Cosopt

Package leaflet: Information for the user

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

(dorzolamide / timolol)
Please read this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What COSOPT is and what it is used for
2. What you need to know before using COSOPT
3. How to use COSOPT
4. Possible side effects
5. How to store COSOPT
6. Contents of the pack and other information

1. What COSOPT is and what it is used for

COSOPT contains two medicines: dorzolamide and timolol.

• Dorzolamide belongs to a group of medicines called "carbonic anhydrase inhibitors".
• Timolol belongs to a group of medicines called "beta-blockers". These medicines lower intraocular pressure in different ways.

COSOPT is prescribed to reduce elevated intraocular pressure in the treatment of glaucoma
when treatment with a single beta-blocker eye drop is not sufficient.

2. What you need to know before using COSOPT

Do not use COSOPT

• if you are allergic to dorzolamide hydrochloride, timolol maleate, or any of the other ingredients of this medicine (listed in section 6).
• if you currently have or have previously had breathing problems such as asthma, or severe chronic obstructive bronchitis (a serious lung disease that may cause shortness of breath, difficulty breathing, and/or long-standing cough).
• if you have a slow heartbeat, heart failure, or heart rhythm disorders (irregular heartbeats).
• if you have severe kidney disease or if you have previously had kidney stones.
• if you have excess acidity in the blood caused by accumulation of chloride in the blood (hyperchloremic acidosis). If you are unsure whether this medicine is suitable for you, consult your doctor or pharmacist.

Warnings and precautions
Talk to your doctor before using COSOPT.
Inform your doctor about any medical or eye conditions you currently have or have had in the past:

• coronary heart disease (symptoms may include chest pain or tightness, shortness of breath, or choking).
• heart failure, low blood pressure.
• heart rhythm disorders such as slow heartbeat.
• breathing problems, asthma, or chronic obstructive pulmonary disease.
• poor blood circulation (such as Raynaud's disease or Raynaud's syndrome).
• diabetes, as timolol may mask the signs and symptoms of low blood sugar levels.
• thyroid gland disorders, as timolol may mask their signs and symptoms.

Before undergoing surgery, inform your doctor that you are using COSOPT, as timolol may alter the effects of certain medicines used during anesthesia.
You should also inform your doctor of any allergies or allergic reactions, including hives, swelling of the face, lips, tongue, and/or throat, which may cause difficulty in breathing or swallowing.
Inform your doctor if you experience muscle weakness or if you have been diagnosed with myasthenia gravis.
Inform your doctor immediately if you experience any eye irritation or any new problems such as eye redness or eyelid swelling.
If you suspect that COSOPT is causing an allergic reaction or hypersensitivity (for example, skin rash, severe skin reaction, or eye redness and itching), stop using this medicine and contact your doctor immediately.
Inform your doctor if you develop an eye infection, suffer an eye injury, undergo any type of eye surgery, or if new symptoms appear or existing symptoms worsen.
When COSOPT is instilled into the eye, it may affect the entire body.
Consult your doctor before using this medicine if you wear soft contact lenses.
For individuals engaged in sports: using this medicine without a therapeutic need constitutes doping and may result in a positive anti-doping test.

Use in children
Experience with COSOPT in infants and children is limited.

Use in elderly patients
In clinical studies with COSOPT, the effects of this medicine observed in elderly patients were similar to those in younger patients.

Use in patients with hepatic impairment
Inform your doctor about any liver problems you currently have or have had in the past.

Other medicines and COSOPT
COSOPT may affect, or be affected by, other medicines you are taking, including other eye drops used to treat glaucoma. Inform your doctor if you are taking or intend to take medicines to lower blood pressure, medicines for heart conditions, or medicines for diabetes treatment.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is particularly important if you are:

• taking medicines to lower blood pressure or treat heart disease (such as calcium channel blockers, beta-blockers, or digoxin).
• taking medicines to treat an irregular heartbeat, such as calcium channel blockers, beta-blockers, or digoxin.
• using another eye drop containing a beta-blocker.
• taking another carbonic anhydrase inhibitor such as acetazolamide.
• taking monoamine oxidase inhibitors (MAOIs).
• taking a parasympathomimetic medicine that may have been prescribed to help you urinate. Parasympathomimetics are also a specific type of medicine sometimes used to regulate intestinal movements.
• taking narcotic drugs such as morphine, used to treat moderate to severe pain.
• taking medicines for diabetes treatment.
• taking antidepressants known as fluoxetine and paroxetine.
• taking a sulfonamide.
• taking quinidine (used to treat certain heart conditions and some types of malaria).

