Duokopt

Patient Information Leaflet

DUOKOPT, 20 mg/ml + 5 mg/ml, eye drops, solution
(Dorzolamide + Timolol)
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

1. What DUOKOPT is and what it is 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 pack and other information

1. What DUOKOPT is and what it is used for

DUOKOPT is a preservative-free eye drop solution.
DUOKOPT contains two active substances: dorzolamide and timolol.

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

DUOKOPT is indicated for the treatment of glaucoma to reduce elevated intraocular pressure when treatment with eye drops containing only a beta-adrenergic receptor inhibitor is insufficient.

2. Important information before using DUOKOPT

When not to use DUOKOPT:

• if the patient is allergic (hypersensitive) to dorzolamide hydrochloride, timolol maleate, or any of the other ingredients of this medicine (listed in section 6);
• if the patient currently has or has previously had respiratory disorders such as asthma or severe chronic obstructive pulmonary disease (a serious lung disease which may cause wheezing, breathing difficulties and/or long-lasting cough);
• if the patient has bradycardia (slow heart rate), heart failure, or cardiac arrhythmias (irregular heartbeat);
• if the patient has severe kidney disease or severe impairment of kidney function, or a history of kidney stones;
• if the patient has excessive blood acidity due to accumulation of chloride ions in the body (hyperchloremic acidosis).

If in doubt whether DUOKOPT may be used, consult a doctor or pharmacist.

Warnings and precautions

Before using DUOKOPT, tell your doctor, pharmacist, or nurse about any current or previous eye disorders or medical conditions:

• ischemic heart disease (symptoms such as chest pain or tightness, shortness of breath, or a feeling of suffocation), heart failure, low blood pressure;
• disturbances in heart rate, such as bradycardia;
• breathing problems, asthma, or chronic obstructive pulmonary disease;
• conditions related to poor blood circulation (such as Raynaud's disease or Raynaud's syndrome);
• diabetes, because timolol may mask the signs and symptoms of low blood sugar (hypoglycemia);
• hyperthyroidism, because timolol may mask its signs and symptoms;
• any allergies or anaphylactic reactions;
• muscle weakness, particularly if myasthenia gravis has been diagnosed.

Before undergoing surgery, inform the attending physician about the use of DUOKOPT, as timolol may alter the effects of certain drugs used for anesthesia.

During treatment with DUOKOPT, contact your doctor immediately if:

• any eye irritation or any new eye problem occurs, such as eye redness or eyelid swelling;
• an allergic reaction or hypersensitivity to DUOKOPT is suspected (e.g. skin rash, severe skin reaction, or eye redness and itching); in such cases, stop using DUOKOPT;
• an eye infection develops, an eye injury occurs, eye surgery is performed, or new or worsening symptoms appear.

After instillation into the eye, DUOKOPT may cause systemic effects.

Use of contact lenses

No studies have been conducted on the use of DUOKOPT in patients wearing contact lenses.

If the patient wears soft contact lenses, he or she should consult a doctor before using DUOKOPT.

Children

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

Elderly patients

In clinical studies, the effect of the dorzolamide and timolol combination (with a preservative) was similar in elderly and younger patients.

Patients with liver function impairment

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

Patients with kidney function impairment

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

Sports

Use of DUOKOPT may result in positive findings in anti-doping tests.

DUOKOPT and other medicines

DUOKOPT may affect the action of other medicines, or other medicines the patient is taking may affect the action of DUOKOPT, including other eye drops used in glaucoma treatment.

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

This is particularly important when:

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

Pregnancy and breastfeeding

Do not use DUOKOPT during pregnancy unless your doctor considers it necessary.

Before taking any medicine, consult your doctor or pharmacist.

Do not use DUOKOPT while breastfeeding. Timolol may pass into breast milk. Before taking any medicine during breastfeeding, consult your doctor.

