البلد: الاتحاد الأوروبي
اللغة: الإنجليزية
المصدر: EMA (European Medicines Agency)
brinzolamide
Novartis Europharm Limited
S01EC04
brinzolamide
Ophthalmologicals
Glaucoma, Open-Angle; Ocular Hypertension
Azopt is indicated to decrease elevated intraocular pressure in:ocular hypertension;open-angle glaucomaas monotherapy in adult patients unresponsive to beta-blockers or in adult patients in whom beta-blockers are contraindicated, or as adjunctive therapy to beta-blockers or prostaglandin analogues.
Revision: 28
Authorised
2000-03-09
21 B. PACKAGE LEAFLET 22 PACKAGE LEAFLET: INFORMATION FOR THE USER AZOPT 10 MG/ML EYE DROPS, SUSPENSION brinzolamide 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 your 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 AZOPT is and what it is used for 2. What you need to know before you use AZOPT 3. How to use AZOPT 4. Possible side effects 5. How to store AZOPT 6. Contents of the pack and other information 1. WHAT AZOPT IS AND WHAT IT IS USED FOR AZOPT contains brinzolamide which belongs to a group of medicines called carbonic anhydrase inhibitors. It reduces pressure within the eye. AZOPT eye drops are used to treat high pressure in the eye. This pressure can lead to an illness called glaucoma. If the pressure in the eye is too high, it can damage your sight. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE AZOPT DO NOT USE AZOPT - if you have severe kidney problems. - if you are allergic to brinzolamide or any of the other ingredients of this medicine (listed in section 6). - if you are allergic to medicines called sulphonamides. Examples include medicines used to treat diabetes and infections and also diuretics (water tablets). AZOPT may cause the same allergy. - if you have too much acidity in your blood (a condition called hyperchloraemic acidosis). If you have further questions, ask your doctor for advice. 23 WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using AZOPT: - if you have kidney or liver problems. - if you have dry eyes or cornea problems. - if you are taking other sulphonamide medicines - if you have a specific form اقرأ الوثيقة كاملة
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT AZOPT 10 mg/ml eye drops, suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of suspension contains 10 mg brinzolamide. Excipient with known effect Each ml of suspension contains 0.1 mg benzalkonium chloride. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Eye drops, suspension. White to off-white suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS AZOPT is indicated to decrease elevated intraocular pressure in: • ocular hypertension • open-angle glaucoma as monotherapy in adult patients unresponsive to beta-blockers or in adult patients in whom beta- blockers are contraindicated, or as adjunctive therapy to beta-blockers or prostaglandin analogues (see also section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology When used as monotherapy or adjunctive therapy, the dose is one drop of AZOPT in the conjunctival sac of the affected eye(s) twice daily. Some patients may have a better response with one drop three times a day. _Special populations_ _Elderly population _ No dose adjustment in elderly patients is necessary. _Hepatic and renal impairment _ AZOPT has not been studied in patients with hepatic impairment and is therefore not recommended in such patients. AZOPT has not been studied in patients with severe renal impairment (creatinine clearance < 30 ml/min) or in patients with hyperchloraemic acidosis. Since brinzolamide and its main metabolite are excreted predominantly by the kidney, AZOPT is therefore contra-indicated in such patients (see also section 4.3). 3 _Paediatric population _ The safety and efficacy of AZOPT in infants, children and adolescents aged 0 to 17 years have not been established. Currently available data are described in sections 4.8 and 5.1. AZOPT is not recommended for use in infants, children and adolescents. Method of administration For ocular use. Nasolacrimal occlusion or gently closing the eyelid after instillation is recommended. This may redu اقرأ الوثيقة كاملة