Krajina: Spojené kráľovstvo
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Levobunolol hydrochloride
Allergan Ltd
S01ED03
Levobunolol hydrochloride
5mg/1ml
Eye drops
Ocular
No Controlled Drug Status
Valid as a prescribable product
BNF: 11060000; GTIN: 5016007492804
1 PACKAGE LEAFLET: INFORMATION FOR THE USER BETAGAN ® 0.5% W/V EYE DROPS, SOLUTION Levobunolol hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. WHAT BETAGAN IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USE BETAGAN 3. HOW TO USE BETAGAN 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE BETAGAN 6. FURTHER INFORMATION 1. WHAT BETAGAN IS AND WHAT IT IS USED FOR BETAGAN is an eye drop. It is used to treat GLAUCOMA by lowering the pressure that builds up in the eye. Your eyeball contains a watery liquid, which is constantly being drained out of the eye, and new liquid is made to replace this. Glaucoma can occur when the liquid does not drain out quickly enough. This leads to raised pressure within the eyeball which can eventually damage your sight. BETAGAN works by reducing the production of liquid. This reduces the pressure inside the eye. BETAGAN belongs to a group of medicines called beta blockers. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE BETAGAN DO NOT USE BETAGAN IF you are allergic to: LEVOBUNOLOL BENZALKONIUM CHLORIDE any other ingredients (see section 6 “Further information”) 2 you have or have had ASTHMA or other lung diseases (for example severe chronic obstructive pulmonary disease (COPD)) where you have difficulty breathing, wheezing or a chronic cough you have or have had HEART PROBLEMS such as slow heart beat, heart failure or heart beat disorders (irregular heart beat) . BETAGAN IS NOT RECOMMENDED FOR USE IN CHILDREN TAKE SPECIAL CARE WITH BETAGAN Talk to your doctor before using BETAGAN if you suffer from, or have in th Prečítajte si celý dokument
OBJECT 1 BETAGAN Summary of Product Characteristics Updated 09-Jan-2018 | Allergan Ltd 1. Name of the medicinal product Betagan Eye Drops 0.5% w/v 2. Qualitative and quantitative composition One ml solution contains 5.0 mg levobunolol hydrochloride, equivalent to 4.4 mg levobunolol. Excipient(s): Contains benzalkonium chloride 0.04 mg/ml. For a full list of excipients, see section 6.1. 3. Pharmaceutical form Eye Drops, Solution A clear, colourless to light yellow solution. 4. Clinical particulars 4.1 Therapeutic indications Reduction of intraocular pressure in chronic open-angle glaucoma and ocular hypertension. 4.2 Posology and method of administration _Adults (including the elderly) _ The usual dose is one drop instilled in the affected eye(s) once or twice daily. Because of diurnal variations in intraocular pressure, satisfactory response is best determined by measuring the intraocular pressure at different times of the day. _Paediatric Population _ Betagan is not recommended for use in children due to lack of safety and efficacy data. Intraocular pressure should be measured approximately four weeks after starting treatment with Betagan as a return to normal ocular pressure can take a few weeks. Method of administration: topical into the conjunctival sac. When using nasolacrimal occlusion or closing the eyelids for 2 minutes, the systemic absorption is reduced. This may result in a decrease in systemic side effects and an increase in local activity. 4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Reactive airway disease including bronchial asthma (or a history of bronchial asthma) or severe chronic obstructive pulmonary disease. Sinus bradycardia, sick sinus syndrome, sino-atrial block, second and third degree atrioventricular block not controlled with a pace maker; overt cardiac failure or cardiogenic shock. 4.4 Special warnings and precautions for use Like other topically applied ophthalmic agents, levobunolol is absorbed systemically. Due to Prečítajte si celý dokument