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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

dexamethasone / levofloxacin

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

• 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 you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.

  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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 adverse 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 it is and how it works

Ducressa is an ophthalmic solution containing levofloxacin and dexamethasone.

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

Dexamethasone is a corticosteroid with anti-inflammatory action (that is, it reduces signs and symptoms such as pain, heat, swelling, and redness).

What this medicine is for

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

2. What you need to know before using Ducressa

Do not use Ducressa

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

If your eye produces sticky discharge, or if your eye is red and has not been examined by a doctor, you may have an infection.

Warnings and precautions

Talk to your doctor before using Ducressa:

• if you are using any other antibiotic treatments, including oral antibiotics. As with any anti-infective agent, prolonged use may lead to antibiotic resistance and overgrowth of pathogenic microorganisms.
• if you have ocular hypertension or have previously experienced it after using an ocular corticosteroid, you may be at risk of recurrence when using Ducressa. If you develop ocular hypertension, inform your doctor.
• if you have glaucoma.
• if you experience visual disturbances or blurred vision.
• if you are using NSAIDs (non-steroidal anti-inflammatory drugs); see section "Other medicines and Ducressa".
• if you have any condition causing thinning of ocular tissues, as prolonged corticosteroid treatment may further thin these tissues and potentially lead to perforation.
• if you have diabetes.

Important information if you wear contact lenses

Do not wear contact lenses during treatment with Ducressa after cataract surgery.

Children and adolescents

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

Other medicines and Ducressa

Tell your doctor or pharmacist:

• if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.
• if you are using any other type of eye drops or ophthalmic ointment before starting Ducressa (see section 3, How to use Ducressa).
• if you are using ocular NSAIDs (to treat eye pain and inflammation), such as ketorolac, diclofenac, bromfenac, or nepafenac. The concomitant use of ocular corticosteroids and ocular NSAIDs may increase the risk of eye healing problems.
• if you are taking ritonavir or cobicistat (used in HIV treatment), as these may increase the levels of dexamethasone in the blood.
• if you are taking probenecid (for gout), cimetidine (for stomach ulcers), or cyclosporine (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 plan to become pregnant, consult your doctor or pharmacist before using this medicine. Ducressa must not be used during pregnancy or breastfeeding.

Driving and using machines

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

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 corneal damage (the transparent layer at the front of the eye), phosphate-containing treatments may, in very rare cases, cause blurred vision due to calcium accumulation. Speak with your doctor, who may prescribe 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 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 foreign body sensation, stinging, or eye pain after using this medicine.

3. How to use Ducressa

Follow exactly the instructions given by your doctor or pharmacist for administering this medicine. If in doubt, consult your doctor or pharmacist again.

The recommended dose is 1 drop into the affected eye every 6 hours. The maximum dose is 4 drops per day. The usual treatment course with Ducressa lasts 7 days, followed, if your doctor considers it appropriate, by another 7 days with a corticosteroid eye drop.

Your doctor will inform you of how long you should continue using the eye drops.

If you are using any other eye medication, you must wait at least 15 minutes between the administration of each eye drop. Ophthalmic ointments should be used last.

Instructions for use:

If possible, ask someone to administer the eye drop for you. Before doing so, ask them to read these instructions together 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.

Take special care to ensure that the tip of the dropper bottle does not come into contact with the eye, the surrounding skin, or fingers.

1. Unscrew the cap from the bottle. Hold the bottle upside down between your thumb and other fingers.
2. Pull down the lower eyelid with one finger until a space opens between the eyelid and the eye. This is where you will place the drop (illustration 2).
3. Tilt your head backward, bring the dropper tip close to the eye, and gently squeeze the middle of the bottle until one drop falls into the eye (illustration 3). Please note that there may be a few seconds' delay between squeezing the bottle and the drop coming out. Do not squeeze the bottle too hard.
4. After using Ducressa, press with a finger on the inner corner of the eye, next to the nose. This will help prevent the medicine from reaching other parts of the body (illustration 4).

If the drop does not fall into the eye, try again. Immediately after use, close the bottle tightly with the cap.

If you use more Ducressa than you should

If you use more of this medicine than you should, you can remove it by rinsing with lukewarm water.

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

If you forget to use Ducressa

If you forget to use this medicine, do not worry; simply use it as soon as possible. Do not use a double dose to make up for a missed dose.

If you stop using Ducressa

If you stop treatment with this medicine earlier than instructed, inform your doctor. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

• Very rarely, this medicine may cause severe allergic reactions (anaphylactic reactions), accompanied by swelling and tightness in the throat, as well as breathing difficulties.
• If you experience any of these symptoms, stop using Ducressa and contact your doctor immediately.
• Cases of inflammation and tendon rupture have been reported in people receiving oral or intravenous fluoroquinolones, especially in elderly patients and in those being treated concomitantly with corticosteroids. Discontinue use of Ducressa if you experience tendon pain or inflammation (tendinitis).

You may also experience one or all of the following effects in one or both eyes:

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

• increased pressure in the eye.

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

• discomfort, itching or irritation, burning, stinging 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
• abnormal sensation in the eye
• increased tearing
• dry and tired eyes
• eye pain
• increased visual clarity
• inflammation or redness (bloodshot eyes) of the front covering of the eye (the conjunctiva)
• inflammation or redness of the eyelid
• sensitivity to light
• sticky eyelids.

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

• increased pupil size
• drooping eyelids
• calcium deposits on the eye surface (corneal calcification)
• tearing and sandy-gritty sensation in the eye (crystalline keratopathy)
• changes in the thickness of the ocular surface
• ulcer on the eye surface
• small holes in the eye surface (corneal perforation)
• inflammation of the eye surface (corneal edema)
• eye inflammation 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
• altered sense of taste
• pruritus
• 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 swelling.

Not known

• Reduced function of the adrenal gland, which may present as low blood sugar, dehydration, weight loss, and confusion about one's location.
• Hormonal problems: excessive body hair growth (particularly in women), muscle weakness and wasting, purple stretch marks on the skin, increased blood pressure, irregular or absent menstruation, changes in body protein and calcium levels, growth delay in children and adolescents, and swelling and weight gain in the body and face (called Cushing's syndrome).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ducressa

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

Do not use this medicine after the expiry date stated on the label of the bottle and the carton, following "EXP". The expiry date refers to the last day of the month indicated.

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

Keep the bottle tightly closed. To prevent infection, discard the bottle 28 days after first opening, and use a new bottle.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ducressa

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

Appearance of the product and contents of the container

Ducressa is a clear, yellowish-green solution, practically free from particles. The dispensed drops appear transparent and colourless. It is supplied in a box 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

For further information about this medicinal product, contact 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 the most recent revision of this leaflet: June 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).