Ducressa

Package leaflet: Information for the user

Warning! Keep the leaflet. Information on the immediate packaging is in a foreign language!
Ducressa
1 mg/ml + 5 mg/ml
eye drops, solution
Dexamethasonum + Levofloxacinum
Please read carefully all the information in this leaflet before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. 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 adverse reactions, including any possible adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.

Table of contents

1. What Ducressa is and what it is 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 Ducressa is and what it is used for

What type of medicine is this and how does it work?
Ducressa eye drops, solution contains levofloxacin and dexamethasone.
Levofloxacin is an antibiotic belonging to a group called fluoroquinolones (sometimes abbreviated as quinolones). It works by killing certain types of bacteria that may cause infection.
Dexamethasone is a corticosteroid with anti-inflammatory action (prevents symptoms such as pain, warmth, swelling, and redness).
What is this medicine used for?
Ducressa is used to prevent and treat inflammation and to prevent possible 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 to any of the other ingredients of this medicine (listed in section 6).
• If the patient has an eye infection for which medications should not be used, such as a viral infection (e.g. herpes keratitis or varicella), fungal infections, or tuberculosis of the eye. Signs of infection may include sticky discharge from the eye or eye redness that has not been examined by a doctor.

Warnings and precautions
Before using Ducressa, discuss the following with your doctor:

• If the patient is using any other antibiotics, including oral antibiotics. As with other anti-infective agents, prolonged use may lead to antibiotic resistance and overgrowth of pathogenic microorganisms.
• If the patient has high intraocular pressure or has previously experienced high intraocular pressure after using an ophthalmic steroid medication. Use of Ducressa may cause recurrence of this condition. The doctor should be informed about high intraocular pressure.
• If the patient has glaucoma.
• If the patient has visual disturbances or blurred vision.
• If the patient is using ophthalmic non-steroidal anti-inflammatory drugs (NSAIDs), see section "Ducressa and other medicines".
• If the patient has a disease causing thinning of ocular tissues, because prolonged steroid treatment may lead to further thinning and possible perforation.
• If the patient has diabetes.

Important information for contact lens wearers
After cataract surgery, contact lenses should not be worn throughout the duration of treatment with Ducressa.

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

Ducressa and other medicines
Tell your doctor or pharmacist if:

• the patient is currently using, has recently used, or plans to use any other medicines, including those obtained without a prescription;
• the patient is using other types of eye drops or eye ointments before starting treatment with Ducressa (see section 3 – How to use Ducressa);
• the patient is using ophthalmic NSAIDs (for eye pain and inflammation), such as ketorolac, diclofenac, bromfenac, and nepafenac. Concomitant use of systemic steroids and ophthalmic NSAIDs may increase the risk of healing problems in the eye;
• the patient is using ritonavir or cobicistat (used in the treatment of HIV), as they may increase blood levels of dexamethasone;
• the patient is using probenecid (for gout), cimetidine (for stomach ulcers), or 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, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine. Ducressa should not be used during pregnancy and breastfeeding.

Driving and operating machinery
If blurred vision occurs shortly after using the medicine, do not drive or operate machinery until vision becomes clear.

Ducressa contains phosphate buffer
The medicine contains 4.01 mg of phosphates per ml, equivalent to 0.12 mg per drop. In cases of severe damage to the transparent front layer of the eye (cornea), phosphate may very rarely cause the appearance of hazy corneal spots due to calcium accumulation during treatment. In such cases, 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, equivalent to 0.0015 mg per drop. Benzalkonium chloride may also cause eye irritation, particularly in cases of dry eyes or corneal diseases (the transparent front layer of the eye). If unusual sensations, stinging, or eye pain occur after using this medicine, consult a doctor.

3. How to use Ducressa

This medicine should always be used exactly as directed by your doctor or pharmacist. If in doubt,
consult 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, followed, if deemed necessary by your doctor,
by 7 additional days of steroid eye drops.
Your doctor will inform you how long you should continue using the drops.
If you are using any other eye medication, you should wait at least 15 minutes between applications of different types of drops.
Ointments should be applied last.

Instructions for use:
If possible, ask someone else to administer the drops for you. That person should be asked to read this instruction together with you.

