Ducressa

PACKAGE LEAFLET

Package leaflet: Information for the user

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 the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Ducressa is and what it is used for
2. What you need to know 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 it and how does it work?
Ducressa eye drops, solution contains levofloxacin and dexamethasone.
Levofloxacin is an antibiotic belonging to a group called fluoroquinolones (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 (reducing 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 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 simplex 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 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 an ophthalmic corticosteroid medication. Use of Ducressa may cause this condition to recur. Inform your 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 disease causing thinning of ocular tissues, because prolonged corticosteroid treatment may lead to further thinning and possible perforation.
• If the patient has diabetes

Important information for contact lens wearers
After cataract surgery, do not wear contact lenses 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, has recently used, or 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 poor wound healing in the eye.
• If the patient is using ritonavir or cobicistat (used in HIV treatment), 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 her 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), phosphates 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 cause eye irritation, particularly in patients with dry eyes or corneal diseases (affecting the transparent front layer of the eye). If the patient experiences unusual eye sensations, 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 instructed.
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 your doctor considers it necessary, 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 used last.

Instructions for use:
If possible, ask someone else to administer the drops for you. That person should read these instructions together with you before use.

1. Wash hands thoroughly (illustration 1).
2. Open the bottle. When opening the bottle for the first time, remove the loose collar from the cap.
   Take care not to let the dropper tip touch the eye, the skin around the eye, or your fingers.
3. Unscrew the cap. Hold the bottle upside down 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 backward and bring the dropper tip close to the eye. Gently squeeze the bottle in the middle to release one drop 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 gently with your finger on the inner corner of the eye (near the nose) for about 1 minute. 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 recap the bottle with the cap.

Use of more Ducressa than recommended
If you use more than the recommended amount of this medicine, rinse the eye gently with lukewarm water.

Missed dose of Ducressa
If you miss a dose, do not worry—simply use the drop 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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Most adverse effects are not serious and involve only the eyes.

• Very rarely, 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, discontinue use of Ducressa immediately and contact your doctor.
• In patients taking oral or intravenous fluoroquinolones, especially elderly patients and those concurrently treated with corticosteroids, tendon swelling and tendon ruptures have been reported. If tendon pain or swelling (tendonitis) occurs, treatment with Ducressa should be discontinued.

In the patient's eye(s), some or all of the following effects may also occur:

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 eye fatigue;
• eye pain;
• increased brightness of 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 effects 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 manifest 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 mass (known as "Cushing's syndrome").

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 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 authorization holder.
Reporting adverse effects helps to provide 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 stated on the bottle and carton following the term
"EXP". 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 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.
This medicine does not require any special storage conditions.
Medicines must 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 package and other information

What Ducressa contains

• The active substances are levofloxacin in the form of hemihydrate and dexamethasone in the form of sodium phosphate. One millilitre of solution contains 5 mg levofloxacin and 1 mg dexamethasone.
• The other ingredients are monobasic sodium phosphate monohydrate, dibasic sodium phosphate dodecahydrate, 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, slightly greenish-yellow solution, practically free from solid particles, even though the dispensed drops may appear colourless and clear. It is supplied in a pack containing one white, plastic bottle with a capacity of 5 ml with a white dropper cap. The plastic bottle is closed with a screw cap.
Marketing Authorisation Holder
Santen Oy
Niittyhaankatu 20
33720 Tampere
Finland
Manufacturer
Santen Oy
Kelloportinkatu 1
33100 Tampere
Finland
This medicinal product is authorised in the European Economic Area countries 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
Detailed information about this medicinal product is available on the website of the
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
http://urpl.gov.pl