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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

(dorzolamide / timolol)

Read all of 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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. How to store Duokopt
6. Contents of the pack and other information

1. What Duokopt is and what it is used for

Duokopt is a preservative-free ophthalmic solution.

Duokopt 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 medicines reduce intraocular pressure in different ways.

Duokopt is prescribed to lower elevated intraocular pressure in the treatment of glaucoma when the use of a beta-blocker eye drop alone is not adequate.

2. What you need to know before using Duokopt

Do not use Duokopt:

• If you are allergic (hypersensitive) to dorzolamide hydrochloride, timolol maleate, or to any of the other components of this medicine (listed in section 6).
• If you have or have previously had respiratory problems such as asthma, or severe chronic obstructive bronchitis (a serious lung disease that may cause wheezing, difficulty breathing, and/or long-standing cough).
• If you have a slow heartbeat, heart failure, or heart rhythm disorders (irregular heartbeats).
• If you have severe kidney disease or a history of kidney stones.
• If you have excess blood acidity caused by an accumulation of chlorides in the blood (hyperchloremic acidosis).

If you are unsure whether you should use Duokopt, contact your doctor or pharmacist.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use Duokopt, if you have any current or past medical or eye conditions, including:

• Coronary heart disease (symptoms may include chest pain or tightness, difficulty breathing, or shortness of breath), heart failure, low blood pressure.
• Heart rhythm disorders such as a slow heartbeat.
• Respiratory problems, asthma, or chronic obstructive pulmonary disease.
• Poor blood circulation disorders (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 type of allergy or anaphylactic reaction.
• Muscle weakness, especially if diagnosed with myasthenia gravis.

Inform your doctor that you are using Duokopt before undergoing surgery, as timolol may alter the effect of certain 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 Duokopt is causing you an allergic or hypersensitivity reaction (e.g., skin rash, severe skin reaction, or red, itchy eyes), stop using Duokopt.
• You develop an eye infection, suffer an eye injury, undergo eye surgery, or develop a reaction involving new symptoms or worsening of existing ones.

When Duokopt is applied to the eye, it may affect the entire 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 preserved dorzolamide/timolol combination formulation in infants and children. The use of Duokopt is not recommended in children aged 0 to 18 years.

Use in elderly patients

In clinical studies with the preserved dorzolamide/timolol combination formulation, the effects of this medicine were similar in elderly patients and younger patients.

Use in patients with hepatic 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 medicine contains timolol, which may cause a positive result in doping tests.

Use of Duokopt with other medicines

Duokopt may affect, or be affected by, other medicines you are taking, including other eye drops used to treat glaucoma.

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

This is particularly important if you are:

• Taking medicines to lower blood pressure or treat heart conditions (such as calcium channel blockers, beta-blockers, or digoxin).
• Taking medicines to treat an irregular or abnormal heartbeat, such as calcium channel blockers, beta-blockers, or digoxin.
• Using another eye drop containing beta-blockers.
• Taking another carbonic anhydrase inhibitor, such as acetazolamide.
• Taking monoamine oxidase inhibitors (MAOIs), used to treat depression.
• Taking a parasympathomimetic medicine, which may have been prescribed to help with urination. Parasympathomimetics are also a specific type of medicine sometimes used to help restore normal intestinal movements.
• 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 conditions 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, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Driving and use of machines

No studies have been conducted on the effects on the ability to drive or operate machinery. Adverse effects associated with Duokopt, such as blurred vision, 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 for this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again. The appropriate dose and duration of treatment will be determined by your doctor.

Dosage

• The recommended dose is one drop in the affected eye or eyes in the morning and at night.
• If you are using Duokopt at the same time as another eye drop, the drops should be administered 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 surrounding areas. It may become contaminated with bacteria capable of causing eye infections that could lead to serious eye damage, or even loss of vision. 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 instructions below when using this product:

If you use more Duokopt than you should

If too many drops are applied into the eye or if you swallow some of the contents of the bottle, you may experience effects such as dizziness, difficulty breathing, or a slower heartbeat. Contact your doctor immediately.

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

If you forget to use Duokopt

It is important that you use Duokopt exactly as prescribed by your doctor.

