Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
brinzolamide, timolol maleate
Novartis Europharm Limited
S01ED51
brinzolamide, timolol
Ophthalmologicals
Glaucoma, Open-Angle; Ocular Hypertension
Decrease of intraocular pressure (IOP) in adult patients with open angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction.
Revision: 16
Authorised
2008-11-25
22 B. PACKAGE LEAFLET 23 PACKAGE LEAFLET: INFORMATION FOR THE USER AZARGA 10 MG/ML + 5 MG/ML EYE DROPS, SUSPENSION brinzolamide/timolol 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 illnesses 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 AZARGA is and what it is used for 2. What you need to know before you use AZARGA 3. How to use AZARGA 4. Possible side effects 5. How to store AZARGA 6. Contents of the pack and other information 1. WHAT AZARGA IS AND WHAT IT IS USED FOR AZARGA contains two active substances, brinzolamide and timolol, which work together to reduce pressure within the eye. AZARGA is used to treat high pressure in the eyes, also called glaucoma or ocular hypertension, in adult patients that are more than 18 years of age and in whom high pressure in the eyes cannot be controlled effectively by one medicine alone. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE AZARGA DO NOT USE AZARGA • If you are allergic to brinzolamide, medicines called sulphonamides (examples include medicines used to treat diabetes, infections and also diuretics (water tablets)), timolol, beta- blockers (medicines used to lower blood pressure or to treat heart disease) or any of the other ingredients of this medicine (listed in section 6). • If you have now or have had in the past respiratory problems such as asthma, severe long lasting obstructive bronchitis (severe lung condition which may cause wheezing, difficulty in breathing and/or long standing cough) or other types of breathing problems. • If you have severe hay fever • If you have a slow heart beat, hea Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT AZARGA 10 mg/ml + 5 mg/ml eye drops, suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml of suspension contains 10 mg brinzolamide and 5 mg timolol (as timolol maleate). Excipient with known effect One ml of suspension contains 0.10 mg benzalkonium chloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Eye drops, suspension (eye drops) White to off-white uniform suspension, pH 7.2 (approximately). 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Decrease of intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Use in adults, including the elderly _ The dose is one drop of AZARGA in the conjunctival sac of the affected eye(s) twice daily. When using nasolacrimal occlusion or closing the eyelids, the systemic absorption is reduced. This may result in a decrease in systemic side effects and an increase in local activity (see section 4.4). If a dose is missed, treatment should be continued with the next dose as planned. The dose should not exceed one drop in the affected eye (s) twice daily. When substituting another ophthalmic antiglaucoma medicinal product with AZARGA, the other medicinal product should be discontinued and AZARGA should be started the following day. _Special populations _ _Paediatric population _ The safety and efficacy of AZARGA in children and adolescents aged 0 to 18 years have not yet been established. No data are available. _Hepatic and renal impairment _ No studies have been conducted with AZARGA or with timolol 5 mg/ml eye drops in patients with hepatic or renal impairment. No dosage adjustment is necessary in patients with hepatic impairment or in patients with mild to moderate renal impairment. 3 AZARGA has not been studied in patients with severe renal impairment (creatinine clearance <30 ml/min) or in pat Pročitajte cijeli dokument