• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

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

Eylea contains the active substance aflibercept. It belongs to a group of medicines called antineovascularistion agents.

Your doctor will inject Eylea into your eye to treat eye disorders in adults called:

• wet age-related macular degeneration (wet AMD)
• visual impairment due to diabetic macular oedema (DMO).

These disorders affect the macula. The macula is the central part of the light sensitive membrane at the back of the eye. It is responsible for clear vision.

Wet AMD is caused when abnormal blood vessels form and grow below the macula. The abnormal blood vessels may leak fluid or blood into the eye. Leaky blood vessels that cause swelling of the macula cause DMO. Both disorders may impact your vision.

Eylea stops growth of new abnormal blood vessels in the eye. Eylea can help to stabilise and often improve vision.

• are allergic to aflibercept or any of the other ingredients of this medicine (listed in section 6)
• have an infection in or around the eye
• have pain or redness in your eye (severe eye inflammation).

Talk to your doctor before receiving Eylea if you:

• have glaucoma – an eye condition caused by high pressure in the eye
• have a history of seeing flashes of light or dark floating spots and if their size or number suddenly increases
• had eye surgery in the last 4 weeks or eye surgery is planned in the next 4 weeks.

Tell your doctor immediately if you develop:

• redness of the eye
• eye pain
• increased discomfort
• blurred or decreased vision
• increased sensitivity to light

These may be symptoms of an inflammation or infection and your doctor may stop giving you Eylea.

Furthermore, it is important for you to know that:

• the safety and efficacy of Eylea when administered to both eyes at the same time have not been studied and such use may increase risk of experiencing side effects.
• injections with Eylea may cause an increase in eye pressure in some patients within 60 minutes of the injection. Your doctor will monitor this after each injection.
• your doctor will check for other risk factors that may increase the chance of a tear or detachment of one of the layers at the back of the eye. In such cases your doctor will give you Eylea with caution.
• women who could become pregnant must use effective birth control during treatment and for at least 4 months after the last injection of Eylea.

The use of substances similar to those contained in Eylea is potentially related to the risk of blood clots blocking blood vessels, which may lead to heart attack or stroke. Theoretically, this could also happen after an injection of Eylea into the eye. If you had a stroke, a mini-stroke or a heart attack within the last 6 months, your doctor will give you Eylea with caution.

The use of Eylea in children or adolescents under 18 has not been studied because the diseases indicated occur mainly in adults. Therefore, its use in this age group is not relevant.

Tell your doctor if you are using, have recently used or might use any other medicines.

• Women who could become pregnant must use effective birth control during treatment and for at least 4 months after the last injection of Eylea.
• There is limited experience on the use of Eylea in pregnant women. Women should not receive Eylea during pregnancy unless the potential benefit to the woman outweighs the potential risk to the unborn child.
• Small amounts of Eylea may pass into human milk. The effect on breast-fed newborns/infants are unknown. Eylea is not recommended during breast-feeding.

Therefore, if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you receive this medicine.

After receiving Eylea, you may experience some temporary vision problems. Do not drive or use machines as long as these last.

This medicine contains 0.021 mg of polysorbate 20 in each 0.07 ml dose which is equivalent to 0.3 mg/ml. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

Your healthcare professional will inject Eylea into your eye (intravitreal injection).

Before the injection, your healthcare professional will use a disinfectant eyewash to clean your eye carefully to prevent infection. Your healthcare professional will give you an eye drop (local anaesthetic) to numb the eye to reduce or prevent pain from the injection.

Make a new appointment with your doctor as soon as possible.

Speak with your doctor before stopping treatment. Stopping treatment may increase your risk of vision loss and your vision may worsen.

Contact your doctor immediately if you have any of the following:

• common side effect, which may affect up to 1 in 10 people
  • clouding of the lens (cataract)
  • bleeding in the back of the eye (retinal haemorrhage)
  • increase of pressure inside the eye
  • bleeding inside the eye (vitreous haemorrhage)
• uncommon side effect, which may affect up to 1 in 100 people
  • certain forms of clouding of the lens (cataract subcapsular/nuclear)
  • detachment, tear or bleeding of the light-sensitive layer at the back of the eye, resulting in flashes of light with floaters, sometimes progressing to a loss of vision (retinal detachment or tear)

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

• allergic reactions
• moving spot in your vision (vitreous floaters)
• detachment of the gel-like substance inside the eye (vitreous detachment)
• reduced sharpness of vision
• eye pain
• bleeding inside the eye (conjunctival haemorrhage)
• damage to the clear layer of the eyeball in front of the iris (punctate keratitis, corneal abrasion)

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

• detachment or tear of one of the layers in the back of the eye, resulting in flashes of light with floaters, sometimes progressing to a loss of vision (retinal pigment epithelial tear/detachment)
• inflammation in the iris, of other parts of the eye, or the gel-like substance inside the eye (uveitis, iritis, iridocyclitis, vitritis)
• certain forms of clouding of the lens (cataract cortical)
• damage to the front layer of the eyeball (corneal erosion)
• blurred vision
• eye pain at injection site
• a feeling of having something in the eye
• increased tear production
• bleeding at the injection site
• redness of the eye
• swelling of the eyelid
• redness of the eye (ocular hyperaemia)
• irritation at injection site

Rare (may affect up to 1 in 1 000 people):

• swelling of the front layer of the eyeball (corneal oedema)
• clouding of the lens (lenticular opacities)
• degeneration of the light sensitive membrane at the back of the eye (retinal degeneration)
• eyelid irritation

Not known (frequency cannot be estimated from the available data):

• inflammation of the white part of the eye associated with redness and pain (scleritis)

Besides the above the following side effects may occur although they have not been reported in clinical studies:

• abnormal sensation in eye
• damage to the surface of the clear front layer of the eye (corneal epithelium defect)
• inflammation of other parts of the eye (anterior chamber flare)
• serious inflammation or infection inside the eye (endophthalmitis)
• blindness
• clouding of the lens due to injury (traumatic cataract)
• pus in the eye (hypopyon)
• severe allergic reactions

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 Yellow Card Scheme at 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 aflibercept. 1 ml solution contains 114.3 mg aflibercept. Each pre-filled syringe contains 0.184 ml. This provides a usable amount to deliver a single dose of 0.07 ml containing 8 mg aflibercept.
• The other ingredients are: sucrose, arginine hydrochloride, histidine hydrochloride monohydrate, histidine, polysorbate 20, water for injections.

See ‘Eylea contains polysorbate 20’ in section 2 for more information.

Eylea 114.3 mg/ml solution for injection in pre-filled syringe is a solution for injection (injection).

The solution is colourless to pale yellow.

Pack size: 1 pre-filled syringe.