Ozurdex 700 microgramos implante intravitreo en aplicador

Product Information for the Patient

OZURDEX 700Intravitreal Implant in Applicator (700 micrograms)

dexamethasone

Read this entire product information carefully before starting to use this medication because it contains important information for you.

• Keep this product information, as you may need to read it again.
• If you have any doubts, consult your doctor.
• If you consider that any of the adverse effects you are experiencing is severe or if you notice any adverse effect not mentioned in this product information, inform your doctor. See section 4.

1.What OZURDEX is and for what it is used

2.What you need to know before starting to use OZURDEX

3.How to use OZURDEX

4.Possible adverse effects

5.Storage of OZURDEX

6.Contents of the package and additional information

The active ingredient of OZURDEX is dexamethasone. Dexamethasone belongs to a group of medications known as corticosteroids.

OZURDEX is used to treat adult patients with:

• Loss of vision due to diabetic macular edema (DME), if you have already undergone cataract surgery, or if you have not responded to other treatments or are not suitable for them. Diabetic macular edema is an inflammation of the light-sensitive layer at the back of the eye called the macula. DME is a disease that affects some people with diabetes.

• Loss of vision in adults caused by blockage of the eye veins. This blockage causes a buildup of fluids that leads to inflammation in the macula area of the retina (a light-sensitive layer located at the back of the eye).

Inflammation of the macula can cause damage that affects your central vision, which is used for tasks such as reading. OZURDEX acts by reducing this macular inflammation, helping to reduce or prevent further damage to the macula.

• Inflammation of the back of the eye. This inflammation causes a reduction in vision and/or presence of floaters in the eye (black spots or fine lines that move across the field of vision). OZURDEX reduces this inflammation.

Do not use OZURDEX

• if you are allergic to dexamethasone or any of the other ingredients in this medicine (listed in section 6);
• if you have any type of infection in your eye or around it (bacterial, viral, or fungal);
• if you have glaucoma or high eye pressure that cannot be controlled with the medicines you are taking;
• if the eye to be treated does not have a lens or if the back of the lens capsule has been broken;
• if the eye to be treated has undergone cataract surgery and has an artificial lens implanted in the front compartment of the eye (anterior chamber intraocular lens) or attached to the white part of the eye (sclera) or the colored part of the eye (iris), and if the back of the lens capsule has been broken.

Warnings and precautions

Before your OZURDEX injection, tell your doctor if:

• you have undergone cataract surgery, iris surgery (the colored part of the eye that controls the amount of light that enters the eye), or vitreous (gel) removal surgery from the inside of the eye;
• you are taking any medication to thin the blood;
• you are taking any oral or eye anti-inflammatory steroid or non-steroid medication; or
• you have had a history of herpes simplex infection in your eye (a long-lasting ulcer or a wound in the eye).

OZURDEX injection may cause infection, pain, or redness in the eye, or even retinal detachment or tear. It is essential to identify and treat these problems as soon as possible. Inform your doctor immediately if you develop increased eye pain or discomfort, worsening red eyes, flashes, sudden increase in floaters, partial vision blockage, reduced vision, or increased sensitivity to light after the injection.

In some patients, OZURDEX may increase eye pressure, potentially leading to glaucoma. You may not notice it, so your doctor will perform regular checks and, if necessary, provide treatment to reduce eye pressure.

In most patients who have not undergone cataract surgery, a cataract (clouding of the lens) may develop after repeated treatment with OZURDEX, resulting in reduced vision and possibly requiring surgery to remove the cataract. Your doctor will help you decide when to have the surgery, but you should be aware that until you are ready for the surgery, your vision may be as poor or worse than before starting OZURDEX injections.

The implant may move from the back to the front of the eye in patients with a tear in the back of the lens capsule and/or those with an opening in the iris. This movement may cause swelling of the transparent layer in the front of the eye and blurred vision. If it continues for a long time and is not treated, it may require tissue transplantation.

OZURDEX has not been studied in both eyes at the same time, and therefore it is not recommended. Your doctor should not inject OZURDEX in both eyes at the same time.

Children and adolescents

OZURDEX has not been studied in children and adolescents, and therefore it is not recommended.

