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Ducressa eye drops 5ml.

Product Code: Ducressa eye drops 5ml.
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What Ducresa is and what it is used for
What medicine is Ducreza and how it works
Ducreza is a solution of eye drops containing levofloxacin and dexamethasone.
Levofloxacin is an antibiotic of the type called fluoroquinolones (or sometimes abbreviated quinolones). It works by killing certain types of bacteria that can cause infections.
Dexamethasone is a corticosteroid and has anti-inflammatory action (stopping symptoms such as pain, fever, swelling and redness).

What your medicine is for
Ducreza is used to prevent and treat inflammation and to prevent possible eye infection after cataract surgery in adults.

2. What you need to know before using Ducreza
Do not use Ducres:
if you are 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 you suffer from an eye infection for which you are not using a medicine, including a viral infection (such as herpes simplex, keratitis or chickenpox), fungal infections and tuberculosis of the eye
You probably have an infection if you have sticky secretions from your eye or if you have a red eye that has not been seen by a doctor.

Precautionary warnings
Talk to your doctor before using Ducreza:

If you are using any other antibiotic medicine, including oral antibiotics. As with other anti-infective drugs, long-term use can lead to antibiotic resistance and, as a result, to the multiplication of pathogenic microorganisms.
If you suffer from high pressure in the eye or if you have had high pressure in the eye as a result of using steroid eye medicine. There is a risk that this will happen to you again if you use Ducreza. Tell your doctor if you suffer from high pressure in the eye.
If you have glaucoma.
If you have a visual impairment or blurred vision.
If you are using ophthalmic NSAIDs (non-steroidal anti-inflammatory drugs), see section "Other medicines and Ducreza".
If you have a disorder that causes thinning of the eye tissues, as prolonged steroid treatment can cause additional thinning and possible perforation.
If you have diabetes.
Important information if you use contact lenses
Contact lenses should not be used during treatment with Ducresa after cataract surgery.

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

Other drugs and Ducres
Tell your doctor or pharmacist

if you are using, have recently taken or might take any other medicines, including medicines obtained without a prescription.
if you apply any other eye drops or eye ointment before using Ducres (see section 3 - 'How to use Ducres'). if you are using ophthalmic NSAIDs (used for pain and inflammation of the eye) such as ketorolac, diclofenac, bromfenac and nepafenac. Concomitant use of ophthalmic steroids and ocular NSAIDs may increase the likelihood of more difficult healing of the operated eye.
if you are using ritonavir or cobicistat (used to treat HIV) as they may increase the amount of dexamethasone in your blood.
if you use probenecid (used to treat gout), cimetidine (used to treat stomach ulcers) or cyclosporine (used to prevent transplant rejection), as they may alter the absorption and metabolism of levofloxacin.
Pregnancy and lactation
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Ducreza should not be used during pregnancy or breastfeeding.

Driving and using machines
If your vision is temporarily blurred for a short time after using this medicine, you should not drive or use machines until your vision clears.

Ducreza contains phosphate buffer
This medicine contains 4.01 mg of phosphate per milliliter, which corresponds to 0.12 mg per drop. If you suffer from severe damage to the transparent layer in the front of the eye (the cornea), in very rare cases phosphates can cause cloudy spots on the cornea due to the accumulation of calcium during treatment. Talk to your doctor, who may prescribe a phosphate-free medicine.
Ducreza contains benzalkonium chloride
This medicine contains 0.05 mg benzalkonium chloride per milliliter, which corresponds to 0.0015 mg per drop.

Benzalkonium chloride may cause eye irritation, especially if you have a 'dry eye' or corneal damage (the clear layer in the front of the eye). If you have an unusual feeling in your eye, such as burning or pain in your eye after taking this medicine, talk to your doctor.

3. How to use Ducreza
Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, talk to your doctor or pharmacist.

The recommended dose is 1 drop in the affected eye every 6 hours. The maximum dose is 4 drops daily. Usually the whole course of treatment with Dukresa is 7 days, followed, if deemed necessary by the doctor, by 7 days of steroid eye drops.

Your doctor will tell you how long to apply the drops.

