Label: information for the user

Ducressa 1mg/ml + 5mg/ml eye drop solution

dexamethasone / levofloxacin

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.

-This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist,even if they are not listed in this label. See section4.

1.What is Ducressa and for what it is used

2.What you need to know before starting to use Ducressa

3.How to use Ducressa

4.Adverse effects

5.Storage of Ducressa

6.Contents of the package and additional information

What type of medication is it and how it works

Ducressa is an eye drop solution containing levofloxacino and dexametasona.

Levofloxacino is an antibiotic of the fluoroquinolone type (occasionally abbreviated as quinolone). It works by destroying certain types of bacteria that can cause infections.

Dexametasona is a corticosteroid with anti-inflammatory effects (i.e., it eliminates signs and symptoms such as pain, heat, inflammation, and redness).

What is this medication used for

Ducressa is used to prevent and treat eye inflammation and prevent possible eye infections after cataract surgery in adults.

Do not use Ducressa

• if you are allergic to levofloxacin (or other quinolones) or dexamethasone (or other corticosteroids) or any of the other ingredients in this medication (listed in section6).
• if you have an eye infection that is not being treated with any medication, including viral infections (such as herpes simplex keratitis or varicella), fungal infections, and tuberculosis of the eye.

If your eye is producing a sticky discharge, or if you have redness in the eye and have not treated it with a doctor, you may have an infection.

Warnings and precautions

Consult your doctor before starting to use Ducressa:

• if you are using any other antibiotic treatment, including oral antibiotics. Like any other anti-infective agent, prolonged use can produce resistance to antibiotics, leading to excessive proliferation of pathogenic microorganisms.
• if you have glaucoma or have had it after using an ocular corticosteroid, you are at risk of developing it again if you use Ducressa. If you have glaucoma, inform your doctor.
• if you have visual disturbances or blurred vision.
• if you are using nonsteroidal anti-inflammatory drugs (NSAIDs), see the section «Other medications and Ducressa».
• if you have any condition that causes thinning of the ocular tissues, as prolonged use of corticosteroids can cause further thinning and perforation of the tissues.
• if you have diabetes.

Important information if using contact lenses

After cataract surgery, do not wear contact lenses during treatment with Ducressa.

Children and adolescents

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

Other medications and Ducressa

Inform your doctor or pharmacist

• if you are using, have used recently, or may need to use any other medication, including one purchased without a prescription.
• if you are being administered any other type of eye drop or ointment before starting to use Ducressa (see section3, How to use Ducressa).
• if you are using ocular NSAIDs (to treat eye pain and inflammation), such as ketorolac, diclofenac, bromfenac, and nepafenac. The simultaneous use of ocular corticosteroids and ocular NSAIDs may increase the risk of problems with wound healing in the eye.
• if you are using ritonavir or cobicistat (used to treat HIV), as these may increase the amount of dexamethasone in the blood.
• if you are using probenecid (to treat gout), cimetidine (to treat stomach ulcers), and cyclosporine (to prevent transplant rejection), as these medications may alter the absorption and metabolism of levofloxacin.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication. Ducressa should not be used during pregnancy or breastfeeding.

Driving and operating machinery

If you experience temporary blurred vision after using this medication, do not drive or operate machinery until your vision is clear.

Ducressa contains phosphate buffer

This medication contains 4.01mg of phosphate per ml, corresponding to 0.12mg per drop. If you have severe damage to the cornea (the transparent layer at the front of the eye), treatment with phosphates, in rare cases, may cause blurred vision due to calcium accumulation. Talk to your doctor, who may prescribe a treatment without phosphates.

Ducressa contains benzalkonium chloride

This medication contains 0.05mg of benzalkonium chloride per ml, corresponding to 0.0015mg per drop.

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases (the transparent layer at the front of the eye). Consult your doctor if you experience a strange sensation, burning, or pain in the eye after using this medication.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is 1 drop in the affected eye every 6 hours. The maximum dose is 4 drops per day. In total, the usual treatment with Ducressa lasts 7 days, to which, if the doctor deems it necessary, 7 more days with a corticosteroid eye drop will be added.

Your doctor will inform you of the time you will have to apply the eye drop.

If you are administering any other medication in the eye, you must wait at least 15 minutes between the administration of one eye drop and another. Ophthalmic ointments should be used last.

Method of use:

If possible, ask someone to apply the eye drop for you. Before they do, ask them to read these instructions with you.

1) Wash your hands carefully (illustration 1).

2) Open the bottle.Remove the ring that separates from the cap when opening the bottle for the first time.

Be especially careful that the tip of the dropper does not come into contact with the eye, the surrounding skin, or your fingers.

3) Unscrew the cap from the bottle. Hold the bottle downwards, between your thumb and other fingers.

4) Displace the lower eyelid with a finger, until a space opens between the eyelid and the eye. That is where you will deposit the drop (illustration 2).

