TRIPRIM trimethoprim 300 mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

trimethoprim, Quantity: 300 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: pregelatinised maize starch; sodium starch glycollate; magnesium stearate

Administration route:

Oral

Units in package:

7 tablets

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

This product accepted for registration as 'currently supplied' at the time of commencement of the Act. Conditions varied as approved in the letter of 6 April 1992 from Dr H. Arora. Indicated for the treatmenet of acute urinary tract infections caused by sensitive organisms.

Product summary:

Visual Identification: A biconvex, round white tablet embossed "TRIPRIM" and scored on the upper face. Bottom face plain.; Container Type: Bottle; Container Material: Glass; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-08-02

Patient Information leaflet

TRIPRIM- Consumer Medicine Information
Page 1 of 4
TRIPRIM
™
_TRIMETHOPRIM _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about TRIPRIM tablets.
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 TRIPRIM
against the benefits they expect it
will have.
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 TRIPRIM IS USED
FOR
The name of your medicine is
TRIPRIM. The active ingredient is
called
_trimethoprim_
.
_ _
_Trimethoprim_
belongs to a group
of medicines called antibiotics.
TRIPRIM is used to treat urinary
tract infections caused by bacteria.
It works by stopping the growth of
bacteria that are causing your
infection.
USE TRIPRIM ONLY AS DIRECTED
AND CONSULT A HEALTH CARE
PROFESSIONAL IF PAIN OR SYMPTOMS
PERSIST.
TRIPRIM is not recommended for
use in children under the age of 6
years.
The safety and effectiveness of
TRIPRIM in children under the
age of 6 years has not been
established.
Your doctor may have prescribed
this medicine for another
condition.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY TRIPRIM
HAS BEEN PRESCRIBED FOR YOU.
TRIPRIM tablets are only
available with a doctor’s
prescription.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE TRIPRIM IF YOU ARE
ALLERGIC TO:
•
Trimethoprim or any other
antibiotics
•
Any of the ingredients listed at
the end of this leaflet.
Some of the symptoms of an
allergic reaction to TRIPRIM may
include red, itchy skin rashes,
difficulty in breathing, swelling of
the face, lips or throat or faintness.
DO NOT USE IT AFTER THE EXPIRY
DATE (EXP.) PRINTED ON THE PACK.
DO NOT TAKE TRIPRIM IF THE
PACKAGING IS TORN OR SHOWS SIGNS
OF TAMPERING.
If it has expired or is damaged,
return it to your pharmacist for
disposal.
_BEFORE YOU START TO TAKE

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – TRIPRIM (TRIMETHOPRIM)
1
NAME OF THE MEDICINE
Trimethoprim
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
A synthetic antibacterial.
Each tablet contains 300mg of trimethoprim.
For full list of excipients, see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
White biconvex, round tablet embossed ‘TRIPRIM’ and scored on the
upper face. Bottom face plain.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Triprim is indicated for the treatment of acute urinary tract
infections caused by sensitive organisms.
4.2
D
OSE AND METHOD OF ADMINISTRATION
ADULTS AND CHILDREN OVER 12 YEARS: 300mg daily for 7 days.
CHILDREN OVER 6 YEARS: 150mg daily for 7 days.
CHILDREN UNDER 6 YEARS: There is no information available at present
concerning the appropriate dose
of Triprim in children under the age of 6 years.
In the treatment of acute urinary tract infection due to susceptible
organisms it is not necessary to
use Triprim for longer than 7 days.
To ensure maximal urinary concentrations it may be advantageous to
take the dose before bedtime.
The dose may be taken with food to minimise the possibility of
gastrointestinal disturbance.
4.3
C
ONTRAINDICATIONS
2
Triprim should not be given to patients with a history of trimethoprim
hypersensitivity.
Patients with severely impaired renal function (creatinine clearance
less than 10 mL/min) should not
be prescribed Triprim unless the plasma concentration of trimethoprim
is monitored repeatedly
during treatment.
Triprim should not be given to patients with severe haematological
disorders or documented
megaloblastic anaemia due to folate deficiency.
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
POSSIBLE FOLATE DEFICIENCY
Care should be exercised in treating suspected folate deficient
patients. Folate supplementation
should be considered. Folinic acid (3-6 mg/day) as calcium folinate,
may be administered without
interfering with the antibacterial activity of trimethoprim.
Regular monthly blood counts are advisable when trimethoprim is given
for long