Eyreida 0.3mg/ml eye drops, solution

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Eyreida Eye Drops are contained within a novel multidose eye drop bottle, which allows for the solution not to contain any preservatives.

Due to the design of the container, administration with these eye drops is not the same as standard eye drop bottles.

• Prior to first use, practice using the drops away from the eye. Slowly squeeze the bottle to deliver one drop in the air to get used to the pressure and time required to deliver one drop.
• Please note that there might be a few seconds delay between squeezing and the drop coming out. Do not squeeze too hard, or more than one drop may come out.
• After use and prior to recapping, the bottle should be shaken once in a downwards direction, without touching the dropper tip, in order to remove any residual liquid on the tip. This is necessary in order to ensure delivery of subsequent drops.
• If more than one type of eye drop is used, leave at least 5 minutes between administration of each eye drop solution.

Please read the full instructions on the correct use of this product in Section 3 of the leaflet (‘‘How to use Eyreida’’), before using these eye drops.

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

• if you are allergic to bimatoprost or any of the other ingredients of this medicine (listed in section 6).

Talk to your doctor or pharmacist before using Eyreida.

Please tell your doctor or pharmacist, if:

• you have any breathing problems.
• you have liver or kidney problems.
• you have had a cataract surgery in the past.
• you have or have had low blood pressure or low heart rate.
• you have had a viral infection or inflammation of the eye.

During treatment, Eyreida may cause a loss of fat around the eye, which may cause your eyelid crease to deepen, your eye to appear sunken (enophthalmos), your upper eyelid to droop (ptosis), the skin around your eye to tighten (involution of dermatochalasis) and the lower white part of your eye to become more visible (inferior scleral show). The changes are typically mild, but if pronounced, they can affect your field of vision. The changes may disappear if you stop taking Eyreida. Eyreida may also cause your eyelashes to darken and grow, and cause the skin around the eyelid to darken too. The colour of your iris may also go darker.

These changes may be permanent. The change may be more noticeable if you are only treating one eye.

If you have a history of contact hypersensitivity to silver, you should not use this product as dispensed drops may contain traces of silver.

Eyreida has not been tested in children under the age of 18 and therefore should not be used by patients under 18 years.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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

Bimatoprost may get into breast milk, so you should not breast-feed while you are taking this medicine.

Your sight may become blurred for a short time just after using Eyreida. You should not drive or use machines until your sight is clear again.

Before instillation of the eye drops:

• Wash your hands before opening the bottle.
• Do not use this medicine if you notice that the tamper-proof seal on the bottle neck is broken before you first use it.
• At the first use, after cap removal, without positioning the eyedropper above the eye, slowly squeeze the bottle to deliver one drop in the air to get used to the pressure and time required to deliver one drop.
  In case of difficulties of delivering one drop at a time, this step might be repeated.
• Choose the position that you find most comfortable for the instillation of the drops (you can sit down, lie on your back, or stand in front of a mirror).

1. Hold the bottle directly below the cap and turn the cap to open the bottle. Do not touch anything with the tip of the bottle to avoid contamination of the solution.

2. Tilt your head backwards and hold the bottle above your eye.

3. Pull the lower eyelid down and look up. Squeeze the bottle gently in the middle and let a drop fall into your eye. Please note that there might be a few seconds delay between squeezing and the drop coming out. Do not squeeze too hard.
If you are not sure how to administer your medicine, ask your doctor or pharmacist.

4. Blink a few times so that the drop spreads over the eye.
5. Repeat the instructions 2. – 4. to deliver a drop into the other eye also, if your doctor has instructed you to do this. Sometimes only one eye needs to be treated and your doctor will advise if this applies to you and which eye needs treatment.

6. After use and prior to recapping, the bottle should be shaken once in a downwards direction, without touching the dropper tip, in order to remove any residual liquid on the tip. This is necessary in order to ensure delivery of subsequent drops.
7. After you have used all doses there will be some Eyreida left in the bottle. You should not be concerned since an extra amount of Eyreida has been added and you will get the full amount of Eyreida that your doctor has prescribed. Do not attempt to use the excess medicine remaining in the bottle after you have completed the course of treatment.

Do not use the eye drops for longer than 28 days after first opening the bottle.

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

If you use more of this medicine than you should, it is unlikely to cause you any serious harm. Put your next dose in at the usual time. If you are worried, talk to your doctor or pharmacist.

If you forget to use this medicine, use a single drop as soon as you remember, and then go back to your regular routine. Do not take a double dose to make up for a forgotten dose.

Eyreida should be used every day to work properly. If you stop using Bimatoprost 0.3mg/ml eye drops solution the pressure inside your eye may go up, therefore talk to your doctor before stopping this treatment.

In very rare cases, some patients with severe damage to the clear layer at the front of the eye (the cornea) have developed cloudy patches on the cornea due to calcium build-up during treatment.

If you get any side effects, talk to your doctor, pharmacist or nurse.

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

• The active substance is Bimatoprost.
• The other ingredients are: sodium chloride, disodium hydrogen phosphate heptahydrate, citric acid monohydrate, sodium hydroxide or hydrochloric acid (for pH adjustment), water for injections.

Eyreida eye drops solution is presented as a clear, colourless aqueous solution in a white opaque 5ml LDPE bottle and white Novelia nozzle (HDPE and silicone) with a blue tip and sealed with a white HDPE cap.

Pack sizes: 1 or 3 bottles in a cardboard box.

Not all pack sizes may be marketed.

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