Driving and operating machinery

No studies have been conducted on the effect of DUOKOPT on the ability to drive or operate machinery. However, undesirable effects such as blurred vision associated with the use of DUOKOPT may affect the ability to drive and/or operate machinery. Do not drive or operate machinery until the patient feels better or clear vision returns.

3. How to use DUOKOPT

This medicine should always be used exactly as prescribed by the doctor. If in doubt, consult the doctor or pharmacist. The doctor determines the appropriate dose and duration of treatment.
Dosage

• 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, an interval of at least 10 minutes should be maintained between the administration of the medicines.
• Do not change the dose without consulting your doctor.
• Do not let the tip of the bottle touch the eye or surrounding areas. This may lead to bacterial contamination, which could result in an eye infection causing serious damage or even loss of vision. To avoid possible contamination of the bottle, avoid contact between its tip and any surface.

Instructions for use
It is important to follow these instructions when using the product:

	Before first use, check whether the safety cap is intact. Then unscrew the safety cap firmly to open the bottle.
	1. Before each use, wash hands thoroughly and remove the cap from the bottle tip. Avoid touching the bottle tip with fingers.
Press the bottle several times with the dropper tip pointing downwards to activate the pump mechanism, until the first drop appears. This procedure applies only for the first use of the medicine and is not necessary for subsequent administrations.
	2. Place the thumb on the tab at the top of the bottle and the index finger on the base of the bottle. Then also place the middle finger on the other tab at the base of the bottle. Hold the bottle upside down.
	3. To administer, tilt the head slightly backwards and hold the bottle with the dropper pointing vertically downwards over the eye. With the index finger of the other hand, gently pull down the lower eyelid. The space formed is called the lower conjunctival sac. Avoid contact between the dropper tip and fingers or eyes. To instil a drop into the lower conjunctival sac of the affected eye(s), press the bottle briefly and firmly. Due to automatic dosing, a drop is released precisely with each pump action.
If the drop does not fall, gently shake the bottle to remove any residual drop remaining at the tip. In such case, repeat step 3.
	4. Close the eyelids and with a finger press gently on the inner corner of the eye near the nose for 2 minutes. This helps prevent systemic absorption of the drop.
	5. Immediately after use, replace the cap on the bottle tip.

Use of a higher than recommended dose of DUOKOPT eye drops
If too many drops are administered into the eye or if the contents of the bottle are swallowed, in addition to other symptoms, dizziness, breathing difficulties or a sensation of slowed heart function may occur. You should contact a doctor immediately.

Missed dose of DUOKOPT eye drops
It is important to use DUOKOPT exactly 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 administer the missed dose and return to your regular dosing schedule.
Do not use a double dose to make up for a missed dose.

Stopping treatment with DUOKOPT eye drops
Before discontinuing treatment, consult your doctor.
If you have any further doubts regarding the use of this medicine, consult your doctor, pharmacist or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Treatment with the eye drops can usually be continued unless the adverse effects are severe. If you have any concerns, contact your doctor or pharmacist. Do not stop using DUOKOPT without consulting your doctor.

Allergic reactions
Generalised allergic reactions, including subcutaneous oedema, may occur in areas such as the face and limbs and may block the airways, causing difficulty in swallowing or breathing, urticaria or itchy rash, localised and generalised skin rash, pruritus, and severe, sudden, life-threatening allergic reaction. If any of these symptoms occur in a patient, treatment with DUOKOPT should be discontinued immediately and medical advice should be sought without delay.

Very common: may affect more than 1 in 10 people:
Sensation of burning and stinging in the eye, altered taste sensation.

Common: may affect up to 1 in 10 people:
Redness of the eyes and skin around the eyes, tearing or itchy eyes, corneal epithelial defects (damage to the front layer of the eyeball), swelling and/or eye irritation and skin irritation around the eyes, sensation of a foreign body in the eye, decreased corneal sensitivity (inability to feel a foreign body in the eye and inability to feel pain), eye pain, dry eyes, blurred vision, headache, sinusitis (feeling of nasal congestion or fullness), nausea, fatigue and feeling of tiredness.

