Cystadrops 3.8 mg/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.

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

Cystadrops is an eye drops solution that contains the active substance cysteamine (also known as mercaptamine).

It is used to reduce the quantity of cystine crystals in the surface of the eye (cornea) in adults and children from 2 years of age with cystinosis.

Cystinosis is a rare hereditary disease in which the body is unable to remove excess cystine (an amino acid), causing cystine crystals to accumulate in various organs (such as kidney and eyes).

Accumulation of crystals in the eye can lead to increased sensitivity to light (photophobia), corneal deterioration (keratopathy) and loss of vision .

If you are allergic to cysteamine or any of the other ingredients of this medicine (listed in section 6).

Talk to your doctor or pharmacist before using Cystadrops.

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

Even if the level of Cystadrops in the blood is negligible, precautions should be taken.

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.

You may find that your vision is blurred for a few minutes just after using Cystadrops. Do not drive or use machines until your vision is clear.

This medicine contains 5 micrograms benzalkonium chloride in each drop which is equivalent to 0.1 mg/ml.

Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. You should remove contact lenses before using this medicine and put them back 15 minutes afterwards.

Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor.

• The recommended dose is 1 drop in each eye, 4 times a day during waking hours.
• The recommended interval between each application is 4 hours (for example, you can have your eye drops at 8.00 am, 12.00 am, 4.00 pm and 8.00 pm).
• To avoid sticky eyes in the morning, it is recommended to apply the last drop of the day at least 30 minutes before going to bed.
• The dose may be gradually decreased (to a minimum total daily dose of 1 drop in each eye) by your doctor based on eye examinations.

Only use the drops in your eyes (ocular use).

To use the eye drops, please follow the instructions below carefully. Those instructions are also available as an animated movie on www.cystadrops.net ‘QR code to be included’

• Cystadrops must be brought back at room temperature before the first administration. It will facilitate the use of the drops.
• Immediately before using a vial for the first time, write the date of opening in the space provided on the carton box.
• Wash your hands carefully in order to avoid contamination by bacteria of the content in the vial.
• Remove the green protective cap (picture 1).
• Remove the metal seal (picture 2).
• Remove the grey stopper (picture 3) from the vial.
• Do not touch the opening of the vial after removing the grey stopper.

• Take the dropper out of its sachet, without touching the end intended to be attached to the vial, and attach it (picture 4) to the vial. Do not remove the dropper from the vial.

• Make sure that you do not lose the small white cap (picture 5) that comes on the top of the dropper.

• Check the opening date that you wrote down on the carton box. Cystadrops can be used for up to 7 days from the time of opening.
• Get the dropper bottle and a mirror.
• Wash your hands.

• Hold the dropper bottle, pointing down, between your thumb and fingers. Move firmly the dropper bottle up and down to facilitate the filing of the dropper.
• Unscrew the small white cap from the dropper.
• Tilt your head back. Pull down your eyelid with a clean finger, until there is a “pocket” between the eyelid and your eye. The drop will go in here (picture 6).

• Bring the dropper bottle tip close to the eye. Use the mirror if it helps.
• Do not touch your eye or eyelid, surrounding areas or other surfaces with the dropper. It could infect the drops.
• Gently squeeze the dropper to release one drop of Cystadrops at a time. Take special care not to touch the tip of the dropper with your fingers.
• After using Cystadrops, press a finger into the corner of your eye by the nose (picture 7), then gently massage your upper eyelid to spread the eye drops over the eye.

• To avoid potential irritation, remove excess medicine around the eye with a moist tissue (picture 8).
• Repeat the step 3 for the other eye.
• Replace the small white cap on the dropper immediately after use.

• Place the dropper bottle into the carton box.
• Keep Cystadrops at room temperature (it will facilitate the use of the dropper).
• Discard 7 days after opening.

Try again.

Ensure that there is at least a 10 minute gap between using Cystadrops and the other eye medicine. Administer eye ointments last.

Do not use the drops with your lenses in. After using the drops wait 15 minutes before putting your lenses back in.

If you put too many drops in your eyes, rinse your eyes out, preferably with saline solution (or if not available with warm water). Do not put in any more drops until it is time for your next regular dose.

Wait for your next scheduled application and then continue with your regular routine. Do not use a double dose to make up for a forgotten dose.

Cystadrops must be used every day for the medicine to work properly. If you stop using Cystadrops, cystine crystals accumulation in the eye (cornea) may increase and lead to increased sensitivity to light (photophobia), corneal deterioration (keratopathy) and loss of vision. Therefore talk to your doctor before stopping this treatment.

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 national reporting system 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 cysteamine (mercaptamine), as hydrochloride. One mL of eye drops solution contains 3.8 mg of cysteamine.
• The other ingredients are benzalkonium chloride (see section 2 under ‘Cystadrops contains benzalkonium chloride’), disodium edetate, carmellose sodium, citric acid monohydrate, sodium hydroxide, hydrochloric acid and water for injections.

Cystadrops is a clear and viscous eye drops solution.

Each box contains:

• 1 amber glass vial containing 5 mL of eye drops solution,
• 1 dropper applicator.

Cystadrops is available in pack containing 1 box or in multipack containing 4 boxes.

Not all pack sizes may be marketed in your country

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