DUOKOPT 20mg/mL + 5mg/mL Eye Drops Solution

2. What you need to know before you use Duokopt

Do not useDuokopt:

• If you are allergic (hypersensitive) to dorzolamida 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, severe chronic obstructive pulmonary disease (a serious lung disease that can cause wheezing, difficulty breathing, and/or coughing that has been present for a long time).
• If you have a slow heart rate, heart failure, or heart rhythm disturbances (irregular heartbeats).
• If you have severe kidney disease or a history of kidney stones.
• If you have excess acidity of the blood caused by an accumulation of chlorides in the blood (hyperchloremic acidosis).

If you are not sure if you should use Duokopt, 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 shortness of breath), heart failure, low blood pressure.
• Heart rhythm disturbances such as decreased 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.
• Overactivity of the thyroid gland, as timolol may mask signs and symptoms.
• Any type of allergy or anaphylactic reaction.
• Muscle weakness, especially in cases of diagnosed myasthenia gravis.

Tell your doctor that you are using Duokopt before undergoing surgery, as timolol may affect the effect of some medicines used during anesthesia.

Contact your doctor immediately if during treatment with Duokopt:

• You develop any eye irritation or new problems in the eyes, such as redness of the eyes or swelling of the eyelids.
• You suspect that Duokopt is causing an allergic reaction or hypersensitivity (e.g., skin rash, severe skin reaction, or redness and itching of the eyes), stop using Duokopt.
• 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.

When Duokopt is applied to the eye, it can affect the whole body.

If you wear contact lenses

Duokopt has not been studied in patients who wear contact lenses.

If you wear soft contact lenses, you should consult your doctor before using Duokopt.

Use in children

There is limited experience with the use of the dorzolamida/timolol combination formulation with preservatives in infants and children. Duokopt is not recommended for use in children from 0 to 18 years.

Use in elderly patients

In studies with the dorzolamida/timolol combination formulation with preservatives, the effects of this medicine were similar in both elderly and younger patients.

Use in patients with liver impairment

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

Use in patients with kidney impairment

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

Use in athletes:

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

Use of Duokopt with other medicines

Duokopt may affect or be affected by other medicines you are using, including other eye drop solutions for the treatment of glaucoma.

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicine.

This is especially 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 a heart rhythm disturbance (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) used to treat depression.
• Taking a parasymphaticomimetic medicine that may have been prescribed to help eliminate urine. Parasymphaticomimetics are also a specific type of medicine that is sometimes used to help restore normal movement through the intestine.
• Taking narcotics, such as morphine, used to treat moderate to severe pain.
• Taking medicines to treat diabetes.
• Taking medicines to treat depression, such as fluoxetine or paroxetine.
• Taking a sulfonamide.
• Taking quinidine (used to treat heart diseases 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 medicine.

Do not use Duokopt if you are breastfeeding. Timolol may pass into breast milk. Consult your doctor before using any medicine during breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Driving and using machines

No studies have been conducted on the effects on the ability to drive and use machines. There are side effects associated with Duokopt, 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.

3. How to use Duokopt

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. The suitable dose and duration of treatment will be established by your doctor.

Dose

• The recommended dose is one drop in the affected eye(s) 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 dose of the medicine without consulting your doctor.
• Do not let the tip of the bottle touch the eyes or the areas surrounding them. It may become contaminated with bacteria that can cause eye infections and lead to serious damage to the eyes, even vision loss. To avoid possible contamination of the bottle, avoid letting the tip of the bottle come into contact with any surface.

Instructions for use

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

If you use more Duokopt than you should

If too many drops are applied to the eye or you 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. Consult 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 medicine and the amount ingested.

If you forget to use Duokopt

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

If you forget to apply a dose, you should 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 normal dosing schedule.

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

If you stop treatment with Duokopt

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, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You can usually continue using the drops, unless the effects are severe. If you are concerned, consult your doctor or pharmacist. Do not stop using Duokopt without talking to your doctor.

Allergic reactions

Generalized reactions including swelling under the skin that can occur in areas such as the face and limbs, and can obstruct the airways, causing difficulty swallowing or breathing, hives or skin rash, generalized and localized rash, itching, severe allergic reaction that suddenly puts life at risk. 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 itching of the eyes, erosion of the cornea (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 that something is in the eye and does not feel pain), eye pain, dry eyes, blurred vision, headache, sinusitis (feeling of tension or congestion in the nose), nausea, weakness/fatigue, and fatigue.

Uncommon: may affect up to 1 in 100 people:

Dizziness, depression, inflammation of the iris, vision changes including changes in refraction (due in some cases to the 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:

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, detachment of the layer under the retina that contains blood vessels after filtration surgery, which can cause vision changes, drooping eyelid (making the eye remain half-closed), double vision, crusts on the eyelid, swelling of the cornea (with symptoms of vision changes), 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), edema (fluid accumulation), cerebral ischemia (reduced blood supply to the brain), chest pain, strong and/or irregular heartbeats (palpitations), heart attack, Raynaud's phenomenon, swollen and/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 failure, runny or congested nose, nasal bleeding, constriction of airways in the lungs, cough, throat irritation, dry mouth, diarrhea, 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, and 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 can cause side effects similar to those seen with oral or injected beta-blockers. The incidence of side effects after administration in the eyes is less than when, for example, medicines are administered orally or injected.

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

Frequency not known: 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 side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Duokopt

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

Do not use Duokopt after the expiration date stated on the carton and bottle after CAD. The expiration date is the last day of the indicated month.

This medicine does not require special storage conditions.

Duokopt should be used within 2 months after the initial opening of the bottle. Note the date of the first opening on the carton.

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

6. Package Contents and Additional Information

Composition of Duokopt

• The active ingredients 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 ingredients are:hydroxyethylcellulose, mannitol, sodium citrate, sodium hydroxide, and water for injectable preparations.

Appearance of the Product and Package Contents

Duokopt is a clear to slightly yellowish solution.

Duokopt is available in the following package sizes:

• a 5 ml multidose bottle (with a minimum of 125 drops without preservatives, 1 month of treatment) that includes a pump equipped with a device with ergonomic supports.
• a 10 ml multidose bottle (with a minimum of 250 drops without preservatives, 2 months of treatment) including a pump equipped with a device with ergonomic supports.
• 1 box with three 5 ml multidose bottles (3 months of treatment) that includes for each bottle a pump equipped with a device with ergonomic supports.
• 3 boxes of a 5 ml multidose bottle wrapped in protective foil (3 months of treatment) that includes a pump equipped with a device with ergonomic supports.
• 1 box of two 10 ml multidose bottles (4 months of treatment) that includes for each bottle a pump equipped with a device with ergonomic supports.
• 2 boxes of a 10 ml multidose bottle wrapped in protective foil (4 months of treatment) that includes a pump equipped with a device with ergonomic supports.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

LABORATOIRES THEA

12, RUE LOUIS BLERIOT

63017 CLERMONT-FERRAND CEDEX 2

FRANCE

Manufacturer

DELPHARM TOURS

RUE PAUL LANGEVIN

37170 CHAMBRAY LES TOURS

FRANCE

Or

LABORATOIRES THEA

12, RUE LOUIS BLÉRIOT

63017 CLERMONT-FERRAND CEDEX 2

FRANCE

Or

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, 2ª planta

08008 Barcelona

Spain

This medicine 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, Slovak Republic…………....…Dualkopt

Date of the Last Revision of this Prospectus:October 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/.