Package Leaflet: Information for the User

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

(dorzolamide / timolol)

Read this 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse. See section 4.

1.What Duokopt is and what it is used for

2.What you need to know before using Duokopt

3.How to use Duokopt

4.Possible side effects

5.Storage of Duokopt

6.Contents of the pack and additional information

Duokoptis an eye drop solution, without preservatives.

Duokoptcontains two active ingredients: 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..

Duokoptis prescribed to reduce elevated intraocular pressure in the treatment of glaucoma when the use of a beta blocker eye drop alone is not suitable..

Do not useDuokopt:

• If you are allergic (hypersensitive) to dorzolamide hydrochloride, timolol maleate, or any of the other components of this medication (listed in section 6).
• If you have or have had respiratory problems, such as asthma, 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 to useDuokopt, contact your doctor or pharmacist.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Duokopt, about any current or past medical or eye problems:

• Coronary heart disease (symptoms may include chest pain or tightness, difficulty breathing, or a feeling of suffocation), heart failure, low blood pressure.
• Irregular heart rhythms, such as a decrease in 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.
• Any type of allergy or anaphylactic reaction.
• Muscle weakness, especially in cases of diagnosed myasthenia gravis.

Inform your doctorthat you are using Duokopt before undergoing surgery, as timolol may affect the effect of some medications used during anesthesia.

Contact your doctor immediately if during treatment with Duokopt:

• You develop any eye irritation or new eye problems, such as redness of the eyes or swelling of the eyelids.
• You suspect that Duokoptis causing an allergic reaction or hypersensitivity(for example, skin rash, severe skin reaction, or redness and itching of the eyes),stop usingDuokopt.
• You 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.

Duokoptapplied to the eye may affect the whole body

If you wear contact lenses

Duokopthas not been studied in patients who wear contact lenses.

If you wear soft contact lenses, consult your doctor before usingDuokopt.

Use in children

There is limited experience with the combined formulation of dorzolamide/timolol with preservatives in infants and children.Do not use Duokopt in children from 0 to 18 years.

Use in elderly patients

In studies with the combined formulation of dorzolamide/timolol with preservatives, the effects of this medication were similar in both elderly patients and younger patients.

Use in patients with liver impairment

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

Use in patients with renal impairment

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

Use in athletes:

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

Use of Duokopt with other medications

Duokopt may affect or be affected by other medications you are using, including other eye drops for glaucoma treatment.

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

This is particularly important if you are:

• Taking medications to lower blood pressure or 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), which are used to treat depression.
• Taking a cholinomimetic, which may have been prescribed to help eliminate urine. Cholinomimetics are also a specific type of medication that may be 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 medications to treat depression, such as fluoxetine or paroxetine.
• Taking a sulfonamide.
• Taking quinidine (used to treat heart disease and some types of malaria).

Pregnancy and breastfeeding

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

Consult your doctor or pharmacist before using any medication.

Do not use Duokoptif you are breastfeeding your child. Timolol may pass into breast milk.Consult your doctor before using any medication during breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consultyour doctor before using this medication.

Driving and operating machinery

No studies have been conducted on the effects on the ability to drive and operate machinery. There are adverse effects associated with Duokopt, 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.

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 dose and treatment duration will be established by your doctor.

Dose

• The recommended dose is one drop in the affected eye or eyes in the morning and at night..
• If you use Duokopt 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 bottle touch your eyes or the surrounding areas. You may contaminate it with bacteria capable of causing eye infections that can cause serious eye damage, including vision loss. To avoid possible contamination of the bottle, avoid letting the tip of the bottle come into contact with any surface.,

Usage Instructions

It is essential to follow the following instructions when using this product:

If you use more Duokopt than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20 indicating the medication and the amount ingested.

If you forget to useDuokopt

It is essential that you use Duokopt as your doctor has indicated.

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..

If you interrupt treatment withDuokopt

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

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse..

Like all medications, this medication may cause side effects, although not everyone will experience them..

You can usually continue using the drops unless the side effects are severe. If you are concerned, consult your doctor or pharmacist. Do not stop usingDuokoptwithout talking to your doctor.

