COSOPT 20 mg/ml + 5 mg/ml, eye drops, solution

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 20/09/19

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 9/1/2019

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Santen UK Limited

Santen UK Limited

Company Products

Medicine NameActive Ingredients
Medicine Name COSOPT 20 mg/ml + 5 mg/ml, eye drops, solution Active Ingredients Dorzolamide Hydrochloride, Timolol Maleate
Medicine Name COSOPT Preservative-Free 20 mg/ml + 5 mg/ml, eye drops, solution in single-dose container Active Ingredients Dorzolamide Hydrochloride, Timolol Maleate
Medicine Name IKERVIS 1 mg/mL eye drops, emulsion Active Ingredients Ciclosporin
Medicine Name Saflutan 15 micrograms/ml eye drops, solution Active Ingredients Tafluprost
Medicine Name SAFLUTAN 15 micrograms/ml eye drops, solution in single-dose container Active Ingredients Tafluprost
Medicine Name Taptiqom 15 micrograms/ml + 5 mg/ml eye drops, solution in single-dose container Active Ingredients Tafluprost, Timolol Maleate
Medicine Name Timoptol 0.25% and 0.5% w/v Eye Drops Solution Active Ingredients Timolol Maleate
Medicine Name TRUSOPT 20 mg/ml eye drops, solution Active Ingredients Dorzolamide Hydrochloride
Medicine Name TRUSOPT Preservative-Free 20 mg/ml eye drops, solution Active Ingredients Dorzolamide Hydrochloride
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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 20 September 2019 PIL

Reasons for updating

  • XPIL Updated

Updated on 20 September 2019 PIL

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - manufacturer

Updated on 20 September 2019 PIL

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - manufacturer

Free text change information supplied by the pharmaceutical company

Changes have been made due to introduction of product in new new bottle

Updated on 9 January 2019 PIL

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 4 - how to report a side effect
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 9 January 2019 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.2

.......

Method of administration

  1. Wash your hands
  1. Open the container. Take special care that the tip of the dropper container does not touch your eye, the skin around your eye or your fingers.
  1. Tilt your head backwards and hold the container upside down over the eye.
  1. Pull the lower eyelid downwards and look up. Hold and gently squeeze the container on the flattened sides of the container and let one drop fall into the space between the lower eyelid and the eye.
  1. Press a finger into the corner of your eye, by the nose, or close your eyelids for 2 minutes. This helps to stops the medicine from getting into the rest of the body.
  1. Repeat steps 3 to 5 with the other eye if instructed to do so by your doctor.
  1. Put the cap back on and close the container tightly.

[OCUMETER PLUS containers only]

  1. Before using the medication for the first time, be sure the Safety Strip on the front of the containerbottle is unbroken. A gap between the containerbottle and the cap is normal for an unopened containerbottle.

....................

Section 6.5

6.5     Nature and contents of container

COSOPT containers contain 5 ml of solution. Two alternate containers may be marketed.

White translucent low-density polyethylene container, a transparent dropper tip and a white cap

or

The OCUMETER Plus Ophthalmic Dispenser consistingconsists of a translucent, high‑density polyethylene container with a sealed dropper tip, a flexible fluted side area which is depressed to dispense the drops, and a 2‑piece cap assembly. The 2‑piece cap mechanism punctures the sealed dropper tip upon initial use, then locks together to provide a single cap during the usage period. Tamper evidence is provided by a safety strip on the container label. The OCUMETER Plus Ophthalmic Dispenser contains 5 ml of solution.

COSOPT is available in the following packaging configurations:

1 x 5 ml (single 5 ml containers)

3 x 5 ml (three 5 ml containers)

6 x 5 ml (six 5 ml containers)

Not all pack sizes may be marketed.

Section 10

November 2018 July 2015

Updated on 4 January 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 4 January 2016 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)