Cystadrops

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



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1. NAME OF THE MEDICINAL PRODUCT 
 
Cystadrops 3.8 mg/mL eye drops solution 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each mL contains mercaptamine hydrochloride equivalent to 3.8 mg mercaptamine (cysteamine). 
 
Excipient with known effect:  
Each mL of eye drops solution contains 0.1 mg of benzalkonium chloride. 
 
For the full list of excipients, see section 6.1. 
 
  
3. PHARMACEUTICAL FORM 
 
Eye drops solution. 
 
Viscous, clear solution. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Cystadrops is indicated for the treatment of corneal cystine crystal deposits in adults and children from 
2 years of age with cystinosis. 
 
4.2 Posology and method of administration 
 
Treatment with Cystadrops should be initiated under the supervision of a physician experienced in the 
management of cystinosis. 
 
Posology 
 
The recommended dose is one drop in each eye, 4 times a day during waking hours. The 
recommended interval between each instillation is 4 hours. The dose could be decreased progressively 
(to a minimum total daily dose of 1 drop in each eye) depending on the results of ophthalmic 
examination (such as, corneal cystine crystal deposits, photophobia). 
If the patient misses an instillation, the patient should be told to continue the treatment with the next 
instillation. 
The dose should not exceed 4 drops a day in each eye.  
The accumulation of corneal cystine crystals increases if Cystadrops is discontinued. The treatment 
should not be stopped. 
 
Paediatric population 
Cystadrops may be used in paediatric patients from 2 years of age at the same dose as in adults (see 
section 5.1).  
The safety and efficacy of Cystadrops in children aged less than 2 years has not been established. No 
data are available. 
 
Method of administration  
 
For ocular use. 
 



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Before the first admnistration, in order to facilitate the administration, the patient should be told to 
bring back Cystadrops at room temperature. After first opening, the patient should be told to keep the 
dropper bottle at room temperature. 
 
To avoid sticky eyes in the morning, the patient should be advised to apply the last drop of the day at 
least 30 minutes before going to bed. 
 
To prevent contamination of the dropper tip and solution, care must be taken not to touch the eyelids, 
surrounding areas, or other surfaces with the dropper tip of the dropper bottle. 
 
The patient should be told to discard the dropper bottle after 7 days of use. 
 
In case of concomitant therapy with other topical ocular medicinal products, an interval of ten minutes 
should be allowed between successive applications. Eye ointments should be administered last. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
4.4 Special warnings and precautions for use 
 
Cystadrops contains benzalkonium chloride which may cause eye irritation. 
 
Benzalkonium chloride, which is commonly used as a preservative in ophtalmic products, has also 
been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy. Monitoring is 
required. 
 
Contact lenses 
Benzalkonium chloride is known to discolour soft contact lenses. Contact with soft contact lenses 
should be avoided. Patients should be instructed to remove contact lenses prior to the administration of 
the eye drops and wait at least 15 minutes before re-inserting contact lenses. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
No interaction studies have been performed. 
 
Since the recommended total daily dose of cysteamine base is no more than approximately 0.4% of the 
highest recommended oral dose of cysteamine base in any age group, no interactions with orally 
administered medicinal products are anticipated. 
 
4.6 Fertility, pregnancy and lactation 
 
The recommended total daily ocular dose of cysteamine is no more than approximately 0.4% of the 
highest recommended dose of oral cysteamine in any age group. Systemic exposure of cysteamine 
following ocular administration is therefore lower than following oral administration. Although no 
effects during pregnancy and breast-feeding are anticipated, since systemic exposure to cysteamine is 
negligible, precautions should be taken with concomitant treatment with oral cysteamine. 
 
Pregnancy 
There are no adequate data from the use of cysteamine in pregnant women. Studies in animals have 
shown reproductive toxicity, including teratogenesis (see section 5.3). The potential risk for humans is 
unknown. The effect on pregnancy of untreated cystinosis is also unknown.  
Therefore, oral cysteamine should not be used during pregnancy, particularly during the first trimester, 
unless clearly necessary. 
If a pregnancy is diagnosed or planned, the treatment should be carefully reconsidered and the patient 
must be advised of the possible teratogenic risk of cysteamine. 



