3.8 mg/ml eye drops, solution 
Cysteamine (mercaptamine)

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It may harm them, even if they show symptoms similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

This leaflet contains information about: 
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 packaging and other information 

1. What Cystadrops is and what it is used for

What Cystadrops is

Cystadrops are eye drops that contain the active substance cysteamine (also called mercaptamine).

What it is used for

It is used to reduce the number of cystine crystals on the surface of the eye (cornea) in adults and children over 2 years who have cystinosis.

What is cystinosis

Cystinosis is an unusual, inherited disease in which the body cannot break down excess cystine (an amino acid ), which leads to accumulations of cystine crystals in various organs (such as kidneys and eyes). Accumulations of crystals in the eye can lead to increased photosensitivity ( photophobia ), damage to the cornea ( keratopathy ), and impaired vision.

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 cautions

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

Although the level of Cystadrops in your blood is negligible, you should be careful.

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.

Driving and using machines

You may experience blurred vision for a few minutes after using Cystadrops. Do not drive or use machines until you see clearly again.

Cystadrops contain benzalkonium chloride

This medicine contains 5 micrograms of benzalkonium chloride per drop, equivalent to 0.1 mg/ml.

Benzalkonium chloride can be absorbed by soft contact lenses and can discolor the contact lenses. Remove contact lenses before using the medicine and wait at least 15 minutes before re-inserting the contact lenses.

Benzalkonium chloride can be irritating to the eyes, especially if you have dry eyes or problems with the cornea (the clear membrane at the front of the eye). If you experience irritation, tingling, or pain in the eye after using the medicine, consult a doctor.

3. How to use Cystadrops

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Recommended dose

  • The recommended dose is 1 drop in each eye, 4 times a day.
  • The recommended interval between dosing sessions is 4 hours (for example, you can take the eye drops at 8.00, 12.00, 16.00, and 20.00).
  • It is recommended that you take the last drop of the day at least 30 minutes before bedtime to avoid sticky eyes in the morning.
  • Dose one can be reduced gradually (to a minimum daily dose of 1 drop in each eye) by your doctor, depending on the results of the eye examination.

Use only eye drops ( ocular use).

Step 1: Before using the bottle for the first time

  • Cystadrops must be allowed to reach room temperature before the first dose. This makes it easier to give the drops.
  • Before using the eye drops for the first time, write the date of opening in the field on the carton.
  • Wash your hands thoroughly to avoid contaminating the contents of the bottle with bacteria.
  • Remove the green protective cover (Fig. 1).
  • Remove the metal seal (Fig. 2).
  • Remove the gray stopper (Fig. 3) from the bottle.
  • Do not touch the opening of the bottle after removing the gray stopper.
Figures 1,2 and 3
  • Remove the drip tip from the package without touching the end to be attached to the bottle and attach the drip tip (Fig. 4) to the bottle. Do not remove the drip tip from the bottle.
Figures 4 and 5
  • Be careful not to loosen the small white sleeve (Fig. 5) located on top of the drip tip.

Step 2: Before using the eye drops

  • Check the opening date you entered on the carton. Cystadrops can be used for up to 7 days after opening.
  • Get the drip bottle and a mirror.
  • Wash your hands.

Step 3: Use the eye drops

  • Hold the drip bottle between your thumb and fingers with the tip facing down. Move the drip bottle up and down to get the drops in the drip tip.
  • Unscrew the small white sleeve from the drip tip.
  • Tilt your head back. Pull the eyelid down with a cleaned finger so that a “pocket” is formed between the eyelid and the eye. The drop should be placed there (picture 6).
Figure 6
  • Place the tip of the dropper bottle close to the eye. Use the mirror if it facilitates.
  • Do not touch the eye, eyelid, area around the eye, or other surfaces with the drip tip. It can infect the drops.
  • Gently press the drop tip to obtain one drop of Cystadrops at a time. Be especially careful not to touch the tip of the drip tip with your fingers.
  • After using Cystadrops, place a finger in the corner of the eye near the nose (Fig. 7) and gently massage the upper eyelid to spread the eye drops over the eye.
Picture 7
  • Remove excess medicine around the eyes with a damp napkin (Fig. 8), to avoid possible irritation.
  • Repeat step 3 for the other eye.
  • Put the small white sleeve back on the drip tip immediately after use.
Picture 8

Step 4: Store the eye drops after use

  • Place the dropper bottle in the carton.
  • Store Cystadrops at room temperature (this facilitates the use of the drip tip).
  • Discard 7 days after opening.

If a drop comes out of the eye

Please try again.

If you are taking Cystadrops with other eye medicines

Be sure to wait at least 10 minutes between using Cystadrops and other eye medicines. Use eye ointment last.