Pregnancy and breastfeeding
Talk to your doctor or pharmacist before taking any medicine.

Use during pregnancy
Do not use COSOPT during pregnancy unless your doctor considers it necessary.

Use during breastfeeding
Do not use COSOPT while breastfeeding. Timolol may be excreted in breast milk. Consult your doctor before taking any medicine while breastfeeding.

Driving and using machines
The effects of COSOPT on the ability to drive or operate machinery have not been specifically studied. COSOPT may cause side effects such as blurred vision, which may impair your ability to drive and/or operate machinery. You should avoid driving or operating machinery until you feel well and your vision is clear.

COSOPT contains benzalkonium chloride
If you wear soft contact lenses, consult your doctor before using COSOPT (the preservative benzalkonium chloride may discolor contact lenses).

3. How to use COSOPT

Use this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist. The appropriate dose and duration of treatment will be determined by your physician.

The recommended dose is one drop in the affected eye(s) in the morning and one drop in the evening.

If this medicine is used together with other eye drops, the drops should be administered at least 10 minutes apart.

Do not change the dose of this medicine without consulting your doctor.

The dropper tip must not touch the eye or surrounding areas. It may become contaminated with bacteria, which could lead to eye infections that may cause serious damage to the eye, including loss of vision. To avoid possible contamination of the dropper, always wash your hands before using this medicine and do not let the dropper tip touch any surface. If you suspect the medicine may be contaminated, or if an eye infection develops, contact your doctor immediately before continuing to use this container.

Instructions for use

Do not use the container if the plastic safety seal around the neck of the bottle is missing or broken. When opening the container for the first time, tear off the plastic safety seal.

Each time you use COSOPT:

1. Wash your hands.
2. Open the container. Be careful not to let the dropper tip touch the eye, the skin around the eye, or your fingers.
3. Tilt your head backward and hold the

container upside down over the eye.

4. Pull the lower eyelid downward and

look upward. Hold the container and gently squeeze the flattened sides to release one drop into the space between the lower eyelid and the eye.

5. Press with one finger at the corner of the eye,

near the nose, or close the eyelids for 2 minutes. This helps prevent the medicine from draining into the rest of the body.

6. Repeat steps 3 to 5 for the other eye if your doctor has prescribed treatment for both eyes.
7. Replace the cap and close the container firmly.

[Only for OCUMETER PLUS containers]

1. Before using the medicine for the first time, ensure that the safety seal on the front of the container is intact. A small gap between the container and the cap is normal for an unopened container.

►

2. First, wash your hands, then tear the safety seal to break the seal.

3. To open the container, unscrew the cap by turning it in the direction indicated by the arrows on the top of the cap. Do not pull the cap directly off the container. Removing the cap by pulling will prevent the dropper from working properly.

4. Tilt your head backward and gently pull down the lower eyelid to form a pocket between the eyelid and the eye.

5. Turn the container upside down and gently press with your thumb or index finger on the compressible area (as shown) until one single drop has been instilled into the eye, as prescribed by your doctor.

DO NOT LET THE DROPPER TIP TOUCH THE EYE OR EYELID.

6. After using COSOPT, press with one finger at the corner of the eye, near the nose, or close the eyelids for 2 minutes. This helps prevent the medicine from passing into the rest of the body.

