Patient Leaflet Updated 10-Dec-2019 | Alimera Sciences Limited
ILUVIEN 190 micrograms intravitreal implant in applicator
PACKAGE LEAFLET: INFORMATION FOR THE USER
ILUVIEN 190 micrograms intravitreal implant in applicator
Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
What is in this leaflet
1. What ILUVIEN is and what it is used for
2. What you need to know before you are given ILUVIEN
3. How ILUVIEN is administered
4. Possible side effects
5. How to store ILUVIEN
6. Contents of the pack and other information
1. WHAT ILUVIEN IS AND WHAT IT IS USED FOR
ILUVIEN is a tiny tube that is inserted into the eye and releases very small amounts of the active ingredient, fluocinolone acetonide, for up to 3 years. Fluocinolone acetonide belongs to a group of medicines called corticosteroids.
ILUVIEN is used to treat vision loss associated with diabetic macular oedema when other available treatments have failed to help. Diabetic macular oedema is a condition that affects some people with diabetes and causes damage to the light-sensitive layer at the back of the eye responsible for central vision, the macula. The active ingredient (the drug fluocinolone acetonide) helps to reduce the inflammation and the swelling that builds up in the macula in this condition. ILUVIEN can therefore help to improve the damaged vision or stop it from getting worse.
ILUVIEN is used to prevent relapses of inflammation of the back of the eye. This inflammation can cause floaters which are black dots or wispy lines that move across what you can see (‘field of vision’) or can cause loss of vision by damaging the part of the eye responsible for good vision, called the ‘macula’. The loss of vision may not improve unless the inflammation is treated. ILUVIEN helps to reduce the inflammation and the swelling that it can cause in the back of the eye. It can help improve your sight or stop it from getting worse. It may stop future attacks of inflammation.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ILUVIEN
You must not receive ILUVIEN:
Warnings and precautions
Children and adolescents (below 18 years of age)
The use of ILUVIEN in children and adolescents has not been studied and is therefore not recommended.
Other medicines and ILUVIEN
Please tell your doctor if you are using or have recently used any other medicines, including medicines bought without a prescription.
Pregnancy, breast-feeding and fertility
Driving and using machines
After ILUVIEN treatment you may experience some temporary vision blurring. If this happens, do not drive or use machines until this resolves.
3. HOW ILUVIEN IS ADMINISTERED
The ILUVIEN injection will be administered by your eye doctor.
ILUVIEN is given as a single injection into your eye. Afterwards, your doctor will monitor your vision regularly.
Before the injection, your doctor will use antibiotic eye drops and wash your eye carefully to prevent infection. Your doctor will also give you a local anaesthetic to prevent any pain that the injection might cause.
Before and after the injection, your doctor may ask you to use antibiotic eye drops in order to prevent any possible eye infection. Please follow these instructions carefully.
If the effect of the implant wears off and your doctor recommends it, another implant may be injected into your eye. This applies only if you are administered Iluvien for the treatment of diabetic macular oedema.
If you have any further questions on the use of this medicine, ask your doctor.
4. POSSIBLE SIDE EFFECTS
Like all medicines, ILUVIEN can cause side effects, although not everybody gets them.
With administration of ILUVIEN, there may be some side effects, mostly in the eye. Occasionally the injection 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 discomfort, worsening redness of your eye, flashing lights and sudden increase in floaters, partial blocked vision, decreased vision or increased sensitivity to light after your injection. Other side effects may include increased or decreased eye pressure or clouding of the eye’s natural lens. Increased pressure in the eye which damages the optic nerve (glaucoma) may be more likely if the pressure inside your eye is higher than average before treatment. Your doctor will discuss the risks of this with you before treatment. The symptoms you might experience and what you should do if you experience these symptoms are described in Section 2 of this leaflet (Warnings and precautions).
The following side effects may be seen with ILUVIEN:
Very common (affects more than 1 in 10 patients)
Increased eye pressure, clouding of the eye’s natural lens (cataract) or eye surgery to correct the cataract.
Common (affects between 1 and 10 in every 100 patients)
Increased pressure in the eye which damages the optic nerve (glaucoma), detachment of the light-sensitive layer from the back of the eye (retinal detachment), bleeding in the white part of your eye or inside the eye, small particles or spots in vision (floaters), a feeling of looking through mist or fog, decreased pressure in the eye which causes sudden pain and blurred vision, Loss of your usual field of vision,eye pain or irritation, reduced vision, or eye surgery or procedure to relieve increased eye pressure or to remove the gel material that fills the back of the eye, increased protein and cells in the front of the eye due to inflammation, foreign body sensation in the eye, dry eye.
Uncommon (affects fewer than 1 in every 100 patients)
Blockage of the blood vessels at the back of the eye, new blood vessel growth inside the eye, ulcer on the white of the eye, changes in the gel material that fills the back of the eye, clouding of the bag holding the lens of the eye, redness of the eye, itching or infection of the eye, thinning of the white outer layer of the eye, trauma to the eye from the injection of the medicine, unplanned movement of implant through white part of eye, and/or other complications from the injection, movement of the ILUVIEN implant from the back to the front of the eye, involuntary closing of the eyelids, achy and sore eyes with sudden inset of severe pain at times associated with blurred vison, deposits on the eye’s outermost layer, painful eye condition caused by a scratch on the surface of the eye, swelling of the eye.
The most common non-visual side effect reported to be possibly caused by the drug or by the injection procedure is headache.
Reporting of side effects
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE ILUVIEN
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What ILUVIEN contains
What ILUVIEN looks like and contents of the pack
ILUVIEN consists of a tiny light brown tube (approximately 3.5 mm x 0.37 mm) which is preloaded in an applicator system. The preloaded applicator is placed in a polycarbonate tray and sealed with a peelable lid. Each sealed tray is provided in a carton which includes the package leaflet.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
This leaflet was last revised in 09/2019
This medicinal product is authorised in the following Member States of the EEA under the invented name ‘Iluvien’:
Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, The Netherlands, Norway, Poland, Portugal, Spain, Sweden, United Kingdom.
Detailed information on this medicine is available on the website of the HPRA: https://www.hpra.ie and the MHRA: https://www.gov.uk/pil-spc
Royal Pavilion, Wellesley Road, Aldershot, Hamsphire, GU11 1PZ, UK
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