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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

dorzolamide / timolol

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet as 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, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What COSOPT eye drops, solution is and what it is used for
2. What you need to know before using COSOPT eye drops, solution
3. How to use COSOPT eye drops, solution
4. Possible side effects
5. How to store COSOPT eye drops, solution

Contents of the pack and other information

1. What Cosopt eye drops solution 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 reduce eye pressure in different ways.

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

2. What you need to know before using Cosopt eye drops solution

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 wheezing, difficulty breathing, and/or long-standing cough).
• if you have a slow heartbeat, heart failure, or heart rhythm disorders (irregular heartbeats).
• if you suffer from severe kidney disease or have a history of kidney stones.
• if you have excess blood acidity caused by an accumulation of chlorides in the blood (hyperchloremic acidosis).

If you are unsure whether you should use this medicine, 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 eye conditions:

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

Inform your doctor, before undergoing surgery, that you are using COSOPT, as timolol may alter the effects of certain 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 have 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 eyelid swelling, consult your doctor immediately.

If you suspect that COSOPT is causing you an allergic reaction or hypersensitivity (for example, skin rash, severe skin reaction, or redness and itching of the eyes), stop using this medicine and consult your doctor immediately.

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

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

Children

Limited clinical data are available on administration in infants and children.

Elderly patients

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

Use in patients with hepatic impairment

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

Use of COSOPT with other medicines

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

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

Use in athletes: This medicine contains timolol, which may result in a positive test in doping controls.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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 medicine while breastfeeding.

Driving and using machines

No studies have been conducted on the effects on the ability to drive or use machines. Adverse effects associated with COSOPT, such as blurred vision, 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 medicine contains approximately 0.002 mg of benzalkonium chloride per 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 medicine 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 foreign body sensation, stinging, or eye pain after using this medicine.

3. How to use Cosopt eye drops solution

Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again. Your doctor will determine the appropriate dosage and duration of treatment.

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

If you are using this medicine at the same time as 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.

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

Instructions for use:

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

Each time you use COSOPT:

If you use more COSOPT than you should

If you apply too many drops to the eye or accidentally swallow any of the contents, you may experience effects such as dizziness, difficulty breathing, or a slower heartbeat.

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

If you forget to use COSOPT

It is important to use this medicine exactly as your doctor has instructed.

If you forget to apply a dose, apply it as soon as possible. However, if it is almost time for the next dose, do not take the missed dose and continue with 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 with this medicine, consult your doctor first.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Serious adverse effects:

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

Generalized reactions including swelling beneath the skin, which may occur in areas such as the face and limbs, and may obstruct the airways, potentially causing difficulty swallowing, shortness of breath, hives or itchy rash, widespread or localized rash, itching, or a severe allergic reaction that suddenly becomes life-threatening.

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

The following adverse reactions have been reported with COSOPT or with 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, altered taste

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

Redness in and around the eye(s), tearing or eye itching, corneal erosion (damage to the front layer of the eyeball), inflammation and/or irritation in and around the eye(s), sensation of a foreign body in the eye, decreased corneal sensitivity (inability to sense that something is in the eye and lack of pain sensation), eye pain, dry eyes, blurred vision, headache, sinusitis (feeling of pressure or congestion in the nose), nausea, weakness/tiredness and fatigue.

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

Dizziness, depression, iris inflammation, visual disturbances, including changes in refraction (in some cases due to discontinuation 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 (an immune disease that may cause inflammation of internal organs), tingling or numbness in the hands or feet, insomnia, nightmares, memory loss, increased signs and symptoms of myasthenia gravis (a muscle disorder), decreased libido, stroke, transient myopia that resolves upon discontinuation of therapy, detachment of the lower layer of the retina containing blood vessels after filtration surgery, which may cause visual disturbances, drooping eyelid (causing the eye to remain partially closed), double vision, eyelid crusting, corneal swelling (with symptoms of visual disturbances), low eye pressure, ringing sounds in the ear, low blood pressure, changes in the rhythm or rate of heartbeat, 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, strong heartbeats that may be rapid or irregular (palpitations), 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), difficulty breathing, worsening of lung function, runny or congested nose, nosebleeds, constriction of airways in the lungs, cough, throat irritation, dry mouth, diarrhea, contact dermatitis, hair loss, skin rash with a silvery-white appearance (psoriasiform rash), Peyronie's disease (which may cause penile curvature), allergic-type reactions such as skin rash, hives, itching, and in rare cases possible swelling of the lips, eyes, and mouth, wheezing, or severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Like other medicines applied to the eyes, timolol is absorbed into the bloodstream. This may cause adverse effects similar to those seen with oral beta-blockers. The incidence of adverse effects after topical ophthalmic administration is lower than when medicines are taken orally or injected. The additional adverse effects listed include reactions occurring within the class of beta-blockers when used to treat ocular disorders.

Frequency not known (frequency cannot be estimated from available data):

Low blood glucose levels, heart failure, a type of heart rhythm disturbance, abdominal pain, vomiting, muscle pain not caused by exercise, sexual dysfunction, hallucinations, sensation of a foreign body in the eye, abnormal sensitivity of the eyes to light, increased heart rate, and increased blood pressure.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Cosopt eye drops solution

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

Do not use this medicine after the expiry date stated on the label of the container and the carton, following EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage temperature. Keep the container in the outer packaging to protect it from light.

COSOPT must be used within 28 days of first opening the container.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of COSOPT

• The active substances are dorzolamide and timolol.

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

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

Appearance of the product and contents of the pack

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

COSOPT is supplied in a translucent white container containing 5 ml of solution. The plastic container is closed with a white screw cap.

The security strip on the container label provides evidence that the medicine has not been tampered with.

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)

Only certain pack sizes may be marketed.

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, 7º
28045 – Madrid
Spain

This medicinal product is authorized in 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, the Netherlands, Portugal, Spain, Sweden, and the United Kingdom (Northern Ireland): COSOPT

Date of the most recent review of this leaflet: 01/2026

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/