APO-NITROFURANTOIN nitrofurantoin 100 mg capsule bottle pack

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Aktiva substanser:

nitrofurantoin, Quantity: 100 mg

Tillgänglig från:

Arrotex Pharmaceuticals Pty Ltd

Läkemedelsform:

Capsule, hard

Sammansättning:

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

Administreringssätt:

Oral

Enheter i paketet:

30 capsules

Receptbelagda typ:

(S4) Prescription Only Medicine

Terapeutiska indikationer:

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.

Produktsammanfattning:

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

Bemyndigande status:

Registered

Tillstånd datum:

2018-12-21

Bipacksedel

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

Produktens egenskaper

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