Uncommon: may affect up to 1 in 100 people:
Dizziness, depression, iritis (inflammation of the iris), visual disturbances, including refractive changes (in some cases due to discontinuation of miotic drugs), bradycardia (slowed heart rate), fainting, breathing difficulties (dyspnoea), indigestion, and kidney stones.

Rare: may affect up to 1 in 1000 people:
Systemic lupus erythematosus (an autoimmune disease that may cause inflammation of internal organs), tingling or numbness in hands or feet, insomnia, nightmares, memory loss, worsening of objective and subjective symptoms of myasthenia (a muscle disorder), loss of libido, stroke, transient myopia which may resolve after discontinuation of the medicine, choroidal detachment (detachment of the vascular layer beneath the retina, which contains blood vessels) following filtration procedures, which may cause visual disturbances, ptosis (drooping eyelid causing the eyelid to be half-closed), double vision, formation of crusts on the eyelids, corneal oedema (resulting in visual disturbances), low intraocular pressure, tinnitus, hypotension (low blood pressure), changes in heart rhythm or rate, congestive heart failure (a heart condition characterised by breathlessness and swelling of feet and legs due to fluid accumulation), oedema (fluid accumulation), cerebral ischaemia (reduced blood flow to the brain), chest pain, strong heartbeats which may be fast or irregular (palpitations), myocardial infarction, Raynaud's disease, swelling of hands and feet or cold hands and feet, and poor circulation in upper and lower limbs, leg muscle cramps and/or leg pain while walking (claudication), shortness of breath, respiratory failure, rhinitis (nasal mucosal inflammation), nosebleeds, bronchoconstriction (narrowing of the airways in the lungs), cough, throat irritation, dryness of the mouth, diarrhoea, contact dermatitis, hair loss, silvery scaling skin rash (psoriasis-like rash), Peyronie's disease (which may lead to penile curvature), allergic reactions such as skin rash, urticaria, pruritus, and in rare cases swelling of the lips, eyelids and oral cavity, wheezing or severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Like other medicines administered locally to the eyes, timolol is absorbed into the bloodstream. This may lead to adverse effects similar to those observed after oral administration of beta-adrenergic receptor blocking agents. Adverse effects occur less frequently with topical eye drops than with oral or injectable administration of these medicines.

The following adverse effects have been reported during use of medicines from this class in the treatment of eye diseases

Not known: frequency cannot be estimated from available data
Low blood sugar levels, heart failure, cardiac arrhythmias, tachycardia (increased heart rate), increased blood pressure, abdominal pain, vomiting, muscle pain unrelated to physical exertion, sexual dysfunction, dyspnoea, sensation of a foreign body in the eye (feeling that something is in the eye), hallucinations.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse.

Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Adverse effects can also be reported to the marketing authorisation holder.

Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store DUOKOPT

Keep out of the 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) refers to the last day of the stated month.
No special storage precautions are required.
DUOKOPT can be used for up to 2 months after first opening. The date of first opening should be recorded on the carton.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and other information

What DUOKOPT contains

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

What DUOKOPT looks like and contents of the pack
DUOKOPT is a clear, colourless to slightly yellow solution.
DUOKOPT is available in the following pack sizes:

• HDPE bottle containing 5 ml (at least 125 drops, preservative-free, one month of treatment) with a dosing pump and protective cap, in a cardboard box.
• HDPE bottle containing 10 ml (at least 250 drops, preservative-free, two months of treatment) with a dosing pump and protective cap, in a cardboard box.
• One cardboard box containing three 5 ml HDPE bottles (three months of treatment), each with a dosing pump and protective cap.
• One cardboard box containing two 10 ml HDPE bottles (four months of treatment), each with a dosing pump and protective cap.

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 authorised in 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

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