COSOPT 20 mg /Ml + 5 Mg/Ml Krople Do Oczu, Roztwór

Treść ulotki

1. COSOPT 20 mg/ml + 5 mg/ml eye drops, solution
   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. Package contents and other information
2. COSOPT without preservative 20 mg/ml + 5 mg/ml eye drops, solution
   1. What COSOPT without preservative is and what it is used for
   2. What you need to know before using COSOPT without preservative
   3. How to use COSOPT without preservative
   4. Possible side effects
   5. How to store COSOPT without preservative
   6. Package contents and other information

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

(dorzolamide / timolol)

Read this leaflet carefully before you start using this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you use 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 lower elevated intraocular pressure in the treatment of glaucoma
when monotherapy with beta-blocker eye drops 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 have or have had respiratory problems, such as asthma, or severe chronic obstructive bronchitis (a severe lung disease that can cause shortness of breath, difficulty breathing and/or long-standing cough).
• If you have a slow heartbeat, heart failure or heart rhythm disturbances (irregular heartbeat).
• If you have severe kidney disease or problems, or if you have had kidney stones in the past.
• If you have an excess of acidity in the blood caused by the accumulation of chloride in the blood (hyperchloremic acidosis). If you are not sure if this medicine is right for you, ask your doctor or pharmacist.

Warnings and precautions
Talk to your doctor before using COSOPT
Tell your doctor about any medical or eye problems you have now or have had in the past:

• 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.
• Respiratory problems, asthma or chronic obstructive lung 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 disease as timolol may mask the signs and symptoms of it.

Before undergoing surgery, you must inform your doctor that you are using COSOPT
because timolol may change the effects of some medicines used during anesthesia.
You should also tell your doctor about any allergies or allergic reactions including hives,
swelling of the face, lips, tongue and/or throat that can cause difficulty breathing or
swallowing.
Inform your treating doctor if you have muscle weakness or if you have been diagnosed with
myasthenia gravis.
Immediately inform your treating doctor if you experience any eye irritation or
any new problem such as eye redness or eyelid swelling.
If you suspect that COSOPT is the cause of an allergic reaction or hypersensitivity (for
example, rash, severe skin reaction, or redness and itching of the eye) stop using
this medicine and contact your treating doctor immediately.
Inform your treating doctor if you develop an eye infection, or an eye injury occurs, you undergo any type of eye surgery or if new symptoms develop or existing symptoms worsen.
When you instill COSOPT into the eye, it can have an effect on the entire body.
Consult your treating doctor before using this medicine if you are using soft contact lenses.
For those who play sports: the use of the medicine without a therapeutic need constitutes doping and
may still result in a positive doping test.

Use in children
There is limited experience with COSOPT in infants and children.

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

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

Other medicines and COSOPT
COSOPT can influence or be influenced by other medicines you are taking, including other
eye drops for the treatment of glaucoma. Tell your doctor if you are taking or intend to take medicines to
lower blood pressure, medicines for the heart or medicines for diabetes.
Tell 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 antagonists, beta-blockers or digoxin).
• Taking medicines to treat a heart rhythm disorder such as calcium antagonists, 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 particular types of medicines that are sometimes used to normalize bowel movements.
• Taking narcotics such as morphine used for the therapy of moderate to severe pain.
• Taking medicines for the therapy of diabetes.
• Taking antidepressants known as fluoxetine and paroxetine.
• Taking a sulfonamide.
• Taking quinidine (used to treat 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 if you are pregnant unless your doctor considers it necessary.

Use while breastfeeding
Do not use COSOPT if you are breastfeeding. Timolol may be excreted in breast milk. Ask your doctor for advice before taking any medicine while breastfeeding.

Driving and using machines
The effects on the ability to drive and use machines have not been studied. There are
side effects associated with the use of COSOPT, such as blurred vision, which can interfere
with the ability to drive vehicles and/or use machines. You should avoid driving or using machines until
you feel well or your vision is not blurred.

COSOPT containsbenzalkonium chloride
If you use soft contact lenses, you should consult your doctor before using COSOPT (the
preservative benzalkonium chloride can alter the color of the lenses).

