Ducressa

Package Leaflet: Information for the User

Warning! Keep the Leaflet! Information on the Immediate Packaging in a Foreign Language.

Ducressa, 1 mg/ml + 5 mg/ml, Eye Drops, Solution

Dexamethasone + Levofloxacin

Read the Leaflet Carefully Before Using the Medicinal Product, as it Contains Important Information for the Patient.

• Keep this leaflet, so you can read it again if you need to.
• In case of any doubts, consult a doctor or pharmacist.
• This medicinal product has been prescribed to you specifically. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform 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 medicinal product 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 with anti-inflammatory effects (it stops symptoms such as pain, feeling of heat, swelling, and redness).

What is this medicinal product used for?

Ducressa is used to prevent and treat inflammatory conditions and to prevent potential eye infection 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 medicinal product (listed in section 6).
• 6).
• If the patient has an eye infection for which they are not receiving treatment, such as a viral infection (e.g., herpes simplex keratitis or chickenpox), fungal infections, or eye tuberculosis. Infection may be indicated by a sticky discharge from the eye or redness of the eye that has not been examined by a doctor.

Warnings and precautions

Before using Ducressa, discuss 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 medicinal product. Using Ducressa may cause this phenomenon 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 ophthalmic non-steroidal anti-inflammatory drugs (NSAIDs), see section "Ducressa and other medicinal products".
• If the patient has a disease that causes thinning of the eye tissues, as prolonged treatment with steroids may result in further thinning and potential perforation.
• If the patient has diabetes.

Important information for patients wearing contact lenses

After cataract surgery, do not wear contact lenses 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 medicinal products

Tell your doctor or pharmacist

• About all medicinal products the patient is currently taking or has recently taken, as well as any medicinal products the patient plans to take, including those obtained without a prescription.
• About using other types of eye drops or eye ointments before starting treatment with 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 healing problems in the eye.
• 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 alter 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 medicinal product. Ducressa should not be used during pregnancy and breastfeeding.

Driving and using machines

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

Ducressa contains phosphate buffer

The medicinal product contains 4.01 mg of phosphates per ml, which corresponds to 0.12 mg per drop. In the case of severe damage to the transparent layer in front of the eye (cornea), phosphate may, in very rare cases, cause the appearance of cloudy spots on the cornea due to calcium accumulation during treatment. In such a case, the patient should consult a doctor, who may recommend treatment with phosphate-free preparations.

Ducressa contains benzalkonium chloride

The medicinal product 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 transparent layer in front of the eye). If, after using this medicinal product, the patient experiences unusual sensations in the eye, stinging, or eye pain, they should consult a doctor.

3. How to use Ducressa

This medicinal product should always be used exactly as prescribed by your doctor or pharmacist. In case of doubts, consult a 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 deems 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 medicinal product, they should wait at least 15 minutes between using drops of different types. 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 ring from the cap.Be careful not to let the dropper tip touch the eye, the skin around the eye, or the fingers.
• 3) Unscrew the bottle cap. Hold the bottle with the nozzle pointing down, between the thumb and fingers.
• 4) Pull the lower eyelid down to form a "pocket" between the eyelid and the eye. The medicinal product should be dropped into this pocket (illustration 2).
• 5) Tilt your head back and bring the dropper tip 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 the medicinal product, press the corner of the eye near the nose with your finger. This helps prevent the medicinal product 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.
To prevent infections, the bottle should be discarded 28 days after it was first opened, and a new one should be used.

Using more than the recommended dose of Ducressa

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

Missing a dose of Ducressa

If a dose 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 treatment with Ducressa

If treatment with Ducressa is stopped earlier than recommended, the doctor should be informed. In case of any further doubts about using this medicinal product, consult a doctor or pharmacist.

4. Possible side effects

Like all medicinal products, Ducressa 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 medicinal product may cause severe allergic reactions (anaphylactic reactions), which are accompanied by swelling and pressure in the throat and difficulty breathing.
• In case of any of these symptoms, 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, swelling and tendon ruptures have occurred. In case of pain or swelling of the tendons (tendinitis), stop using Ducressa.

In the eye(s) of the patient, the following side effects may also occur:

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 eye fatigue;
• eye pain;
• photophobia;
• swelling or redness (conjunctival hyperemia) of the front membrane of the eye (conjunctiva);
• swelling or redness of the eyelid;
• photophobia;
• sticky eyelids.

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

• increased pupil size;
• drooping eyelids;
• calcification of the eye surface (corneal calcification);
• tear-like 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);
• inflammation of the eye, causing 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), muscle weakness and 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 face (known as "Cushing's syndrome").

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting side effects will help gather more information on the safety of this medicinal product.

5. How to store Ducressa

Keep the medicinal product out of sight and reach of children.
Do not use this medicinal product after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
Do not use this medicinal product 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, the bottle should be discarded 28 days after it was first opened, and a new one should be used.
There are no special precautions for storage.
Medicinal products should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicinal products that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Ducressa contains

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

What Ducressa looks like and what the pack contains

Ducressa is a clear, greenish-yellow solution that is practically free of particles, even if the dropped drops appear clear and colorless. It is supplied in a pack containing one 5 ml bottle with an LDPE dropper and an HDPE cap in a cardboard box.
For more detailed information, contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, the country of export:

Santen Oy
Niittyhaankatu 20
33720 Tampere
Finland

Manufacturer:

Santen Oy
Kelloportinkatu 1
33100 Tampere
Finland

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Romania, the country of export:13368/2020/01

Parallel import authorization number: 27/24

This medicinal product 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 approval of the leaflet: 18.01.2024

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