Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Bimatoprost
Allergan Ltd
S01EE03
Bimatoprost
300microgram/1ml
Eye drops
Ocular
No Controlled Drug Status
Valid as a prescribable product
BNF: ; GTIN: 5016007204223
1 PACKAGE LEAFLET: INFORMATION FOR THE USER LUMIGAN 0.3 MG/ML, EYE DROPS, SOLUTION, 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 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 0.3 mg/mL single-dose is and what it is used for 2. What you need to know before you use LUMIGAN 0.3 mg/mL single-dose 3. How to use LUMIGAN 0.3 mg/mL single-dose 4. Possible side effects 5. How to store LUMIGAN 0.3 mg/mL single-dose 6. Contents of the pack and other information 1. WHAT LUMIGAN 0.3 MG/ML SINGLE-DOSE IS AND WHAT IT IS USED FOR LUMIGAN 0.3 mg/mL single-dose is an antiglaucoma preparation. It belongs to a group of medicines called prostamides. LUMIGAN 0.3 mg/mL single-dose 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. This medicine does not contain a preservative. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE LUMIGAN 0.3 MG/ML SINGLE-DOSE DO NOT USE THIS MEDICINE: - If you are allergic to bimatoprost or any of the other ingredients of Read the complete document
OBJECT 1 LUMIGAN 0.3 MG/ML EYE DROPS, SOLUTION, IN SINGLE-DOSE CONTAINER Summary of Product Characteristics Updated 07-Apr-2016 | Allergan Ltd 1. Name of the medicinal product LUMIGAN 0.3 mg/mL eye drops, solution, in single-dose container 2. Qualitative and quantitative composition One ml of solution contains 0.3 mg bimatoprost. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Eye drops, solution, in single-dose container. 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. For single use only, one container is sufficient to treat both eyes. Any unused solution should be discarded immediately after use. _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 (multi-dose formulation), 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. 4.4 Special warnings and precautions for use Ocular Before treatment is initiated, pati Read the complete document