Država: Australija
Jezik: engleski
Izvor: Department of Health (Therapeutic Goods Administration)
nitrofurantoin, Quantity: 50 mg
Micro Labs 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
4 Capsule (starter pack), 30 Capsules
(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
URODANTIN 1 URODANTIN 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 URODANTIN? URODANTIN contains active ingredient Nitrofurantoin. Nitrofurantoin is used to treat infections of the urinary system caused by bacteria, for example, bladder infection For more information, see Section 1. Why am I using URODANTIN? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE URODANTIN? Do not use if you have ever had an allergic reaction to URODANTIN 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 use URODANTIN? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicine may interfere with URODANTIN 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 URODANTIN? Your doctor or pharmacist will tell you how to take your medicine. More instructions can be found in Section 4. How do I use URODANTIN ? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING URODANTIN? THINGS YOU SHOULD DO Remind any doctor, dentist or pharmacist you visit that you are using URODANTIN If the symptoms of your infection do not improve, or if they become worse, tell your doctor. If you become pregnant while you are taking URODANTIN, tell your doctor. THINGS YOU SHOULD NOT DO Do not stop using URODANTIN suddenly (if relevant). If you do not complete the full course prescribed by your doctor, all of the bacteria causing your infection may not be killed. URODANTIN 2 Do not take antacid preparations at the same time as URODANTIN . These preparations may affect how well URODANTIN works. DRIVING OR USING MACHINES Be careful driving or operating machinery until you know how URODANT Pročitajte cijeli dokument
AUSTRALIAN PRODUCT INFORMATION-URODANTIN (NITROFURANTOIN) 1. NAME OF THE MEDICINE Urodantin Capsules 50 mg and 100 mg (nitrofurantoin macrocrystals) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 50 mg and 100 mg of Urodantin capsule contains 50 mg and 100 mg of Nitrofurantoin respectively. _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 Pročitajte cijeli dokument