Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
Bimatoprost
Laboratoires Thea
S01EE03
Bimatoprost
Eye gel in single-dose container
bimatoprost
Not marketed
2023-06-23
1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ELYMBUS 0.1 MG/G EYE GEL IN SINGLE-DOSE CONTAINER _ _ bimatoprost 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 Elymbus is and what it is used for 2. What you need to know before you use Elymbus 3. How to use Elymbus 4. Possible side effects 5. How to store Elymbus 6. Contents of the pack and other information 1. WHAT ELYMBUS IS AND WHAT IT IS USED FOR Elymbus is an antiglaucoma preparation. It belongs to a group of medicines called prostamides. Elymbus eye gel is used to reduce high pressure in the eye in adults. This medicine may be used on its own or with other drops called beta-blockers which also reduce pressure. Your eye contains a clear, watery liquid that feeds the inside of the eye. Liquid is constantly being drained out of the eye and new liquid is made to replace this. If the liquid cannot drain out quickly enough, the pressure inside the eye builds up. This medicine works by increasing the amount of liquid that is drained. This reduces the pressure inside the eye. If the high pressure is not reduced, it could lead to a disease called glaucoma and eventually damage your sight. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ELYMBUS DO NOT USE ELYMBUS - if you are allergic to bimatoprost or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Elymbus. Talk to your doctor, if: - You have any breathing problems - You have liver or kidney proble Прочетете целия документ
Health Products Regulatory Authority 23 June 2023 CRN00CTJL Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Elymbus 0.1 mg/g eye gel in single-dose container 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One g of eye gel contains 0.1 mg bimatoprost. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye gel. Colourless opalescent gel. pH: 6.9 – 7.9. Osmolality: 250 – 350 mosmol/kg. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Reduction of elevated intraocular pressure in chronic open-angle glaucoma and ocular hypertension in adults (as monotherapy or as adjunctive therapy to beta-blockers). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is one drop in the affected eye(s) once daily, administered in the evening. The dose should not exceed once daily, as more frequent administration may lessen the intraocular pressure lowering effect. _SPECIAL POPULATIONS_ _Patients with hepatic impairment_ Elymbus has not been studied in patients with moderate to severe hepatic impairment and should therefore be used with caution in such patients. In patients with a history of mild liver disease or abnormal alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin at baseline, bimatoprost 0.3 mg/ml eye drops, solution (preserved formulation) had no adverse effect on liver function over 24 months. _Patients with renal impairment_ Elymbus has not been studied in patients with renal impairment and should therefore be used with caution in such patients. _Paediatric population_ The safety and efficacy of Elymbus in children aged 0 to 18 years has not yet been established. _ _ Method of administration Ocular use. The use of bimatoprost in contact lens wearers has not been studied. Therefore, contact lenses should be removed before instillation of the eye gel and may be reinserted after 15 minutes. If more than one topical ophthalmic medicinal product is being used, they should be administered at least 15 minutes before Elymbus. El Прочетете целия документ