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Intended for UK patients and members of the public

Brinzolamide/Timolol Eye Drops

Active Ingredients

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.

Report a side effect or a product complaint

Brinzolamide/timolol Accord 10mg/ml + 5mg/ml Eye Drops, Suspension

PL Number:
20075/1373
MA Holder:
Accord Healthcare Limited
Product Classification:
POM
Product Status:
Active

Product Documentation

  • SmPC 4.2, 4.6, 5.3 and the PIL have been updated in line with the reference product Azopt. Additional editorial updates have been made to the PIL.

  • Description of update:

    IB, B.II.b.1.z Introduction of an alternative irradiation sterilization site for all primary packaging components (i.e., bottles, droppers and caps): BGS Beta-Gamma-Service GmbH & Co. KG, Fritz-Kotz-Strasse 12 + 16, 51674 Wiehl, Germany.

    IB, B.II.b.1.z Introduction of an alternative irradiation sterilization site for all primary packaging components (i.e., bottles, droppers and caps): BGS Beta-Gamma-Service GmbH & Co. KG, John-Deere-Straße 1 + 3, 76646 Bruchsal, Germany

    IB, B.II.e.2.z Change in the irradiation dose and bioburden limit of the primary packaging (bottle, dropper and cap) adopted by the new alternative sites. The gamma irradiation dose is changed from 25 - 45 KGy, which is used at the current irradiation sterilization site, BBF Sterilisationsservice GmbH, to 17.5 - 50 kGy to be used at the proposed irradiation sterilization sites, BGS Beta-Gamma-Service GmbH & Co. KG, (Wiehl and Bruchsal).

    The bioburden limit is changed from Max 50 CFU, which is used at the current irradiation sterilization site, BBF Sterilisationsservice GmbH, to Max 9 CFU to be used at the proposed irradiation sterilization sites, BGS Beta-Gamma-Service GmbH & Co. KG, (Wiehl and Bruchsal).

    IB, B.II.e.4.c Change of the shape/dimensions of the 5 ml pack size, where the size/capacity of the LDPE bottle is changed from 5 ml to 10 ml. The dimensions of the bottle are changed from 42.1 - 42.7 mm (5 ml capacity) to 51.8 ± 0.4mm (10 ml capacity).

    PIL sections updated: 6 only.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.

Report a side effect or a product complaint

General FAQs

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