3. How to use COSOPT

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist. The appropriate dose and duration of treatment will be established by your
doctor.
The recommended dose is one drop in the morning and one drop in the evening to be instilled in the affected eye(s).
If this medicine is used together with other eye drops, the drops must be instilled at an
interval of at least 10 minutes.
Do not change the dose of the medicine without consulting your doctor.
The tip of the dropper must not come into contact with the eye or the surrounding areas. It may
become contaminated with bacteria, which can cause eye infections that can induce serious eye damage, including loss of vision. To avoid possible contamination of the
dropper, wash your hands before using this medicine and do not rest the
tip of the dropper on any surface. If you think the medicine may be
contaminated, or if you develop an eye infection, 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 container is
missing or broken. When you open 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 particularly careful that the tip of the dropper container does not touch your eye, the skin around your eye, or your fingers.
• 3. Tilt your head back and hold the container upside down over your eye.

• 4. Pull down your lower eyelid and look up. Hold the container and gently press on the flattened sides and let one drop fall into the space between your lower eyelid and your eye.

• 5. Press with a finger on the corner of your eye, near your nose, or close your eyelids for 2 minutes. This helps to prevent the medicine from passing into the rest of your body.
• 6. Repeat steps 3 to 5 with the other eye if it has been prescribed by your doctor.
• 7. Replace the cap and close the container tightly.

[Only OCUMETER PLUS containers]

• 1. Before using the medicine for the first time, make sure that the safety seal located on the front of the container is intact. A space between container and cap is normal for a container that has not yet been opened.

►

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

• 3. To open the container, unscrew the cap by rotating it in the direction indicated by the arrows that are on top of the cap. Do not pull the cap directly off the container. Pulling the cap directly off will prevent the dropper from working properly.

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

• 5. Turn the container upside down and press gently with your thumb or index finger at the level of the compressible area (as shown) until a single drop has been introduced
  into the eye, as prescribed by your doctor.

DO NOT LET THE TIP OF THE DROPPER COME INTO CONTACT WITH THE EYE OR THE
EYELID.

• 6. After using COSOPT, press with a finger on the corner of your eye, near your nose, or close your eyelids for 2 minutes. This helps to stop the passage of the medicine into the rest of your body.

• 7. If administering the drops is difficult after opening the container for the first time, replace the cap on the container and tighten (not excessively) and then remove by turning the cap in the opposite direction as indicated by the arrows on 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 on tightly again. The arrow on the left side of the cap must be aligned with the arrow on the left side of the container label to ensure a proper seal. Do not tighten excessively to avoid damaging the container and cap.
• 10. The dropper is calibrated for the release of a single drop; therefore, DO NOT widen the hole in the dropper.
• 11. Once the doses are exhausted, the container will still contain some residue of COSOPT. The container actually contains an excess of this medicine to ensure the availability of the complete dose of COSOPT prescribed by your doctor. Do not remove the excess medicine from the container.

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

If you forget to take COSOPT
It is important that this medicine is administered according to the methods and times prescribed by
your doctor. If you forget to instill a dose, take that dose as soon as
possible. However, if it is almost time for the next dose, skip the forgotten dose
and resume your usual dosing schedule.
Do not take a double dose to make up for a missed dose.

