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

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 corsticosteroids) or any of the other ingredients of this medicine (listed in section 6).

-       if you are suffering from an eye infection that you are not using medicine for including viral (like herpes simplex, keratitis or varicella), fungal infections and tuberculosis of the eye.

You could have an infection if you have a sticky discharge from your eye or if you have a red eye that has not been seen by a doctor.

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 bottle label and carton after “EXP”. The expiry date refers to the last day of that month.

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

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This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) EEA under the following names:

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, United Kingdom (Northern Ireland)

Dugressa: France

This leaflet was last revised in April 2022.

Detailed information on this medicine is available on the websites of the Medicines & Healthcare products Regulatory Agency (MHRA), www.mhra.gov.uk, and the Health Products Regulatory Authority (HPRA), www.hpra.ie.

This leaflet was last revised in  06/2020 April 2022

4.3 Contraindications

·       Hypersensitivity to active substance levofloxacin or to other quinolones, to dexamethasone, or to other steroids, or to any of the excipients listed in section 6.1;

·       Herpes simplex, keratitis, varicella and other viral disease of the cornea and conjunctiva;

·       Mycobacterial infections of the eye caused by, but not limited to, acid-fast bacilli such as Mycobacterium tuberculosis, Mycobacterium leprae, or Mycobacterium avium;

·       Fungal diseases of ocular structures;

·       Untreated purulent infection of the eye.

4.8 Undesirable effects

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Levofloxacin

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Description of selected adverse reactions 

Increase of intraocular pressure

Increase of the intra-ocular pressure (IOP) and glaucoma may occur. Prolonged use of corticosteroid treatment may result in ocular hypertension/glaucoma (especially for patients with previous high IOP induced by steroids or with pre-existing high IOP or glaucoma). Children and elderly patients may be particularly susceptible to steroid-induced IOP rise (see section 4.4). Diabetics are also more prone to develop subcapsular cataracts following prolonged topical steroid administration.

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5.1 Pharmacodynamic properties

Dexamethasone:

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Clinical efficacy:

The efficacy of Ducressa has been investigated in a controlled study to evaluate the non-inferiority of the Ducressa vs. a standard treatment with a commercial formulation of tobramycin (0.35%) and dexamethasone (0.1%) eye drops for the prevention and treatment of inflammation and prevention of infection associated with cataract surgery in adults. The Investigator in charge of evaluating study parameters was blinded to treatment assignment. Patients who completed their cataract surgery without complications were assigned to [Product name] eye drops, 1 drop 4 times a day for 7 days, followed by dexamethasone 0.1% eye drops, 1 drop 4 times a day, for an additional 7 days, or to reference tobramycin + dexamethasone eye drops, 1 drop 4 times a day for 14 days.

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 10. DATE OF REVISION OF THE TEXT

16 December 2021 15 June 2022

Add UK specific information (including UK AE reporting details) to enable joint pack with UK

New leaflet for new product

New SPC for new product