5) Tilt your head back, bring the tip of the bottle close to the eye, and carefully squeeze the bottle in half until a drop falls into the eye (illustration 3). Please note that, from the moment you squeeze the bottle and the drop comes out, a few seconds may pass. Do not squeeze the bottle too hard.

6) After using Ducressa, press with a finger the inner corner of the eye, next to the nose. This will help you avoid the medication reaching other parts of your body (illustration 4).

If the drop does not fall into the eye, try again. Close the bottle tightly with the cap immediately after using it.

Using more Ducressa than you should:

If you use more of this medication than you should, you can remove it by washing with warm water.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20.

Forgetting to use Ducressa:

If you forget to use this medication, do not worry, just apply it as soon as possible. Do not apply a double dose to compensate for the missed doses.

Interrupting treatment with Ducressa:

If you interrupt treatment with this medication before the indicated time, inform your doctor. If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may cause side effects, although not everyone will experience them. Most side effects are not serious and only affect the eye.

• In very rare cases, this medication may cause severe allergic reactions (anaphylactic reactions), accompanied by inflammation and a feeling of constriction in the throat, as well as breathing difficulties.
• If you experience any of these symptoms, discontinue use of Ducressa and contact your doctor immediately.
• Cases of inflammation and tendon rupture have been reported in people receiving oral or intravenous fluoroquinolones, especially in older patients and those treated simultaneously with corticosteroids. Discontinue use of Ducressa if you experience tendon pain or inflammation (tendinitis).

You may also experience some of these effects or all of them in the/your eye(s):

Very common(may affect more than 1 in 10 people):

• Increased eye pressure.

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

• Discomfort, itching, or irritation, burning, stinging in the eye
• Blurred or decreased vision
• Mucus in the eye.

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

• Delayed corneal healing
• Ocular infections
• Abnormal sensation in the eye
• Increased tear production
• Dry and tired eyes
• Eyepain
• Improved visual acuity
• Inflammation or redness (bloodshot eyes) of the corneal surface
• Inflammation or redness of the eyelid
• Light sensitivity
• Sticky eyelids.

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

• Pupil dilation
• Eyelid drooping
• Calcium accumulation on the surface of the eye (corneal calcification)
• Tear production and sandy sensation in the eye (crystalline keratopathy)
• Change in the thickness of the ocular surface
• Ulcer on the surface of the eye
• Small holes in the surface of the eye (corneal perforation)
• Inflammation of the surface of the eye (corneal edema)
• Inflammation of the eye causing pain and redness (uveitis).

You may experience effects in other parts of the body, including:

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

• Headache
• Alteration of taste
• Pruritus
• nasal congestion or rhinorrhea.

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

• Allergic reactions, such as a skin rash.

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

• Facial inflammation.

Not known

• Adrenal gland dysfunction, which may be perceived as low blood sugar, dehydration, weight loss, and confusion about where you are.
• Endocrine problems: excessive hair growth (particularly in women), muscle weakness and wasting, purple striae on the skin of the body, increased blood pressure, irregular or absent menstruation, changes in protein and calcium levels in the body, delayed growth in children and adolescents, and swelling and weight gain of the body and face (Cushing's syndrome).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label of the bottle and the box, after “CAD”. The expiration date is the last day of the month indicated.

Do not use this medication if you observe, before starting a new bottle, that the plastic ring around the cap and neck is missing or broken.

Keep the bottle tightly closed. To prevent infections, you must discard the bottle 28days after opening it for the first time, and use a new bottle.

This medication does not require special storage conditions.

Medications should not be thrown away through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition of Ducressa

• The active principles are levofloxacin in the form of hemihydrate and dexamethasone in the form of sodium phosphate. Each milliliter of solution contains 5 mg of levofloxacin and 1 mg of dexamethasone.
• The other excipients are dihydrogen phosphate monohydrate, disodium hydrogen phosphate dodecahydrate, sodium citrate, benzalkonium chloride, sodium hydroxide/hydrochloric acid (for pH adjustment), and water for injection preparations.

Appearance of the product and contents of the packaging

Ducressa is a transparent, yellowish-green solution, practically free of particles. The expelled drops appear transparent and colorless. It is supplied in a box containing a white plastic vial of 5 ml, with a white dropper. The plastic vial is closed with a screw cap.

Holder of the marketing authorization

Santen Oy

Niittyhaankatu 20

33720 Tampere

Finland

Responsible manufacturer for the release of batches

Santen Oy

Kelloportinkatu 1

33100 Tampere

Finland

For more information about this medication, please contact the local representative of the marketing authorization holder:

Santen Pharmaceutical Spain, S.L.

Acanto, 22, 7th floor

28045 Madrid

Spain

Phone: 91 414 24 85

Last review date of this leaflet: June 2022

The detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).