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Breast-feeding 
Cysteamine excretion in human's milk is unknown. However, due to the results of animal studies in 
breast-feeding mothers and neonates (see section 5.3), women taking oral cysteamine should not 
breast-feed. 
 
Fertility 
No data on the effect of cysteamine on human fertility are available. Studies in animals have shown a 
reduction on fertility (see section 5.3). 
 
4.7 Effects on ability to drive and use machines 
 
Cystadrops may have a minor influence on the ability to drive and use machines. 
Temporary (in average less than 1 minute) blurred vision or other visual disturbances may affect the 
ability to drive or use machines. 
If blurred vision occurs at instillation, the patient must wait until the vision clears before driving or 
using machines. 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
The most common adverse reactions are eye pain, ocular hyperaemia, eye pruritus, lacrimation 
increased, blurred vision or eye irritation. The majority of these adverse reactions are transient and 
most are mild or moderate. 
 
Tabulated list of adverse reactions 
The following adverse reactions were reported during clinical trials and the French NPU programme 
with Cystadrops. Reported adverse reactions are listed below, by system organ class and by frequency 
(by patient).  
Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10),  uncommon 
(≥ 1/1,000 to < 1/100), rare (≥ 1/10,000  to < 1/1,000), very rare (< 1/10,000), not known (cannot be 
estimated from the available data).  
 

 
Paediatric population 
Frequency, type and severity of adverse reactions in children are the same as in adults. 
69 paediatric patients were followed through clinical trials and the French NPU programme. 19 
patients were under 6 years old, 21 between 6 and 12 years old and 29 between 12 and 18 years old. 
 
Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 

System organ class Adverse reactions 

Eye disorders Very common : eye pain, vision blurred, eye irritation, ocular hyperaemia, eye pruritus, lacrimation increased, deposit eye 

 

Common : abnormal sensation in eye, dry eye, foreign body 
sensation in eye, eyelid oedema, eyelid irritation, visual 
impairment, hordeolum 
 

General disorders and administration 
site conditions 

Very common : instillation site discomfort (mainly sticky eyes 
and sticky eyelashes) 

 Common : instillation site pain  

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


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4.9 Overdose 
 
Overdose is unlikely to occur with ocular administration.  
 
In case of accidental ingestion, monitoring and symptomatic management of the patient should be 
implemented.  
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Ophtalmologicals, other ophtalmologicals, ATC code: S01XA21.   
 
Mechanism of action 
Cysteamine reduces corneal cystine crystal accumulation acting as a cystine-depleting agent by 
converting cystine to cysteine and cysteine-cysteamine mixed disulfides. 
 
Clinical efficacy and safety 
Two clinical trials were performed with Cystadrops: a single arm clinical trial on 8 children and adults 
(OCT-1 study) and a randomised, multi-centre, open label, active controlled phase III clinical trial 
(CHOC study) conducted on 32 patients. 
 
OCT-1 study 
This study assessed the safety and efficacy of Cystadrops during 5 years. Dose adaptation was 
performed following ocular examination. None of the patients discontinued treatment over the 5 year 
follow-up.  
The efficacy was assessed with In-Vivo Confocal Microscopy total score (IVCM score) by 
quantifying the cystine crystals in the 7 layers of the cornea. After 30 days of treatment and at a 
median frequency of 4 instillations per day, an average 30% decrease in the IVCM total score was 
observed. A mean decrease in corneal cystine crystal deposits of 30%, in comparison with baseline, 
was maintained over time with a median dosing regimen of 3 drops/eye/day (range 1-3 drops) for 7 of 
the 8 patients. Photophobia tended to improve over time. 
 
CHOC study 
This study was a randomised, controlled trial to assess the efficacy and the safety profile of 
Cystadrops following a period of 90 days of treatment at a dose regimen of 4 drops/eye/day. The 
IVCM total score was the primary efficacy endpoint. 15 patients were exposed to Cystadrops. The 
mean IVCM total score was calculated for 11 patients. A trend towards a lower IVCM total score in 
Cystadrops arm was observed at day 30. The mean decrease by 40% in the Cystadrops arm was 
confirmed at day 90. Superiority of Cystadrops was demonstrated compared to the control arm 
(cysteamine hydrochloride 0.10%) p<0.001 95% CI (2.11; 5.58). Superiority of Cystadrops was also 
demonstrated for photophobia rated by the investigator compared to the control arm (cysteamine 
hydrochloride 0.10%) p< 0.048 95% CI (0.23; 1.14). 
 
