Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
ACETAZOLAMIDE SODIUM
Mercury Pharmaceuticals Ltd
S01EC; S01EC01
ACETAZOLAMIDE SODIUM
500 milligram(s)
Powder for solution for injection
Product subject to prescription which may not be renewed (A)
Carbonic anhydrase inhibitors; acetazolamide
Not marketed
1978-04-01
PATIENT INFORMATION LEAFLET DIAMOX® POWDER FOR SOLUTION FOR INJECTION 500MG/VIAL (Acetazolamide) Please read all of this leaflet carefully before you start using this medicine. It provides important information about this medicine. Keep this leaflet. You may need to read it again. If you have any questions or are not sure about anything, ask your doctor or pharmacist. 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 DIAMOX® is and what it is used for 2. Before you use DIAMOX® 3. How to use DIAMOX® 4. Possible side effects 5. How to store DIAMOX® 6. Further information 1. WHAT DIAMOX® IS AND WHAT IT IS USED FOR DIAMOX® Powder for Solution for Injection 500mg/viaI belongs to a group of drugs called carbonic anhydrase inhibitors. DIAMOX® is used to treat the eye condition glaucoma, and also fluid retention and epilepsy. 2. BEFORE YOU USE DIAMOX® If the answer to any of the following questions is “YES” you should talk to your doctor before administration of DIAMOX® Powder for Solution for Injection 500mg/vial as it may not be suitable for you: • are you pregnant, breast feeding or trying for a baby? • are you allergic to sulpha-containing medicines? • have you ever had an allergic reaction to acetazolamide, sulphonamides, sulphonamide derivatives or to any of the ingredients in the formulation? • do you have liver problems? • do you have or have you ever had kidney problems such as kidney stones? • do you have trouble passing urine? • do you have lung problems such as chronic bronchitis or emphysema? • are you taking medicines for your heart such as cardiac glycosides (e.g. digoxin), blood pressure, to thin your blood (e.g. warfarin), to lower the sugar in your blood, or for epilepsy (in particular, phenytoin, primidone or carbamazepine)? • are you taking any of the following: methotrexate, pyrimethamine or trimethoprim; or steroids such as prednisolone? • are you tak Læs hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Diamox Powder for Solution for Injection 500 mg/vial 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains Acetazolamide Sodium equivalent to Acetazolamide 500mg. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for solution for injection. Sterile, white, lyophilised powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS DIAMOX is an enzyme inhibitor which acts specifically on carbonic anhydrase. It is indicated in the treatment of: i) GLAUCOMA: DIAMOX is useful in glaucoma (chronic simple (open angle) glaucoma, secondary glaucoma, and perioperatively in acute angle closure glaucoma where delay of surgery is desired in order to lower intraocular pressure) because it acts on inflow, decreasing the amount of aqueous secretion. ii) ABNORMAL RETENTION OF FLUIDS: DIAMOX is a diuretic whose effect is due to the effect on the reversible hydration of carbon dioxide and dehydration of carbonic acid reaction in the kidney. The result is renal loss of HCO 3- ion which carries out sodium, water and potassium. DIAMOX can be used in conjunction with other diuretics when effects on several segments of the nephron are desirable in the treatment of fluid retaining states. iii) EPILEPSY: In conjunction with other anticonvulsants best results with DIAMOX have been seen in petit mal in children. Good results, however, have been seen in patients, both children and adults, with other types of seizures such as grand mal, mixed seizure patterns, myoclonic jerk patterns etc. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Læs hele dokumentet