Label: Information for the User

COSOPT PF 20 mg/ml + 5 mg/ml Eye Drops 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 refer to 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 who may 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 section 4.

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

COSOPT PF eye drop solution is a sterile solution that does not contain any preservative.

Do not use COSOPT PF

• 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 pulmonary disease (a serious lung disease that can cause wheezing, difficulty breathing and/or persistent coughing for a long time).
• If you have a slow heart rate, heart failure or irregular heart rhythms.
• 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 medicine, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctorbefore starting to use COSOPT PFif you have or have had in the past:

• coronary heart disease (symptoms may include chest pain or tightness, difficulty breathing or feeling of suffocation), heart failure, low blood pressure.
• irregular heart rhythms such as decreased heart rate.
• respiratory problems, asthma or chronic obstructive pulmonary disease.
• poor blood circulation disease (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.
• any allergy or anaphylactic reaction.
• muscle weakness or if you have been diagnosed with myasthenia gravis.
• if you wear soft contact lenses,COSOPT PF has not been studied in patients who use contact lenses.

If you have a history of contact hypersensitivity to silver, do not use this medicine as the drops dispensed may contain traces of silver from the closure of the container.

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

COSOPT PF when instilled in the eye may affect the whole body.

Inform your doctor if during treatment with COSOPT PF you:

• develop any eye irritation or any new eye problems, such as redness of the eyes or swelling of the eyelids.
• suspect that COSOPT PF is causing an allergic reaction or hypersensitivity (for example, skin rash, severe skin reaction, or redness and itching in the eye). Stop using this medicine and consult your doctor immediately.
• develop 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.

Children

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

Use in elderly patients

In studies with COSOPT (preservative-free formulation), the effects were similar in elderly patients and younger patients.

Use in patients with liver impairment

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

Other medicines and COSOPT PF

COSOPT PF may affect or be affected by other medicines 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 medicine. This is particularly important if you are:

• taking medications to lower blood pressure or to treat heart disease (such as calcium channel blockers, beta blockers or digoxin).
• taking medications to treat irregular heart rhythms 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 cholinomimetic that may have been prescribed to help you urinate. Cholinomimetics are also a type of medication that is sometimes used to help restore normal movements through the intestine.
• taking narcotics, such as morphine used to treat moderate to severe pain.
• taking medications to treat diabetes.
• taking antidepressants known as fluoxetine and paroxetine.
• taking a sulfonamide.
• taking quinidine (used to treat heart rhythm disorders and some types of malaria).

Pregnancy and breastfeeding

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

Use in pregnancy

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

Use in breastfeeding

Do not use COSOPT PF if you are breastfeeding your child. Timolol may pass into breast milk.

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 PF, such as blurred vision, that 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.

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

The recommended doseis one drop in the affected eye(s) in the morning and at night.

If you are using COSOPT PF at the same time as another eye drop, the drops must be instilled at least 10 minutes apart.

Do not change the medication dose without consulting your doctor.

If you have difficulty administering the eye drop, ask for help from a family member or caregiver.

Do not allow the tip of the multidose container to touch the eye or the areas around the eye. This could cause eye injury. Additionally, the eye drop could become contaminated with bacteria that may cause eye infections leading to serious eye damage, and even vision loss. To avoid possible contamination of the multidose container, wash your hands before using this medication and avoid allowing the tip of the multidose container to come into contact with any surface.

Usage instructions

Before dispensing the drops in the eye:

• Wash your hands before opening the bottle.
• Do not use this medication if you detect that the safety seal on the neck of the bottle is broken before the first opening.
• When first using, before dispensing a drop in the eye, you must practice using the dropper by slowly squeezing it to dispense a drop outside the eye.
• When you are sure you can dispense one drop at a time, you should position yourself in the most comfortable position to dispense the drops (you can sit, lie down, or stand in front of a mirror).
• Each time you open a new bottle, discard one drop to activate the bottle.

Dispensing:

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

1. Incline your head back and hold the bottle above your eye.

1. Lower your eyelid and look up. Gently press the center of the bottle and let one drop fall into your eye. Please note that there may be a slight delay between pressing the bottle and the drop falling. Do not press too hard.

1. Close your eye and press the inner corner of your eye with your finger for about two minutes. This helps prevent the drop from reaching the rest of your body.

1. Repeat steps 2-4 to instill a drop in the other eye, if your doctor has instructed you to do so. Sometimes treatment is only needed in one eye, and your doctor will inform you if this is the case and which eye needs treatment.

1. After each use and before replacing the cap, you must shake the bottle once downwards, without touching the dropper tip, to remove any remaining liquid from the tip. This is necessary to ensure the supply of the next drops.

1. Wipe away any excess solution from the skin around your eye.

1. At the end of the 2-month validity period of the medication once opened, there will be a little COSOPT PF left in the bottle. Do not attempt to use the remaining excess medication in the bottle after completing your treatment. Do not use the eye drop for more than 2 months after the first opening of the bottle.

