Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Austell Pharmaceuticals (Pty) Ltd
3,0 g
GRANULES
EACH SACHET CONTAINS FOSFOMYCIN TROMETAMOL EQUIVALENT TO FOSFOMYCIN 3,0 g
Registered
Austell Pharmaceuticals (Pty) Ltd, 54/20.1.1/0078.076, Fosfomycin 3 g granules for oral solution 2023.05.23 (v3) Page 1 of 8 APPROVED PATIENT INFORMATION LEAFLET FOR MEDICINES FOR HUMAN USE: FOSFOMYCIN 3 G AUSTELL SCHEDULING STATUS: S4 FOSFOMYCIN 3 G AUSTELL GRANULES FOR ORAL SOLUTION FOSFOMYCIN TROMETAMOL CONTAINS SUGAR (SUCROSE: 2,213 G PER SACHET) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING FOSFOMYCIN 3 G AUSTELL_ _ • Keep this leaflet. You may need to read it again. • If you have further questions, please ask your doctor, pharmacist, nurse or other health care provider. • FOSFOMYCIN 3 g AUSTELL has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours. _ _ WHAT IS IN THIS LEAFLET 1. What FOSFOMYCIN 3 g AUSTELL is and what it is used for 2. What you need to know before you take FOSFOMYCIN 3 g AUSTELL 3. How to take FOSFOMYCIN 3 g AUSTELL 4. Possible side effects 5. How to store FOSFOMYCIN 3 g AUSTELL 6. Contents of the pack and other information 1. WHAT FOSFOMYCIN 3 G AUSTELL IS AND WHAT IT IS USED FOR Austell Pharmaceuticals (Pty) Ltd, 54/20.1.1/0078.076, Fosfomycin 3 g granules for oral solution 2023.05.23 (v3) Page 2 of 8 FOSFOMYCIN 3 g AUSTELL contains fosfomycin trometamol. Fosfomycin trometamol is an antibiotic that works by killing bacteria which can cause infections. FOSFOMYCIN 3 g AUSTELL is used to treat or prevent uncomplicated bladder infections. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FOSFOMYCIN 3 G AUSTELL DO NOT TAKE FOSFOMYCIN 3 G AUSTELL • if you are hypersensitive (allergic) to fosfomycin or any of the other ingredients of FOSFOMYCIN 3 g AUSTELL (listed in section 6) • if you have severe kidney problems (creatinine clearance below 10 mL/min) • are undergoing haemodialysis. If you are uncertain whether any of these apply to you, please discuss this with your doctor or pharmacist before taking FOSFOMYCIN 3 g AUSTELL. WARNINGS AND PRECAUTIONS Tell your doctor or healt Read the complete document
Austell Pharmaceuticals (Pty) Ltd, 54/20.1.1/0078.076, Fosfomycin 3 g granules for oral solution 2023.05.23 (v2) Page 1 of 11 APPROVED PROFESSIONAL INFORMATION FOR MEDICINES FOR HUMAN USE: FOSFOMYCIN 3 G AUSTELL NOTE: BOTH THE PI AND PIL WILL BE INCLUDED IN THE PACKAGING OF THIS MEDICINE. SCHEDULING STATUS S4 1. NAME OF THE MEDICINE FOSFOMYCIN 3 g AUSTELL granules for oral solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One sachet contains fosfomycin trometamol equivalent to 3,0 g fosfomycin. Excipient with known effect: Contains sugar (sucrose: 2,213 g per sachet), see section 4.4. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Granules for oral solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS FOSFOMYCIN 3 g AUSTELL is indicated: • as a single dose in the treatment of acute uncomplicated lower urinary tract infections caused by sensitive _E. coli_, in women and female adolescents. Austell Pharmaceuticals (Pty) Ltd, 54/20.1.1/0078.076, Fosfomycin 3 g granules for oral solution 2023.05.23 (v2) Page 2 of 11 • for prophylaxis in diagnostic and surgical transurethral procedures in adult men. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY The recommended dose for uncomplicated urinary tract infections in women, including the elderly up to seventy-five years, is a single 3 g dose. _ _ The recommended dose for prophylaxis prior to transurethral surgical and diagnostic procedures in adult men, including the elderly, is two doses of 3 g. The first dose should be taken three hours before surgery. The second dose should be taken twenty-four hours after surgery. METHOD OF ADMINISTRATION FOSFOMYCIN 3 g AUSTELL is administered orally after reconstitution in water. To be taken at least two hours prior to the next meal. 4.3 CONTRAINDICATIONS • Hypersensitivity to fosfomycin trometamol or to any of the excipients listed in section 6.1. • severe renal insufficiency (creatinine clearance < 10 mL/min) • patients undergoing haemodialysis. 4.4 SPECIAL WARNINGS AND PRECAUTIONS F Read the complete document