Duokopt

Leaflet attached to the packaging: information for the user

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

(Dorzolamide + Timolol)

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep the leaflet, so you can read it again if you need to.
• If you have any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is DUOKOPT and what is it used for
• 2. Important information before using DUOKOPT
• 3. How to use DUOKOPT
• 4. Possible side effects
• 5. How to store DUOKOPT
• 6. Contents of the packaging and other information

1. What is DUOKOPT and what is it used for

DUOKOPT is an eye drop solution without preservatives.
DUOKOPT contains two active substances: dorzolamide and timolol.

• Dorzolamide belongs to a group of medicines called "carbonic anhydrase inhibitors".
• Timolol belongs to a group of medicines called "beta-adrenergic receptor blockers" (beta-adrenolytics). These medicines lower intraocular pressure through different mechanisms.

DUOKOPT is recommended for the treatment of glaucoma to lower elevated intraocular pressure, when the use of eye drops containing only a beta-adrenergic receptor blocker is not sufficient.

2. Important information before using DUOKOPT

When not to use DUOKOPT:

In case of doubts about whether DUOKOPT can be used, consult a doctor or pharmacist.

Warnings and precautions

Before using DUOKOPT, tell your doctor or pharmacist or nurse about all current or past eye disorders and diseases:

• ischemic heart disease (symptoms such as chest pain or feeling of pressure in the chest, shortness of breath or feeling of suffocation), heart failure, low blood pressure;
• heart rate disorders, such as slow heart rate;
• breathing problems, asthma, or chronic obstructive pulmonary disease;
• diseases related to poor blood circulation (such as Raynaud's disease or Raynaud's syndrome);
• diabetes, as timolol may mask the subjective and objective symptoms of low blood sugar (hypoglycemia);
• hyperthyroidism, as timolol may mask its subjective and objective symptoms;
• any allergies or anaphylactic reactions;
• muscle weakness, especially in cases of diagnosed myasthenia (Myasthenia gravis).

Before surgery, inform your doctor about the use of DUOKOPT, as timolol may affect the action of certain anesthetics.
During therapy with DUOKOPT, contact your doctor immediately if the patient:

• experiences any eye irritation or new eye problems, such as redness of the eye or swelling of the eyelids;
• suspects that DUOKOPT is causing an allergic reaction or hypersensitivity (e.g., skin rash, severe skin reaction, or redness and itching of the eye), then stop using DUOKOPT;
• develops an eye infection, suffers an eye injury, undergoes eye surgery, or experiences new or worsening symptoms.

After administration to the eye, DUOKOPT may cause systemic effects.

Use of contact lenses

No studies have been conducted on the use of DUOKOPT in patients using contact lenses.
If the patient wears soft contact lenses, they should consult a doctor before using DUOKOPT.

Children

There is limited data on the use of the combination of dorzolamide and timolol in the form with a preservative in infants and children. DUOKOPT is not recommended for use in children from birth to 18 years.

Elderly patients

In studies conducted with the combination of dorzolamide and timolol in the form with a preservative, the action of this medicine was similar in elderly patients and younger patients.

Patients with liver function disorders

Inform your doctor about any current or past liver function disorders.

Patients with kidney function disorders

Inform your doctor about any current or past kidney function disorders.

Sports

The use of DUOKOPT may result in positive results during anti-doping tests.

DUOKOPT and other medicines

DUOKOPT may affect the action of other medicines, or other medicines used by the patient may affect the action of DUOKOPT, including other eye drops used to treat glaucoma.
Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
This is especially important in the case of:

• taking medicines that lower blood pressure or are used to treat heart diseases (such as calcium channel blockers, beta-adrenergic receptor blockers, or digoxin);
• taking medicines used to treat heart rhythm disorders or restore a regular heart rhythm (such as calcium channel blockers, beta-adrenergic receptor blockers, or digoxin);
• using other eye drops containing beta-adrenergic receptor blockers;
• taking other carbonic anhydrase inhibitors, such as acetazolamide;
• taking monoamine oxidase inhibitors (MAOIs) used to treat depression;
• taking parasympathomimetic (cholinergic) medicines, which may be prescribed for urinary disorders. Parasympathomimetic medicines are also sometimes used to restore normal motility (movement) of the intestines;
• taking narcotics, such as morphine, used to treat moderate to severe pain;
• taking antidiabetic medicines;
• taking antidepressants, such as fluoxetine and paroxetine;
• taking sulfonamide medicines;
• taking quinidine (a medicine used to treat heart diseases and certain types of malaria).

