Nchi: Malta
Lugha: Kiingereza
Chanzo: Medicines Authority
ACETAZOLAMIDE
Crescent Pharma International Limited 260, Triq San Albert, Gzira GZR 1150, Malta
S01EC01
ACETAZOLAMIDE 250 mg
TABLET
ACETAZOLAMIDE 250 mg
POM
OPHTHALMOLOGICALS
Licence number in the source country: NOT APPLICAPABLE
Authorised
2020-11-24
PACKAGE INFORMATION LEAFLET ACETAZOLAMIDE CRESCENT TABLETS 250MG Please read all of this leaflet carefully before you start taking this medicine. Keep the leaflet, you may need to read it again. If you have any questions or are not sure about anything, 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 tell your doctor or pharmacist In this leaflet 1. What Acetazolamide Crescent Tablets 250mg are and what it is used for 2. Before you take Acetazolamide Crescent Tablets 250mg 3. How to take Acetazolamide Crescent Tablets 250mg 4. Possible side effects 5. How to store Acetazolamide Crescent Tablets 250mg 6. Further information 1. WHAT ACETAZOLAMIDE CRESCENT TABLETS 250MG ARE AND WHAT IT IS USED FOR These tablets contain the active ingredient Acetazolamide, which is one of the group of medicines called carbonic anhydrase inhibitors. These are used in the treatment of abnormal retention of fluids and epilepsy. They are also used to treat chronic simple glaucoma, secondary glaucoma and before an operation in acute angle closure glaucoma. 2. BEFORE YOU TAKE ACETAZOLAMIDE CRESCENT TABLETS 250MG DO NOT TAKE THESE TABLETS IF : • you are allergic to Acetazolamide, sulphonamides or any of the ingredients in the tablets • you have low blood levels of sodium or potassium • you have kidney disease or kidney problems • you have liver disease including cirrhosis, or liver problems • you have an underactive adrenal gland • you have hyperchloremic acidosis (high levels of chloride in the blood). DO NOT TAKE THESE TABLETS FOR A LONG TERM IF: • you suffer from chronic congestive angle-closure glaucoma. CHECK WITH YOUR DOCTOR BEFORE TAKING THESE TABLETS IF: • you have lung problems such as bronchitis, asthma, wheezing or emphysema • you have a history of kidney stones as this medicine may cause further Soma hati kamili
Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Acetazolamide Crescent Tablets 250 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 250 mg of Acetazolamide. For excipients, see 6.1 3 PHARMACEUTICAL FORM Acetazolamide Crescent Tablets are presented as white flat bevelled edge tablets engraved with R and crescent moon logo on one side and A / 303 either side of a break-line on the other. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Acetazolamide Crescent Tablets 250 mg are indicated in the treatment of 1. 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. Acetazolamide acts on inflow, decreasing the amount of aqueous secretion. 2. Abnormal retention of fluids Acetazolamide acts on the reversible hydration of carbon dioxide and hydration of the carbonic acid reaction in the kidney resulting in renal loss of bicarbonate ion which carries out sodium, water and potassium. It 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. 3. Epilepsy When used in conjunction with other anticonvulsants best results have been seen in petit mal in children. Good results have been seen in both children and adults with grand mal, mixed seizure patterns and myoclonic jerk patterns. Page 2 of 8 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: Oral. Dosage 1. Glaucoma (simple acute congestive and secondary) Adults: 1 – 4 tablets daily, in divided doses for amounts over 250 mg daily. 2. Abnormal retention of fluid (congestive heart failure, drug-induced oedema) Adults: Initially 1 – 1½ tablets once daily in the morning. If after an initial response, patient fails to continue to lose oedema fluid, do not increase the dose but allow for kidney recovery by omitting a day. Best results Soma hati kamili