Manufacturer:

Santen Oy

Niittyhaankatu 20 33720,

Kelloportinkatu 1, 33100 Tampere

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This leaflet was last revised in November 2019March 2020.

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,  or breathingshortness of breath, hives or itchy rash, localised and generalised 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 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 June 2018November 2019.

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,  or breathingshortness of breath, hives or itchy rash, localised and generalised 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 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 June 2018November 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

Deleted: HPRA postal address, phone and fax numbers

SPC section 10 - date changed:

November 2018 February 2020

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

Section 4.2

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Method of administration

1. Wash your hands

2. 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.

3. Tilt your head backwards and hold the container upside down over the eye.

4. 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.

5. 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.

6. Repeat steps 3 to 5 with the other eye if instructed to do so by your doctor.

7. 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.

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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