7. If administering the drops is difficult after first opening the container, replace the cap on the container and squeeze (not too tightly), then remove it by turning the cap in the opposite direction as indicated by the arrows on the top of the cap.
8. Repeat steps 4 and 5 for the other eye if your doctor has prescribed treatment for both eyes.
9. Screw the cap back on tightly. The arrow on the left side of the cap must align with the arrow on the left side of the container label to ensure proper closure. Do not over-tighten, to avoid damaging the container and cap.
10. The dropper is calibrated to deliver a single drop; therefore, DO NOT enlarge the dropper opening.
11. After all doses have been used, the container will still contain some residual COSOPT. The container includes an excess of the medicine to ensure that the full prescribed dose of COSOPT is available. Do not remove the excess medicine from the container.

If you use more COSOPT than you should
If you instill too many drops into the eye or if the dropper contents are swallowed, you may experience, among other effects, mild dizziness, difficulty breathing, or a sensation of slowed heartbeat. Contact your doctor immediately.

If you forget to use COSOPT
It is important that this medicine is administered exactly as prescribed by your doctor. If you miss a dose, instill it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and return to your regular dosing schedule.
Do not use a double dose to make up for a forgotten dose.

If you stop using COSOPT
If you wish to discontinue treatment, discuss this first with your doctor.
If you have any further questions about the use of this product, consult your doctor or pharmacist.

4. Possible side effects

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

Serious side effects:
If you notice any of the following side effects, stop using this medicine and contact your doctor immediately, as they may be signs of a reaction to the medicine.
Generalised allergic reactions including swelling under the skin which may occur in areas such as the face and limbs, and may obstruct the airways, causing difficulty swallowing, shortness of breath, hives or itchy rash, localised and generalised skin rash, itching, sudden severe allergic reaction that could be life-threatening.

Generally, you may continue using the drops unless the side effects are severe. If you are concerned, consult your doctor or pharmacist. Do not stop using COSOPT without speaking to your doctor.

The frequency of the possible side effects listed below is defined using the following convention:
Very common (affects more than 1 in 10 people)
Common (affects from 1 to 10 people in 100)
Uncommon (affects from 1 to 10 people in 1,000)
Rare (affects from 1 to 10 people in 10,000)
Not known (frequency cannot be estimated from the available data)

The following adverse reactions have been reported with COSOPT or one of its components in clinical studies or after marketing:

Very common:
Burning and stinging in the eyes, taste disturbance

Common:
Redness of the eye(s) and surrounding area, tearing or itching of the eye(s), corneal erosion (damage to the front layer of the eyeball), swelling and/or irritation of the eye(s) and surrounding area, sensation of a foreign body in the eye, reduced corneal sensitivity (inability to feel a foreign body in the eye and absence of pain), eye pain, dry eyes, blurred vision, headache, sinusitis (feeling of pressure or fullness in the nose), nausea, weakness/tiredness, fatigue

Uncommon:
Dizziness, depression, inflammation of the iris, visual disturbances including changes in refraction (in some cases due to discontinuation of miotic therapy), slow heart rate, fainting, shortness of breath, indigestion, kidney stones

Rare:
Systemic lupus erythematosus (an autoimmune disease that may cause inflammation of internal organs), tingling or numbness in the hands or feet, insomnia, nightmares, memory loss, worsening of signs and symptoms of myasthenia gravis (a muscle disorder), decreased sexual desire, stroke, temporary myopia which may resolve upon discontinuation of treatment, detachment of the layer located beneath the retina containing blood vessels following filtering surgery, which may cause visual disturbances, drooping eyelids (causing the eye to remain partially closed), double vision, crusting of the eyelids, corneal oedema (with symptoms of visual disturbances), ocular hypotension, ringing in the ears, low blood pressure, changes in heart rhythm or heart rate, congestive heart failure (heart disease with shortness of breath and swelling of feet and legs due to fluid accumulation), oedema (fluid accumulation), cerebral ischaemia (reduced blood supply to the brain), chest pain, strong heartbeat which may be rapid or irregular (palpitations), heart attack, Raynaud's phenomenon, swollen or cold hands and feet and reduced circulation in arms and legs, leg cramps and/or leg pain during walking (claudication), shortness of breath, impaired lung function, nasal discharge or nasal congestion, nosebleeds, airway constriction in the lungs, cough, throat irritation, dry mouth, diarrhoea, contact dermatitis, hair loss, skin rash with a silvery-white appearance (psoriasiform rash), Peyronie's disease (which may cause curvature of the penis), allergic-type reactions including skin rashes, urticaria, itching, in rare cases possible swelling of lips, eyes and mouth, shortness of breath, or severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis)