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

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

If you stop using Duokopt

If you wish to discontinue treatment with this medicine, consult your doctor first.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

Allergic reactions

Generalized reactions including swelling beneath the skin that may occur in areas such as the face and limbs, and may obstruct the airways, potentially causing difficulty swallowing or breathing, hives or itchy rash, generalized and localized rash, itching, severe allergic reaction suddenly endangering life (anaphylaxis). If you experience 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, altered taste.

Common: may affect up to 1 in 10 people:

Redness of and around the eye(s), tearing or itchy eyes, corneal erosion (damage to the front layer of the eyeball), inflammation and/or irritation of and around the eye(s), sensation of a foreign body in the eye, decreased corneal sensitivity (reduced ability to sense foreign objects in the eye and lack of pain sensation), eye pain, dry eyes, blurred vision, headache, sinusitis (feeling of pressure or congestion in the nose), nausea, weakness/tiredness and fatigue.

Uncommon: may affect up to 1 in 100 people:

Dizziness, depression, inflammation of the iris, visual disturbances including changes in refraction (in some cases due to discontinuation of miotic therapy), slow heart rate (reduced heartbeat), fainting, difficulty breathing (dyspnea), indigestion, kidney stones.

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

Systemic lupus erythematosus (an autoimmune disease that may cause inflammation of internal organs), tingling or numbness of the hands or feet, insomnia, nightmares, memory loss, increased signs and symptoms of myasthenia gravis (a muscle disorder), decreased sexual desire, stroke, transient myopia that resolves upon discontinuation of therapy, detachment of the vascular layer of the retina following filtration surgery which may cause visual disturbances, drooping eyelid (causing the eye to remain partially closed), double vision, eyelid crusting, corneal swelling (with symptoms of visual disturbances), low eye pressure, ringing sounds in the ear (tinnitus), low blood pressure, changes in the rhythm or rate of heartbeat, 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 heartbeats that may be rapid or irregular (palpitations), heart attack, Raynaud's phenomenon, swollen or cold hands and feet and reduced circulation in arms and legs, leg cramps and/or leg pain when walking (claudication), shortness of breath, respiratory failure, runny or stuffy nose, nosebleeds, narrowing of the airways in the lungs, cough, throat irritation, dry mouth, diarrhea, contact dermatitis, hair loss, skin rash with silvery appearance (psoriasiform rash), Peyronie's disease (which may cause penile curvature), allergic-type 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).

Like other eye medications, timolol is absorbed into the bloodstream. This may cause side effects similar to those observed with oral beta-blockers. The incidence of adverse effects after ocular administration is lower than when, for example, medications are administered orally or by injection.

The following adverse effects have been observed with medicines of the same class when used for the treatment of ocular disorders.

Frequency not known: cannot be estimated from available data

Low blood glucose 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, breathing difficulty, sensation of a foreign body in the eye, hallucinations.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide 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 expiry date stated on the carton and bottle after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Duokopt

• The active substances are: dorzolamide and timolol. Each ml contains 20 mg of dorzolamide (as 22.25 mg dorzolamide hydrochloride) and 5 mg of timolol (as 6.83 mg timolol maleate).
• The other components are: hydroxyethylcellulose, mannitol, sodium citrate, sodium hydroxide and water for injections.

Nature of the product and contents of the container

Duokopt is a transparent, slightly yellow solution.

Duokopt is available in the following pack sizes:

• 5 ml multidose bottle (with a minimum of 125 drops, preservative-free, 1 month treatment) including a pump equipped with a device with ergonomic supports.
• 10 ml multidose bottle (with a minimum of 250 drops, preservative-free, 2 months treatment) including a pump equipped with a device with ergonomic supports.
• 1 box containing three 5 ml multidose bottles (3 months treatment), each including a pump equipped with a device with ergonomic supports.
• 3 boxes of one 5 ml multidose bottle wrapped in protective foil (3 months treatment), each including a pump equipped with a device with ergonomic supports.
• 1 box containing two 10 ml multidose bottles (4 months treatment), each including a pump equipped with a device with ergonomic supports.
• 2 boxes of one 10 ml multidose bottle wrapped in protective foil (4 months treatment), each including a pump equipped with a device with ergonomic supports.

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 medicinal product is authorised 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 most recent revision of this leaflet: October 2023

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