Label: information for the user

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

dorzolamida / timolol

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section4.

Contents of the package and additional information

COSOPT contains two medications: dorzolamide and timolol.

• Dorzolamide belongs to a group of medications called "carbonic anhydrase inhibitors".
• Timolol belongs to a group of medications called "beta-blockers".

These medications lower eye pressure in different ways.

COSOPT is prescribed to reduce elevated intraocular pressure in the treatment of glaucoma when the use of a beta-blocker eye drop as monotherapy is not suitable.

No use COSOPT

• If you are allergic to dorzolamide hydrochloride, timolol maleate, or any of the other components of this medication (listed in section6).
• If you have or have had respiratory problems, such as asthma or severe chronic obstructive pulmonary disease (a serious lung disease that can cause wheezing, difficulty breathing, and/or long-standing cough).
• If you have a slow heart rate, heart failure, or irregular heart rhythm.
• If you have severe kidney disease or a history of kidney stones.
• If you have excessive blood acidity caused by a buildup of chloride in the blood (hyperchloremic acidosis).

If you are unsure whether you should use this medication, consult your doctor or pharmacist.

Warnings and Precautions

Consult your doctor before starting to use COSOPT.

Inform your doctor of any current or past medical or ocular problems:

• Coronary heart disease (symptoms may include chest pain or tightness, difficulty breathing, or choking), heart failure, low blood pressure.
• Irregular heart rhythm, such as decreased heart rate.
• Respiratory problems, asthma, or chronic obstructive pulmonary disease.
• Poor blood circulation (such as Raynaud's disease or Raynaud's syndrome).
• Diabetes, as timolol may mask signs and symptoms of low blood sugar.
• Hyperthyroidism, as timolol may mask signs and symptoms.

Inform your doctor before undergoing surgery that you are using COSOPT, as timolol may affect the effects of some medications used during anesthesia.

Also, inform your doctor about any allergies or allergic reactions, including hives, swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing.

Inform your doctor if you experience muscle weakness or have been diagnosed with myasthenia gravis (muscle weakness).

If you develop any other eye irritation or new eye problems, such as eye redness or swelling of the eyelids, consult your doctor immediately.

If you suspect that COSOPT is causing an allergic reaction or hypersensitivity (such as skin rash, severe skin reaction, or eye redness and itching), stop using this medication and consult your doctor immediately.

Inform your doctor if you experience an eye infection, if you suffer an eye injury, if you undergo eye surgery, or if you develop a reaction that includes new symptoms or worsening of existing ones.

COSOPT may affect the entire body when instilled in the eye.

Children

There is limited clinical data on the administration in infants and children.

Older patients

In studies with COSOPT, the effects of this medication were similar in older patients and younger patients.

Use in patients with liver impairment

Inform your doctor if you have or have had liver problems.

Use of COSOPT with other medications

COSOPT may affect or be affected by other medications you are using, including other eye drops for glaucoma treatment. Inform your doctor if you are using or plan to use medications to lower blood pressure, heart medications, or diabetes medications. Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. This is particularly important if you are:

• Using medications to lower blood pressure or treat heart disease (such as calcium channel blockers, beta blockers, or digoxin).
• Using medications to treat irregular heart rhythm, such as calcium channel blockers, beta blockers, or digoxin.
• Using another eye drop that contains beta blockers.
• Using another carbonic anhydrase inhibitor, such as acetazolamide.
• Using monoamine oxidase inhibitors (MAOIs).
• Using a cholinergic agonist that may have been prescribed to help eliminate urine. Cholinergic agonists are also a type of medication that may be used to help restore normal movements through the intestines.
• Using narcotics, such as morphine used to treat moderate to severe pain.
• Using medications to treat diabetes.
• Using antidepressants known as fluoxetine and paroxetine.
• Using a sulfonamide.
• Using quinidine (used to treat heart disorders and some types of malaria).

Use in athletes: This medication contains timolol, which may produce a positive result in doping control tests.

Pregnancy and lactation

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

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

Do not use COSOPT if you are breastfeeding. Timolol may pass into breast milk. Ask your doctor for advice before taking any medication during breastfeeding.

Driving and operating machinery

No studies have been conducted on the effects on the ability to drive or operate machinery. There are adverse 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

This medication contains approximately 0.002 mg of benzalkonium chloride in each drop, equivalent to 0.075 mg/ml.

Benzalkonium chloride may be absorbed by soft contact lenses, altering their color. Remove contact lenses before using this medication and wait 15 minutes before reinserting them.

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases (the transparent layer at the front of the eye). Consult your doctor if you experience a strange sensation, stinging, or eye pain after using this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. Your doctor will establish the appropriate dosage and treatment duration.

The recommended dose is one drop in the affected eye or eyes in the morning and at night.

If you use this medication at the same time as another eye drop, the drops should be applied at least 10 minutes apart.

Do not change the medication dose without consulting your doctor.

Do not let the tip of the container touch your eyes or the surrounding areas. It may be contaminated with bacteria capable of causing eye infections that can cause serious eye damage, including loss of vision. To avoid possible contamination of the container, wash your hands before using this medication and avoid letting the tip of the container come into contact with any surface. If you think your medication may be contaminated, or if you develop an eye infection, consult your doctor immediately to see if you can continue using this container.

Usage Instructions:

Do not use the container if the plastic safety seal around the neck of the container is not there or is broken. When opening the container for the first time, remove the plastic safety seal.