Like other medicines administered by the ophthalmic route, timolol is absorbed into the bloodstream. This may cause side effects similar to those seen with oral beta-blockers. The incidence of side effects after topical ophthalmic administration is lower than when medicines are, for example, taken orally or injected. Additional side effects listed include reactions observed within the class of beta-blockers when used to treat eye conditions:

Not known:
Low blood glucose levels, heart failure, a type of heart rhythm disorder, abdominal pain, vomiting, muscle pain not caused by exercise, sexual dysfunction, hallucination, and sensation of a foreign body in the eye (feeling that something is in the eye).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store COSOPT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container label and on the box after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature. Keep the container in the outer packaging to protect the medicine from light.
Once the COSOPT container has been opened for the first time, it must be used within 28 days.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What COSOPT contains

• The active substances are dorzolamide and timolol. Each ml contains 20 mg of dorzolamide (equivalent to 22.26 mg of dorzolamide hydrochloride) and 5 mg of timolol (equivalent to 6.83 mg of timolol maleate).
• The other excipients are: hydroxyethylcellulose, mannitol, sodium citrate, sodium hydroxide and water for injections. Benzalkonium chloride is added as a preservative.

Description of the appearance of COSOPT and contents of the pack
COSOPT is a clear, colourless or almost colourless, slightly viscous solution.
Cosopt is contained in a container made of translucent white plastic with 5 ml of solution. The plastic container is closed with a white screw cap.
The OCUMETER Plus Ophthalmic Dispenser consists of a translucent plastic container containing 5 ml of solution.
Tamper-evidence is provided by a security band located on the container label.
Pack sizes:
1 x 5 ml (one 5 ml container)
3 x 5 ml (three 5 ml containers)
6 x 5 ml (six 5 ml containers)
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Santen Italy S.r.l.
Via Roberto Lepetit, 8/10
20124 Milano, Italy

Manufacturer
Fareva Mirabel
Route de Marsat, Riom;
63963 Clermont-Ferrand, Cedex 9
France
Santen Oy
Kelloportinkatu 1
33100 Tampere
Finland

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom:
COSOPT

Package leaflet: Information for the user

COSOPT preservative-free 20 mg/ml + 5 mg/ml eye drops, solution

(dorzolamide / timolol)
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What COSOPT preservative-free is and what it is used for
2. What you need to know before using COSOPT preservative-free
3. How to use COSOPT preservative-free
4. Possible side effects
5. How to store COSOPT preservative-free
6. Contents of the pack and other information

1. What COSOPT preservative-free is and what it is used for

COSOPT preservative-free contains two medicines: dorzolamide and timolol.

• Dorzolamide belongs to a group of medicines called "carbonic anhydrase inhibitors".
• Timolol belongs to a group of medicines called "beta-blockers". These medicines reduce intraocular pressure in different ways.

COSOPT preservative-free is prescribed to lower elevated intraocular pressure in the treatment of glaucoma when monotherapy with beta-blocker eye drops is not sufficient.
COSOPT preservative-free eye drops, solution, is a sterile solution that does not contain a preservative.

2. What you should know before using COSOPT preservative-free

Do not use COSOPT preservative-free

• if you are allergic to dorzolamide hydrochloride, timolol maleate, or any of the other ingredients of this medicine (listed in section 6).
• if you currently have or have previously had breathing problems such as asthma, or severe chronic obstructive bronchitis (a serious lung disease that may cause shortness of breath, difficulty breathing, and/or long-standing cough).
• if you have a slow heartbeat, heart failure, or heart rhythm disorders (irregular heartbeats).
• if you have severe kidney disease, or if you have previously had kidney stones.
• if you have excess blood acidity caused by accumulation of chloride in the blood (hyperchloremic acidosis). If you are unsure whether it is safe for you to use this medicine, consult your doctor or pharmacist.