1. Wash hands thoroughly (illustration 1).
2. Open the bottle. When opening the bottle for the first time, remove the loose tamper-evident ring from the cap.
   Pay special attention to ensure that the tip of the dropper does not touch the eye, the skin around the eye, or fingers.
3. Unscrew the cap. Hold the bottle pointing downwards, between thumb and fingers.
4. Gently pull down the lower eyelid with a finger to form a "pocket" between the eyelid and the eye. The drop should be instilled here (illustration 2).
5. Tilt the head backwards and bring the dropper tip close to the eye. Gently squeeze the middle of the bottle to allow a drop to fall into the eye (illustration 3).
   Note that there may be a delay of several seconds between squeezing the bottle and the drop emerging. Do not squeeze the bottle too hard.
6. After instilling Ducressa, press with a finger on the inner corner of the eye near the nose. This helps prevent the medicine from draining into the rest of the body (illustration 4).

If the drop misses the eye, try again. Immediately after use, tightly replace the cap on the bottle.

Using more Ducressa than recommended
If more of this medicine is used than recommended, the eye can be rinsed with lukewarm water.

Missing a dose of Ducressa
If you miss a dose, do not worry; simply use it as soon as possible. Do not use a double dose to make up for a missed dose.

Stopping Ducressa earlier than recommended
Inform your doctor if you plan to stop using this medicine earlier than recommended. If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Most adverse reactions are not severe and affect only the eyes.

• In very rare cases, this medicine may cause severe allergic reactions (anaphylactic reactions), accompanied by swelling and tightness in the throat and breathing difficulties.
• If any of these symptoms occur, stop using Ducressa immediately and contact your doctor.
• In patients receiving oral or intravenous fluoroquinolones, especially elderly patients and those receiving concomitant corticosteroid therapy, tendon swelling and tendon ruptures have been reported. If tendon pain or swelling (tendonitis) occurs, treatment with Ducressa should be discontinued.

The following reactions may also occur in the patient's eye(s):
Very common (may occur in more than 1 in 10 people):

• increased intraocular pressure.

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

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

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

• delayed corneal healing;
• eye infections;
• unusual sensations in the eye;
• excessive tearing;
• dryness and fatigue of the eye;
• eye pain;
• brighter vision;
• swelling or redness (bloodshot eyes) of the front layer of the eye (conjunctiva);
• swelling or redness of the eyelid;
• light sensitivity;
• sticky eyelids.

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

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

In other parts of the body, the following reactions may occur:
Uncommon (may occur in up to 1 in 100 people):

• headache;
• altered taste;
• itching;
• nasal congestion or runny nose.

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

• allergic reactions such as skin rash.

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

• facial swelling.

Frequency not known

• decreased adrenal gland function, which may present as low blood glucose levels, dehydration, weight loss, and feeling disoriented;
• hormonal problems: excessive body hair growth (especially in women), muscle weakness and atrophy, purple stretch marks on the skin, elevated blood pressure, irregular or absent menstruation, changes in protein and calcium levels in the body, growth suppression in children and adolescents, and swelling with increased body and facial weight (known as “Cushing's syndrome”).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

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 stated on the packaging. The expiry date refers to the last day of the stated month.
Do not use this medicine if the plastic tamper-evident seal around the cap and neck of the bottle is missing or broken before opening a new bottle.
Keep the bottle tightly closed. To prevent contamination, discard the bottle 28 days after first opening and use a new one.
No special storage conditions are required.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Ducressa contains

• The active substances are levofloxacin in the form of levofloxacin hemihydrate and dexamethasone in the form of dexamethasone sodium phosphate. Each millilitre of solution contains 5 mg levofloxacin and 1 mg dexamethasone.
• Other ingredients: monosodium dihydrogen phosphate monohydrate, disodium phosphate dodecahydrate, sodium citrate, benzalkonium chloride solution, sodium hydroxide/hydrochloric acid, diluted (for pH adjustment), water for injections.

What Ducressa looks like and contents of the pack
Ducressa is a clear, slightly greenish-yellow solution practically free from visible particles, even though spilled drops may appear colourless and clear. It is supplied in a pack containing one 5 ml LDPE bottle with an LDPE dropper and HDPE cap, packed in a cardboard box.
For further information, contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Romania, the country of export:
Santen Oy
Niittyhaankatu 20
33720 Tampere
Finland
Manufacturer:
Santen Oy
Kelloportinkatu 1
33100 Tampere
Finland
Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing Authorisation Number in Romania, the country of export: 13368/2020/01
Parallel Import Licence Number: 317/25
This medicinal product is authorised for sale in the European Economic Area and 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.