Paediatric population 
Clinical data on safety and efficacy were collected during the 2 clinical trials (OCT-1 and CHOC 
studies). In total 15 paediatric patients were exposed to Cystadrops whereof 3 subjects (including one 
2 year and one 3 year old subject) being less than 6 years of age. The efficacy and safety results are 
similar in both paediatric and adult populations. 
 
The European Medicines Agency has deferred the obligation to submit the results of studies with 
Cystadrops in one or more subsets of the paediatric population in the treatment of corneal cystine 
crystal deposits in cystinosis patients (see section 4.2 for information on paediatric use). 
 



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5.2 Pharmacokinetic properties 
 
Human pharmacokinetic assessment following ocular administration of Cystadrops was not 
performed.  
 
Similarly to other topically administered ocular products, systemic absorption is likely to occur.  
However it should be considered that the recommended daily dose of cysteamine applied as eye drops 
is no more than approximately 0.4% of the highest recommended daily oral dose of cysteamine in any 
age group.  
 
5.3 Preclinical safety data 
 
Systemic exposure following ocular administration is anticipated to be low. When there is concomitant 
use of ocular and oral treatment with cysteamine the contribution to any systemic risk from ocular 
administration is considered negligible. 
 
Preclinical data on oral cysteamine: 
Genotoxicity studies have been performed: induction of chromosome aberrations in cultured 
eukaryotic cell lines has been reported and specific studies with cysteamine did not show any 
mutagenic effects in the Ames test or any clastogenic effect in the mouse micronucleus test. 
 
Reproduction studies showed embryofoetotoxic effects (resorptions and post-implantation losses) in 
rats at the 100 mg/kg/day dose level and in rabbits receiving cysteamine 50 mg/kg/day. Teratogenic 
effects have been described in rats when cysteamine is administered over the period of organogenesis 
at a dose of 100 mg/kg/day.  
This is equivalent to 0.6 g/m2/day in the rat, which is less than half the recommended clinical 
maintenance dose of cysteamine, i.e. 1.30 g/m2/day. A reduction of fertility was observed in rats at 
375 mg/kg/day, a dose at which body weight gain was retarded. At this dose, weight gain and survival 
of the offspring during lactation was also reduced. High doses of cysteamine impair the ability of 
lactating mothers to feed their pups. Single doses of the drug inhibit prolactin secretion in animals.  
 
Administration of cysteamine in neonate rats induced cataracts. 
 
High doses of cysteamine, either by oral or parenteral routes, produce duodenal ulcers in rats and mice 
but not in monkeys.  Experimental administration of the drug causes depletion of somatostatin in 
several animal species. The consequence of this for the clinical use of the drug is unknown.  
 
No carcinogenic studies have been conducted with cysteamine. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Benzalkonium chloride 
Disodium edetate 
Carmellose sodium 
Citric acid monohydrate 
Sodium hydroxide (for pH adjustment) 
Hydrochloric acid (for pH adjustment) 
Water for injections 
 
6.2 Incompatibilities 
 



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In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal 
products. 
 
6.3 Shelf life 
 
6 months 
 
After first opening: 7 days. Store below 25°C. Do not refrigerate. Keep the dropper bottle tightly 
closed in the outer carton in order to protect from light. 
 
6.4 Special precautions for storage 
 
Before first opening:  
Store in a refrigerator (2°C - 8°C). 
Keep the vial in the outer carton in order to protect from light. 
 
For storage conditions after first opening of the medicinal product, see section 6.3. 
 
6.5 Nature and contents of container 
 
5 mL solution in a 10 mL amber glass vial closed by a bromobutyl stopper and sealed with an 
aluminium tear-off cap. A PVC dropper applicator with HDPE closure is packed separately and 
included in each carton box.  
 
Each carton box contains 1 vial and 1 dropper applicator. 
 