If you have any doubts about how to administer your medication, ask your doctor, pharmacist, or nurse.

Using more COSOPT PF than you should

If you apply too many drops to the eye or swallow something from the bottle, among other effects, you may feel drowsy, have difficulty breathing, or notice that your heart beats slower. Contact your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20.Indicating the medication and the amount taken. It is recommended to bring the container and the medication leaflet to the healthcare professional.

Missing a dose of COSOPT PF

It is essential to use COSOPT PF as prescribed by your doctor.

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 planned dose schedule normally.

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

Stopping treatment with COSOPT PF

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

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

Like all medications, this medication 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 medication and seek immediate medical help, as they may be signs of a medication reaction.

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

• Chest pain, edema (fluid accumulation), changes in heart rate or rhythm, congestive heart failure (heart disease with difficulty breathing and swelling of feet and legs due to fluid accumulation), heart attack, heart block, low blood pressure, cerebral ischemia (reduced blood flow to the brain), stroke.
• Difficulty breathing, respiratory failure, constriction of airways in the lungs.
• Signs and symptoms of systemic allergic reactions, including angioedema, urticaria, pruritus, rash, anaphylaxis.
• Severe skin reactions, including swelling under the skin.

Other side effects:

You may continue to use the eye drops unless the side effects are severe. If you are concerned, consult your doctor or pharmacist. Do not stop using COSOPT PF without talking to your doctor.

The following adverse reactions have been reported with COSOPT PF 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):

• Eye effects: redness in and around the eye or eyes, tearing or eye irritation, corneal erosion (damage to the front layer of the eyeball), swelling and/or irritation in and around the eye or eyes, sensation of something in the eye, decreased corneal sensitivity (having something in the eye and not noticing it), eye pain, dry eyes, blurred vision.
• General effects: headache, sinusitis (sensation of tension or congestion in the nose), nausea, weakness/fatigue, fatigue.

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

• Eye effects: iritis inflammation, vision changes including refractive changes (in some cases due to suspension of miotic therapy).
• General effects: dizziness, depression, decreased heart rate, fainting, shortness of breath, indigestion, kidney stones.

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

• Eye effects: transient myopia that can be resolved when treatment is stopped, retinal detachment that can cause visual disturbances after glaucoma filtration surgery, drooping eyelid (keeping the eye partially closed), double vision, eyelid crusts, corneal edema (with visual disturbance symptoms), low eye pressure.
• General effects:palpitations (strong heartbeats that may be rapid or irregular),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), cough, throat irritation, dry mouth, insomnia, nightmares, memory loss, tingling or numbness in hands or feet, increased signs and symptoms of myasthenia gravis (muscle disorder), decreased libido, systemic lupus erythematosus (immune disease that can cause inflammation of internal organs), ringing in the ears, rhinitis, nasal bleeding, diarrhea, contact dermatitis, hair loss, psoriasiform eruption (skin rash with a silver-white appearance), Peyronie's disease (can cause penile curvature), allergic reactions such as rash, hives, itching, in rare cases possible swelling of lips, eyes, and mouth, tinnitus.

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.

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

Low blood sugar levels, 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 prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

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

Do not store at a temperature above 25°C.

After the first opening of the bottle, the solution may be used for2 months. The bottle must be kept tightly closed.

Do not use this medication if you detect that the seal is broken before using the packaging for the first time.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

COSOPT PF 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 hydroxyethylcellulose, mannitol, sodium citrate, sodium hydroxide, and water for injection preparations.

Product appearance and packaging contents

COSOPT PF is a transparent, colorless or almost colorless, slightly viscous, practically particle-free solution, presented in a white plastic bottle with a white Novelia dropper cap and a white plastic screw cap, tamper-evident.

Packaging sizes: 1, 2, or 3 bottles in a box.

Only some packaging 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

Or

Tubilux Pharma, S.p.A.

Via Costarica 20/22

00071 Pomezia, Rome

Italy

For more information about this medication, please contact the local representative of the marketing authorization holder:

Santen Pharmaceutical Spain, S.L.

Acanto, 22, 7th floor

28045 – Madrid

Phone: 91 414 24 85

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

Bulgaria, Croatia, Cyprus, Greece, United Kingdom (Northern Ireland):COSOPT iMulti

Belgium, Luxembourg:COSOPT Sine Conservans

Czech Republic:COSOPT bez konzervacních prísad

Denmark:COSOPT Multi ukonserveret

Sweden:Cosopt sine

Finland, Germany, Iceland, Norway, Lithuania: COSOPT sine

Hungary, Portugal:COSOPT Multi

Italy:COSOPT senza conservante

Latvia, Spain:COSOPT PF

Netherlands:COSOPT Multidose conserveermiddelvrij

Poland:COSOPT PF Multi

Romania:COSOPT fara conservant

Slovakia:COSOPT Multi Dose Free

Slovenia:COSOPT brez konzervansa

France:COSTEC

Last review date of this leaflet:March 2023

For detailed information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)