Country: Ástralía
Tungumál: enska
Heimild: Department of Health (Therapeutic Goods Administration)
nitrofurantoin, Quantity: 100 mg
Pfizer Australia Pty Ltd
Capsule, hard
Excipient Ingredients: maize starch; purified talc; lactose monohydrate; Gelatin; quinoline yellow; titanium dioxide; sodium lauryl sulfate; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide; simethicone
Oral
30 capsules
(S4) Prescription Only Medicine
INDICATIONS AS AT 1 JANUARY 1991 : Treatment of urinary tract infections such as cystitis and pyelitis when due to susceptible pathogens. Nitrofurantoin does not reach effective levels in plasma and consequently is not indicated for cortical or perinephric abscesses and in cases of prostatitis.
Visual Identification: A hard-shell, no. 2, locking, gelatin capsule, opaque yellow cap and opaque yellow body, "Eaton 009" is printed on both cap and body in black edible ink; Container Type: Bottle; Container Material: HDPE; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
1997-05-29
MACRODANTIN ® _Nitrofurantoin_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start taking MACRODANTIN. This leaflet answers some common questions about MACRODANTIN. It does not contain all the available information and it does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the expected benefits it will have for you. Take MACRODANTIN as instructed and follow the advice given in this leaflet. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. Keep this leaflet with the medicine. You may need to read it again. WHAT MACRODANTIN IS USED FOR MACRODANTIN is used to treat infections of the urinary system caused by bacteria, for example, bladder infections. MACRODANTIN is an antibiotic which belongs to a group of medicines called nitrofurans. It works by killing or stopping the growth of the bacteria and other organisms causing these infections. Your doctor may have prescribed MACRODANTIN for another reason. Ask your doctor if you have any questions about why MACRODANTIN has been prescribed for you. These medicines are only available with a doctor's prescription. BEFORE YOU TAKE MACRODANTIN _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE MACRODANTIN IF: 1. you have an allergy to MACRODANTIN or any other nitrofuran, or to any of the ingredients listed at the end of this leaflet. Symptoms of an allergic reaction include skin rash, itching, difficulty with breathing, fever and chills. 2. you have severe kidney problems 3. you are pregnant and close to giving birth. INFANTS UNDER ONE MONTH OF AGE SHOULD NOT BE GIVEN MACRODANTIN. Do not take MACRODANTIN if the packaging is torn or shows signs of tampering. Do not take it after the expiry date (EXP) printed on the pack. _BEFORE YOU START TAKING IT_ YOU MUST TELL YOUR DOCTOR IF: 1. you are pregnant or intend to become pregnant. Your doctor will discuss the risks and benefits of ta Lestu allt skjalið
Version: pfpmacrc10420 Supersedes: pfpmacrc10513 Page 1 of 11 AUSTRALIAN PRODUCT INFORMATION – MACRODANTIN ® (NITROFURANTOIN) 1. NAME OF THE MEDICINE Nitrofurantoin 2. QUALITATIVE AND QUANTITATIVE COMPOSITION MACRODANTIN is available in 50 mg and 100 mg capsules. NOTE: MACRODANTIN (nitrofurantoin macrocrystals) is a larger crystal form of nitrofurantoin. The absorption of MACRODANTIN is slower and the excretion of MACRODANTIN is somewhat less, when the two are compared. The reduced incidence of gastrointestinal intolerance with MACRODANTIN is probably due to delayed and decreased absorption; this however does not significantly reduce clinical effectiveness. A number of patients who cannot tolerate nitrofurantoin tablets can take MACRODANTIN capsules without nausea. EXCIPIENT WITH KNOWN EFFECT: Lactose monohydrate For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM 50 mg capsules: yellow/white, marked EATON 008 100 mg capsules: yellow, marked EATON 009 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of urinary tract infections such as cystitis and pyelitis when due to susceptible pathogens. Nitrofurantoin does not reach effective levels in plasma and consequently is not indicated for cortical or perinephric abscesses and in cases of prostatitis. 4.2 DOSE AND METHOD OF ADMINISTRATION To be taken with food or milk. Adults: 50-100 mg four times a day. DO NOT EXCEED 400 mg DAILY. Prophylactic therapy: 50 mg or 100 mg nocte. Version: pfpmacrc10420 Supersedes: pfpmacrc10513 Page 2 of 11 Children: Should be calculated on the basis of 5-7 mg/kg body weight per 24 hours to be given in divided doses four times a day. Nitrofurantoin should not be administered to infants under one month of age. Therapy should be continued for at least one week and for at least 3 days after sterility of the urine is obtained. Continued infection indicates the need for re-evaluation. If the drug is to be used for prophylactic or for long-term suppressive therapy, consideration should be g Lestu allt skjalið