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

Remove text re Ocumeter+ bottle from sections 4.2 & 6.5 as no longer marketed.

6.3     Shelf life

23 years.

COSOPT should be used no longer than 28 days after first opening the container.

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10.     DATE OF REVISION OF THE TEXT

October 202102 February 2022

Section 2

Warnings and precautions

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When COSOPT is instilled into the eye, it may affect the entire body.

If you wear soft contact lenses, you should consult your doctor before using this medicine.

Use in children Children

There is limited experience with COSOPT in infants and children.

Use in elderlyElderly

In studies with COSOPT, the effects of this medicine were similar in both elderly and younger patients.

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Pregnancy and breast-feeding

AskIf you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking anythis medicine.

Use in pregnancy

Do not use COSOPT if you are pregnant unless your doctor considers it necessary.

Use in breast-feeding

Do not use COSOPT if you are breast-feeding. Timolol may get into your milkbreastmilk. Ask your doctor for advice before taking any medicine during breast-feeding.

Driving and using machines

No studies on the effects on the ability to drive or use machines have been performed. There are side effects associated with COSOPT, such as blurred vision, which may affect your ability to drive and/or operate machinery. Do not drive or operate machinery until you feel well or your vision is clear.

COSOPT contains benzalkonium chloride

If you wearThis medicine contains approximately 0.002 mg benzalkonium chloride in each drop which is equivalent to 0.075 mg/ml.

Benzalkonium chloride may be absorbed by soft contact lenses, you and may change the colour of the contact lenses. You should consultremove contact lenses before using this medicine and put them back 15 minutes afterwards.

Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor before using COSOPT (the preservative benzalkonium chloride may possibly discolour the lenses)..

Section 4 side effects

Explanation of frequency added next to relevant paragraph instead as table at top of section.

Northern Ireland added after UK in country list

This leaflet was last revised in FebruaryMay 2021.

Section 2

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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.

Excipients with known effect: Benzalkonium chloride 0.075 mg/ml.

One ml of eye drops solution contains 0.075 mg benzalkonium chloride and one drop contains about 0.002 mg of benzalkonium chloride.

For the full list of excipients, see section 6.1.

Section 4.4

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       Benzalkonium chloride

Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface. Should be used with caution in dry eye patients and in patients where the cornea may be compromised. Patients should be monitored in case of prolonged use.

Contact Lens Use

COSOPT contains benzalkonium chloride as preservative. Contact lenses should be removed prior to application and wait at least 15 minutes before reinsertion. Benzalkonium chloride is known to discolour soft contact lenses.This medicinal product contains the preservative benzalkonium chloride, which may cause eye irritation. Remove contact lenses prior to application and wait at least 15 minutes before reinsertion. Benzalkonium chloride is known to discolour soft contact lenses.

Paediatric population

See section 5.1.

Section 10

February 2020 October 2021

This leaflet was last revised in March 2020February 2021.

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