Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
bimatoprost
AbbVie Deutschland GmbH & Co. KG
S01EE03
bimatoprost
Prostaglandin analogues, Ophthalmologicals
Glaucoma, Open-Angle; Ocular Hypertension
Reduction of elevated intraocular pressure in chronic open-angle glaucoma and ocular hypertension (as monotherapy or as adjunctive therapy to beta-blockers).,
Revision: 37
Authorised
2002-03-08
50 B. PACKAGE LEAFLET 51 PACKAGE LEAFLET: INFORMATION FOR THE USER LUMIGAN 0.1 MG/ML, EYE DROPS, SOLUTION 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 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 LUMIGAN 0.1 mg/ml is and what it is used for 2. What you need to know before you use LUMIGAN 0.1 mg/ml 3. How to use LUMIGAN 0.1 mg/ml 4. Possible side effects 5. How to store LUMIGAN 0.1 mg/ml 6. Contents of the pack and other information 1. WHAT LUMIGAN 0.1 MG/ML IS AND WHAT IT IS USED FOR LUMIGAN is an antiglaucoma preparation. It belongs to a group of medicines called prostamides. LUMIGAN eye drops are used to reduce high pressure in the eye. 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 LUMIGAN 0.1 MG/ML DO NOT USE LUMIGAN 0.1 MG/ML: - if you are allergic to bimatoprost or any of the other ingredients of this medicine (listed in section 6). - if you have had to stop using eye drops in the past because of a side effect of the preservative benzalkonium chloride. WAR Lesen Sie das vollständige Dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT LUMIGAN 0.1 mg/ml eye drops, solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml of solution contains 0.1 mg bimatoprost. Excipient with known effect: One ml of solution contains 0.2 mg benzalkonium chloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Eye drops, solution. Colourless solution. 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. _Paediatric population: _ The safety and efficacy of LUMIGAN in children aged 0 to 18 years has not yet been established. Patients with hepatic and renal impairment: LUMIGAN has not been studied in patients with renal or 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 had no adverse effect on liver function over 24 months. Method of administration If more than one topical ophthalmic medicinal product is being used, each one should be administered at least 5 minutes apart. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. LUMIGAN 0.1 mg/ml is contraindicated in patients who have had a suspected previous adverse reaction to benzalkonium chloride that has led to discontinuation. 3 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Ocular Before treatment is initiated, patients should be informed of the possibility of prostaglandi Lesen Sie das vollständige Dokument