מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
Brinzolamide
Rowex Ltd
S01EC; S01EC04
Brinzolamide
10 milligram(s)/millilitre
Eye drops, suspension
Product subject to prescription which may be renewed (B)
Carbonic anhydrase inhibitors; brinzolamide
Marketed
2014-07-04
PACKAGE LEAFLET: INFORMATION FOR THE USER BRINZOLAMIDE SANDOZ 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 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 Brinzolamide Sandoz is and what it is used for 2. What you need to know before you use Brinzolamide Sandoz 3. How to use Brinzolamide Sandoz 4. Possible side effects 5. How to store Brinzolamide Sandoz 6. Contents of the pack and other information 1. WHAT BRINZOLAMIDE SANDOZ IS AND WHAT IT IS USED FOR BRINZOLAMIDE SANDOZ CONTAINS BRINZOLAMIDE WHICH BELONGS TO A GROUP OF MEDICINES called carbonic anhydrase inhibitors. It reduces pressure within the eye. BRINZOLAMIDE SANDOZ 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 BRINZOLAMIDE SANDOZ DO NOT USE BRINZOLAMIDE SANDOZ - 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). Brinzolamide Sandoz 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. WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR or pharmacist before using Brinzolamide Sandoz - IF YOU HAVE KIDNEY OR LIVE קרא את המסמך השלם
Health Products Regulatory Authority 22 August 2022 CRN00D4CF Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Brinzolamide Sandoz 10mg/ml eye drops, suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of suspension contains 10 mg brinzolamide (0.33 mg brinzolamide per drop). Excipient(s) with known effect Each 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. White to off-white suspension, pH 7.1 – 7.9 and osmolality 270 – 320 m Osm/kg. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Brinzolamide Sandoz 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 Brinzolamide Sandoz 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 Brinzolamide has not been studied in patients with hepatic impairment and is therefore not recommended in such patients. Brinzolamide has not been studied in patients with severe renal impairment (creatinine clearance <30ml/min) or in patients with hyperchloraemic acidosis. Since brinzolamide and its main metabolite are excreted predominantly by the kidney, Brinzolamide Sandoz is therefore contraindicated in such patients (see also section 4.3). Paediatric population The safety and efficacy of Brinzolamide Sandoz in infants, children and adolescents aged 0 to 17 years has not been established. Currently available data are described insections 4.8 and 5.1. Br קרא את המסמך השלם