CYSTADROPS 3.8 MG/ML Eye drops, solution

Зміст інструкції

1. Cystadrops 3.8 mg/mL eye drops, solution
   1. What Cystadrops is and what it is used for
   2. What you need to know before using Cystadrops
   3. How to use Cystadrops
   4. Possible side effects
   5. How to store Cystadrops
   6. Contents of the pack and other information

Cystadrops 3.8 mg/mL eye drops, solution

cysteamine (mercaptamine)

Read this leaflet carefully before you start using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 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

1. What Cystadrops is and what it is used for

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

What it is used for
It is used to reduce the amount of cystine crystals on the surface of the eye (cornea) in adults and
children from 6 months of age with cystinosis.

What is cystinosis
Cystinosis is a rare hereditary disease in which the body is unable to remove excess
cysteine (an amino acid), causing the accumulation of cystine crystals in various organs (such as the kidneys and the
eyes). The accumulation of crystals in the eye can cause increased sensitivity to light (photophobia),
corneal damage (keratopathy) and vision loss.

2. What you need to know before using Cystadrops

Do not use Cystadrops
If you are allergic to cysteamine or any of the other ingredients of this medicine (listed in
section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Cystadrops.

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

Pregnancy and breastfeeding
Even though the level of Cystadrops in the blood is negligible, precautions must be taken.
If you are pregnant, suspect you are pregnant, are planning a pregnancy or are breastfeeding, ask your
doctor or pharmacist for advice before using this medicine.

Driving and using machines
Immediately after using Cystadrops, your vision may be blurred for a few minutes. Do not drive and do
not use machines until your vision returns to normal.

Cystadrops contains benzalkonium chloride
This medicine contains 5 micrograms of benzalkonium chloride in each drop, equivalent to
0.1 mg/mL.
Benzalkonium chloride can be absorbed by soft contact lenses and cause them to change
color. You must remove your contact lenses before using this medicine and wait at least
15 minutes before wearing them again.
In addition, benzalkonium chloride can cause eye irritation, especially if you suffer from dry eyes
or corneal disorders (the transparent layer in the front of the eye). If, after using
this medicine, you experience an abnormal sensation in your eyes, stinging or eye pain, consult your
doctor.

3. How to use Cystadrops

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.

Recommended dose

• The recommended dose is 1 drop in each eye, 4 times a day during waking hours.
• The recommended interval between applications is 4 hours (for example, you can apply the eye drops at 8 am, 12 pm, 4 pm and 8 pm).
• To avoid having your eyelids "stuck together" upon waking, it is recommended to apply the last drop of the day at least 30 minutes before going to bed.
• Based on the results of the ophthalmological examination, your doctor may decide to gradually reduce the dose (up to a minimum daily dose of 1 drop in each eye).

It must be used only as an eye drop (ophthalmic use).

When using the eye drops, it is necessary to carefully follow the following instructions.These instructions
are also available in the form of an animated video at www.cystadrops.net ‘QR code to
be included’

Step 1: Before using a vial for the first time

• Cystadrops must be brought to room temperature before the first administration. This will make using the drops easier.
• Immediately before using a vial for the first time, write the date of opening in the designated space on the box.
• Wash your hands thoroughly to avoid contaminating the contents of the vial with bacteria.
• Remove the green protective cap (figure 1).
• Remove the metal seal (figure 2).
• Remove the grey cap (figure 3) from the vial.
• Do not touch the opening of the vial after removing the grey cap.

remove
remove
remove

protective
green
cap
grey
metal
seal
vial

• Extract the dropper from its sachet without touching the end to be inserted into the vial and insert it into the vial (figure 4). Do not remove the dropper from the vial.

white
cap
white
cap
rotate and
press
for
the
dropper
dropper
vial
vial

• Make sure not to lose the white cap (figure 5) that covers the dropper tip.

Step 2: Before using the eye drops

• Check the opening date that was written on the box. Cystadrops can be used up to 7 days after opening.
• Take the dropper vial and a mirror.
• Wash your hands.

Step 3: Using the eye drops

• Hold the dropper vial upside down between your thumb and other fingers. Shake the dropper vial vigorously to facilitate filling the dropper.
• Unscrew the white cap from the dropper.
• Tilt your head back. Lower your eyelid with a clean finger to form a pouch between your eyelid and your eye. The drop should be instilled in this area (figure 6).



• Bring the tip of the vial close to your eye. Use the mirror if it can be helpful.
• Do not touch your eye, eyelid, surrounding areas or other surfaces with the dropperto avoid infecting the drops remaining in the vial.
• Gently press the dropper, releasing one drop of Cystadrops at a time. Be careful not to touch the tip of the dropper with your fingers.
• After applying Cystadrops, press with your finger on the inner corner of your eye, near your nose (figure 7), and gently massage your upper eyelid to distribute the eye drops over your eye.



• To avoid possible irritation, remove any excess medicine around your eye with a damp tissue (figure 8).
• Repeat step 3 for the other eye.
• Replace the white cap on the dropper immediately after use.



Step 4: How to store the eye drops after use

• Place the dropper vial back in the box.
• Store Cystadrops at room temperature (this will make using the dropper easier).
• Dispose of 7 days after opening.

If a drop does not enter your eye
Try again .
If you use Cystadrops with another medicine for topical ocular use
Allow at least 10 minutes between instilling Cystadrops and the other medicine. Ointment
should be used last.

If you wear soft contact lenses
Do not use the eye drops while wearing your lenses. After using the eye drops, wait 15 minutes before
reinserting them.

If you use more Cystadrops than you should
If you put in too much eye drops, wash your eyes preferably with saline solution (if not possible, with
lukewarm water). Do not instill any more eye drops until the time of the next dose.