Warnings and precautions
Consult your doctor before using COSOPT preservative-free if you currently have or have previously had:

• coronary heart disease (symptoms may include chest pain or tightness, shortness of breath, or suffocation), heart failure, low blood pressure.
• heart rate disorders such as slow heartbeat.
• breathing problems, asthma, or chronic obstructive pulmonary disease.
• poor blood circulation (such as Raynaud's disease or Raynaud's syndrome).
• diabetes, as timolol may mask the signs and symptoms of low blood sugar levels.
• overactive thyroid gland, as timolol may mask its signs and symptoms.
• any allergic or anaphylactic reaction.
• muscle weakness or have been diagnosed with myasthenia gravis.
• If you wear soft contact lenses, COSOPT preservative-free has not been studied in patients wearing contact lenses.

If you have a history of contact sensitivity to silver, you must not use this medicine, as the dispensed drops may contain traces of silver from the container closure.
Before undergoing surgery, inform your doctor that you are using COSOPT preservative-free, as timolol may alter the effects of certain medicines used during anesthesia.
When COSOPT preservative-free is instilled into the eye, it may affect the entire body.
Inform your doctor if, during treatment with COSOPT preservative-free, you:

• develop any eye irritation or any new problems such as eye redness or eyelid swelling.
• suspect that COSOPT preservative-free is causing an allergic or hypersensitivity reaction (for example, skin rash, severe skin reaction, or eye redness and itching). Stop using this medicine and contact your doctor immediately.
• develop an eye infection, experience an eye injury, undergo any type of eye surgery, or develop a reaction including new or worsening symptoms. For those engaged in sports: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

Children
There is limited experience with COSOPT (preserved formulation) in infants and children.
Use in the elderly
In clinical studies with COSOPT (preserved formulation), the effects of this medicine observed in elderly patients were similar to those in younger patients.
Use in patients with hepatic impairment
Inform your doctor of any current or past liver problems.
Other medicines and COSOPT preservative-free
COSOPT preservative-free may affect or be affected by other medicines you are taking, including other eye drops for the treatment of glaucoma. Inform your doctor if you are taking or intend to take medicines to lower blood pressure, medicines for the heart, or medicines to treat diabetes. Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine. This is particularly important if you are:

• taking medicines to lower blood pressure or to treat heart disease (such as calcium channel blockers, beta-blockers, or digoxin).
• taking medicines to treat an irregular heartbeat, such as calcium channel blockers, beta-blockers, or digoxin.
• using another eye drop containing a beta-blocker.
• taking another carbonic anhydrase inhibitor such as acetazolamide.
• taking monoamine oxidase inhibitors (MAOIs).
• taking a parasympathomimetic medicine that may have been prescribed to help you urinate. Parasympathomimetics are also a specific type of medicine sometimes used to normalize intestinal movements.
• taking narcotics such as morphine used to treat moderate to severe pain.
• taking medicines for diabetes therapy.
• taking antidepressants known as fluoxetine and paroxetine.
• taking a sulfonamide medicine.
• taking quinidine (used to treat heart conditions and certain types of malaria).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Use during pregnancy
Do not use COSOPT preservative-free during pregnancy unless your doctor considers it necessary.
Use during breastfeeding
Do not use COSOPT preservative-free while breastfeeding. Timolol may be excreted in breast milk.
Driving and using machines
No studies have been conducted on the ability to drive or use machines. Undesirable effects associated with the use of COSOPT preservative-free, such as blurred vision, may affect your ability to drive and/or use machines. Do not drive or operate machinery until you feel well or your vision is clear.

