Ducressa

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging 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 the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, 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. 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 fluorochinolones (sometimes abbreviated as quinolones). It works by killing certain types of bacteria that may cause infection.
Dexamethasone is a corticosteroid with anti-inflammatory action (it suppresses 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 such medicines should not be used, such as a viral infection (for example, herpes simplex keratitis or varicella), 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 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 medicine. 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 with 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 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.
• About the use of other types of eye drops or ointments before starting treatment with Ducressa (see section 3 - How to use Ducressa).
• About the use of ophthalmic NSAIDs (for eye pain and inflammation), such as ketorolac, diclofenac, bromfenac, and nepafenac. Concomitant use of oral steroids and ophthalmic NSAIDs may increase the risk of healing problems in the eye.
• About the use of ritonavir or cobicistat (used in the treatment of HIV), as they may increase blood levels of dexamethasone.
• About the use of 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, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine. Ducressa should not be used during pregnancy or breastfeeding.

Driving and using machines
If blurred vision occurs shortly after using the medicine, the patient should 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 deposits 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 patients with dry eyes or corneal diseases (affecting the transparent front layer of the eye). If the patient experiences unusual sensations in the eye, such as stinging or pain 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,
please 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, after which, if deemed necessary by the doctor,
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.
Eye ointments should be applied last.

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

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.
   Pay special attention not to let the dropper tip 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. Instill the drop into this pocket (illustration 2).
5. Tilt the head backwards and bring the dropper tip close to the eye. Gently squeeze the bottle in the middle to 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 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 does not enter the eye, try again. Immediately after use, tightly replace the cap on the bottle.

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

Missed dose of Ducressa
If you forget to use the medicine, 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 treatment earlier than recommended
Inform your doctor if you wish to stop treatment 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 everybody will experience them.
Most adverse effects are not serious and affect only the eyes.

• In very rare cases, this medicine may cause serious 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 receiving concomitant corticosteroid therapy, tendon swelling and tendon ruptures have been reported. If tendon pain or swelling (tendinitis) occurs, treatment with Ducressa should be discontinued.

The following effects 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 reduced 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 eye fatigue;
• 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.

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

• increased pupil size;
• drooping eyelids;
• calcium deposits on the surface of the eye (corneal calcification);
• tears and sensation of sand in the eye (crystalline keratopathy);
• changes in the thickness of the eye surface;
• 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).

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

• headache;
• altered taste;
• itching;
• stuffy 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 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, 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 effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. 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, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse effects helps to 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 seal 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 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. One millilitre of solution contains 5 mg of levofloxacin and 1 mg of dexamethas游戏副本