6.6 Special precautions for disposal and other handling 
 
The patient should be advised to follow the instructions below for opening of the vial and attachement 
of the dropper applicator: 
 

• Wash your hands carefully in order to avoid microbiological contamination 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, 
attach it (picture 4) to the vial and do not remove it. 

 

remove 
remove 

remove 

metal seal 

vial 

green protective cap grey 
stopper 



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

 
 
7. MARKETING AUTHORISATION HOLDER 
 
Recordati Rare Diseases 
Immeuble “Le Wilson”  
70, Avenue du Général de Gaulle 
92800 Puteaux 
France 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1049/001 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 19 January 2017 
 
10. DATE OF REVISION OF THE TEXT 
 
 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 
  

vial 

vial 

dropper 

dropper 

small white cap turn and push 
to attach 

small white cap 

http://www.ema.europa.eu/


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ANNEX II 

 

A.            MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE  

B.            CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

 
C.            OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
D.            CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 

 



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A.         MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 

Name and address of the manufacturer(s) responsible for batch release 

Recordati Rare Diseases 
Immeuble "Le Wilson" 
70, avenue du Général de Gaulle 
FR-92800 Puteaux 
France 
 
Recordati Rare Diseases 
Eco River Parc 
30, rue des Peupliers  
F-92000 Nanterre 
France 
 
The printed package leaflet of the medicinal product must state the name and address of the 
manufacturer responsible for the release of the concerned batch. 

B.         CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product 
Characteristics, section 4.2). 

 

C.            OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
AUTHORISATION  

• Periodic safety update reports  
The requirements for submission of periodic safety update reports for this medicinal product are set 
out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 
2001/83/EC and any subsequent updates published on the European medicines web-portal. 

The marketing authorisation holder shall submit the first periodic safety update report for this 
product within 6 months following authorisation.  

D.            CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 
EFFECTIVE USE OF THE MEDICINAL PRODUCT 

                               

• Risk Management Plan (RMP) 
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the 
agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent 
updates of the RMP. 

An updated RMP should be submitted: 

• At the request of the European Medicines Agency; 

• Whenever the risk management system is modified, especially as the result of new 
information being received that may lead to a significant change to the benefit/risk profile or 
as the result of an important (pharmacovigilance or risk minimisation) milestone being 
reached.   



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ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
  



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A. LABELLING 
  



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PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON BOX 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Cystadrops 3.8 mg/mL eye drops solution 
cysteamine  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each mL contains 3.8 mg of cysteamine (mercaptamine), as hydrochloride. 
 
 
3. LIST OF EXCIPIENTS 
 
Benzalkonium chloride (see leaflet for further information), disodium edetate, carmellose sodium, 
citric acid monohydrate, sodium hydroxide, hydrochloric acid, water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Eye drops solution 
 
1 vial of 5 mL 
 
 
5. METHOD AND ROUTE OF ADMINISTRATION 
 
Read the package leaflet before use. 
Ocular use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
 
8. EXPIRY DATE 
 
EXP 
 
Discard 7 days after first opening. 
Opened on: 
 



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9. SPECIAL STORAGE CONDITIONS 
 
Before first opening: store in a refrigerator. Keep the vial in the outer carton in order to protect from 
light. 
After first opening: keep the dropper bottle tightly closed in the outer carton in order to protect from 
light. Store below 25°C. Do not refrigerate. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Recordati Rare Diseases 
Immeuble “Le Wilson”  
70 Avenue du Général de Gaulle 
92800 Puteaux 
France  
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1049/001 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Cystadrops 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:   



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MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
VIAL LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION 
 
Cystadrops 3.8 mg/mL eye drops solution 
cysteamine  
Ocular use. 
 
 
2. METHOD OF ADMINISTRATION 
 
 
 
3. EXPIRY DATE 
 
EXP 
 
Discard 7 days after first opening. 
 
 
4. BATCH NUMBER 
 
Batch 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
5 mL 
 
 
6. OTHER 
 
 
  



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B. PACKAGE LEAFLET 



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Package leaflet: Information for the patient 
 

Cystadrops 3.8 mg/mL eye drops solution 
cysteamine (mercaptamine) 

 
 
Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
- 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. 
 
 
What is in 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 eye drops solution that contains the active substance cysteamine (also known as 
mercaptamine). 
 
