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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Santen Oy, Niittyhaankatu 20, 33720 Tampere, Finland.

Manufacturer: Laboratoires Merck Sharp & Dohme-Chibret, Mirabel Plant, Route de Marsat, Riom 63963 Clermont Ferrand Cedex 9, France.

Santen Oy, Kelloportinkatu 201, 33100 Tampere, Finland.

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This leaflet was last revised in March 2020February 2021.

3. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects:

If you experience any of the following side effects, stop using this medicine and seek immediate medical advice as these could be signs of a reaction to the medicine.

You can usually carry on taking the drops, unless the effects are serious. If you're worried, talk to a doctor or pharmacist. Do not stop using COSOPT Preservative-Free without speaking to your doctor. 

Generalized allergic reactions including swelling beneath the skin that can occur in areas such as the face and limbs, and can obstruct the airway which may cause difficulty swallowing, shortness of breath or breathing, hives or itchy rash, localized and generalized rash, itchiness, severe sudden life-threatening allergic reaction.

You can usually carry on taking the drops, unless the effects are serious. If you're worried, talk to a doctor or pharmacist. Do not stop using COSOPT Preservative-Free without speaking to your doctor.

....

Frequency Uncommon – text below changed

shortness of breathdifficulty breathing (dyspnoea),

Frequency Rare - text below changed

…forceful heartbeat that may be rapid or irregular (palpitations)palpitations (a quicker and/or irregular heartbeat)…

Frequency not known- text below added:

… hallucination and foreign body sensation in eye (feeling that there is something in your eye).

 

Reporting of side effects

HPRA postal address, phone and fax numbers deleted

Section 6

 

This leaflet was last revised in December 201November 2019.

SPC Section 4.8 – added:

Psychiatric disorders: hallucination

Eye disorders: foreign body sensation in eye

Cardiac disorders: palpitations

Respiratory, thoracic, and mediastinal disorders: dyspnoea

 

Reporting of suspected adverse reactions

HPRA postal address, phone and fax numbers deleted

 

SPC section 10

December 2017   February 2020



 

 

6.5    Nature and contents of container

 

Cosopt Preservative-Free is available in 0.2 ml low density polyethylene single dose containers in a foil sachet containing 15 or 10 single -dose containers.

 

Pack sizes:

 

30 x 0.2 ml (2 sachets with 15 single dose containers or 3 sachets with 10 single-dose containers)

60 x 0.2 ml (4 sachets with 15 single dose containers or 6 sachets with 10 single-dose containers)

120 x 0.2 ml (8 sachets with 15 single dose containers or 12 sachets with 10 single-dose containers)

 

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

 

Not all pack sizes may be marketed.

 

6.6    Special precautions for disposal and other handling

 

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

 

Instructions for use

 

Open the foil sachet which contains 15the individual single dose containers. There are three strips of 5 single dose containers each in the sachet. Write the date of first opening on the sachet.

 

Every time you use COSOPT Preservative-Free

10.       DATE OF REVISION OF THE TEXT

 

SeptemberDecember 2017

 



 

 

6.5    Nature and contents of container

 

Cosopt Preservative-Free is available in 0.2 ml low density polyethylene single dose containers in a foil sachet containing 15 or 10 single -dose containers.

 

Pack sizes:

 

30 x 0.2 ml (2 sachets with 15 single dose containers or 3 sachets with 10 single-dose containers)

60 x 0.2 ml (4 sachets with 15 single dose containers or 6 sachets with 10 single-dose containers)

120 x 0.2 ml (8 sachets with 15 single dose containers or 12 sachets with 10 single-dose containers)

 

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

 

Not all pack sizes may be marketed.

 

6.6    Special precautions for disposal and other handling

 

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

 

Instructions for use

 

Open the foil sachet which contains 15the individual single dose containers. There are three strips of 5 single dose containers each in the sachet. Write the date of first opening on the sachet.

 

Every time you use COSOPT Preservative-Free

10.       DATE OF REVISION OF THE TEXT

 

SeptemberDecember 2017

 

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

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

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.

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.

None provided

None provided