Kraj: Wielka Brytania
Język: angielski
Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)
Levobunolol hydrochloride
Waymade Healthcare Plc
S01ED03
Levobunolol hydrochloride
5mg/1ml
Eye drops
Ocular
No Controlled Drug Status
Valid as a prescribable product
BNF: 11060000
PACKAGE LEAFLET: INFORMATION FOR THE USER BETAGAN ® UNIT DOSE 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. The name of your medicine is Betagan Unit Dose 0.5% w/v Eye Drops Solutionl, but will be referred to as Betagan throughout the remainder of the leaflet. 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 any other ingredients (see section 6 “Further information”) • 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 Przeczytaj cały dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Betagan 0.5% w/v Unit Dose Eye Drops, Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One ml solution contains 5.0 mg levobunolol hydrochloride, equivalent to 4.4 mg levobunolol. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye Drops, solution. A clear, colourless to brown 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 Posology _Adults (including the elderly) _ The recommended adult dose is one drop of Betagan once or twice daily in the affected eye(s). Discard product after use. _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 the beta-adrenergic component of Betagan (levobunolol), the same types of cardiovascular, pulmonary and adverse reactions as seen with systemic beta-blockers may occur. Incidence of systemic ADRs after topical ophthalmi Przeczytaj cały dokument