If you stop taking COSOPT
If you want to stop treatment, talk to your doctor first.
If you have any further questions about the use of this product, ask your doctor or
pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Serious side effects:
If you notice the appearance of the following side effects, stop using this medicine and consult your doctor immediately as these could be signs of a reaction to the medicine.
Generalized allergic reactions including swelling under the skin that can occur in areas such as the face and limbs, and can obstruct the airways which can cause difficulty swallowing, shortness of breath, hives or itchy rash, localized and generalized rash, itching, severe allergic reaction with life-threatening risk.
You can usually continue to take the drops unless the effects are serious. If you are concerned, consult your doctor or pharmacist. Do not stop using COSOPT without talking to your doctor.
The frequency of possible side effects listed below is defined using the following convention:
Very common (affects more than 1 in 10 users)
Common (affects 1 to 10 users in 100)
Uncommon (affects 1 to 10 users in 1,000)
Rare (affects 1 to 10 users in 10,000)
Not known (frequency cannot be defined on the basis of 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 sensation in the eyes, altered taste
Common:
Redness of the eye(s) and surrounding area, tearing or itching in the eye(s), corneal erosion (damage to the front layer of the eyeball), swelling and/or irritation of the eye(s) and surrounding area, foreign body sensation in the eye, decreased corneal sensitivity (you do not feel the presence of a foreign body in the eye and do not feel pain), eye pain, dry eye, blurred vision, headache, sinusitis (feeling of tension or fullness in the nose), nausea, weakness/fatigue, tiredness
Uncommon:
Dizziness, depression, inflammation of the iris, visual disturbances including changes in refraction (due in some cases to discontinuation of miotic therapy), slowed heartbeat, fainting, shortness of breath, indigestion and kidney stones
Rare:
Systemic lupus erythematosus (an autoimmune disease that can cause inflammation of internal organs), tingling or numbness in the hands or feet, insomnia, nightmares, memory loss, an increase in the signs and symptoms of myasthenia gravis (muscle disorder), decreased sexual desire, stroke, temporary myopia that may resolve with discontinuation of treatment, detachment of the layer located under the retina containing blood vessels following filtering surgery which may cause visual disturbances, drooping eyelids (making the eye half-closed), double vision, crusting on the eyelids, corneal edema (with symptoms of visual disturbances), low intraocular pressure, ringing sounds in the ear, low blood pressure, changes in heart rate or rhythm, congestive heart failure (heart disease with shortness of breath and swelling of the feet and legs due to fluid accumulation), edema (fluid accumulation), cerebral ischemia (reduced blood supply to the brain), chest pain, strong heartbeat that may be fast or irregular (palpitations), heart attack, Raynaud's phenomenon, swollen or cold hands and feet and reduced circulation in the arms and legs, leg cramps and/or leg pain during walking (claudication), shortness of breath, impaired lung function, nasal secretion or congestion, nosebleeds, constriction of the airways in the lungs, cough, sore throat, dry mouth, diarrhea, contact dermatitis, hair loss, rash with a silvery-white appearance (psoriasiform rash), Peyronie's disease (which can cause a curvature of the penis), allergic-type reactions including rashes, hives, itching, in rare cases swelling of lips, eyes and mouth, shortness of breath, or severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis)
As with other medicines administered via ophthalmic route, timolol is absorbed into the bloodstream. This can cause side effects similar to those seen with oral beta-blockers. The incidence of side effects after topical ophthalmic administration is lower than when the medicines are, for example, taken orally or injected. Further side effects listed include reactions seen within the beta-blocker class 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 foreign body sensation in the eye (feeling that something is in the eye).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you 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 which is stated on the label of the container and on the
pack after “Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature. Keep the container
in the outer packaging to protect the medicine from light.
Once opened for the first time, the COSOPT container must be used within 28 days
afterwards.
Do not dispose of any medicine in 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 ingredients 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 package contents
COSOPT is a clear, colorless to slightly colored, slightly viscous solution.
Cosopt is presented in a container consisting of a translucent white plastic container 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.
Evidence of tampering is provided by a security seal 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 and Manufacturer
Marketing Authorisation Holder
Santen Italy S.r.l.
Via Roberto Lepetit, 8/10

• 20124 Milan

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 Member States of the European Economic Area under the
following denominations:
Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands,
Portugal, Spain, Sweden, United Kingdom:
COSOPT

COSOPT without preservative 20 mg/ml + 5 mg/ml eye drops, solution

(dorzolamide / timolol)

Read this leaflet carefully before you start using this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What COSOPT without preservative is and what it is used for
• 2. What you need to know before you use COSOPT without preservative
• 3. How to use COSOPT without preservative
• 4. Possible side effects
• 5. How to store COSOPT without preservative
• 6. Contents of the pack and other information

1. What COSOPT without preservative is and what it is used for

COSOPT without preservative 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 without preservative is prescribed to lower elevated intraocular pressure in the
treatment of glaucoma when monotherapy with beta-blocker eye drops is not sufficient.
COSOPT without preservative eye drops, solution is a sterile solution that does not contain a preservative.

2. What you need to know before using COSOPT without preservative

Do not use COSOPT without preservative

• if you are allergic to dorzolamide hydrochloride, to timolol maleate or to any of the other ingredients of this medicine (listed in section 6).
• If you have now or have had in the past breathing problems, such as asthma, or severe chronic obstructive bronchitis (a severe lung disease that can 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 problems, or if you have had kidney stones in the past.
• If you have an excess of acidity in the blood caused by the accumulation of chloride in the blood (hyperchloremic acidosis). If you are not sure if it is right for you to use this medicine, ask your doctor or pharmacist.

Warnings and precautions
Talk to your doctor before using COSOPT without preservative if you currently have or have had in the
past:

• coronary heart disease (symptoms may include chest pain or a feeling of pressure, shortness of breath, or suffocation), heart failure, low blood pressure.
• Heart rate disorders such as slow heartbeat.
• Breathing problems, asthma or chronic obstructive lung disease.
• Poor blood circulation (such as Raynaud's disease or Raynaud's syndrome).
• Diabetes because timolol can mask the signs and symptoms of low blood sugar levels.
• Hyperactivity of the thyroid gland as timolol can 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 without preservative has not been studied in patients who wear contact lenses.

