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Santen UK Limited

Salisbury Hall, St Albans, AL2 1BU, UK
Telephone: +44 (0)1727 615110
E-mail: enquiries@santen.co.uk
WWW: http://www.santen.ie
Medical Information Direct Line: +353 1 695 0008
Medical Information e-mail: medinfo@santen.co.uk
Customer Care direct line: +44 (0)1727 615110
Summary of Product Characteristics last updated on medicines.ie: 11/08/2017
SPC COSOPT Preservative-Free 20 mg/ml + 5 mg/ml, eye drops, solution in single-dose container

When a pharmaceutical company changes an SPC or PIL, 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 11/08/2017 and displayed until Current
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   03-Aug-2017
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



1.      NAME OF THE MEDICINAL PRODUCT

 

COSOPT® Preservative-Free 20 mg/ml + 5 mg/ml, eye drops, solution in single-dose container solution,

single-dose container


3.      PHARMACEUTICAL FORM

 

Eye drops, solution in single-dose containersolution, single dose container

 

Clear, colourless to nearly colourless, slightly viscous solution, with a pH between 5.5 and 5.8, and an osmolality of 242 -323 mOsmol/kg.


6.3       Shelf life

 

2 years30 months

 

Cosopt Preservative-Free should be used no longer than 15 days after first opening the sachet. Discard any unused single dose containers after that time. 

 

Discard the opened single dose container immediately after first use.

 

6.4       Special precautions for storage

 

Do not store above 3025°C.

Do not freeze.

Store in the original package foil sachet in order to protect from light.

 

6.5       Nature and contents of container

 

COSOPT Preservative-Free is available in 0.2 ml low density polyethylene single- dose containers in an aluminium foil sachet containing 15 single-dose containers.

 

Pack sizes:

30 x 0.2 ml (2 sachets with 15 single dose containers)

60 x 0.2 ml (4 sachets with 15 single dose containers)

120 x 0.2 ml (8 sachets with 15 single dose containers)

 

Note: Different shapes of the single-dose containers are available.

 

Not all pack sizes may be marketed.


10.    DATE OF REVISION OF THE TEXT


February 2017 3 August 2017

Updated on 20/04/2017 and displayed until 11/08/2017
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
  • Change to section 2 - Qualitative and quantitative composition
Date of revision of text on the SPC:   01-Apr-2017
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



2.      QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Each ml contains 22.26 mg of dorzolamide hydrochloride corresponding to 20 mg dorzolamide and 6.83 mg of timolol maleate corresponding to 5 mg timolol.

 

One drop (about 0.03-0.05 mL) contains on average 0.8 mg of dorzolamide and 0.2 mg of timolol.

 

For the full list of excipients, see section 6.1.


6.5    Nature and contents of container

 

COSOPTCosopt Preservative-Free is available in 0.2 ml low density polyethylene single dose containers in an aluminum sachet containing 15 single -dose containers.

 

Pack sizes:

 

30 x 0.2 ml (2 sachets with 15 single dose containers)

60 x 0.2 ml (4 sachets with 15 single dose containers)

120 x 0.2 ml (8 sachets with 15 single dose containers)

 

Note: Different shapes of the single-dose containers are available. Please see section 6.6 for shape-specific diagrams and instructions for use.

 

Not all pack sizes may be marketed.

6.6    Special precautions for disposal and other handling

 

No special requirements.

 

The dose is one drop of Cosopt Preservative Free in the (conjunctival sac of the) affected eye(s) two times daily.

 

Do not allow the single-dose container to touch the eye or areas around the eye. It could cause injury to your eye. It may also become contaminated with bacteria that can cause eye infections leading to serious damage of the eye, even loss of vision. To avoid contamination of the eye drop solution, a new single dose container should be opened immediately prior to each use; there is enough solution in each container for both eyes if your doctor has told you to use the drops in both eyes.

 

Discard the opened container with any remaining contents immediately after use.

 

Instructions for use:
existing text & diagram replaced by new diagram AND text below

  1. Wash your hands.
  2. Take the strip of containers from the sachet.
  3. Detach one single-dose container from the strip.
  4. Put the remaining strip back in the sachet and fold the edge to close the sachet.
  5. To open the container, twist off the tab. (Picture A).
  6. Hold the container between your thumb and index finger. Note that the tip of the container must not show more than 5 mm above the edge of your index finger. (Picture B).
  7. Tilt your head backwards or lie down. Place your hand on your forehead. Your index finger should be aligned with your eyebrow or resting on the bridge of the nose. Look up. Pull the lower eyelid downwards with the other hand. Do not allow any part of the container to touch your eye or any area around your eye. Gently squeeze the container to let one drop fall into the space between the lid and the eye. (Picture C). Do not blink while applying the drop to your eye. Each single dose container contains enough solution for both eyes.
  8. Close your eye and press the inner corner of the eye with your finger for about two minutes. This helps to stop the medicine from getting into the rest of the body. (Picture D).
  9. Wipe off any excess solution from the skin around the eye

If your doctor has told you to use drops in both eyes, repeat steps 7 to 9 for your other eye

6.         After putting the drop into the eye, throw away the used single dose container even if there is solution  remaining to avoid contamination of the preservative free solution.

 

7.         Store the remaining containers in the foil sachet; the remaining containers must be used within 15 days after opening of the sachet. If there are any containers left 15 days after opening the sachet they should be safely thrown away and a fresh sachet opened.  It is important to continue to use the eye  drops as prescribed by your doctor.

9.      DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORIZATION

 

Date of first authorisation: 1 September 2006

Date of last renewal: 22nd December 20156 March 2008

 

 

10.       DATE OF REVISION OF THE TEXT

 

July 2015April 2017

 

If you are not sure how to administer your medicine, ask your doctor, pharmacist or nurse.

Updated on 04/01/2016 and displayed until 20/04/2017
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

None provided

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Active Ingredients

 
   Dorzolamide Hydrochloride
   Timolol Maleate