3. How to use COSOPT preservative-free

Use this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist. The appropriate dose and duration of treatment will be determined by your doctor.
The recommended dose is one drop in the affected eye(s) in the morning and one drop in the evening.
If you are using COSOPT preservative-free together with another eye drop, the drops should be administered at least 10 minutes apart.
Do not change the dose of this medicine without consulting your doctor.
If you have difficulty administering the eye drops, ask a family member or caregiver for assistance.
The tip of the multidose container must not touch the eye or surrounding areas. This may cause eye injury. The eye drop solution may also become contaminated with bacteria, which can lead to eye infections that may result in serious eye damage, including loss of vision. To avoid possible contamination of the multidose container, wash your hands before using this medicine and keep the tip of the container away from any surface.

Instructions for use
Before instilling the eye drops:

• Wash your hands before opening the bottle.
• Do not use this medicine if you notice that the tamper-evident seal on the neck of the bottle is broken before first use.
• When using the bottle for the first time, practice using it by gently pressing it to release one drop away from the eye before applying it to the eye.
• Once you feel confident in your ability to dispense one drop at a time, choose the position that is most comfortable for instilling the drops (you may sit, lie on your back, or stand in front of a mirror).
• Each time a new bottle is opened, discard the first drop.

Instillation:

1. Hold the bottle directly below the cap and twist the cap to open the bottle. Do not touch anything with the tip of the bottle to avoid contaminating the solution.

2. Tilt your head backward and hold the bottle over the eye.
3. Pull down the lower eyelid and look upward. Gently press the bottle in the center to release one drop into the eye. Note that there may be a delay of a few seconds between pressing and the drop coming out. Do not press too hard.

4. Close the eye and press gently with a finger on the inner corner of the eye for about two minutes. This helps prevent the medicine from passing into the rest of the body.

5. Repeat steps 2–4 to instill a drop into the other eye, if instructed by your doctor. Sometimes only one eye needs treatment, and your doctor will advise you accordingly.
6. After each use and before replacing the cap, shake the bottle once downward without touching the dropper tip to remove any residual liquid from the tip. This is necessary to ensure proper delivery of subsequent drops.

7. Wipe away any excess solution from the skin around the eye.
8. After the recommended in-use storage period of 2 months, some COSOPT preservative-free solution will remain in the bottle. Do not attempt to use any remaining medicine after completing the treatment course. Do not use the eye drops for more than 2 months after first opening the bottle. If you are unsure how to administer the medicine, consult your doctor, pharmacist, or nurse.

If you use more COSOPT preservative-free than you should
If you instill too many drops into the eye or if the dropper contents are swallowed, you may experience, among other effects, mild dizziness, difficulty breathing, or a sensation of slowed heartbeat. Contact your doctor immediately.
If you forget to use COSOPT preservative-free
It is important to use COSOPT preservative-free exactly as prescribed by your doctor.
If you miss a dose, use the medicine as soon as possible. However, if it is almost time for your next dose, skip the missed dose and return to your regular dosing schedule. Do not use a double dose to make up for a missed dose.
If you stop using COSOPT preservative-free
If you wish to stop treatment, speak to your doctor first.
If you have any further questions about the use of this product, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects:
If you notice any of the following side effects, stop using this medicine and consult a doctor immediately, as they may be signs of a reaction to the medicine.
Rare (may affect up to 1 in 1,000 people):

• Chest pain, oedema (fluid accumulation), changes in heart rhythm or heart rate, congestive heart failure (heart disease causing shortness of breath or swelling of feet and legs due to fluid accumulation), cardiac arrest, heart block, low blood pressure, cerebral ischaemia (reduced blood supply to the brain), stroke.
• Shortness of breath, respiratory failure, airway constriction in the lungs.
• Signs and symptoms of systemic allergic reactions, including angioedema, urticaria, itching, rash, anaphylaxis.
• Severe skin reactions, including swelling under the skin.

Other side effects:
You can usually continue using the drops unless the side effects are severe. If you are concerned, speak to your doctor or pharmacist. Do not stop using COSOPT preservative-free without talking to your doctor.
The following adverse reactions have been reported with COSOPT preservative-free or one of its components in clinical studies or during marketing:
Very common (may affect more than 1 in 10 people):

• Burning and stinging in the eyes, altered taste.

