE 5 ML VIAL + BOX FOR 3 VIALS X 5 ML +
BOX FOR 6 VIALS X 5 ML

1. NAME OF THE MEDICINAL PRODUCT

Brinzolamide and Timolol Mylan 10 mg/ml + 5 mg/ml eye drops, suspension
Brinzolamide and Timolol
Generic medicine

2. QUALITATIVE AND QUANTITATIVE COMPOSITION IN TERMS OF ACTIVE

SUBSTANCE
1 ml of eye drops suspension contains 10 mg of brinzolamide and 5 mg of timolol (as timolol
maleate)

3. LIST OF EXCIPIENTS

Contains: Benzalkonium chloride, mannitol (E421), carbomer, disodium edetate, sodium chloride, hydrochloric acid and/or sodium hydroxide, purified water.
See the package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Eye drops, suspension
1 x 5 ml
3 x 5 ml
6 x 5 ml

5. METHOD AND ROUTE OF ADMINISTRATION

For ophthalmic use.
Shake well before use.
Read the instructions for use before administration.

6. SPECIAL WARNING TO KEEP THE MEDICINAL PRODUCT

OUT OF SIGHT AND REACH OF CHILDREN
Keep out of sight and reach of children.
7. OTHER SPECIAL WARNING(S), IF NECESSARY
8. EXPIRY DATE
EXP.
Do not use after 4 weeks from the first opening of the bottle.
Date of opening:
9. SPECIAL PRECAUTIONS FOR THE STORAGE OF THE MEDICINAL PRODUCT
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF THE MEDICINAL PRODUCT
NOT USED OR WASTE MATERIALS DERIVING FROM SUCH MEDICINAL PRODUCT, IF
NECESSARY

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

MARKETING AUTHORISATION HOLDER:
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan
Italy

12. MARKETING AUTHORISATION NUMBER(S)

13. BATCH NUMBER

Batch No.:

14. GENERAL SUPPLY CONDITION

To be sold upon presentation of a medical prescription.
15. INSTRUCTIONS FOR USE
16. BRAILLE INFORMATION
Brinzolamide and Timololo Mylan

17. UNIQUE IDENTIFIER – TWO-DIMENSIONAL BARCODE

Two-dimensional barcode including unique identifier.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:
SN:
NN:
Blue Box
Price €
May affect the ability to drive vehicles and operate machinery

MINIMUM INFORMATION REQUIRED ON PRIMARY PACKAGING FOR
SMALL-SIZED PACKS
BOTTLE LABEL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION

Brinzolamide and Timolol Mylan 10 mg/ml + 5 mg/ml eye drops, suspension
2. ROUTE OF ADMINISTRATION
3. EXPIRY DATE
EXPIRY:
Date of opening:

4. BATCH NUMBER

Batch:

5. CONTENTS BY WEIGHT, VOLUME OR UNIT

5 ml

6. OTHER

Mylan S.p.A.