Ducressa

Package leaflet: Information for the user

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

• 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 you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

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 kind 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 fluorquinolones (sometimes referred to simply as quinolones). It works by killing certain types of bacteria that may cause infection.
Dexamethasone is a corticosteroid with anti-inflammatory action (it reduces 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 potential eye infection following 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 chickenpox), fungal infections, or tuberculosis of the eye. Signs of infection may include 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 the following with your doctor:

• If the patient is using any other antibiotics, including oral antibiotics. As with other antimicrobial 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 a steroid ophthalmic medication. Use of Ducressa may cause recurrence of this condition. Inform the doctor if you have 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 with other medicines".
• If the patient has a condition causing thinning of ocular tissues, because long-term 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 with other medicines
Tell your doctor or pharmacist:

• About all medicines the patient is currently using or has recently used, as well as any medicines the patient plans to use, including over-the-counter medicines.
• If the patient is using other types of eye drops or eye ointments before starting Ducressa (see section 3 - How to use Ducressa).
• If the patient is using ophthalmic NSAIDs (for eye pain and inflammation), such as ketorolac, diclofenac, bromfenac, or nepafenac. Concomitant use of systemic steroids and ophthalmic NSAIDs may increase the risk of healing problems in the eye.
• If the patient is using ritonavir or cobicistat (used in the treatment of HIV), as they may increase blood levels of dexamethasone.
• If 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 or 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 cloudy spots on the cornea 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 eye or corneal disease (the transparent front layer of the eye). If the patient experiences unusual sensations in the eye, such as stinging or eye pain after using this medicine, consult a doctor.

3. How to use Ducressa

This medicine should always be used exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are not sure.
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, after which, if your doctor considers it necessary, steroid eye drops should be used for the following 7 days.
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 applying drops of different types. 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 these instructions together with you before use.

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. Pay special attention not to let the dropper tip of the bottle touch the eye, the skin around the eye, or your fingers.
3. Unscrew the cap. Hold the bottle pointing downwards, between your thumb and fingers.
4. Gently pull down the lower eyelid with your finger to form a "pocket" between the eyelid and the eye. This is where the drop should be instilled (illustration 2).
5. Tilt your head backwards and bring the dropper tip close to the eye. Gently squeeze the bottle in the middle and allow one drop to fall into the eye (illustration 3). Please 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 gently with your 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, close the bottle tightly with the cap.

Use of more Ducressa than recommended
If you use more of this medicine than you should, rinse the eye with warm water.

If you forget to use Ducressa
If you forget to use the medicine, do not worry. Simply use it as soon as you remember. Do not use a double dose to make up for a forgotten 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, ask 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 serious 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.
• Tendon swelling and tendon ruptures have been reported in patients receiving oral or intravenous fluoroquinolones, particularly in elderly patients and those receiving concomitant corticosteroid therapy. If tendon pain or swelling (tendonitis) occurs, treatment with Ducressa should be discontinued.

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

• increased intraocular pressure.

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

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

Uncommon (may affect 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 affect 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 thickness of the eye surface;
• ulcer on the eye surface;
• 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 affect up to 1 in 100 people):

• headache;
• altered 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 gland function, which may present as low blood glucose levels, dehydration, weight loss, and feeling disoriented;
• hormonal problems: excessive body hair growth (particularly in women), muscle weakness and atrophy, purple stretch marks on the skin, high 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Ducressa

Keep the 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 ring around the cap and neck 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 instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Ducressa contains

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

What Ducressa looks like and contents of the pack
Ducressa is a clear, slightly greenish-yellow solution practically free from solid particles. Even if the dispensed drops appear clear and colourless, the solution may have a slight tint. It is supplied in a package containing one 5 ml bottle made of LDPE with a dropper made of LDPE and a cap made of HDPE, packed in a cardboard box.
For further detailed information, please contact the responsible party or the parallel importer.
Responsible party in Romania, country of export:
Santen Oy
Niittyhaankatu 20
33720 Tampere
Finland
Manufacturer:
Santen Oy
Kelloportinkatu 1
33100 Tampere
Finland
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Romania (country of export) licence number: 13368/2020/01
Parallel import licence number: 130/25
This medicinal product is authorised 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