If you have a history of contact hypersensitivity to silver, you should not use this medicine
because the dispensed drops may contain traces of silver from the container closure.
Before undergoing surgery, you must inform your doctor that you are using COSOPT without
preservative as timolol can change the effects of some medicines used during
anesthesia.
When COSOPT without preservative is instilled into the eye, it can have an effect on the whole
body.
Tell your doctor if during treatment with COSOPT without preservative you:

• develop any eye irritation or any new problem such as redness of the eye or swelling of the eyelid.
• Suspect that COSOPT without preservative is causing an allergic or hypersensitivity reaction (for example, rash, severe skin reaction, or redness and itching of the eye). Stop using this medicine and contact your doctor immediately.
• Develop an eye infection, or an eye injury occurs, undergo any type of eye surgery or develop a reaction including new symptoms or worsening of symptoms. For those who engage in sports: the use of the medicine without a therapeutic need constitutes doping and may still result in positive doping tests.

Children
There is limited experience with COSOPT (formulation with preservative) in infants and children.

Use in the elderly
In clinical studies with COSOPT (formulation with preservative), the effects of this medicine
observed in elderly patients and younger patients were similar.

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

Other medicines and COSOPT without preservative
COSOPT without preservative can affect or be affected by other medicines you are
taking, including other eye drops for the treatment of glaucoma. Tell your doctor if you are taking or
intend to take medicines to lower blood pressure, medicines for the heart or medicines to
treat diabetes. Tell 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 to treat heart disease (such as calcium antagonists, beta-blockers or digoxin).
• Taking medicines to treat a heart disorder or an irregularity of the heartbeat such as calcium antagonists, 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 particular types of medicines that are sometimes used to normalize bowel 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.
• Taking quinidine (used to treat heart conditions and some types of malaria).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Use in pregnancy
Do not use COSOPT without preservative if you are pregnant unless your doctor considers it
necessary.

Use in breastfeeding
Do not use COSOPT without preservative if you are breastfeeding. Timolol may be excreted in breast milk.

Driving and using machines
Studies have not been conducted on the ability to drive vehicles or use machines. There are side
effects associated with the use of COSOPT without preservative, such as blurred vision, which
may interfere with the ability to drive vehicles and/or use machines. Do not drive or use machinery
until you feel well or your vision is clear.

3. How to use COSOPT without preservative

Use this medicine following the doctor’s instructions exactly. If you have any doubts, consult your
doctor or pharmacist. The appropriate dose and duration of treatment will be established by your doctor.

The recommended doseis one drop in the morning and one in the evening in the affected eye(s).
If you are using COSOPT without preservative with another eye drop, the drops must be instilled at
intervals of at least 10 minutes.
Do not change the dose of the medicine without consulting your treating doctor.
If you have difficulty administering the eye drops, ask for assistance from a family member or caregiver.
The tip of the multi-dose container must not come into contact with the eye or the surrounding areas.
This may cause eye injury. The eye drop solution may also become contaminated with bacteria that
can cause eye infections that can lead to serious eye damage, including vision loss. To avoid possible contamination of the multi-dose container, wash your hands before using
this medicine and keep the tip of the multi-dose 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 you use the bottle for the first time, before dispensing a drop into the eye, you must practice using the bottle by pressing it gently to release a drop away from the eye.
• When you feel confident that you can dispense one drop at a time, choose the position you find most comfortable for instilling the drops (you can sit, lie on your back, or stand in front of a mirror).
• Each time a new bottle is opened, discard one drop

Instillation:

• 1. Take the bottle directly under the cap and turn the cap to open the bottle. Do not touch anything with the tip of the bottle to avoid contamination of the solution.
• 2. Tilt your head back and hold the bottle above your eye.

• 3. Pull down your lower eyelid and look up. Gently press the bottle in the center and let one drop fall into your eye. Keep in mind that there may be a few seconds delay between pressing and the drop coming out. Do not press too hard.

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

• 5. Repeat instructions 2 - 4 to release one drop into the other eye, if your doctor has told you to do so. Sometimes only one eye needs to be treated and your doctor will advise you if this applies to you and which eye needs treatment.
• 6. After each use and before replacing the cap, the bottle must be shaken once downwards, without touching the dropper tip to remove any liquid residue from the tip. This is necessary to ensure the dispensing of subsequent drops.

• 7. Remove any excess solution from the skin around your eye.
• 8. After the 2-month in-use shelf life of the medicine has expired, some residue of COSOPT without preservative will remain in the bottle. Do not attempt to use any excess medicine remaining in the bottle after completing the treatment cycle. Do not use the eye drops more than two months after first opening the bottle. If you are unsure about how to administer the medicine, ask your doctor, pharmacist or nurse.

