Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
mercaptamine hydrochloride
Recordati Rare Diseases
S01XA21
mercaptamine
Ophthalmologicals
Cystinosis
Cystadrops is indicated for the treatment of corneal cystine crystal deposits in adults and children from 2 years of age with cystinosis.
Revision: 8
Authorised
2017-01-18
21 B. PACKAGE LEAFLET 22 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 BREAS Aqra d-dokument sħiħ
_ _ 1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 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. 3 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. T Aqra d-dokument sħiħ