Pregnancy and breastfeeding

Do not use DUOKOPT during pregnancy, unless your doctor considers it necessary.
Before using any medicine, consult your doctor or pharmacist.
Do not use DUOKOPT during breastfeeding. Timolol may pass into breast milk. Before taking any medicine during breastfeeding, consult your doctor.

Driving and using machines

No studies have been conducted on the impact on the ability to drive vehicles or operate machinery. There are side effects associated with the use of DUOKOPT, such as blurred vision, which may affect the ability to drive vehicles and/or operate machinery. Do not drive vehicles or operate machinery until you feel better or your vision returns to normal.

3. How to use DUOKOPT

Always use this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist. Your doctor will determine the correct dose and duration of treatment.

Dose

• The usual dose is one drop into the affected eye(s) in the morning and evening.
• If DUOKOPT is used at the same time as other eye drops, wait at least 10 minutes between administering the medicines.
• Do not change the dose of the medicine without consulting your doctor.
• Do not touch the tip of the bottle to the eye or its surroundings. This may lead to bacterial contamination, which can cause eye infection leading to serious damage or even loss of vision. To avoid possible contamination of the bottle, avoid contact between the tip and any surface.

Instructions for use

It is essential to follow these instructions when using the product:

	Before using the medicine for the first time, check that the protective cap is intact. Then, unscrew the protective cap tightly to open the bottle.
	1. Before each use, wash your hands thoroughly and remove the cap from the tip of the bottle. Avoid touching the tip of the bottle with your fingers.
Press the bottle with the dropper down several times to activate the pumping mechanism until the first drop appears. This procedure only applies to the first use of the medicine and is not necessary for subsequent administrations.
	2. Place your thumb on the tab at the top of the bottle and your index finger on the base of the bottle. Then, place your middle finger on the second tab at the base of the bottle. Hold the bottle upside down.
	3. To administer, tilt your head slightly back and hold the bottle with the dropper down vertically over the eye. With the index finger of the other hand, gently pull the lower eyelid down. The created space is called the lower conjunctival sac. Avoid touching the tip of the bottle to your fingers or eyes. To instill a drop into the lower conjunctival sac of the affected eye(s), squeeze the bottle briefly and firmly. Due to the automatic dosing, the drop is released precisely with each pumping.
If a drop does not fall, gently shake the bottle to remove the drop remaining on the tip. In this case, repeat step 3.
	4. Close your eyelids and press the inner corner of the eye near the nose with your finger for 2 minutes. This helps prevent the drop from spreading systemically.
	5. Immediately after use, put the cap back on the tip of the bottle.

Using a higher dose of DUOKOPT than recommended

In case of administration of too many drops or ingestion of the contents of the bottle, among other symptoms, dizziness, breathing difficulties, or a feeling of slowed heart rate may occur. Contact your doctor immediately.

Missing a dose of DUOKOPT

It is essential to use DUOKOPT as directed by your doctor.
If you miss a dose, use it as soon as possible. However, if it is almost time for the next dose, do not use the missed dose, and return to your regular dosing schedule.
Do not use a double dose to make up for the missed dose.

Stopping the use of DUOKOPT

Before stopping the medicine, consult your doctor.
If you have any further doubts about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, DUOKOPT can cause side effects, although not everybody gets them.
The use of the drops can usually be continued, unless the side effects are severe. If you are concerned, contact your doctor or pharmacist. Do not stop using DUOKOPT without consulting your doctor.

Allergic reactions

Generalized allergic reactions, including swelling under the skin, can occur in areas such as the face and limbs and can block the airways, causing difficulty swallowing or breathing, hives, or itchy rash, localized and generalized rash, itching, and severe, sudden, and life-threatening allergic reaction. If the patient experiences any of these symptoms, stop using DUOKOPT and contact your doctor immediately.

Very common: may affect more than 1 in 10 people:

Burning and stinging in the eye, change in taste.

Common: may affect up to 1 in 10 people:

Redness of the eyeball and skin around the eye, tearing or itching of the eye, corneal defects (damage to the front layer of the eyeball), swelling and/or irritation of the eye and skin around the eye, feeling of a foreign body in the eye, decreased sensitivity of the cornea (not feeling a foreign body in the eye and not feeling pain), eye pain, dry eyes, blurred vision, headache, sinusitis (feeling of tension or fullness in the nose), nausea, weakness, and feeling of tiredness.