Allergic reactions

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 or breathing, rashes or itching, generalized and localized eruptions, itching, severe allergic reaction that suddenly puts life in danger.If you have any of these effects, stop using Duokopt and contact your doctor immediately

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 sensitivity of the cornea (does not appreciate having 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 (due in some cases to suspension of miotic treatment), slow heart rate (decrease in heartbeats), fainting, difficulty breathing (dyspnea), indigestion, and kidney stones.

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

SLE (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 filtration surgery that can cause visual disturbances, drooping eyelid (causing the eye to remain half-closed), double vision, crusts on the eyelid, corneal edema (with visual disturbance symptoms), low eye pressure, ringing in the ears, low blood pressure, changes in heart rhythm or speed, 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, respiratory insufficiency, nasal congestion or discharge, nasal bleeding, bronchial constriction in the lungs, cough, throat irritation, dry mouth, diarrhea, contact dermatitis, hair loss, psoriasiform eruption with a silver-white appearance, Peyronie's disease (which can cause curvature of the penis), allergic reactions such as skin rash, itching, hives, in rare cases possible swelling of the lips, eyes, and mouth, panting, or severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Like other eye medications, timolol is absorbed into the blood. This can cause side effects similar to those seen with oral beta-blockers. The incidence of side effects after administration in the eyes is lower than when, for example, medications are administered orally or injected.

The following side effects were observed with medications in the same group when used to treat eye disorders.

Unknown frequency: cannot be estimated from available data

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

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 Pharmacovigilance of Medicinal Products for Human Use: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 Duokopt after the expiration date that appears on the box and bottle after CAD.The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Use Duokopt within 2 months after the initial opening of the bottle. Note the date of the first opening on the box.

Do not dispose of medications through drains or trash. Deposit the containers and unused medications at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and unused medications. By doing so, you will help protect the environment.

Composition of Duokopt

• The active principles are:dorzolamide and timolol. Each ml contains 20 mg of dorzolamide (as 22.25 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.

Aspect of the product and content of the packaging

Duokopt is a transparent to slightly yellowish solution.

Duokopt is available in the following packaging sizes:

• 5 ml multidose vial (with a minimum of 125 drops without preservatives, 1 month of treatment) including a pump equipped with an ergonomic support device.
• 10 ml multidose vial (with a minimum of 250 drops without preservatives, 2 months of treatment) including a pump equipped with an ergonomic support device.
• 1 box with three 5 ml multidose vials (3 months of treatment) including a pump equipped with an ergonomic support device for each vial.
• 3 boxes of a 5 ml multidose vial wrapped in a protective film (3 months of treatment) including a pump equipped with an ergonomic support device.
• 1 box of two 10 ml multidose vials (4 months of treatment) including a pump equipped with an ergonomic support device for each vial.
• 2 boxes of a 10 ml multidose vial wrapped in a protective film (4 months of treatment) including a pump equipped with an ergonomic support device.

Some packaging sizes may only be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratoires Thea

12, RUE LOUIS BLERIOT

63017 CLERMONT-FERRAND CEDEX 2

FRANCE

Responsible for manufacturing

DELPHARM TOURS

RUE PAUL LANGEVIN

37170 CHAMBRAY LES TOURS

FRANCE

O

Laboratoires Thea

12, RUE LOUIS BLÉRIOT

63017 CLERMONT-FERRAND CEDEX 2

FRANCE

O

FARMILA-THEA Farmaceutici S.p.A.

Via Enrico Fermi, 50

20019 Settimo Milanese

ITALY

Local representative:

Laboratorios Thea, S.A.

C/ Enric Granados, nº 86-88, 2nd floor

08008 Barcelona

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Austria, Bulgaria, Cyprus, Denmark, Germany, Greece, Finland, Iceland, Italy, Norway, Poland, Portugal, Romania, Slovenia, Spain, Sweden………………………………...Duokopt

Belgium, Czech Republic, France, Luxembourg, Netherlands, Slovak Republic…………....…Dualkopt

Date of the last review of this leaflet:October 2023

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Products (AEMPS)

http://www.aemps.gob.es/.