COSOPT PF 20 mg/mL + 5 mg/mL EYE DROPS SOLUTION

Introduction

Package Leaflet: Information for the User

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

dorzolamida/timolol

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What COSOPT PF is and what it is used for
2. What you need to know before you use COSOPT PF
3. How to use COSOPT PF
4. Possible side effects
5. Storage of COSOPT PF
6. Contents of the pack and other information

1. What COSOPT PF is and what it is used for

COSOPT PF contains two active substances: dorzolamida and timolol.

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

These active substances lower the pressure in the eye in different ways.

COSOPT PF is used to reduce high pressure in the eye in the treatment of glaucoma when a single beta-blocker eye drop is not enough.

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

2. What you need to know before you use COSOPT PF

Do not use COSOPT PF

• 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 rhythm (irregular heartbeat).
• if you have severe kidney disease or have a 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 starting to use COSOPT PF if you have or have had in the past:

• coronary heart disease (symptoms can include chest pain or tightness, difficulty breathing or choking), heart failure, low blood pressure.
• irregular heartbeats 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.
• 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 wear contact lenses.

If you have a history of contact hypersensitivity to silver, you should not use this medicinal product as the dropper dispensed may contain traces of silver from the bottle cap.

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

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

Tell your doctor if during treatment with COSOPT PF you:

• develop any eye irritation or any new problems in the eyes, 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 of the eye). Stop using this medicine and consult your doctor immediately.
• develop 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.

Children

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

Use in elderly patients

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

Use in patients with impaired hepatic function

Tell 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 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 conditions (such as calcium channel blockers, beta-blockers or digoxin).
• taking medicines to treat irregular heartbeat such as calcium channel blockers, beta-blockers or digoxin.
• using another eye drop that contains a beta-blocker.
• taking another carbonic anhydrase inhibitor such as acetazolamide.
• taking monoamine oxidase inhibitors (MAOIs).
• taking a parasympathomimetic drug which may have been prescribed to help you urinate. Parasympathomimetics are also a particular type of medicine that is sometimes used to help restore normal movement through the intestines.
• 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 conditions and some types of malaria).

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.

Use during pregnancy

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

Use during breast-feeding

Do not use COSOPT PF if you are breast-feeding. Timolol may get into breast milk.

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 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 fine or your vision is clear.

3. How to use COSOPT PF

Use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. The appropriate dosage and duration of treatment will be established by your doctor.

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

If you are using COSOPT PF with another eye drop, the drops should be instilled at least 10 minutes apart.

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

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

Do not allow the tip of the multidose container to touch the eye or the surrounding areas. This could cause you eye injury. Also, the eye drops could become contaminated with bacteria that can cause eye infections leading to serious damage to the eyes, including loss of vision. To avoid possible contamination of the multidose container, wash your hands before using this medicine and avoid touching the tip of the multidose container to any surface.

Instructions for use

Before dispensing the drops into the eye:

• Wash your hands before opening the bottle.
• Do not use this medicine if you notice that the security seal on the bottle neck is broken before the first opening.
• When using for the first time, before dispensing a drop into the eye, you should practice using the dropper by slowly squeezing out a drop into the air away from the eyes.
• When you are confident that you can dispense one drop at a time, place yourself in a comfortable position (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 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.

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

1. Pull the lower eyelid down and look up. Carefully squeeze the middle of the bottle and let one drop fall into the eye. Please note that there may be a small delay between squeezing the bottle and the drop falling. Do not squeeze 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 spreading to other parts of your body.

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

1. After each use and before putting the cap back on, you should shake the bottle once upside down, without touching the dropper tip, to remove any remaining liquid from the tip. This is necessary to ensure the delivery of the next drops.

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

1. At the end of the 2-month period of validity of the medicine after opening, there will be a little COSOPT PF left in the bottle. Do not attempt to use the remaining medicine in the bottle after you have completed the treatment process. Do not use the eye drops for more than 2 months after the first opening of the bottle.

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

If you use more COSOPT PF than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken. It is recommended to take the packaging and the package leaflet of the medicine to the healthcare professional.

If you forget to use COSOPT PF

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

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

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

If you stop using COSOPT PF

If you want to stop treatment with 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 seek medical help immediately as they can be signs of a reaction to the medicine.

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

• Chest pain, swelling (fluid build-up), changes in heart rate or speed, congestive heart failure (heart disease with difficulty breathing and/or swelling of feet and legs due to fluid build-up), heart attack, heart block, low blood pressure, cerebral ischaemia (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 can continue using the eye drops, unless the effects are severe. If you are concerned, talk to 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 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, alteration of taste.

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

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

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

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

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

• Eye effects: transient myopia that can be solved when treatment 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 pressure in the eye.
• General effects: strong heartbeats that can be fast or irregular (palpitations), Raynaud's phenomenon, swollen and/or cold hands and feet and decreased circulation in your arms and legs, cramps in the legs and/or leg pain when walking (claudication), cough, throat irritation, dry mouth, insomnia, nightmares, memory loss, tingling or numbness of hands or feet, increased signs and symptoms of myasthenia gravis (muscle disorder), decreased sexual desire, systemic lupus erythematosus (an immune disease that can cause inflammation of internal organs), ringing in the ears, 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 reactions such as rash, hives, itching, in rare cases possible swelling of the lips, eyes and mouth, ringing in the ears.

As with other eye drops, 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 ophthalmic 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.

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

Low blood sugar levels, 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, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of COSOPT PF

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

Do not store above 25°C.

After first opening of the bottle, the solution can be used for 2 months. The bottle should be kept tightly closed.

Do not use this medicine if you notice that the seal is broken before using the package for the first time.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition of COSOPT PF

• The active substances 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 ingredients are hydroxyethylcellulose, mannitol, sodium citrate, sodium hydroxide, and water for injections.

Appearance and package contents of the product

COSOPT PF is a clear, colorless or almost colorless, slightly viscous solution, practically free of visible particles, presented in a white plastic bottle with a white Novelia drop-tip cap and a white plastic screw cap, tamper-evident.

Package sizes: 1, 2, or 3 bottle(s) in a carton.

Not all package 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 further information about this medicine, please contact the local representative of the marketing authorization holder:

Santen Pharmaceutical Spain, S.L.

Acanto, 22, 7th floor

28045 – Madrid

Tel.: 91 414 24 85

This medicine 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

Date of last revision of this leaflet:March 2023

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