If you put another medicine in your eye, you should wait at least 15 minutes between applying the different types of drops, and the eye ointments should be applied last.

Instructions for use:
If possible, ask someone to put the drops on you. Ask him to read these instructions with you before applying the drops.

1. Wash your hands thoroughly
2. Open the bottle. When opening the bottle for the first time, remove the loose ring from the cap.
Take special care that the tip of the dropper bottle does not touch the eye, the skin around the eye or your fingers.
3. Unscrew the bottle cap. Hold the bottle upside down between your thumb and other fingers.
4. Pull your lower eyelid down with your finger until a "pocket" forms between your eyelid and your eye. The drop should go into the pocket).
5. Tilt your head back, bring the bottle tip close to your eye and gently squeeze the bottle in the middle until a drop falls into your eye. Note that the drop may appear a few seconds late after squeezing. Do not squeeze too hard.
6. After using Ducresa, press the inner corner of the eye with your finger. This helps prevent the medicine from getting into the rest of your body.
If the drop does not fall into your eye, try again. Immediately after use, place the cap on the bottle and close it tightly.

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

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

If you stop using Ducreza
If you stop using this medicine earlier than you have been told, tell your doctor. If you have any further questions on 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.

Very rarely, this medicine may cause severe allergic reactions (anaphylactic reactions) with swelling and tightness of the throat and difficulty breathing.
Stop using Ducreza immediately and contact your doctor if any of these symptoms occur.
There have been cases of swelling and rupture of tendons in people taking fluoroquinolones orally or intravenously, especially in older patients and those treated concomitantly with corticosteroids. Stop using Ducreza if you get tendon pain or swelling (tendinitis).
You may also experience some or all of the following reactions 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, stinging or irritation, burning, itching in the eye,
blurred or reduced vision,
mucus in the eye.
Uncommon (may affect up to 1 in 100 people):

slower than expected corneal healing,
eye infections,
unusual sensation in the eye,
increased tearing,
dry and tired eye,
eye pain
perception of light as brighter than it is,
swelling or redness ("bloodshot eyes") of the anterior surface 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):

increase in pupil size,
drooping eyelid,
deposition of calcium on the surface of the eye (calcification of the cornea),
tearing and sensation of grit in the eye (crystalline keratopathy),
change in the thickness of the surface layer of the eye,
ulcer on the surface of the eye,
small holes on the surface of the eye (perforation of the cornea),
swelling of the surface of the eye (swelling of the cornea),
inflammation of the eye, which causes pain and redness (uveitis).
Effects can also occur in other parts of your body, including:
Uncommon (may affect up to 1 in
Not known:

suppression of adrenal function, which can manifest as low blood sugar, dehydration, weight loss and confusion about where you are,
hormonal problems: increased body hair (especially in women), muscle weakness and loss of muscle mass, purple stretch marks on the skin of the body, high blood pressure, irregular or absent menstruation, change in the amount of protein and calcium in your body, stopping of growth in children and adolescents and swelling and weight gain in the torso and face (Cushing's syndrome).

5. How to store Ducres
Keep out of reach of children.

Do not use this medicine after the expiry date which is stated on the bottle label and carton after EXP or EXP. The expiry date refers to the last day of that month.
Do not use this medicine if you notice that the plastic wrap around the cap and neck of the bottle is missing or damaged before opening a new bottle.
Keep the bottle tightly closed. To prevent infections, you must discard the bottle 28 days after first opening and use a new bottle.
Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the package and additional information
What Ducresa contains
The active substances are levofloxacin in the form of hemihydrate and dexamethasone in the form of dexamethasone sodium phosphate. Each milliliter of solution contains 5 mg levofloxacin and 1 mg dexamethasone.
The other ingredients are sodium dihydrogen phosphate monohydrate, disodium phosphate dodecahydrate, sodium citrate, benzalkonium chloride, sodium hydroxide or hydrochloric acid (for pH adjustment), water for injections.
What Dukresa looks like and contents of the pack
Ducreza is a clear, greenish-yellow solution, practically free of particles, and the individual drops look clear and colorless. It is supplied in a pack containing a 5 ml white plastic bottle with a dropper applicator. The plastic bottle is closed with a screw cap.


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