Other medicines and OZURDEX

Tell your doctor if you are using or have recently used other medicines, including those purchased without a prescription.

Pregnancy and breastfeeding

There is no experience with the use of OZURDEX in pregnant women or breastfeeding women. OZURDEX should not be used during pregnancy or breastfeeding unless your doctor considers it absolutely necessary. If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor before using OZURDEX treatment. Consult your doctor before using any medicine.

Driving and operating machinery

After OZURDEX treatment, your vision may be reduced for a short period. If this occurs, do not drive or operate tools or machinery until your vision improves.

All OZURDEX injections must be administered by a qualified eye specialist doctor.

The recommended dose is the administration of an implanted injection into the eye. If the effect of this injection wears off and your doctor recommends it, another implant can be injected into the eye.

Your doctor will instruct you to use antibiotic eye drops daily for 3 days before and after each injection to prevent eye infection. Follow these instructions carefully.

On the day of the injection, your doctor may use antibiotic eye drops to prevent infection. Before the injection, your doctor will clean your eye and eyelid. Your doctor will also administer a local anesthetic to reduce or prevent any pain caused by the injection. You may hear a "click" during the OZURDEX injection, which is normal.

Detailed instructions for your doctor on how to inject OZURDEX are provided in the medication packaging.

If you have any other questions about using this medication, ask your doctor.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The following side effects have been observed with OZURDEX:

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

• Increased eye pressure
• Cataract (clouding of the lens), hemorrhage in the surface of the eye*

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

• High eye pressure
• Clouding of the posterior part of the lens
• Hemorrhage in the interior of the eye*
• Worsening of vision*
• Difficulty seeing clearly
• Retinal detachment* (separation of the gelatinous vitreous from the posterior layer of the eye)
• Flashes of light in front of the eye*
• Sensation of fog in front of the eye*
• Inflammation of the eyelid
• Ocular pain*
• Seeing flashes of light*
• Swelling of the transparent layer of the eye (cornea)*
• Redness of the eye*
• Headache

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

• Severe inflammation of the posterior part of the eye (usually due to viral infection)
• Severe infection or inflammation within the eye*
• Glaucoma (a condition of the eye in which elevated eye pressure is associated with damage to the optic nerve)
• Retinal detachment* (separation of the posterior layer of the eye)
• Retinal tear* (tear in the posterior layer of the eye)
• Decreased eye pressure associated with leakage of the gelatinous vitreous from the interior of the eye*
• Inflammation within the anterior part of the eye*
• Increased proteins and cells in the anterior part of the eye due to inflammation*
• Abnormal sensation in the eye*
• Itching of the eyelid
• Redness of the white part of the eye*
• Migration of the OZURDEX implant from the posterior to the anterior part of the eye causing blurred vision or worsening of vision and may or may not cause swelling of the transparent layer of the eye (cornea)*
• Accidental incorrect placement of the OZURDEX implant*
• Migraine

*These side effects may be caused by the injection procedure and not by the OZURDEX implant. The more injections you receive, the greater the likelihood of these side effects.

Reporting of side effects

If you experience any type of side effect, consult your doctor, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the national notification system included in theAppendixV.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use OZURDEX after the expiration date that appears on the box and the bag, after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

Composition of OZURDEX

• The active ingredient is dexamethasone.
• Each implant contains 700 micrograms of dexamethasone.
• The other components are: 50:50 poly D,L-lactide-co-glycolide in ester form and

50:50 poly D,L-lactide-co-glycolide in acidic form.

Appearance of OZURDEX and contents of the package

OZURDEX is a rod-shaped implant inside the needle of an applicator. A laminated sealed pouch, inside a box, contains the applicator and a package of desiccant material. A box contains an applicator with an implant, which will be used once and discarded.

Marketing Authorization Holder

AbbVie Deutschland GmbH & Co. KG

Knollstrasse

67061 Ludwigshafen

Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Last review date of this leaflet MM/YYYY

The detailed information about this medication is available on the website of the European Medicines Agency:http://www.ema.europa.eu/.

To request a large print copy of this leaflet, please contact the local representative of the marketing authorization holder.

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