DUCRESSA 1 mg/ml + 5 mg/ml EYE DROPS SOLUTION

Introduction

Package Leaflet: Information for the User

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

dexamethasone / levofloxacin

Read the package leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this package leaflet:

1. What Ducressa is and what it is used for
2. What you need to know before you use 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 it and how does it work

Ducressa is an eye drop solution that contains levofloxacin and dexamethasone.

Levofloxacin is an antibiotic of the fluoroquinolone type (sometimes abbreviated to quinolones). It works by killing certain types of bacteria that can cause infections.

Dexamethasone is an anti-inflammatory corticosteroid (i.e., it makes signs and symptoms such as pain, heat, inflammation, and redness disappear).

What this medicine is used for

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

2. What you need to know before you use Ducressa

Do not use Ducressa

• if you are allergic to levofloxacin (or other quinolones) or dexamethasone (or other corticosteroids) or any of the other ingredients of this medicine (listed in section 6).
• if you have an eye infection that is not being treated with any medicine, including viral infections (such as herpes simplex keratitis or chickenpox), fungal infections, and tuberculosis of the eye.

If your eye produces a sticky discharge, or if your eye is red and has not been treated by 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. As with any other anti-infective agent, prolonged use may lead to antibiotic resistance, resulting in an overgrowth of pathogenic microorganisms.
• if you have ocular hypertension or have had it after using an ocular corticosteroid, you are at risk of having it again if you use Ducressa. If you have ocular hypertension, inform your doctor.
• if you have glaucoma.
• if you have visual disturbances or blurred vision.
• if you are using non-steroidal anti-inflammatory drugs (NSAIDs), see section "Other medicines and Ducressa".
• if you have a disorder that causes thinning of the eye tissues, as prolonged use of corticosteroid treatments may cause further thinning and perforation.
• if you have diabetes.

Important information if you wear contact lenses

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

Children and adolescents

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

Other medicines and Ducressa

Tell your doctor or pharmacist:

• if you are using, have recently used, or might use any other medicine, including those bought without a prescription.
• if you are using any other type of eye drops or ointment before starting to use Ducressa (see section 3, How to use Ducressa).
• if you are using ocular NSAIDs (to treat pain and inflammation in the eye), such as ketorolac, diclofenac, bromfenac, and nepafenac. The simultaneous use of ocular corticosteroids and ocular NSAIDs may increase the risk of eye healing problems.
• 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 cyclosporin (to prevent transplant rejection), as these medicines may alter the absorption and metabolism of levofloxacin.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. Ducressa should not be used during pregnancy or breastfeeding.

Driving and using machines

If you experience temporary blurred vision after using this medicine, do not drive or use machines until your vision is clear.

Ducressa contains phosphate buffer

This medicine contains 4.01 mg of phosphates per ml, which corresponds to 0.12 mg per drop. If you have severe corneal damage, treatment with phosphates, in very rare cases, may cause blurred vision due to calcium accumulation. Talk to your doctor, who may prescribe a phosphate-free treatment.

Ducressa contains benzalkonium chloride

This medicine contains 0.05 mg of benzalkonium chloride per ml, which corresponds to 0.0015 mg per drop.

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases. Consult your doctor if you feel any unusual sensation, itching, or pain in the eye after using this medicine.

3. How to use Ducressa

Follow the instructions for administering this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, 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. The usual treatment with Ducressa lasts 7 days, which may be followed by an additional 7 days with a corticosteroid eye drop if your doctor considers it necessary.

Your doctor will inform you about the duration of treatment.

If you are using any other eye medicine, wait at least 15 minutes between administering one eye drop and another. Ocular ointments should be used last.

Method of administration:

If possible, ask someone to apply the eye drops 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 careful not to let the tip of the dropper bottle come into contact with the eye, the surrounding skin, or your fingers.

1. Unscrew the cap from the bottle. Hold the bottle upside down between your thumb and other fingers.
2. Move the lower eyelid down with one finger until a space is created between the eyelid and the eye. This is where you will place the drop (illustration 2).
3. Tilt your head back, bring the tip of the bottle close to the eye, and gently squeeze the bottle until a drop falls into the eye (illustration 3). Please note that from the moment you squeeze the bottle until the drop falls, a few seconds may pass. Do not squeeze the bottle too hard.
4. After using Ducressa, press the inner corner of your eye, next to your nose, with your finger. This will help prevent the medicine from 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 use.

If you use more Ducressa than you should

If you use more of this medicine than you should, you can rinse it off with warm water.

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

If you forget to use Ducressa

If you forget to use this medicine, do not worry, just apply it as soon as possible. Do not apply a double dose to make up for forgotten doses.

If you stop using Ducressa

If you stop using this medicine before the indicated time, inform your doctor. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects are not serious and only affect the eye.

• In very rare cases, this medicine may cause severe allergic reactions (anaphylactic reactions), accompanied by inflammation and constriction of the throat, as well as breathing difficulties.
• If you experience any of these symptoms, stop using Ducressa and contact your doctor immediately.
• There have been cases of tendon inflammation and rupture in people receiving fluoroquinolones orally or intravenously, especially in older patients and those treated simultaneously with corticosteroids. Stop using Ducressa if you experience pain or inflammation of the tendons (tendinitis).

You may also experience the following effects in the eye(s):

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

• high pressure in the eye.

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

• discomfort, itching, or irritation, burning, stinging in the eye
• blurred or decreased vision
• eye discharge.

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

• delayed corneal healing
• eye infections
• abnormal sensation in the eye
• increased tearing
• dry and tired eyes
• eye pain
• increased visual clarity
• inflammation or redness (red eyes) of the front coating of the eye (the conjunctiva)
• inflammation or redness of the eyelid
• sensitivity to light
• sticky eyelids.

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

• increased pupil size
• drooping eyelids
• calcium accumulation on the surface of the eye (corneal calcification)
• tearing and gritty sensation in the eye (crystalline keratopathy)
• change in the thickness of the eye surface
• ulcer on the surface of the eye
• small holes in the surface of the eye (corneal perforation)
• inflammation of the eye surface (corneal edema)
• inflammation of the eye that causes pain and redness (uveitis).

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

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

• headache
• altered sense of taste
• itching
• nasal congestion 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 inflammation.

Not known

• Reduced function of the adrenal gland, which may be perceived as low blood sugar, dehydration, weight loss, and confusion.
• Hormonal problems: excessive growth of body hair (especially in women), weakness and muscle wasting, purple striae 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 swelling and weight gain of the body and face (called Cushing's syndrome).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help 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 which is stated on the label of the bottle and the carton, after "EXP". The expiry date is the last day of the month shown.

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

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

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Ducressa contains

• The active substances 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 sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate dodecahydrate, sodium citrate, benzalkonium chloride, sodium hydroxide/hydrochloric acid (for pH adjustment), and water for injections.

Appearance and packaging

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

Marketing authorisation holder

Santen Oy

Niittyhaankatu 20

33720 Tampere

Finland

Manufacturer responsible for batch release

Santen Oy

Kelloportinkatu 1

33100 Tampere

Finland

You can obtain further information on this medicine from the local representative of the marketing authorisation holder:

Santen Pharmaceutical Spain, S.L.

Acanto, 22, 7th floor

28045 Madrid

Spain

Tel.: 91 414 24 85

Date of last revision of this leaflet: June 2022

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).