Arrow - Ornidazole

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Ornidazole 500mg;  

Available from:

Teva Pharma (New Zealand) Limited

INN (International Name):

Ornidazole 500 mg

Dosage:

500 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Ornidazole 500mg   Excipient: Hypromellose 60 SH Hypromellose 6 CP Magnesium stearate Maize starch Microcrystalline cellulose Purified talc Titanium dioxide

Units in package:

Blister pack, PVC/aluminium, 10 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Centipharm

Therapeutic indications:

Bacterial vaginosis (non-specific vaginitis).

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/aluminium - 10 tablets - 60 months from date of manufacture stored at or below 30°C protect from light

Authorization date:

2011-02-21

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
ARROW – ORNIDAZOLE
ORNIDAZOLE TABLETS 500MG
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about ARROW - ORNIDAZOLE.
It does not contain all of the available information. It does not take
the place of talking to your
doctor or pharmacist.
All medicines have benefits and risks. Your doctor has weighed the
risks of you taking
ARROW - ORNIDAZOLE against the benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
Keep this leaflet with your medicine. You may need to read it again.
WHAT ARROW - ORNIDAZOLE IS USED FOR
ARROW - ORNIDAZOLE contains the active ingredient ornidazole.
ARROW - ORNIDAZOLE is used to treat people who have certain types of
vaginal, urinary
tract and intestinal infections, or some specific infections that are
in the body. These
infections may be caused by anaerobic bacteria (bacteria that do not
use oxygen) or amoeba
(single celled parasites).
ARROW - ORNIDAZOLE is also used to guard against the possibility of
these types of
infections during surgery (prophylaxis).
ARROW - ORNIDAZOLE belongs to a group of medicines called
antiprotozoals. These
medicines work by targeting the bacteria or amoeba in your body, and
killing them.
Your doctor, however, may have prescribed ARROW - ORNIDAZOLE for
another purpose.
Ask your doctor if you have any questions about why ARROW - ORNIDAZOLE
has been
prescribed for you.
This medicine is available only with a doctor’s prescription.
BEFORE YOU TAKE ARROW - ORNIDAZOLE
_WHEN YOU MUST NOT TAKE IT _
Do not take ARROW - ORNIDAZOLE if:
•
You have had an allergic reaction to ARROW – ORNIDAZOLE other
nitroimidazole
derivatives such as metronidazole (Flagyl
®
, Rozex
®
, Trichozole
®
), or any ingredients listed
at the end of this leaflet
•
The package is torn or shows signs of tampering
•
The expiry date printed on the pack has passed
If you take this medicine after the expiry date has passed, it may not
work as well.
If you are not su

Summary of Product characteristics

Version 1.0
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Arrow – Ornidazole, 500 mg, film coated tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg of ornidazole.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
White to slightly yellowish, cylindrical, biconvex film coated
tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ARROW-ORNIDAZOLE is an antimicrobial agent for the treatment of
infections due to
trichomonads, amoebae, Giardia lamblia and anaerobic bacteria.
1.
Bacterial vaginosis (non-specific vaginitis).
2.
Trichomoniasis. Genitourinary infections in women and men due to
_Trichomonas vaginalis._
3.
Amoebiasis. All intestinal infections due to
_Entamoeba histolytica, _
including amoebic dysentery.
All extraintestinal forms of amoebiasis, especially amoebic liver
abscess.
4.
Giardiasis (lambliasis).
5.
Infections due to anaerobic bacteria. Treatment of infections such as
septicaemia, meningitis,
peritonitis, postoperative wound infections, puerperal sepsis, septic
abortion, and endometritis,
with demonstrated or suspected involvement of susceptible bacteria
(see section 5.1
Pharmacodynamic properties).
6.
Prophylaxis during surgical interventions, particularly those
involving the colon, and in
gynaecological operations.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
TRICHOMONIASIS
_Adults _
There are two possible therapeutic regimens:
(a) Single-dose therapy (for acute trichomoniasis)
(b) Five-day therapy (for
chronic forms of trichomoniasis)
TYPE OF TREATMENT
DAILY DOSAGE (500 MG TABLETS)
(a) Single dose therapy
3 tablets in the evening
(b) Five-day therapy
2 tablets (1 tablet mornings and evenings)
In all cases, the sexual partner
should also be treated using the same oral dosage so as to avoid
reinfection.
_Children _
The dosage for children
is 25 mg per kg bodyweight per day, given in a single dose.
Version 1.0
2
AMOEBIASIS
(a) Three-day treatment of patients with amoebic dysentery
(b) Five-to-ten-day treatment for all forms of amoebiasis
DURATIO