COSOPT 20 mg/ml + 5 mg/ml, eye drops, solution
- Name:
COSOPT 20 mg/ml + 5 mg/ml, eye drops, solution
- Company:
Santen UK Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 24/03/20

XPIL
Package leaflet: information for the user
Package leaflet: information for the user
1. What COSOPT is and what it is used for
1. What COSOPT is and what it is used for
2. What you need to know before you use COSOPT
2. What you need to know before you use COSOPT
3. How to use COSOPT
3. How to use COSOPT
4. Possible side effects
4. Possible side effects
5. How to store COSOPT
5. How to store COSOPT
6. Contents of the pack and other information
6. Contents of the pack and other information
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Santen UK Limited

Company Products
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 24 March 2020 PIL
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Manufacturer:
Santen Oy
, Niittyhaankatu 20 33720
Kelloportinkatu 1, 33100 Tampere
....
This leaflet was last revised in March 2020.November 2019
Updated on 14 February 2020 PIL
Reasons for updating
- XPIL Updated
Free text change information supplied by the pharmaceutical company
XPIL pdated inline with leaflet changes
Section 4 Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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 without speaking to your doctor.
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.
Generalised allergic reactions including swelling beneath the skin that can occur in areas such as the face and limbs, and can obstruct the airways which may cause difficulty swallowing, orshortness of breath, hives or itchy rash, localised and generalised rash, itchiness, severe sudden life-threatening allergic reaction. breathing
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 without speaking to your doctor.
Frequency Uncommon – text below changed
shortness of breath,difficulty 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 November 2019.June 2018
Updated on 14 February 2020 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
- Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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 without speaking to your doctor.
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.
Generalised allergic reactions including swelling beneath the skin that can occur in areas such as the face and limbs, and can obstruct the airways which may cause difficulty swallowing, orshortness of breath, hives or itchy rash, localised and generalised rash, itchiness, severe sudden life-threatening allergic reaction. breathing
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 without speaking to your doctor.
Frequency Uncommon – text below changed
shortness of breath,difficulty 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 November 2019June 2018
Updated on 14 February 2020 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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
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
Deleted: HPRA postal address, phone and fax numbers
SPC section 10 - date changed:
November 2018 February 2020
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 SPC
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
- Wash your hands
- 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.
- Tilt your head backwards and hold the container upside down over the eye.
- 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.
- 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.
- Repeat steps 3 to 5 with the other eye if instructed to do so by your doctor.
- Put the cap back on and close the container tightly.
[OCUMETER PLUS containers only]
- Before using the medication for the first time, be sure the Safety Strip on the front of the container
is unbroken. A gap between the containerbottleand the cap is normal for an unopened containerbottle.bottle
....................
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
OCUMETER Plus Ophthalmic Dispenser consistingThe 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.consists 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 container)s
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 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 4 January 2016 PIL
Reasons for updating
- New PIL for new product