If you wear soft contact lenses

Do not use the drops when you have contact lenses in. After using the drops, wait 15 minutes before putting the lenses back in.

If you use more Cystadrops then you should  

If you use too many drops in the eyes, rinse your eyes, preferably with saline solution (otherwise with warm water). Do not drip in more drops until it is time for your next dose.

If you forget to use Cystadrops

Wait until it is time for the next supply and continue according to the set intervals. Do not take a double dose to make up for forgotten use.

If you stop using Cystadrops

Cystadrops must be used every day for the drug to work properly. If you stop using Cystadrops, the accumulation of cystine crystals in the eye (cornea) may increase and lead to photosensitivity ( photophobia ), damage to the cornea ( keratopathy ), and impaired vision. Therefore, talk to your doctor before stopping treatment.

If you have any further questions on the use of this product, 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 usually continue to use the drops unless the side effects are severe. If you are worried, talk to your doctor or pharmacist. Do not stop using Cystadrops without talking to your doctor.

The following side effects have been reported:

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

  • eye pain
  • red eyes, itchy eyes, irritated eyes (burning sensation)
  • watery eyes
  • Tamsyn
  • discomfort where the drops have been used (mainly sticky eyes and sticky eyelashes ), drug accumulation on the eyelashes, around the eyes

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

  • abnormal feeling in the eye, feeling that there is something in the eye
  • dry eyes
  • swollen eyelids
  • irritated eyelids
  • visual impairment
  • pain where the drops have been used
  • sty

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 bottle label and carton after EXP. The expiration date is the last day of the specified month.

Unopened packaging:

  • Store in a refrigerator (2 ° C – 8 ° C)
  • Store the bottle in the outer carton. Sensitive to light.

Opened packaging:

  • Write the date when you open the bottle in the field on the box.
  • Cystadrops can be used for up to 7 days after opening.
  • Close the dropper bottle tightly and store it in the outer carton. Sensitive to light.
  • Do not store above 25 ° C.
  • Store in a cold place.
  • You must discard the dropper bottle 7 days after opening, even if it is not empty. Use a new bottle.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is cysteamine (mercaptamine), as hydrochloride. One ml of eye drops contains 3.8 mg of cysteamine.
  • The other ingredients are benzalkonium chloride (see section 2 for more information on “Cystadrops contains benzalkonium chloride”), disodium edetate, caramel sodium, citric acid monohydrate, sodium hydroxide, hydrochloric acid, and water for injections.

What the medicine looks like and the contents of the pack

Cystadrops is a clear and viscous eye drop solution.

Each package contains:

  • 1 amber glass bottle containing 5 ml eye drops.
  • 1 drip tip for application.

Cystadrops is available in packs of 1 carton or a multi-pack of 4 cartons.

Not all pack sizes may be marketed in your country.

Marketing Authorization Holder and Manufacturer

Record Rare Diseases

Real Estate “Le Wilson”

70 Avenue du Général de Gaulle

92800 Puteaux

France

Manufacturer

Record Rare Diseases

Real Estate “Le Wilson”

70 Avenue du Général de Gaulle

92800 Puteaux

France

or

Record Rare Diseases

Eco River Parc

30, rue des Peupliers

F-92000 Nanterre

France

Contact the representative of the marketing authorization holder to find out more about this medicine.

BulgariaRecord Rare DiseasesTel: +33 (0) 1 47 73 64 58France Luxembourg / LuxemburgRecordatiTel: +32 2 46101 36Belgium / Belgium
Czech RepublicRecord Rare DiseasesTel: +33 (0) 1 47 73 64 58France HungaryRecord Rare DiseasesTel: +33 (0) 1 47 73 64 58Franciaország
GermanyRecordati Rare Diseases Germany GmbHTel: +49 731 140 554 0 The NetherlandsRecordatiTel: +32 2 46101 36Belgium
GreeceRecord Rare Diseases:Ηλ: + 33 1 47 73 64 58.Αλλία AustriaRecordati Rare Diseases Germany GmbHTel: +49 731 140 554 0Germany
SpainRecordati Rare Diseases Spain SLUTel: + 34 91 659 28 90 PolandRecord Rare DiseasesTel: +33 (0) 1 47 73 64 58France
FranceRecord Rare DiseasesTel: + 33 (0) 1 47 73 64 58 PortugalJaba Recordati SATel: +351 21 432 95 00
CroatiaRecord Rare DiseasesTel: +33 (0) 1 47 73 64 58French RomaniaRecord Rare DiseasesTel: + 33 (0) 1 47 73 64 58France
IrelandRecord Rare Diseases+33 (0) 1 47 73 64 58France SloveniaRecord Rare DiseasesTel: +33 (0) 1 47 73 64 58France

Muhammad Nadeem

Leave a Reply