Ducressa

LEAFLET INCLUDED IN THE PACKAGE

Leaflet included in the package: information for the user

Ducressa 1 mg/mL + 5 mg/mL

Eye drops, solution
Dexamethasone + Levofloxacin

You should carefully read the contents of this leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific person. 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 possible side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Ducressa and what is it used for

What kind of medicine is this and how does it work

The eye drops, solution Ducressa contains levofloxacin and dexamethasone.
Levofloxacin is an antibiotic belonging to the group of fluoroquinolones (sometimes abbreviated as quinolones). Its action involves killing certain types of bacteria that can cause infection.
Dexamethasone is a corticosteroid, it has anti-inflammatory effects (stops symptoms such as pain, feeling of heat, swelling, and redness).

What is this medicine used for?

Ducressa is used to prevent and treat inflammatory conditions and to prevent potential infection of the eye after cataract surgery in adults.

2. Important information before using Ducressa

When not to use Ducressa

• If the patient is allergic to levofloxacin (or other quinolones) or dexamethasone (or other corticosteroids), or any of the other ingredients of this medicine (listed in section 6).
• If the patient has an eye infection for which they are not taking medication, such as a viral infection (e.g., herpes simplex keratitis or chickenpox), fungal infections, or eye tuberculosis. Infection may be indicated by sticky discharge from the eye or redness of the eye that has not been examined by a doctor.

Warnings and precautions

Before using Ducressa, you should discuss this with your doctor:

• If the patient is taking any other antibiotics, including oral antibiotics. Like other anti-infective drugs, prolonged use may lead to antibiotic resistance and, as a result, excessive growth of pathogenic microorganisms.
• If the patient has high eye pressure or has had high eye pressure after using a steroid eye medicine. Taking Ducressa may cause this condition to recur. The doctor should be informed about high eye pressure.
• If the patient has glaucoma
• If the patient has vision disturbances or blurred vision
• If the patient is using eye non-steroidal anti-inflammatory drugs (NSAIDs), see the section "Ducressa and other medicines".
• If the patient has a disease that causes thinning of the eye tissue, as prolonged steroid treatment may result in further thinning and potential perforation.
• If the patient has diabetes

Important information for patients wearing contact lenses

After cataract surgery, contact lenses should not be worn during the entire treatment period with Ducressa.

Children and adolescents

Ducressa is not recommended for children and adolescents under 18 years of age due to the lack of data on safety and efficacy in this age group.

Ducressa and other medicines

Tell your doctor or pharmacist

• About all medicines the patient is currently taking or has recently taken, as well as medicines the patient plans to take, including those obtained without a prescription.
• About using other types of eye drops or eye ointments before starting Ducressa (see section 3 - How to use Ducressa).
• About using ophthalmic NSAIDs (for pain and inflammation of the eye), such as ketorolac, diclofenac, bromfenac, and nepafenac. Concurrent use of oral steroids and ophthalmic NSAIDs may increase the risk of eye healing problems.
• About using ritonavir or cobicistat (used to treat HIV), as they may increase the amount of dexamethasone in the blood
• About using probenecid (for gout), cimetidine (for stomach ulcers), and cyclosporine (to prevent transplant rejection), as they may change the absorption and metabolism of levofloxacin.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine. Ducressa should not be used during pregnancy and breastfeeding.

Driving and using machines

If after a short time of using the medicine, there is temporary blurred vision, the patient should not drive or operate machines until their vision is clear.

Ducressa contains phosphate buffer

The medicine contains 4.01 mg of phosphates per ml, which corresponds to 0.12 mg per drop. In the event of severe damage to the clear layer in front of the eye (cornea), phosphate may, in very rare cases, cause the appearance of cloudy spots on the cornea, resulting from calcium deposition during treatment. In this case, the patient should consult a doctor, who may recommend treatment with phosphate-free preparations.

Ducressa contains benzalkonium chloride

The medicine contains 0.05 mg of benzalkonium chloride per ml, which corresponds to 0.0015 mg per drop. Benzalkonium chloride may also cause eye irritation, especially in the case of dry eyes or corneal diseases (the clear layer in front of the eye). If after taking this medicine, the patient experiences unusual sensations in the eye, stinging, or eye pain, they should consult a doctor.

3. How to use Ducressa

This medicine should always be used exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is 1 drop into the affected eye every 6 hours. The maximum dose is 4 drops per day.
The total treatment period with Ducressa usually lasts 7 days, and then, if the doctor considers it necessary, steroid eye drops should be used for the next 7 days.
The doctor will inform you how long to use the drops.
If the patient is using any other eye medicine, they should wait at least 15 minutes between using different types of drops. Eye ointments should be used last.

Instructions for use:

If possible, the patient should ask someone else to administer these drops. That other person should be asked to read this instruction together with the patient.