Uncommon: may affect up to 1 in 100 people:

Dizziness, depression, uveitis, vision disorders, including changes in refraction (in some cases due to the withdrawal of pupil-constricting medicines), slow heart rate, fainting, breathing difficulties (shortness of breath), indigestion, and kidney stones.

Rare: may affect up to 1 in 1000 people:

Systemic lupus erythematosus (an autoimmune disease that can cause inflammation of internal organs), tingling or numbness of the hands or feet, insomnia, nightmares, memory loss, worsening of myasthenia symptoms (muscle disorder), decreased libido, stroke, transient myopia, which may resolve after discontinuation of the medicine, retinal detachment (a layer under the retina that contains blood vessels) after filtration surgery, which can cause vision disorders, drooping eyelids (causing the eyelids to be half-closed), double vision, formation of styes on the eyelids, corneal edema (leading to vision disorders), low eye pressure, ringing in the ears, low blood pressure, changes in heart rhythm or rate, congestive heart failure (a heart disease characterized by shortness of breath and swelling of the feet and legs due to fluid accumulation), swelling (fluid accumulation), cerebral ischemia (reduced blood flow to the brain), chest pain, rapid or irregular heartbeat (palpitations), myocardial infarction, Raynaud's disease, swelling of the hands and feet or cold hands and feet, and impaired circulation in the upper and lower limbs, muscle cramps in the legs and/or leg pain when walking (claudication), shortness of breath, respiratory failure, rhinitis (runny nose), nosebleeds, bronchospasm, cough, throat irritation, dry mouth, diarrhea, contact dermatitis, hair loss, psoriasiform rash (a rash similar to psoriasis), Peyronie's disease (which can cause curvature of the penis), allergic reactions, such as rash, hives, itching, and in rare cases, swelling of the lips, eyelids, and mouth, wheezing, or severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis).
Like other eye medicines, timolol is absorbed into the bloodstream. This may cause side effects similar to those observed after oral administration of beta-adrenergic receptor blockers. Side effects occur less frequently after the use of eye drops locally than after oral administration or injections.

The following side effects have been reported during the use of medicines from the same group in the treatment of eye diseases

Unknown: frequency cannot be determined from available data

Low blood sugar, heart failure, heart rhythm disorders, rapid heart rate, increased blood pressure, abdominal pain, vomiting, muscle pain unrelated to physical exertion, sexual function disorders, shortness of breath, feeling of a foreign body in the eye, hallucinations.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help gather more information on the safety of this medicine.

5. How to store DUOKOPT

Keep out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle after EXP.
The expiry date (EXP) means the last day of the specified month.
There are no special precautions for storage.
DUOKOPT can be used for 2 months after the first opening. Write the date of the first opening on the carton.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What DUOKOPT contains

• The active substances are:dorzolamide and timolol. Each milliliter of solution contains 20 mg of dorzolamide (as 22.25 mg of dorzolamide hydrochloride) and 5 mg of timolol (as 6.83 mg of timolol maleate).
• Other ingredients:hydroxyethylcellulose, mannitol, sodium citrate, sodium hydroxide (to adjust pH), and water for injections.

What DUOKOPT looks like and what the pack contains

DUOKOPT is a clear, colorless to slightly yellow solution.
DUOKOPT is available in the following pack sizes:

• 5 ml HDPE bottle (at least 125 drops without preservatives, 1 month of treatment) with a dosing pump and protective cap, in a cardboard box.
• 10 ml HDPE bottle (at least 250 drops without preservatives, 2 months of treatment) with a dosing pump and protective cap, in a cardboard box.
• 1 cardboard box with three 5 ml HDPE bottles (3 months of treatment), with a dosing pump and protective cap.
• 1 cardboard box with two 10 ml HDPE bottles (4 months of treatment), with a dosing pump and protective cap.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Laboratoires THEA

12, Rue Louis Blériot
63017 Clermont-Ferrand Cedex 2
France

Manufacturer:

DELPHARM TOURS

Rue Paul Langevin
37170 Chambray Les Tours
France

LABORATOIRES THEA

12, Rue Louis Blériot
63017 Clermont-Ferrand Cedex 2
France

FARMILA-THEA Farmaceutici S.p.A.

Via Enrico Fermi, 50
20019 Settimo Milanese (MI)
Italy

This medicinal product is authorized in the Member States of the European Economic Area under 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, Slovakia ....................................................... Dualkopt

Date of last revision of the leaflet: 26-09-2023

Detailed information about this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.