DUCRESSA 1 mg/5 mg Eye Drops, Solution

Зміст інструкції

1. Ducressa 1 mg/ml + 5 mg/ml
   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. Contents of the pack and other information

Ducressa 1 mg/ml + 5 mg/ml

eye drops, solution
desamethasone / levofloxacin

Read this leaflet carefully before you use this medicine, as it contains important
information for you.

• Keep this leaflet. 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. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 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 type of medicine it is and how it works
Ducressa is an eye drop, solution containing levofloxacin and desamethasone.
Levofloxacin is an antibiotic belonging to the class of fluoroquinolones (also called, for
brevity, quinolones). This antibiotic works by killing certain types of bacteria that can cause
infections.
Desamethasone is a corticosteroid that has an anti-inflammatory action (stops 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 infections
of the eye after cataract surgery.

2. What you need to know before using Ducressa

Do not use Ducressa:

• if you are allergic to levofloxacin (or other quinolones) or to desamethasone (or other corticosteroids) or to any of the other ingredients of this medicine (listed in section 6).
• if you have an eye infection that you are not treating with medicines, including viral infections (e.g. herpes simplex, keratitis or varicella), infections caused by fungi and tuberculosis of the eye. Your eye may have an infection if it has a sticky discharge or if it 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. As with other anti-infectives, prolonged use can induce antibiotic resistance and lead to excessive growth of pathogenic microorganisms.
• If you suffer from high eye pressure, or have suffered from it in the past after using a steroid medicine for the eyes. If you use Ducressa, this problem may recur. If you suffer from high eye pressure, inform your doctor.
• If you have glaucoma.
• If you have vision disorders or blurred vision.
• If you are using NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) read paragraph “Other medicines and Ducressa”.
• If you have disorders that cause thinning of the eye tissues, as prolonged treatment with steroids can cause further thinning and possible perforation.
• If you have diabetes.

Important information if you wear contact lenses
After cataract surgery, you should not wear contact lenses for the entire duration of the
therapy with Ducressa.

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

Other medicines andDucressa
Tell your doctor or pharmacist

• if you are taking, have recently taken or might take any other medicines, including those you bought without a prescription.
• if you were already using any other type of eye drops or eye ointment before using Ducressa (see section 3 - How to use Ducressa).
• if you are using NSAIDs for the eyes (used to counteract pain and inflammation), such as ketorolac, diclofenac, bromfenac and nepafenac. The simultaneous use of NSAIDs and steroids for the eyes can increase the risk of problems with eye healing.
• if you are taking ritonavir or cobicistat (used in the treatment of HIV), as they may increase the level of desamethasone in the blood.
• if you are taking probenecid (to treat gout), cimetidine (to treat stomach ulcers) and cyclosporine (to prevent transplant rejection), as they may alter the absorption and metabolism of levofloxacin.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using this medicine. Ducressa
should not be used during pregnancy or breastfeeding.

Driving and operating machinery
After using this medicine, you may experience temporary blurred vision, if this
happens, do not drive or operate machinery until the problem disappears.

Ducressa contains phosphate buffer
This medicine contains 4.01 mg of phosphates per ml, corresponding to 0.12 mg per drop. If you have a
severe damage to the outermost transparent layer of the eye (the cornea), phosphates may cause, in rare
cases, opaque spots on the cornea due to calcium accumulation during treatment.
Tell your doctor who may advise you on a phosphate-free treatment.

Ducressa contains benzalkonium chloride
This medicine contains 0.05 mg of benzalkonium chloride per ml, corresponding to 0.0015 mg per
drop.
Benzalkonium chloride can also cause eye irritation, especially if you have dry eyes or
corneal disorders (the most superficial transparent layer of the eye). If you experience an
abnormal sensation in the eye, burning or pain after using this medicine, talk to your doctor.

3. How to use Ducressa

Use this medicine following exactly the instructions of 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 cycle with Ducressa is usually 7 days, followed, if your doctor deems it
necessary, by another 7 days of treatment with a steroid eye drop.
Your doctor will indicate 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 apply the drops for you. Ask this person to read the
instructions with you before application.

• 1) Wash your hands carefully (figure 1).
• 2) Open the bottle. Remove the safety ring that detaches from the cap upon first opening of thebottle.The dropper tip must not come into contact with the eye, the area around the eye, or your fingers.
• 3) Unscrew the cap of the bottle. Hold the bottle upside down, gripping it between your thumb and other fingers.
• 4) Lower the lower eyelid with a finger to form a “pocket” between the eyelid and the eye. The drop should be instilled in this area (figure 2).
• 5) Tilt your head back and bring the tip of the bottle close to the eye, then gently press the middle part of the bottle until a drop falls into the eye (figure 3). Keep in mind that a few seconds may pass 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 does not end up in the eye, try again. Screw the cap of the bottle back on tightly immediately after use.

If you use more Ducressa than you should
If you have applied an excessive amount of medicine, rinse the eye with lukewarm water.

If you forget to use Ducressa
If you forget to use this medicine, do not worry and 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 prematurely, inform your doctor. If you have
any doubts 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.
These are mostly non-serious side effects that affect only the eye.

• In very rare cases, this medicine can cause serious allergic reactions (anaphylactic reactions), accompanied by swelling and a feeling of tightness in the throat and difficulty breathing.
• Stop using Ducressa and contact your doctor immediately if any of these symptoms occur.
• Taking fluoroquinolones orally or intravenously can cause swelling and rupture of tendons, particularly in elderly subjects and those treated simultaneously with corticosteroids. Stop using Ducressa if you experience pain or swelling of the tendons (tendonitis).

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

• increased eye pressure. Common(may affect up to 1 in 10 people):
• discomfort, stinging or irritating pain, burning, itching in the eye
• blurred or decreased 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 eye
• eye pain
• brighter vision
• swelling or redness (bloodshot eyes) of the outer coating of the eye (conjunctiva)
• swelling or redness of the eyelid
• sensitivity to light
• sticky eyelids.

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

• pupil dilation
• drooping eyelids
• calcium deposit on the surface of the eye (corneal calcification)
• tearing and a gritty feeling in the eye (crystalline keratopathy)
• change in the thickness of the superficial layer of the eye
• 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)
• inflammation of the eye causing pain and redness (uveitis).

Effects affecting other areas 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 1000 people):

• allergic reactions such as skin rash. Very rare(may affect up to 1 in 10,000 people):
• swelling of the face.

Not known

• reduced function of the adrenal gland, which may manifest as low blood sugar, dehydration, weight loss and confusion.
• Hormonal problems: increased hair growth on the body (especially in women), weakness and muscle atrophy, purple stretch marks on the skin of the body, increased blood pressure, irregular or absent menstrual cycle, 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 get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.
You can also report side effects directly through 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 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 on the
pack after “Exp.”. The expiry date refers to the last day of that month.
Do not use this medicine if, before opening a new bottle, you notice that the plastic film
surrounding the cap and neck of the bottle is damaged or absent.
Keep the bottle tightly closed. To avoid infections, 28 days after first opening, you must
discard the bottle and use a new one.
This medicine does not require special storage precautions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack 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 ingredients are: sodium dihydrogen phosphate monohydrate, disodium phosphate dodecahydrate, 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, light yellowish-green solution, practically free of particles,
although the drop dispensed appears transparent and colourless. It is supplied in a pack containing a
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 with the
following denominations:
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