SIMPLOTAN tinidazole 500 mg tablet blister pack

Nchi: Australia

Lugha: Kiingereza

Chanzo: Department of Health (Therapeutic Goods Administration)

Viambatanisho vya kazi:

tinidazole

Inapatikana kutoka:

Pfizer Australia Pty Ltd

Idhini hali ya:

Registered

Taarifa za kipeperushi

SIMPLOTAN* TABLETS
_Tinidazole (tin-id-azole)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Simplotan. 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 Simplotan
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
READ THIS LEAFLET CAREFULLY BEFORE
STARTING SIMPLOTAN AND KEEP IT WITH
YOUR MEDICINE.
You may need to read it again.
WHAT SIMPLOTAN IS
USED FOR
Simplotan is used to
•
treat certain infections of the male
and female genital systems, liver
and bowel
•
prevent certain infections that
may occur during surgery.
Simplotan is an antibiotic, which
belongs to a group of medicines
called nitroimidazoles.
Simplotan works by killing or
stopping the growth of bacteria
causing your infection.
Simplotan will not work against viral
infections such as colds or flu.
Your doctor, however, may prescribe
Simplotan for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY SIMPLOTAN HAS
BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
SIMPLOTAN
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE SIMPLOTAN IF YOU ARE
ALLERGIC TO:
•
Simplotan
•
any ingredients listed at the end
of the leaflet
•
or related medicines such as
Fasigyn, Flagyl, Metrogyl and
Metozine (not all brands given)
IF YOU ARE NOT SURE IF YOU ARE
ALLERGIC TO ANY OF THE ABOVE, ASK
YOUR DOCTOR.
Symptoms of an allergic reaction
include:
•
asthma, wheezing or shortness of
breath
•
swelling of the face, lips or
tongue which may lead to
difficulty swallowing or breathing
•
hives, itching or skin rash
•
fainting.
DO NOT TAKE SIMPLOTAN IF YOU HAVE
A HISTORY OF ANY BLOOD DISORDER.
DO NOT TAKE SIMPLOTAN IF YOU HAVE
ANY DISEASE OF THE BRAIN, SPINAL
CORD OR NERVES.
DO NOT TAKE SIMPLOTAN IF YOU ARE
PREG

Tabia za bidhaa

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Page 1 of 10
AUSTRALIAN
PRODUCT
INFORMATION
–
SIMPLOTAN
® (TINIDAZOLE)
1.
NAME OF THE MEDICINE
Tinidazole
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Simplotan tablets contain 500 mg of tinidazole.
3.
PHARMACEUTICAL FORM
White, round, biconvex, film coated oral tablets engraved with “FAS
500” on one side and
plain on the other.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Simplotan is indicated for the oral treatment of:
(a)
_Trichomonas_
_vaginalis_
infections of the genito-urinary tract in both female and male
patients. When infection with
_Trichomonas_
_vaginalis_
has been confirmed or is
suspected, simultaneous treatment of the consort is recommended.
(b)
Giardiasis.
(c)
Amoebic Dysentery and Amoebic Liver Abscess.
(d)
Acute Giardiasis and Acute Amoebic Dysentery and Amoebic Liver disease
in children.
(e)
The prevention of infection of the surgical site which may be
contaminated or
potentially contaminated with anaerobic organisms, for example during
colonic, gastro-
intestinal and gynaecological surgery.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
TRICHOMONIASIS
Adult:
2 g (4 x 500 mg tablets) orally as a single stat dose.
GIARDIASIS
Adult:
2 g orally as a single stat dose.
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Supersedes: pfpsimpt11113
Page 2 of 10
Children:
50 mg/kg of body weight given as a single dose, up to a maximum of 2
g. It may
be necessary to repeat this dose once in some cases.
ACUTE AMOEBIC DYSENTERY
Adult:
2 g orally as a single dose for 2 to 3 days. (In the occasional
instance when a
three day course is ineffective, treatment may be continued for ten
days).
Children:
50 mg/kg of body weight up to a maximum of 2 g, given as a single
daily dose on
each three successive days.
AMOEBIC LIVER ABSCESS
Adult:
2 g orally as a single daily dose for 3 days. (In the occasional
instance when a
three day course is ineffective, treatment may be continued for five
days).
Total dosage varies according to the virulence of the
_Entamoeba_
_histolytica_
between 4.5