Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
metronidazole, Quantity: 500 mg
Sanofi-Aventis Australia Pty Ltd
Suppository
Excipient Ingredients: Hard fat
Rectal
0.5g x 10 suppositories
Medicine Registered
(S4) Prescription Only Medicine
Anaerobic infections: Suppositories Treatment of anaerobic infection in patients for whom oral medication is not possible or is contraindicated. Prevention of anaerobic infection in high risk situations in patients for whom oral medication is not possible or is contraindicated. Metronidazole may be used prophylactically to prevent infection of the surgical site which may have been contaminated or potentially contaminated with anaerobic organisms. Procedures in which this may be assumed to have happened include appendicectomy, colonic surgery, vaginal hysterectomy, abdominal surgery in the presence of anaerobes in the peritoneal cavity and surgery performed in the presence of anaerobic septicaemia. Note. Metronidazole is inactive against aerobic and facultative anaerobic bacteria.
Visual Identification: Cream coloured, smooth, torpedo shaped solids, which may have a hole in the base; Container Type: Blister Pack; Container Material: PVC/PE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Registered
1991-10-21
FLAGYL ® F l a g y l ® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING FLAGYL? Flagyl contains the active ingredient metronidazole (tablet and suppository). Flagyl is used to treat certain infections caused by bacteria and other organisms in different parts of the body. It is also used to prevent or treat certain infections that may occur during surgery. For more information, see Section 1. Why am I using Flagyl? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE FLAGYL? Do not use if you have ever had an allergic reaction to Flagyl or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use Flagyl? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Flagyl and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE FLAGYL? Follow the instructions provided and use Flagyl until your doctor tells you to stop. More instructions can be found in Section 4. How do I use Flagyl? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING FLAGYL? THINGS YOU SHOULD DO • Tell your doctor straight away if the symptoms of your infection do not improve or become worse, if you become pregnant or if you are about to start taking any new medicines. • Stop taking this medicine and tell your doctor straight away if you have irrational thoughts, hallucinations, feeling confused or feeling depressed, including thoughts of self-harm or suicide. THINGS YOU SHOULD NOT DO • Do not stop taking Flagyl if you feel better. If you do not complete the full course prescribed by your doctor, all of the bacteria/organisms causing your infection may not be killed. DRIVING OR U Read the complete document
Flagyl-ccdsv17-piv20-24mar22 1 AUSTRALIAN PRODUCT INFORMATION – FLAGYL ® (METRONIDAZOLE) TABLET & SUPPOSITORY 1 NAME OF THE MEDICINE metronidazole 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Flagyl tablets contain 200 mg or 400 mg metronidazole. Flagyl suppositories contain 500 mg metronidazole. For the full list of excipients, see Section List of excipients. 3 PHARMACEUTICAL FORM 200 mg tablets: Round, white to off-white tablets, one face impressed with ‘MTZ 200’ and a break line on the other. 400 mg tablets: Round, white to off-white biconvex tablet, one side impressed with 'MTZ 400' and breakline on reverse. 500 mg suppositories: Cream coloured, smooth, torpedo-shaped solids, which may have a hole in the base. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ANAEROBIC INFECTIONS _ORAL _ Treatment of infections in which anaerobic bacteria have been identified or are suspected as pathogens, particularly _Bacteroides fragilis_ and other species of bacteroides, and other species such as fusobacteria, eubacteria, clostridia and anaerobic streptococci. Flagyl has been used successfully in septicaemia; bacteraemia; brain abscess; necrotising pneumonia; osteomyelitis; puerperal sepsis; pelvic abscess; pelvic cellulitis; postoperative wound infections. _SUPPOSITORIES _ Treatment of anaerobic infection in patients for whom oral medication is not possible or is contraindicated. Prevention of anaerobic infection in high risk situations in patients for whom oral medication is not possible or is contraindicated. Flagyl-ccdsv17-piv20-24mar22 2 Metronidazole may be used prophylactically to prevent infection of the surgical site which may have been contaminated or potentially contaminated with anaerobic organisms. Procedures in which this may be assumed to have happened include appendicectomy, colonic surgery, vaginal hysterectomy, abdominal surgery in the presence of anaerobes in the peritoneal cavity and surgery performed in the presence of anaerobic septicaemia. NOTE: Metronidazole is inactive against aerobic and fa Read the complete document