20 mg / ml + 5 mg / ml eye drops, solution 
dorzolamide / timolol

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not give it to others. It may harm them, even if they show symptoms similar to yours.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Duokopt is and what it is used for 
2. What you need to know before you use 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 Duokopt is and what it is used for

Duokopt is preservative-free eye drops, solution.

Duocopt contains two active substances: dorzolamide and timolol. 

  • Dorzolamide belongs to a group of medicines called carbanhydrase inhibitors.
  • Timolol belongs to a group of medicines called beta-blockers.

These drugs lower the pressure in the eye in different ways. 

Duokopt is used to lower an elevated pressure in the eye in glaucoma ( glaucoma ) when treatment with eye drops containing only beta-blocker is not sufficient.

Dorzolamide and timolol contained in Duokopt may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before using Duokopt

Do not use Duokopt :

  • if you are allergic (hypersensitive) to dorzolamide hydrochloride, timolol maleate, or any of the other ingredients of this medicine (listed in section 6)
  • if you have or have previously had respiratory problems, such as asthma or severe chronic obstructive bronchitis (severe lung disease that may cause wheezing, difficulty breathing, and/or prolonged cough)
  • if you have a low heart rate, heart failure, or heart rhythm disturbances (irregular heartbeat)
  • if you have severe kidney disease or severe kidney problems or have previously had kidney stones
  • if the acidity of your blood is elevated due to elevated chloride levels in the blood (hyperchloraemic acidosis ).

Contact your doctor or pharmacist if you are not sure if you should use Duokopt.

Warnings and cautions

Before using Duokopt, tell your doctor, pharmacist, or nurse about any medical problems or eye problems you may have or have had in the past:

  • coronary heart disease (symptoms may include chest pain or pressure over the chest, shortness of breath, or suffocation), heart failure, low blood pressure
  • heart rhythm disorders such as low heart rate
  • respiratory distress, asthma, or chronic obstructive pulmonary disease (COPD)
  • a disease that involves poor blood circulation (such as Raynaud’s disease or Raynaud’s syndrome)
  • diabetes, because timolol can mask the signs and symptoms of low blood sugar
  • the overactive thyroid gland, as timolol can obscure the signs and symptoms of this
  • allergy or anaphylactic reactions
  • muscle weakness, especially in cases of diagnosed myasthenia gravis.

Tell your doctor before an operation that you are taking Duokopt, as timolol may alter the effect of certain medicines used under anesthesia.

During treatment with Duokopt, contact your doctor immediately if you:

  • feels irritation of any kind in the eye or has other eye problems, such as red eyes or swollen eyelids
  • suspects that Duokopt causes an allergic reaction or hypersensitivity (eg skin rash, severe skin reaction, or redness and itching of the eye). In this case, stop the treatment.
  • develops an eye infection, gets an eye injury, undergoes eye surgery, or develops a reaction with symptoms that worsen or that you have not experienced before.

Duocopt eye drops 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, talk to your doctor before using Duokopt.

Children

Experience in the treatment of infants and children with combined dorzolamide/timolol formulation containing preservatives is limited. Duokopt is not recommended for children aged 0 to 18 years.

Older

In studies with combined dorzolamide/timolol formulation containing preservatives, the effect was comparable in elderly and younger patients. 

Patients with hepatic impairment

Tell your doctor if you have or have had any liver problems in the past.

Patients with renal impairment

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

Use of other medicines and Duokopt

Duokopt can affect or be affected by other medicines you use, including other eye drops for the treatment of glaucoma. 

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

This is especially important if you: 

  • use medicines that lower blood pressure or to treat heart disease (such as calcium channel blockers, beta-blockers, or digoxin )
  • use drugs to treat irregular heartbeats such as calcium channel blockers, beta-blockers, or digoxin
  • use other eye drops that contain a beta-blocker
  • uses another carbohydrate inhibitor such as acetazolamide
  • uses monoamine oxidase inhibitors ( MAOIs ), which are used to treat depression
  • use medicines you have been given for, for example, vomiting problems (parasympathomimetics). Parasympathomimetics are a type of drug that is sometimes also used to restore normal bowel movements.
  • use certain strong painkillers such as morphine
  • use drugs to treat diabetes
  • use antidepressant drugs called fluoxetine and paroxetine
  • use medicines containing a sulfonamide
  • uses quinidine (a medicine used to treat heart disease and certain types of malaria ).

