URODANTIN nitrofurantoin 100 mg capsule bottle pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

nitrofurantoin, Quantity: 100 mg

Available from:

Micro Labs Pty Ltd

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: purified talc; lactose monohydrate; magnesium stearate; pregelatinised maize starch; titanium dioxide; sunset yellow FCF; purified water; quinoline yellow; Gelatin

Administration route:

Oral

Units in package:

30 capsules

Prescription type:

(S4) Prescription Only Medicine

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.

Product summary:

Visual Identification: Yellow, opaque cap and yellow opaque body, size "2", 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

Authorization status:

Registered

Authorization date:

2018-12-21

Patient Information leaflet

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

Summary of Product characteristics

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