If you forget to use Cystadrops
Wait until the next application and then resume with normal instillation times. Do not
use a double dose to make up for a missed one.

If you stop the treatment with Cystadrops
Cystadrops must be used every day for the medicine to be effective. If you stop
using Cystadrops, the accumulation of cystine crystals in the eye (cornea) may increase and
cause increased sensitivity to light (photophobia), corneal degeneration (keratopathy)
and loss of vision. Talk to your doctor before stopping treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You can continue to use it normally unless the side effects are severe. If you have any doubts, ask your
doctor or pharmacist. Do not stop treatment with Cystadrops without first talking to your doctor.
The following side effects have been reported:

Very common side effects(may affect more than 1 in 10 people)

• eye pain
• redness of the eye, eye itching, eye irritation (burning)
• watery eyes
• blurred vision
• discomfort at the site of instillation (mainly stuck eyelids and stuck eyelashes), medicine deposition on the eyelashes and in the periocular area

Common side effects(may affect up to 1 in 10 people)

• abnormal sensation in the eyes, feeling of a foreign body in the eye
• dry eyes
• eyelid swelling
• eyelid irritation
• vision impairment
• pain at the site of instillation
• chalazion

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also
report side effects directly through the national reporting system detailed in Appendix V. By reporting side
effects you can help provide more information on the safety of this medicine.

5. How to store Cystadrops

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label of the vial and on the
pack after Exp.
Before opening:

• Store in a refrigerator (2°C - 8°C).
• Keep the vial in the outer packaging to protect it from light.

After first opening:

• Write the date of opening of the vial in the designated space on the pack.
• Cystadrops can be used for up to 7 days from the date of opening.
• Keep the dropper bottle tightly closed in the outer packaging to protect it from light.
• Store at a temperature below 25°C.
• Do not refrigerate.
• The dropper bottle must be discarded 7 days after first opening even ifit is not empty.Use a new bottle.

Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Cystadrops contains

• The active ingredient is cysteamine (mercaptamine) as hydrochloride. Each mL of solution contains 3.8 mg of cysteamine.
• The other ingredients are: benzalkonium chloride (see section 2 "Cystadrops contains benzalkonium chloride"), disodium edetate, sodium carboxymethylcellulose, citric acid monohydrate, sodium hydroxide, hydrochloric acid and water for injections.

Description of the appearance of Cystadrops and contents of the pack
Cystadrops is a transparent and viscous solution.
Each pack contains:

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

Cystadrops is available in a pack containing 1 box or in a multipack containing 4 boxes.
Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder
Recordati Rare Diseases
Tour Hekla
52, Avenue du Général de Gaulle
92800 Puteaux
France

Manufacturer
Recordati Rare Diseases
Tour Hekla
52, Avenue du Général de Gaulle
92800 Puteaux
France
or
Recordati Rare Diseases
Eco River Parc
30, rue des Peupliers
F-92000 Nanterre
France
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

Belgique/België/BelgienLietuva
Recordati
Tél/Tel: +32 2 46101 36
Recordati AB.
Tel: + 46 8 545 80 230
Švedija

България
Recordati Rare Diseases
Tél: +33 (0)1 47 73 64 58
France

Luxembourg/Luxemburg
Recordati
Tél/Tel: +32 2 46101 36
Belgique/Belgien

Česká republika
Recordati Rare Diseases
Tél: +33 (0)1 47 73 64 58
France

Magyarország
Recordati Rare Diseases
Tél: +33 (0)1 47 73 64 58
France

Danmark
Recordati AB.
Tlf: +46 8 545 80 230
Sverige

Malta
Recordati Rare Diseases
Tel: +33 1 47 73 64 58
France

Deutschland
Recordati Rare Diseases Germany GmbH
Tel: +49 731 140 554 0

Nederland
Recordati
Tel: +32 2 46101 36
België

Eesti
Recordati AB.
Tel: + 46 8 545 80 230
Rootsi

Norge
Recordati AB.
Tlf: +46 8 545 80 230
Sverige

Ελλάδα
Recordati Rare Diseases
Τηλ: +33 1 47 73 64 58
Γαλλία

Österreich
Recordati Rare Diseases Germany GmbH
Tel: +49 731 140 554 0
Deutschland

España
Recordati Rare Diseases Spain S.L.U.
Tel: + 34 91 659 28 90

Polska
Recordati Rare Diseases
Tél: +33 (0)1 47 73 64 58
France

France
Recordati Rare Diseases
Tél: +33 (0)1 47 73 64 58

Portugal
Recordati Rare Diseases SARL
Tel: +351 21 432 95 00

Hrvatska
Recordati Rare Diseases
Tél: +33 (0)1 47 73 64 58
France

România
Recordati Rare Diseases
Tél: +33 (0)1 47 73 64 58
France

Ireland
Recordati Rare Diseases
Tel: +33 (0)1 47 73 64 58
France

Slovenija
Recordati Rare Diseases
Tél: +33 (0)1 47 73 64 58
France

Ísland
Recordati AB.
Simi:+46 8 545 80 230
Svíþjóð

Slovenská republika
Recordati Rare Diseases
Tél: +33 (0)1 47 73 64 58
France

Italia
Recordati Rare Diseases Italy Srl
Tel: +39 02 487 87 173

Suomi/Finland
Recordati AB.
Puh/Tel: +46 8 545 80 230
Sverige

Κύπρος
Recordati Rare Diseases
Τηλ: +33 1 47 73 64 58
Γαλλία

Sverige
Recordati AB.
Tel: +46 8 545 80 230

Latvija
Recordati AB.
Tel: + 46 8 545 80 230
Zviedrija

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines
Agency: https://www.ema.europa.eu. Furthermore, links to other websites on rare diseases
and related therapeutic treatments are provided.