Pregnancy and breastfeeding

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

Ask your doctor or pharmacist for advice before taking any medicine.

Do not use Duokopt if you are breast-feeding. Timolol can be excreted in your breast milk. Ask your doctor for advice before taking any medicine while you are breast-feeding.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed. Duokopt can cause side effects such as blurred vision, which may affect your ability to drive and/or operate machines. Wait to drive or operate machines until you feel good or your vision is clear. You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

3. How to use Duokopt

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. The appropriate dose and duration of treatment are determined by your doctor.

Dosage

  • The usual dose is 1 drop morning and evening in the eye (s) to be treated.
  • If Duokopt is used with other eye drops, the eye drops should be taken at least 10 minutes apart.
  • Do not change the dosage without consulting a doctor.
  • Make sure that the tip of the bottle does not touch the eye or the area around the eye. This can lead to contamination with bacteria that can cause an eye infection, which can lead to serious eye damage, including vision loss. To avoid contaminating the contents of the bottle, make sure that the tip of the bottle does not come into contact with any objects.

Instructions for use

It is important to follow the instructions below when using this medicine:

Make sure the sealed cap is unbroken before using the bottle for the first time. Firmly unscrew the sealed cap to open the bottle.
1. Before each use, wash your hands thoroughly and then remove the cap. Avoid touching the tip of the bottle with your fingers.
Hold the bottle upside down and press down several times, to activate the pump mechanism, until the first drop is visible. This only applies to the very first use and is not necessary for future uses.
2. Place your thumb on the tab on top of the bottle and your index finger on the bottom of the bottle. Then also place the middle finger on the other tab at the bottom of the bottle. Hold the bottle upside down. 
To use, tilt your head back slightly and hold the bottle vertically above your eye. With the index finger of the other hand, gently pull down the lower eyelid. The space created is called the lower subjunctive sac. Avoid touching the tip of the bottle with your fingers or eyes. To apply a drop to the lower conjunctival sac in the affected eye (s),  press quickly and firmly. Thanks to automatic dosing, exactly one drop is released with each pumping.
If no drop comes, gently shake the bottle to remove any remaining drops from the tip of the bottle. In this case, step 3 is repeated.
4. Close the eyelids and press the inner corner of the eye, near the nose, with your finger for 2 minutes. This helps prevent the eye drops from spreading to the rest of the body.

5. Put the cap back on the bottle immediately after use.

If you take more Duokopt than you should

If you have taken too much medicine or if, for example, a child has ingested the medicine, contact a doctor, hospital, or the Poison Information Center for assessment of the risk and advice.

If you have dropped too many drops in the eye or have swallowed some of the contents of the container, you may, among other things, become dizzy, have difficulty breathing, or feel that your heart beats more slowly. Contact a doctor immediately.

If you forget to take Duokopt 

You must always use Duokopt exactly as your doctor has told you. 

If you forget to take a dose, take it as soon as possible. However, if it is time to take the next dose, skip the missed dose and then follow your usual dosing schedule. Do not take a double dose to make up for a forgotten dose.

If you stop using Duokopt

If you want to stop treatment with this medicine, consult your doctor first.

If you have any further questions on the use of this product, 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 to take the drops unless the side effects are severe. If you have any further questions, ask your doctor or pharmacist. Do not stop using Duokopt without talking to a doctor.

Allergic reactions

General allergic reactions including swelling under the skin which may occur on areas such as the face, arms, and legs and may block the airways which may cause difficulty swallowing or breathing, hives or itchy rash, local or general rash, itching, sudden severe life-threatening allergic reaction. If you get any of these side effects, stop using Duokopt and contact your doctor immediately.

Very common (may affect more than 1 user in 10):

Burning and stinging sensation in the eyes, taste changes.

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

Redness in and around the eye/eyes, increased tear flow or itching in the eye/eyes, damage to the cornea (damage to the outer layer of the eye), swelling and/or irritation in or around the eye/eyes, feeling of having something in the eye, decreased sensitivity of the cornea (does not notice that something has entered the eye and does not feel pain), eye pain, dry eyes, blurred vision, headache, sinusitis (it presses or feels full in the nose), nausea, weakness/fatigue, and fatigue.

