Eydelto 20mg/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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Eydelto Eye Drops are contained within a novel multi-dose 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 10 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 Eydelto’’), before using these eye drops.

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

• if you are allergic to dorzolamide hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• if you have severe kidney impair mentor problems, or a prior history of kidney stones.

If you are not sure whether you should use this medicine, contact your doctor or pharmacist.

Tell your doctor or pharmacist about any medical problems you have now or have had in the past, including eye problems and eye surgeries, and about any allergies to any medications.

If you develop any eye irritation or any new eye problems such as redness of the eye or swelling of the eyelids, contact your doctor immediately.

If you suspect that this medicine is causing an allergic reaction (for example, skin rash, severe skin reaction or itching) stop its use and contact your doctor immediately.

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

If you wear contact lenses, you should consult your doctor before using Eydelto.

Dorzolamide (preserved formulation) has been studied in infants and children less than 6 years of age who have raised pressure in the eye(s) or have been diagnosed with glaucoma. For more information talk to your doctor.

In studies with dorzolamide (preserved formulation), the effects of dorzolamide (preserved formulation) were similar in both elderly and younger patients.

Tell your doctor about any liver problems you now have or have suffered from in the past.

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

Tell your doctor about all medicines (including eye drops) that you are using or plan to use, including those obtained without a prescription, particularly another carbonic anhydrase inhibitor such as acetazolamide, or a sulfa medicine such as sulfamethoxazole (medicines used to prevent the growth of bacteria).

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 using this medicine.

Pregnancy

You should not use this medicine during pregnancy. Tell your doctor if you are pregnant or intend to become pregnant.

Breast-feeding

You should not use this medicine during breast-feeding. Tell your doctor if you are breast-feeding or intend to breast-feed.

No studies on the effects on the ability to drive or use machines have been performed. There are side effects associated with this medicine, such as dizziness and blurred vision, which may affect your ability to drive and/or operate machinery. Do not drive or operate machinery until you feel well or your vision is clear.

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.
• When using for the first time, before delivering a drop to the eye, you should first of all practise using the dropper bottle by squeezing it slowly to deliver one drop away from the eye.
• When you are confident that you can deliver one drop at a time, 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).

Instillation:

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, pharmacist or nurse.

4. Blink a few times so that the drop spreads over the eye. Close your eye and press the inner corner of the eye with your finger for about two minutes. This helps to stop the medicine from getting into the rest of the body.

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 each 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. At the end of the 28-day in-use shelf life of the medicine, there will be some Eydelto left in the bottle.
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.

If you put too many drops in your eye or swallow any of the contents of the container, you should contact your doctor immediately.

It is important to use this medicine as prescribed by your doctor.

If you miss a dose, use it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and go back to your regular dosing schedule.

Do not use a double dose to make up for a forgotten dose.

If you want to stop using this medicine talk to your doctor first.

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 dorzolamide.
• Each ml contains 20mg of dorzolamide (as dorzolamide hydrochloride).
• The other ingredients are hydroxyethyl cellulose, mannitol, sodium citrate dihydrate, sodium hydroxide and water for injections.

Eydelto eye drops solution is presented as a 5ml clear, colourless aqueous, slightly viscous solution, in white opaque 11ml LDPE bottle and white Novelia nozzle (HDPE and silicone) 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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