Each time you use COSOPT:

If you use more COSOPT than you should:

If too many drops are applied to the eye or if you swallow some of the contents of the container, among other effects, you may feel drowsy, have difficulty breathing, or notice that your heart is beating more slowly.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20.

If you forget to use COSOPT:

It is essential to administer this medication as your doctor has instructed.

If you forget to apply a dose, administer it as soon as possible. However, if it is almost time for the next dose, do not administer the missed dose and continue with the regular dosing schedule.

Do not use a double dose to compensate for the missed doses.

If you interrupt treatment with COSOPT:

If you want to stop treatment with this medication, consult your doctor first.

If you have any other questions about using this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Severe side effects:

If you experience any of the following side effects, stop using this medicine and consult your doctor immediately, as they may be signs of a medication reaction.

Generalized reactions including swelling under the skin that may occur in areas such as the face and limbs, and may obstruct the airways, causing difficulty swallowing, shortness of breath, hives or rash with itching, generalized and localized rash, itching, severe allergic reaction that suddenly puts life in danger.

Generally, you can 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 talking to your doctor.

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

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

Burning and stinging of the eyes, alteration of taste

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

Redness in and around the eye or eyes, tearing or eye itching, corneal erosion (damage to the front layer of the eyeball), inflammation and/or irritation in and around the eye or eyes, sensation of having something in the eye, decreased corneal sensitivity (does not feel like there is something in the eye and does not feel pain), eye pain, dry eyes, blurred vision, headache, sinusitis (sensation of tension or congestion in the nose), nausea, weakness/fatigue and tiredness.

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

Dizziness, depression, iris inflammation, vision changes, including refractive changes (in some cases due to suspension of miotic therapy), decreased heart rate, fainting, shortness of breath, indigestion and kidney stones.

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

Systemic lupus erythematosus (a disease that can cause inflammation of internal organs), tingling or numbness of the hands or feet, insomnia, nightmares, memory loss, an increase in signs and symptoms of myasthenia gravis (muscular disorder), decreased libido, stroke, transient myopia that resolves upon cessation of therapy, retinal detachment that occurs after glaucoma filtration surgery and may cause visual disturbances, drooping eyelid (causing the eye to remain half-closed), double vision, crusts on the eyelid, corneal edema (with symptoms of visual disturbances), low eye pressure, ringing in the ears, low blood pressure, changes in heart rhythm or rate, congestive heart failure (heart disease with shortness of breath and swelling of feet and legs due to fluid accumulation), edema (fluid accumulation), cerebral ischemia (reduced blood flow to the brain), chest pain, palpitations (strong and irregular heartbeats), heart attack, Raynaud's phenomenon, swollen or cold hands and feet and decreased circulation in arms and legs, leg cramps and/or leg pain when walking (claudication), shortness of breath, pulmonary function deterioration, nasal congestion or discharge, nosebleed, bronchial constriction in the lungs, cough, throat irritation, dry mouth, diarrhea, contact dermatitis, hair loss, psoriasiform rash with a silver-white appearance, Peyronie's disease (which may cause penile curvature), allergic reactions such as skin rash, hives, itching, in rare cases possible swelling of the lips, eyes, and mouth, wheezing, or severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Like other eye medications, timolol is absorbed into the bloodstream. This can cause side effects similar to those that appear with oral beta-blockers. The incidence of side effects after topical ocular administration is lower than when medications, for example, are taken by mouth or injected. Additional listed side effects include reactions that appear within the class of beta-blockers when used to treat eye disorders.

Unknown (frequency cannot be estimated from available data):

Low blood sugar levels, congestive heart failure, a type of heart rhythm alteration, abdominal pain, vomiting, muscle pain not caused by exercise, sexual dysfunction, hallucinations, sensation of a foreign body in the eye (sensation of having something in the eye), increased heart rate, and increased blood pressure.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label of the container and the box after CAD. The expiration date is the last day of the month indicated.

This medication does not require any special temperature for conservation. Store the container in the outer packaging to protect it from light.

COSOPT should be used within 28 days after the initial opening of the container.

Medicines should not be thrown down the drains or in the trash. Dispose of the containers and medicines that you do not need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines that you do not need. In this way, you will help to protect the environment.

COSOPT Composition

• The active principles are dorzolamide and timolol.

Each ml contains 20 mg of dorzolamide (as 22.26 mg of dorzolamide hydrochloride) and 5 mg of timolol (as 6.83 mg of timolol maleate).

• The other components are hydroxyethyl cellulose, mannitol, sodium citrate, sodium hydroxide, and water for injection preparations. Benzalkonium chloride is added as a preservative.

Product appearance and container contents

COSOPT is a clear, colorless, or almost colorless, slightly viscous solution.

COSOPT is presented in a transparent white plastic container with 5 ml of solution. The plastic container is closed with a white screw cap.

The security strip found on the container label provides evidence that the medication has not been manipulated.

Container 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)

Only some container sizes may be commercially available.

Marketing authorization holder and manufacturer

Marketing authorization holder

Santen Oy

Niittyhaankatu 20

33720 Tampere

Finland

Manufacturer

Santen Oy

Kelloportinkatu 1

33100 Tampere

Finland

Local representative

Santen Pharmaceutical Spain S.L.

Acanto, 22, 7th floor

28045 – Madrid

Spain

This medication is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, and United Kingdom (Northern Ireland): COSOPT

Last review date of this leaflet: 09/2023

More detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/