COSOPT 20 mg/ml + 5 mg/ml EYE DROPS SOLUTION

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

Do not use COSOPT

• if you are allergic to dorzolamida hydrochloride, timolol maleate or any of the other ingredients of this medicine (listed in section 6).
• if you have now or have had in the past respiratory problems such as asthma or severe chronic obstructive pulmonary disease (severe lung disease which may cause wheezing, difficulty in breathing and/or coughing for a long time).
• if you have a slow heart rate, heart failure or irregular heart beats (abnormal heart rhythms).
• if you have severe kidney disease or a past history of kidney stones.
• if you have excess acidity of the blood caused by a build-up of chlorides in the blood (hyperchloremic acidosis).

If you are not sure if you should use this medicine, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor before you start using COSOPT.

Tell your doctor about any medical or eye problems you have or have had in the past:

• coronary heart disease (symptoms can include chest pain or tightness, shortness of breath, or choking), heart failure, low blood pressure.
• irregular heart beats such as a slow heart rate.
• respiratory problems, asthma or chronic obstructive pulmonary disease.
• poor circulation (such as Raynaud's disease or Raynaud's syndrome).
• diabetes, as timolol may mask signs and symptoms of low blood sugar.
• overactive thyroid gland, as timolol may mask signs and symptoms.

Tell your doctor before you have surgery that you are using COSOPT, as timolol may affect the way some medicines used during anaesthesia work.

Also, tell your doctor about any allergies or allergic reactions you have had, including rash, facial swelling, or hives, which may cause difficulty in breathing or swallowing.

Tell 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 problems in your eyes, such as eye redness or eyelid swelling, see your doctor immediately.

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

Tell your doctor if you get an eye infection, if you suffer an eye injury, if you have eye surgery, or if you develop a reaction that includes new symptoms or worsening of existing symptoms.

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

Children

There is limited clinical data available for the 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 liver impairment

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

Using 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. Tell your doctor if you are using or plan to use medicines to lower blood pressure, heart medicines, or medicines to treat diabetes. Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. This is particularly important if you are:

• taking medicines to lower blood pressure or to treat heart diseases (such as calcium channel blockers, beta-blockers, or digoxin).
• taking medicines to treat irregular heart beats such as calcium channel blockers, beta-blockers, or digoxin.
• using another eye drop that contains 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 you urinate. Parasympathomimetics are also a type of medicine that is sometimes used to help restore normal bowel 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 sulphonamide.
• taking quinidine (used to treat heart disorders and some types of malaria).

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

Pregnancy and breast-feeding

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

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

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

Driving and using machines

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

COSOPT contains benzalkonium chloride

This medicine 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 and alter their colour. Remove contact lenses before using this medicine and wait 15 minutes before putting them back.

Benzalkonium chloride may cause eye irritation, especially if you have dry eyes or corneal disorders (diseases of the transparent layer on the front of the eye). See your doctor if you experience any unusual feeling, stinging, or pain in the eye after using this medicine.

3. How to use Cosopt eye drops, solution

Follow exactly the instructions for administration of this medicine given by your doctor. If you are not sure, consult your doctor or pharmacist again. Your doctor will decide the appropriate dosage and duration of treatment.

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

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

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

Do not let the tip of the bottle touch your eyes or the areas around them. It may be contaminated with bacteria that can cause eye infections and serious damage to the eye, including loss of vision. To avoid contamination of the bottle tip, wash your hands before using this medicine and avoid touching the tip to any surface. If you think that your medicine may be contaminated, or if you develop an eye infection, consult your doctor immediately to find out if you can continue to use the bottle.

Instructions for use:

Do not use the bottle if the plastic safety strip around the neck of the bottle is damaged or missing. When you first open the bottle, tear off the plastic safety strip.

Every time you use COSOPT:

If you use more COSOPT than you should

If you put too many drops in your eye or swallow some of the contents of the bottle, among other effects, you may feel dizziness, have difficulty breathing, or notice that your heart beats more slowly.

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

If you forget to use COSOPT

It is important to use this medicine as your doctor has told you.

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

Do not use a double dose to make up for missed doses.

If you stop using COSOPT

If you want to stop using this medicine, consult your doctor first.

If you have any other questions about the use of this medicine, 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 experience any of the following side effects, stop using this medicine and see your doctor immediately, as they may be signs of a reaction to the medicine.

Generalised reactions including swelling under the skin which can occur in areas such as the face and limbs and can obstruct the airways, causing difficulty in swallowing, shortness of breath, rash or hives, generalised and localised rash, itching, severe allergic reaction that can suddenly put your life in danger.

Normally you can continue using the drops, unless the effects are severe. If you are concerned, talk to 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, altered taste

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

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

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

Dizziness, depression, inflammation of the iris, changes in vision, including changes in refraction (in some cases due to the 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 (an immune disease that can cause inflammation of internal organs), tingling or numbness of hands or feet, insomnia, nightmares, memory loss, increased signs and symptoms of myasthenia gravis (muscle disorder), decreased sexual desire, stroke, transient myopia that resolves when therapy is stopped, retinal detachment after filtration surgery that can cause visual disturbances, drooping eyelid (making the eye stay half-closed), double vision, crusts on the eyelid, swelling of the cornea (with symptoms of visual disturbances), low eye pressure, ringing in the ears, low blood pressure, changes in heart rate or speed, 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 flow to the brain), chest pain, strong and/or irregular heart beats (palpitations), heart attack, Raynaud's phenomenon, swollen and/or cold hands and feet, and decreased circulation in your arms and legs, leg cramps and/or leg pain when walking (claudication), shortness of breath, worsening of lung function, runny or congested nose, nosebleeds, constriction of airways in the lungs, cough, sore throat, dry mouth, diarrhoea, contact dermatitis, hair loss, skin rash with a white plate-like appearance (psoriasiform rash), Peyronie's disease (which can cause curvature of the penis), 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).

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

Not known (frequency cannot be estimated from the available data):

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

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Cosopt eye drops, solution

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 and carton after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions. Keep the bottle in the outer carton to protect it from light.

COSOPT should be used within 28 days of first opening the bottle.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container Content and Additional Information

COSOPT Composition

• The active ingredients 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 injectable preparations. Benzalkonium chloride is added as a preservative.

Product Appearance and Container Content

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

COSOPT is presented in a translucent white container with 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 medication has not been tampered with.

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 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, 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 the United Kingdom (Northern Ireland): COSOPT

Date of the last revision of this prospectus: 09/2023

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/