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

Dizziness, depression, inflammation of the iris, visual disturbances including refractive errors (in some cases due to discontinuation of treatment with so-called miotics), low heart rate, fainting, difficulty breathing ( dyspnoea ), indigestion, and kidney stones.

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

Systemic lupus erythematosus ( SLE , an immune disorder that can cause inflammation of internal organs) , tingling or numbness in the hands or feet, difficulty falling asleep, nightmares, memory loss, worsening signs and symptoms of myasthenia gravis (muscle disease), decreased sexual desire, stroke, temporary nearsightedness which may disappear when treatment is stopped, loosening of the blood vessel-containing membrane that lies under the retina after filtration surgery which can cause visual disturbances, drooping eyelids (which causes the eye to be half closed), double vision, scabs around the eyelids, swelling of the cornea (with symptoms of visual disturbance ), low pressure in the eye, earrings, low blood pressure, change in heart rate or rhythm, chronic heart failure (heart disease with shortness of breath, swollen feet and legs due to fluid retention), edema (fluid retention), cerebral ischemia (decreased blood supply to the brain), chest pain, severe heartbeat or rapid heartbeat (palpitations), heart attack, Raynaud’s phenomenon, swelling or cold hands and feet as well as decreased blood circulation in the arms and legs, leg cramps and / or pain in the legs when walking (claudicatio), shortness of breath, respiratory failure, runny or stuffy nose, nosebleeds, contraction of airways in the lungs, cough, throat irritation, dry mouth , diarrhea, contact dermatitis(skin inflammation), hair loss, rash with a silvery appearance (psoriasis-like rash), Peyronie’s disease (which can cause a bend of the penis), reactions of allergic type such as skin rash, hives , itching , in rare cases possible swelling of the lips, eyes and mouth, wheezing or severe skin reactions ( Stevens-Johnson syndrome , toxic epidermal necrolysis ).

Like other medicines given to your eyes, timolol is absorbed into your bloodstream. This can cause similar side effects as those seen with oral beta-blockers. The incidence of side effects when giving medicines locally in the eye is lower than when medicines are taken orally or injected, for example. 

Additional side effects observed for the same drug group in the treatment of eye diseases:

No known frequency (cannot be calculated from the available data):

Low blood sugar levels, heart failure, a type of heart rhythm disorder, abdominal pain, vomiting, muscle pain not caused by exercise, sexual dysfunction, shortness of breath, the feeling of debris in the eye, hallucination.

5. How to store Duokopt

Keep out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and bottle (EXP). The expiration date is the last day of the specified month.

No special storage instructions.

Duokopt can be used up to 2 months after the first opening. When opening the bottle for the first time, write the date on the outer carton.

The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

What Duokopt contains

  • The active substances are: dorzolamide and timolol . 1 ml contains 20 mg dorzolamide (as 22.25 mg dorzolamide hydrochloride) and 5 mg timolol (as 6.83 mg timolol maleate).
  • The other ingredients are hydroxyethylcellulose, mannitol, sodium citrate, sodium hydroxide for pH adjustment, and water for injections.

What the medicine looks like and the contents of the pack

Duokopt is a clear, colorless to pale yellow solution.

Duokopt is available in the following pack sizes:

  • 5 ml multidose vial (at least 125 preservative-free drops) with a pump with ergonomic administration system.
  • 10 ml multidose vial (at least 250 preservative-free drops) with a pump with an ergonomic administration system.
  • 1 carton of 3×5 ml multidose vials with a pump with ergonomic administration system.
  • 1 carton of two 10 ml multidose vials with a pump with ergonomic administration system.

Not all packaging may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Laboratories THEA

12 Rue Louis Blériot

63017 Clermont-Ferrand Cedex 2

France

Manufacturer

DELPHARM TOURS

Rue Paul Langevin

37170 Chambray-lès-Tours

France

or

Laboratories THEA

12 Rue Louis Blériot

63017 Clermont-Ferrand Cedex 2

France

This medicinal product is authorized under the European Economic Area under the names:

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

Belgium, Czech Republic, France, Luxembourg, Netherlands, Slovakia: Dualkopt

Muhammad Nadeem

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