Common (may affect up to 1 in 10 people):

• Eye effects: redness of the eye(s) and surrounding area, tearing or itching of the eye(s), corneal erosion (damage to the front layer of the eyeball), swelling and/or irritation of the eye(s) and surrounding area, sensation of a foreign body in the eye, reduced corneal sensitivity (presence of a foreign body in the eye without feeling pain), eye pain, dry eyes, blurred vision.
• General side effects: headache, sinusitis (feeling of pressure or fullness in the nose), nausea, weakness/tiredness, fatigue.

Uncommon (may affect up to 1 in 100 people):

• Eye effects: inflammation of the iris, visual disturbances including changes in refraction (due in some cases to discontinuation of miotic therapy).
• General side effects: dizziness, depression, slow heart rate, fainting, shortness of breath, indigestion, kidney stones.

Rare (may affect up to 1 in 1,000 people):

• Eye effects: temporary myopia which may resolve when treatment is discontinued, detachment of the layer located beneath the retina containing blood vessels following filtering surgery which may cause visual disturbances, drooping of the eyelids (causing the eye to remain partially closed), double vision, crusting of the eyelids, corneal swelling (with symptoms of visual disturbances), low eye pressure.
• General side effects: strong heartbeat which may be fast or irregular (palpitations), Raynaud's phenomenon, swelling or coldness of hands and feet and reduced circulation in arms and legs, leg cramps and/or leg pain during walking (claudication), cough, throat irritation, dry mouth, insomnia, nightmares, memory loss, tingling or numbness in hands or feet, worsening of signs and symptoms of myasthenia gravis (a muscle disorder), decreased sexual desire, systemic lupus erythematosus (an immune disease that may cause inflammation of internal organs), ringing sounds in the ear, rhinitis, nosebleed, diarrhoea, contact dermatitis, hair loss, rash with a silvery-white appearance (psoriasiform rash), Peyronie's disease (which may cause curvature of the penis), allergic-type reactions such as rashes, urticaria, itching, and in rare cases possible swelling of the lips, eyes and mouth, wheezing.

Like other medicines administered by the ophthalmic route, timolol is absorbed into the bloodstream. This may cause side effects similar to those seen with oral beta-blockers. The incidence of side effects after topical ophthalmic administration is lower than when medicines are, for example, taken by mouth or injected. Additional side effects listed include reactions observed within the class of beta-blockers when used to treat eye conditions.
Not known (frequency cannot be estimated from the available data):
Low blood glucose levels, abdominal pain, vomiting, muscle pain not caused by exercise, sexual dysfunction, hallucination, sensation of a foreign body in the eye (feeling that something is in the eye), increased heart rate, and increased blood pressure.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store COSOPT preservative-free

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and bottle after
Exp. The expiry date refers to the last day of that month.
Do not store above 25°C.
After first opening the bottle, the solution can be used for 2 months. The bottle must
be kept tightly closed.
Do not use this medicine if you notice the seal is broken the first time you use the container.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What COSOPT preservative-free contains

• The active substances are dorzolamide and timolol. Each ml contains 20 mg of dorzolamide (equivalent to 22.26 mg of dorzolamide hydrochloride) and 5 mg of timololo (equivalent to 6.83 mg of timolol maleate).
• The other excipients are: hydroxyethylcellulose, mannitol, sodium citrate, sodium hydroxide, and water for injections.

Description of the appearance of COSOPT preservative-free and contents of the pack
COSOPT preservative-free is a clear, colourless or almost colourless, slightly viscous solution,
practically free from visible particles, contained in a white plastic bottle with a white Novelia dropper
applicator and a white plastic tamper-evident screw cap.
Pack sizes: 1, 2, or 3 bottles in a cardboard box
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Santen Italy S.r.l.
Via Roberto Lepetit, 8/10
20124 Milano
Italy

Manufacturers
Tubilux Pharma SpA
Via Costarica 20/22
00071 Pomezia (Roma)
Italy

Santen Oy
Kelloportinkatu 1
33100 Tampere
Finland

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names: