Cystadrops · 4.1 Therapeutic indications · 1

HOS-216719 · has-adverse-reaction-information · PDF-Seite 4

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). System organ class Adverse reactions Very common : eye pain, vision blurred, eye irritation, ocular Eye disorders 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 Very common : instillation site discomfort (mainly sticky eyes site conditions and sticky eyelashes) Common : instillation site pain Paediatric population Frequency, type and severity of adverse reactions in children are the same as in adults. 74 paediatric patients were followed through clinical trials and the French NPU programme. 5 patients were below 2 years old , the youngest was 13 months old, 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 4 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.

HOS-216715 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-216714 · has-indication-information · PDF-Seite 2

Cystadrops is indicated for the treatment of corneal cystine crystal deposits in adults and children from 6 months of age with cystinosis.

HOS-216717 · has-interaction-information · PDF-Seite 3

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.

HOS-216718 · has-pregnancy-information · PDF-Seite 3

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. 3 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. 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).

HOS-216716 · has-warning-information · PDF-Seite 3

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. Excipents with known effect 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.