What it is used for 
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. 
 
What is 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 . 
 
 
2. What you need to know before you use 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 using, have recently used or might use any other medicines. 
 
Pregnancy and breast-feeding 
Even if the level of Cystadrops in the blood is negligible, precautions should be taken. 



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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 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. 
 
Cystadrops contains benzalkonium chloride 
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. 
 
 
 
3. How to use Cystadrops 
 
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure. 
 
Recommended dose 
• 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’ 
 
Step 1: Before using a vial for the first time 

• 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. 

 
 

 
 

remove 
remove 

remove 

http://www.cystadrops.net/


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• 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. 
 

Step 2: Before using the eye drops 
• 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. 

 
Step 3: Using the eye drops 

• 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. 

metal seal 

vial 

green protective cap grey 
stopper 

vial 

vial 

dropper 

dropper 

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• 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. 

 

 
                                                              
 
Step 4: Storing the eye drops 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. 

 
If a drop misses your eye 
Try again.  
 
If you use Cystadrops with another eye medicine 
Ensure that there is at least a 10 minute gap between using Cystadrops and the other eye medicine. 
Administer eye ointments last. 
 
If you wear soft contact lenses 
Do not use the drops with your lenses in. After using the drops wait 15 minutes before putting your 
lenses back in. 
 
If you use more Cystadrops than you should 
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. 
 
If you forget to use Cystadrops 
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. 
 
If you stop using Cystadrops 
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 sensitity to light 



21 

(photophobia), corneal deterioration (keratopathy) and loss of vision. Therefore talk to your doctor 
before stopping this 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 usually carry on taking the drops, unless the effects are serious. If you are worried, talk to 
your doctor or pharmacist. Do not stop using Cystadrops without speaking to your doctor. 
 
The following side effects were reported: 
 
Very common side effects (may affect more than 1 in 10 people) 

• eye pain 
• eye redness, eye itching, eye irritation (burning) 
• watery eyes 
• blurred vision 
• discomfort where the drops have been instilled (mainly sticky eyes and sticky eyelashes), 

medicine deposit on the eyelashes, around the eyes 
 
Common side effects (may affect up to 1 in 10 people) 

• abnormal sensation in eye, a feeling of something in the eye 
• dry eyes  
• swollen eyelid 
• irritation of eyelid 
• visual impairement 
• pain where the drops have been instilled 
• stye 

 
Reporting of side effects 
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 
listed 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 vial label and the carton after 
EXP.The expiry date refers to the last day of that month. 
 
Before opening:  

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

 
After first opening: 

• Write down the date you opened the vial in the space on the carton. 
• Cystadrops can be used for up to 7 days from the time of opening. 
• Keep the dropper bottle tightly closed in the outer carton in order to protect from light. 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


22 

• Store below 25°C. 
• Do not refrigerate. 
• You must throw away the dropper bottle 7 days after you first opened it even if it is not 

empty. Use a new vial.  
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Cystadrops contains  
- 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. 

 
What Cystadrops looks like and contents of the pack 
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. 

 
 
Marketing Authorisation Holder 
 
Recordati Rare Diseases 
Immeuble “Le Wilson”  
70 Avenue du Général de Gaulle 
92800 Puteaux  
France 
 
Manufacturer 
 
Recordati Rare Diseases 
Immeuble “Le Wilson”  
70 Avenue du Général de Gaulle 
92800 Puteaux  
France 
 
or 
 
Recordati Rare Diseases 
Eco River Parc 
30, rue des Peupliers  
F-92000 Nanterre 
France 
 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
Belgique/België/Belgien 
Recordati 
Tél/Tel: +32 2 46101 36 

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



23 

Švedija 
 

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

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

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

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

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

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

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 
Francja  
 

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

Portugal 
Jaba Recordati S.A. 
Tel: +351 21 432 95 00 
 

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

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

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 
Francija  
 

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

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



24 

 
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 

United Kingdom 
Recordati Rare Diseases UK Ltd. 
Tel: +44 (0)1491 414333 

 
 
 
This leaflet was last revised in  
  
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. There are also links to other websites about rare diseases and treatments. 
 
 

http://www.ema.europa.eu/

	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET