Ducressa

PACKAGE LEAFLET

Package leaflet: Information for the user

Ducressa 1 mg/ml + 5 mg/ml

eye drops, solution
dexamethasone / levofloxacin
Please read this entire leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this 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. Package contents and other information

1. What Ducressa is and what it is used for

What type of medicine it is and how it works
Ducressa is an ophthalmic solution containing levofloxacin and dexamethasone.
Levofloxacin is an antibiotic belonging to the class of fluoroquinolones (also referred to, for short, as quinolones). This antibiotic works by killing certain types of bacteria that can cause infections.
Dexamethasone is a corticosteroid that exerts an anti-inflammatory action (suppressing symptoms such as pain, heat, swelling, and redness).
What this medicine is used for
Ducressa is used to prevent and treat inflammation and to prevent possible eye infections following cataract surgery.

2. What you should know before using Ducressa

Do not use Ducressa:

• if you are allergic to levofloxacin (or to other quinolones) or to dexamethasone (or to other corticosteroids) or to any of the other ingredients of this medicine (listed in section 6).
• if you have an eye infection that is not being treated with medicines, including viral infections (e.g. herpes simplex, keratitis or varicella), fungal infections, or tuberculosis of the eye. Your eye may be infected if it produces sticky discharge or is red and has not been examined by a doctor.

Warnings and precautions
Talk to your doctor before using Ducressa:

• if you are using other antibiotics, including oral antibiotics. Like other anti-infective agents, prolonged use may lead to antibiotic resistance and overgrowth of pathogenic microorganisms.
• if you have elevated intraocular pressure or have had it in the past after using an ophthalmic steroid medication. Using Ducressa may cause this condition to recur. If you have elevated intraocular pressure, inform your doctor.
• if you have glaucoma.
• if you have visual disturbances or blurred vision.
• if you are using NSAIDs (Non-Steroidal Anti-Inflammatory Drugs), please read the section “Other medicines and Ducressa”.
• if you have conditions causing thinning of the eye tissues, as prolonged steroid treatment may cause further thinning and possibly lead to perforation.
• if you have diabetes.

Important information if you wear contact lenses
After cataract surgery, you must not wear contact lenses throughout the entire duration of treatment with Ducressa.
Children and adolescents
Ducressa is not recommended in children and adolescents under 18 years of age due to lack of data on safety and efficacy in this age group.
Other medicines and Ducressa
Inform your doctor or pharmacist:

• if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
• if, before using Ducressa, you were already using any other type of eye drops or eye ointment (see section 3 - How to use Ducressa).
• if you are using ophthalmic NSAIDs (used to reduce pain and inflammation), such as ketorolac, diclofenac, bromfenac, and nepafenac. The concomitant use of NSAIDs and corticosteroids in the eye may increase the risk of impaired eye healing.
• if you are taking ritonavir or cobicistat (used in the treatment of HIV), as they may increase the blood levels of dexamethasone.
• if you are taking probenecid (for gout), cimetidine (for gastric ulcer), or cyclosporine (to prevent transplant rejection), as they may alter the absorption and metabolism of levofloxacin.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine. Ducressa must not be used during pregnancy or breastfeeding.
Driving and using machines
After using this medicine, you may experience temporary blurred vision. If this occurs, do not drive or operate machinery until this symptom resolves.
Ducressa contains phosphate buffer
This medicine contains 4.01 mg of phosphates per ml, equivalent to 0.12 mg per drop. If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may very rarely cause calcium deposits leading to opaque corneal spots during treatment. Inform your doctor, who may recommend a phosphate-free treatment.
Ducressa contains benzalkonium chloride
This medicine contains 0.05 mg of benzalkonium chloride per ml, equivalent to 0.0015 mg per drop.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eye or corneal disorders (the eye’s most superficial transparent layer). If you experience an abnormal sensation in the eye, such as burning or pain after using this medicine, speak to your doctor.

3. How to use Ducressa

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is 1 drop in the affected eye every 6 hours. The maximum dose is 4 drops
per day. The treatment course with Ducressa is usually 7 days, followed, if your doctor considers it
necessary, by another 7 days of treatment with a steroid eye drop.
Your doctor will determine the duration of treatment.
If you are using other eye drops or ophthalmic ointments, you must wait at least 15 minutes between
each application. Ophthalmic ointments should be applied last.
Instructions for use:
If possible, ask another person to administer the drops to you. Ask this person to read the
instructions together with you before administration.

