NITROFURANTOIN MLABS nitrofurantoin 50 mg capsule bottle pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

nitrofurantoin, Quantity: 50 mg

Available from:

Micro Labs Pty Ltd

Pharmaceutical form:

Capsule, hard

Composition:

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

Administration route:

Oral

Units in package:

30 Capsules, 4 Capsule (starter pack)

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 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

Authorization status:

Registered

Authorization date:

2018-12-21

Patient Information leaflet

NITROFURANTOIN MLABS
1
NITROFURANTOIN MLABS
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 NITROFURANTOIN MLABS?
NITROFURANTOIN MLABS 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 NITROFURANTOIN
MLABS? in the full
CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE NITROFURANTOIN MLABS?
Do not use if you have ever had an allergic reaction to NITROFURANTOIN
MLABS 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
NITROFURANTOIN MLABS?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicine may interfere with NITROFURANTOIN MLABS 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 NITROFURANTOIN MLABS?
Your doctor or pharmacist will tell you how to take your medicine.
More instructions can be found in Section 4. How do I use
NITROFURANTOIN MLABS ?
in the full
CMI.
5.
WHAT SHOULD I KNOW WHILE USING NITROFURANTOIN MLABS?
THINGS YOU SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are
using NITROFURANTOIN MLABS
•
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
NITROFURANTOIN MLABS, tell your doctor.
NITROFURANTOIN MLABS
2
THINGS YOU SHOULD NOT DO
•
Do not stop using NITROFURANTOIN MLABS 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.
•
Do
not
take
antacid
preparations
at
the
sa

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION- APO-NITROFURANTOIN
(NITROFURANTOIN)
1.
NAME OF THE MEDICINE
APO-NITROFURANTOIN Capsules 50 mg and 100 mg (nitrofurantoin
macrocrystals
)
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