OZURDEX 700 micrograms intravitreal implant in applicator

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. See section 4.

1. What OZURDEX is and what it is used for
2. What you need to know before you are given OZURDEX
3. How OZURDEX is used
4. Possible side effects
5. How to store OZURDEX
6. Contents of the pack and other information

• if you are allergic to dexamethasone or any of the other ingredients of this medicine (listed in section 6)
• if you have an infection of any kind in or around your eye (bacterial, viral or fungal)
• if you have glaucoma or high pressure inside your eye which is not controlled properly with the medicines you may be using
• if the eye to be treated does not have a lens and the back of the lens capsule (“the bag”) has been ruptured
• if the eye to be treated has undergone cataract surgery and has a man-made lens, which was implanted in the front compartment of the eye (anterior chamber intraocular lens) or was fixed to the white portion of the eye (sclera) or to the coloured part of the eye (iris), and the back of the lens capsule (“the bag”) has been ruptured

Before your OZURDEX injection tell your doctor if:

• You have had cataract surgery, iris surgery (the coloured part of the eye that controls the amount of light that enters into the eye) or surgery to remove the gel (called the vitreous) from within the eye
• You are taking any medicines to thin the blood
• You are taking any steroid or non-steroidal anti-inflammatory medicines by mouth or applied to the eye
• You have had a herpes simplex infection in your eye in the past (an ulcer on the eye that has been there a long time, or sores on the eye)

Occasionally the injection of OZURDEX may cause an infection inside the eye, pain or redness in the eye, or a detachment or tear of the retina. It is important to identify and treat these as soon as possible. Please tell your doctor immediately if you develop increased eye pain or increased discomfort, worsening redness of your eye, flashing lights and sudden increase in floaters, partially blocked vision, decreased vision or increased sensitivity to light after your injection.

In some patients the eye pressure may increase with the possible development of glaucoma. This is something you may not notice so your doctor will monitor you regularly and, if necessary provide treatment to lower the eye pressure.

In the majority of patients who have not yet had an operation for cataract, a clouding of the eye's natural lens (a cataract) may occur after repeated treatment with OZURDEX. If this occurs your vision will decrease, and you are likely to need an operation to remove the cataract. Your doctor will help you to decide when is the most appropriate time to perform this operation, but you should be aware that until you are ready for your operation your vision may be as bad or worse than it was before you started receiving your OZURDEX injections.

The implant can 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 who have an opening in the iris. This can lead to swelling of the clear layer in the front of the eye and cause blurred vision. If this continues for a long time and is left untreated, it may require tissue transplantation.

The injection of OZURDEX into both eyes at the same time has not been studied and is not recommended. Your doctor should not inject OZURDEX into both eyes at the same time.

The use of OZURDEX in children and adolescents has not been studied and is therefore not recommended.

Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

There is no experience of using OZURDEX in pregnant women or during breast-feeding. OZURDEX should not be used during pregnancy or breast-feeding unless your doctor thinks it is clearly necessary. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, discuss this with your doctor before OZURDEX treatment. Ask your doctor for advice before taking any medicine.

After OZURDEX treatment you may experience some reduced vision for a short time. If this happens, do not drive or use any tools or machines until your vision improves.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via: the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is dexamethasone.
• Each implant contains 700 micrograms of dexamethasone.
• The other ingredients are: Ester terminated 50:50 poly D,L-lactide-co-glycolide and Acid terminated 50:50 poly D,L-lactide-co-glycolide, and hypromellose.

OZURDEX is a rod-shaped implant which is stored inside the needle of an applicator. The applicator and a packet of drying material are sealed in a foil pouch. The pouch is packaged in a plastic tray with lid, which is packaged in a carton box. One carton contains one applicator with one implant which will be used once and thrown away.