1. Wash your hands thoroughly (Figure 1).
2. Open the bottle. Remove the security ring, which detaches from the cap upon first opening the
   bottle.
   The tip of the dropper must not come into contact with the eye, the area around the eye, or with fingers.
3. Unscrew the bottle cap. Hold the bottle pointing downwards, gripping it between your thumb and other fingers.
4. Pull down the lower eyelid with a finger to form a "pocket" between the eyelid and the eye. The drop should be instilled into this pocket (Figure 2).
5. Tilt your head backward and bring the tip of the bottle close to the eye. Gently press the center of the bottle until one drop falls into the eye (Figure 3). Note that it may take a few seconds between pressing the bottle and the drop coming out. Do not press too hard.
6. After applying Ducressa, press with a finger on the inner corner of the eye near the nose. This will prevent the medicine from spreading throughout the body (Figure 4).

If a drop misses the eye, try again. Immediately after use, screw the cap back on tightly.
If you use more Ducressa than you should
If you have applied an excessive amount of the medicine, rinse the eye with lukewarm water.
If you forget to use Ducressa
If you forget to use this medicine, do not worry; apply it as soon as possible. Do not apply a double
dose to make up for the missed dose.
If you stop using Ducressa
If you stop treatment with this medicine earlier than planned, inform your doctor. If you have any
doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them. Most of the side effects are non-serious and affect only the eye.

• Very rarely, this medicine may cause severe allergic reactions (anaphylactic reactions), accompanied by swelling and a feeling of tightness in the throat and breathing difficulties.
• Stop using Ducressa and contact your doctor immediately if any of these symptoms occur.
• Oral or intravenous administration of fluoroquinolones may cause swelling and rupture of tendons, particularly in elderly patients and in those being treated concomitantly with corticosteroids. Stop using Ducressa if tendon pain or swelling (tendinitis) occurs.

One or more of the following eye-related side effects may also occur in one or both eyes:
Very common (may affect more than 1 in 10 people):

• increased eye pressure.
  Common (may affect up to 1 in 10 people):
• eye discomfort, stinging, irritation, burning, or itching
• blurred or reduced vision
• presence of mucus in the eye.

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

• delayed healing of corneal wounds
• eye infections
• abnormal sensation in the eye
• increased tearing
• dry and tired eyes
• eye pain
• increased brightness of vision
• swelling or redness (bloodshot eyes) of the outer lining 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):

• pupil dilation
• drooping of the eyelids
• calcium deposits on the surface of the eye (corneal calcification)
• tearing and sensation of sand in the eye (crystalline keratopathy)
• changes in thickness of the eye's surface layer
• ulcer on the surface of the eye
• small holes on the surface of the eye (corneal perforation)
• swelling of the surface of the eye (corneal edema)
• eye inflammation causing pain and redness (uveitis).

Side effects affecting other parts of the body may also 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:

• reduced adrenal gland function, which may present as low blood sugar levels, dehydration, weight loss, and confusion.
• Hormonal problems: increased body hair growth (especially in women), muscle weakness and atrophy, purple stretch marks on the skin, increased blood pressure, irregular or absent menstrual periods, changes in protein and calcium levels in the body, delayed growth in children and adolescents, and body and facial swelling and weight gain (known as “Cushing's syndrome”).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at: www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ducressa

Keep this medicinal product out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the bottle label and on the
carton after “Exp.”. The expiry date refers to the last day of that month.
Do not use this medicinal product if, before opening a new bottle, you notice that the plastic seal
covering the cap and neck of the bottle is damaged or missing.
Keep the bottle tightly closed. To avoid infection, discard the bottle and use a new one
28 days after first opening.
This medicinal product requires no special storage conditions.
Do not dispose of any medicinal product via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ducressa contains

• The active substances are levofloxacin, as hemihydrate, and dexamethasone, as sodium phosphate. Each millilitre of solution contains 5 mg of levofloxacin and 1 mg of dexamethasone.
• The other components are: monohydrate sodium dihydrogen phosphate, dodecahydrate disodium phosphate, sodium citrate, benzalkonium chloride, sodium hydroxide – hydrochloric acid (for pH adjustment), water for injections.

Description of the appearance of Ducressa and contents of the pack
Ducressa is a clear, pale yellow-green solution, practically free from particles, although the dispensed drop appears colourless and transparent. It is supplied in a pack containing one 5 ml plastic bottle with a white dropper. The plastic bottle is closed with a screw cap.
Marketing Authorisation Holder and Manufacturer:
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 Member States of the European Economic Area under the following names:
Ducressa: Austria, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden
Dugressa: France