• 1) Wash your hands thoroughly (illustration 1).
• 2) Open the bottle. When opening the bottle for the first time, remove the loose collar from the cap.Be careful not to let the tip of the bottle with the dropper touch the eye, the skin around the eye, or the fingers.
• 3) Unscrew the bottle cap. Hold the bottle with the tip down, between the thumb and fingers.
• 4) Pull the lower eyelid down to create a "pocket" between the eyelid and the eye. The medicine should be dropped into this pocket (illustration 2).
• 5) Tilt your head back and bring the tip of the bottle close to the eye, then gently squeeze the bottle in the middle and let the drop fall into the eye (illustration 3). Remember that there may be a few-second delay between squeezing the bottle and the drop coming out. Do not squeeze the bottle too hard.
• 6) After administering Ducressa, press the corner of the eye near the nose with your finger. This helps prevent the medicine from entering the rest of the body (illustration 4)

If the drop does not get into the eye, try again. Immediately after use, the bottle should be tightly closed again.

Using more Ducressa than recommended

In case of using more of this medicine than recommended, it can be rinsed with warm water.

Missing a dose of Ducressa

If a dose of the medicine is missed, do not worry, just use it as soon as possible. Do not use a double dose to make up for the missed dose.

Stopping the use of Ducressa

If you want to stop using the medicine earlier than recommended, tell your doctor. If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most side effects are not serious and only affect the eyes.

• In very rare cases, this medicine may cause severe allergic reactions (anaphylactic reactions), which are accompanied by swelling and pressure in the throat and difficulty breathing.
• If any of these symptoms occur, stop using Ducressa and contact a doctor immediately.
• In people taking fluoroquinolones orally or intravenously, especially the elderly and those treated with corticosteroids at the same time, tendon swelling and ruptures have occurred. If pain or swelling of the tendons (tendinitis) occurs, stop using Ducressa.

The patient's eye(s) may also experience some or all of the following side effects:

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

• high eye pressure.

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

• discomfort, stinging, or irritation, burning, itching in the eye;
• blurred or impaired vision,
• mucus in the eye.

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

• prolonged corneal healing;
• eye infections;
• unusual sensations in the eye;
• increased tearing;
• dryness and fatigue of the eye;
• eye pain;
• blurred vision;
• swelling or redness (conjunctival hyperemia) of the front membrane of the eye (conjunctiva);
• swelling or redness of the eyelid;
• sensitivity to light;
• sticky eyelids.

Rare(may affect up to 1 in 10,000 people):

• increased pupil size;
• drooping eyelids;
• calcium deposits on the surface of the eye (corneal calcification);
• tears and feeling of sand in the eye (crystalline keratopathy);
• change in the thickness of the eye surface;
• ulcer on the eye surface;
• small holes in the eye surface (corneal perforation);
• swelling of the eye surface (corneal edema);
• eye inflammation that causes pain and redness (uveitis).

In other parts of the body, the following side effects may occur:

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

• headache;
• change in taste;
• itching;
• stuffy or runny nose.

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

• allergic reactions, such as skin rash.

Very rare(may affect up to 1 in 10,000 people):

• facial swelling.

Frequency not known

• decreased adrenal function, which may manifest as low blood sugar, dehydration, weight loss, and disorientation;
• hormone problems: excessive hair growth on the body (especially in women), weakness and muscle wasting, purple stretch marks on the skin, high blood pressure, irregular or absent menstruation, changes in protein and calcium levels in the body, growth retardation in children and adolescents, and swelling and weight gain of the body and face (known as "Cushing's syndrome").

Reporting side effects

If side effects occur, including any possible side effects not listed in this leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocides,
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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Ducressa

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label of the bottle and carton after "EXP". The expiry date refers to the last day of that month.
Do not use this medicine if the plastic ring around the cap and neck is missing or broken before opening a new bottle.
Keep the bottle tightly closed. To prevent infections, discard the bottle 28 days after first opening and use a new one.
This medicine does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Ducressa contains

• The active substances of the medicine are levofloxacin in the form of hemihydrate and dexamethasone in the form of sodium phosphate. One milliliter of the solution contains 5 mg of levofloxacin and 1 mg of dexamethasone.
• The other ingredients are disodium phosphate dodecahydrate, sodium phosphate monohydrate, sodium citrate, benzalkonium chloride, sodium hydroxide/hydrochloric acid (for pH adjustment), water for injections

What Ducressa looks like and contents of the pack

Ducressa is a clear, yellowish-green solution that is practically free of particles, even if the dropped drops appear clear and colorless. It is available in a pack containing one white, plastic bottle with a capacity of 5 ml and a white dropper. The plastic bottle is closed with a cap.

Marketing authorization holder

Santen Oy
Niittyhaankatu 20
33720 Tampere
Finland

Manufacturer

Santen Oy
Kelloportinkatu 1
33100 Tampere
Finland

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Ducressa: Austria, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, Greece, Spain, Ireland, Iceland, Liechtenstein, Lithuania, Latvia, Netherlands, Germany, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Sweden, Hungary, Italy, United Kingdom (Northern Ireland)
Dugressa: France

Date of last revision of the leaflet: 06/2022

Detailed information on this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocides
http://urpl.gov.pl