If you take more COSOPT without preservative than you should
If you instill too many drops into your eye or if the contents of the dropper are swallowed, you may experience, among other effects, a mild feeling of dizziness, difficulty breathing, or a feeling of slowed heartbeat. Contact your doctor immediately.

If you forget to take COSOPT without preservative
It is important to take COSOPT without preservative as prescribed by your doctor.
If you forget a dose, take the medicine as soon as possible. However, if it is almost time for the
next dose, skip the missed dose and resume your usual dosing schedule.
Do not take a double dose to make up for a missed dose.

If you stop taking COSOPT without preservative
If you want to stop treatment, talk to your doctor first.
If you have any further questions about the use of this product, ask 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 these could be signs of a reaction to the medicine.

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

• Chest pain, edema (fluid retention), altered heart rate or rhythm, congestive heart failure (heart disease with shortness of breath or swelling of the feet and legs due to fluid accumulation), cardiac arrest, heart block, low blood pressure, cerebral ischemia (reduced blood supply to the brain), stroke.
• Shortness of breath, respiratory failure, constriction of the airways 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 to take the drops unless the effects are serious. If you are worried
consult your doctor or pharmacist. Do not stop using COSOPT without preservative without talking
to your doctor.
The following adverse reactions have been reported with COSOPT without preservative or one of its
components in clinical studies or during post-marketing:

Very common (may affect more than 1 in 10 people):

• Burning and stinging sensation in the eyes, altered taste.

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

• Effects on the eye: 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, foreign body sensation in the eye, decreased corneal sensitivity (foreign body in the eye and not feeling pain), eye pain, dry eye, blurred vision.
• General side effects: headache, sinusitis (feeling of fullness or congestion in the nose), nausea, weakness/fatigue, tiredness.

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

• Effects on the eye: inflammation of the iris, visual disturbances including changes in refraction (due in some cases to discontinuation of miotic therapy).
• General side effects: dizziness, depression, slowed heartbeat, fainting, shortness of breath, indigestion, kidney stones.

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

• Effects on the eye: temporary myopia that may resolve when treatment is stopped, detachment of the localized layer under the retina containing blood vessels following filtering surgery which may cause visual disturbances, drooping of the eyelid (making the eye half-closed), double vision, crusting on the eyelids, corneal swelling (with symptoms of visual disturbances), low pressure in the eye.
• General side effects: strong heartbeat that may be fast or irregular (palpitations), Raynaud's phenomenon, swelling or coldness of the hands and feet and reduced circulation in the arms and legs, leg cramps and/or leg pain during walking (claudication), cough, sore throat, dry mouth, insomnia, nightmares, memory loss, tingling or numbness in the hands or feet, increased signs and symptoms of myasthenia gravis (muscle disorder), decreased libido, systemic lupus erythematosus (an autoimmune disease that can cause inflammation of

internal organs), ringing sounds in the ear, rhinitis, nosebleeds, diarrhea, contact dermatitis, hair loss, skin rash with a silvery-white appearance (psoriasiform rash), Peyronie's disease (which can cause a curvature of the penis), allergic-type reactions such as skin rashes, urticaria, itching, in rare cases possible swelling of the lips, eyes and mouth, wheezing.
As with other ophthalmic medications, timolol is absorbed into the bloodstream. This can
cause side effects similar to those seen with oral beta-blockers. The incidence of side
effects after topical ophthalmic administration is lower than when the medications are,
for example, taken by mouth or injected. Further adverse effects listed include reactions
seen within the class of beta-blockers when used to treat eye conditions.

Frequency not known (the frequency cannot be estimated from the available data):
Low blood glucose levels, abdominal pain, vomiting, muscle pain not caused by
exercise, sexual dysfunction, hallucination, foreign body sensation in the eye (feeling
that something is in the eye), increased heart rate and increased blood pressure.

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

5. How to store COSOPT without preservative

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date indicated on the carton and the bottle after
Exp. The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
After the first opening of 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 that the seal is broken the first time you use the container.
Do not dispose of any medicine in 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 without preservative contains

• The active ingredients 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.

Description of the appearance of COSOPT without preservative and package contents
COSOPT without preservative is a clear, colorless or almost colorless, slightly viscous solution,
practically free from visible particles, contained in a white plastic bottle with a white Novelia dropper applicator
and with a white tamper-evident plastic 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

Manufacturer
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 denominations: