Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
nitrofurantoin, Quantity: 50 mg
Arrotex Pharmaceuticals Pty Ltd
Capsule, hard
Excipient Ingredients: pregelatinised maize starch; magnesium stearate; purified talc; lactose monohydrate; titanium dioxide; sunset yellow FCF; purified water; quinoline yellow; Gelatin
Oral
30 Capsules, 4 Capsule (starter pack)
(S4) Prescription Only Medicine
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: Yellow, opaque cap and white opaque body, size 3 plain, hard gelatin capsule filled with yellow coloured powder.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2018-12-21
APO-NITROFURANTOIN 1 APO-NITROFURANTOIN _nitrofurantoin _ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about this medicine. It does not contain all the available information. 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 benefits they expect it will have for you. 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 THIS MEDICINE IS USED FOR Nitrofurantoin is used to treat infections of the urinary system caused by bacteria, such as bladder infections. It 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. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is not addictive. This medicine is only with a doctor's prescription. BEFORE YOU TAKE THIS MEDICINE _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • any medicine containing nitrofurantoin or any other nitrofuran • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin DO NOT TAKE THIS MEDICINE IF YOU HAVE OR HAVE HAD SEVERE KIDNEY PROBLEMS. DO NOT TAKE THIS MEDICINE IF YOU ARE PREGNANT. It may affect your developing baby if you take it during pregnancy. DO NOT GIVE THIS MEDICINE TO A CHILD UNDER THE AGE OF 1 MONTH. Safety and effectiveness in children younger than 1 month have not been established. DO NOT TAKE THIS MEDICINE Read the complete document
AUSTRALIAN PRODUCT INFORMATION- APO-NITROFURANTOIN (NITROFURANTOIN) 1. NAME OF THE MEDICINE Nitrofurantoin. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each APO-NITROFURANTOIN capsule contains either 50 mg or 100 mg of nitrofurantoin. Nitrofurantoin is a synthetic antibacterial nitrofuran derivative. It occurs as lemon yellow crystals, or fine powder, and is very slightly soluble in water or alcohol. However, solubility of the drug in water and urine increases with rises in pH. Nitrofurantoin darkens on exposure to light or to alkali and is decomposed upon contact with metals other than stainless steel or aluminium. In view of this, the drug should not be exposed to light. Note: Nitrofurantoin macrocrystals is a larger crystal form of nitrofurantoin. The absorption of nitrofurantoin macrocrystals is slower and the excretion is somewhat less, when the two are compared. The reduced incidence of gastrointestinal intolerance with nitrofurantoin macrocrystals 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 nitrofurantoin macrocrystals capsules without nausea.’ Excipient with known effect: “lactose monohydrate”. For a full list of excipients, SEE SECTION 6.1 LIST OF EXCIPIENTS 3. PHARMACEUTICAL FORM Nitrofurantoin 50 mg Capsule: Yellow, opaque cap and white opaque body, size “3" plain, hard gelatin capsule filled with yellow coloured powder. Nitrofurantoin 100 mg Capsules: Yellow, opaque cap and yellow opaque body, size "2", plain, hard gelatin capsule filled with yellow coloured powder. 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. Dosage Read the complete document