TRIMETHOPRIM VIATRIS trimethoprim 300 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

trimethoprim, Quantity: 300 mg

Available from:

Alphapharm Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: lactose monohydrate; povidone; sodium starch glycollate; purified talc; magnesium stearate

Administration route:

Oral

Units in package:

7 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

This product approved for registration as a variation of a product accepted for inclusion in the ARTG as 'currently supplied' at the commencement of the Act. Indications are held in ARTG paper records. Previous Product Number AUST R 17577 and 43120. Product Information not reviewed. INDICATIONS AS AT 5 DECEMBER 1984 : Treatment of acute urinary tract infections caused by sensitive organisms.

Product summary:

Visual Identification: 9.5mm white normal convex tablet marked TM/300 on on side, G on reverse.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2020-09-07

Patient Information leaflet

TRIMETHOPRIM
MYLAN
_trimethoprim_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about TRIMETHOPRIM
MYLAN .
It does not contain all 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
TRIMETHOPRIM MYLAN against
the benefits expected 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 TRIMETHOPRIM
MYLAN IS USED FOR
TRIMETHOPRIM MYLAN is used
to treat infections of the urinary tract
caused by bacteria.
TRIMETHOPRIM MYLAN belongs
to a group of medicines called
antibiotics. It works by stopping the
growth of the bacteria that is causing
your infection.
USE TRIMETHOPRIM MYLAN
ONLY AS DIRECTED AND CONSULT A
HEALTH CARE PROFESSIONAL IF PAIN OR
SYMPTOMS PERSIST.
TRIMETHOPRIM MYLAN will not
work against infections caused by
viruses, such as colds or flu.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY
TRIMETHOPRIM MYLAN HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
TRIMETHOPRIM MYLAN for
another reason.
TRIMETHOPRIM MYLAN is
available only with a doctor's
prescription.
TRIMETHOPRIM MYLAN is not
recommended for use in children
under 6 years of age, as the safety
and effectiveness of
TRIMETHOPRIM MYLAN in this
age group has not been established.
BEFORE YOU TAKE
TRIMETHOPRIM
MYLAN
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE TRIMETHOPRIM
MYLAN IF YOU ARE ALLERGIC TO ANY
OTHER MEDICINES CONTAINING
TRIMETHOPRIM OR ANY OF THE
INGREDIENTS LISTED AT THE END OF THIS
LEAFLET.
Some of the symptoms of an allergic
reaction may include red, itchy skin
rashes, itching or hives; swelling of
the face, lips or tongue which may
cause difficulty in swallowing or
breathing; wheezing or shortness of
breath.
DO NOT TAKE TRIMETHOPRIM
MYLAN IF YOU HAVE:
•
a severe blood disorder or
anaemia
•
severe kidney problems.
DO NOT TAKE TRIMETHO

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
TRIMETHOPRIM MYLAN
_Trimethoprim tablets _
1
NAME OF THE MEDICINE
Trimethoprim
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each TRIMETHOPRIM MYLAN tablet contains trimethoprim 300 mg as the
active ingredient.
Excipients with known effect: lactose and traces of sulfites and
galactose.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
TRIMETHOPRIM MYLAN (trimethoprim) 300 mg: 9.5mm white normal convex
tablet marked TM/300 on one
side, G on reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of acute urinary tract infections caused by sensitive
organisms.
4.2
DOSE AND METHOD OF ADMINISTRATION
_ADULTS AND CHILDREN OVER 12 YEARS _
One tablet daily for 7 days.
_CHILDREN OVER 6 YEARS _
Half a table daily for 7 days.
_CHILDREN UNDER 6 YEARS _
There is no information available at present concerning the
appropriate dose of trimethoprim in children under
the age of 6 years.
_RENAL FAILURE _
The use of trimethoprim in patients with creatinine clearance of less
than 15 mL/minute is not recommended. If
the creatinine clearance is between 15 and 30 mL/minute, a reduced
dose should be considered.
In the treatment of acute urinary tract infection due to susceptible
organisms it is not necessary to use
trimethoprim for longer than 7 days.
To ensure maximal urinary concentration it may be advantageous to take
the dose before bedtime. The dose may
be taken with some food to minimise the possibility of
gastrointestinal disturbance.
4.3
CONTRAINDICATIONS
Trimethoprim 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
trimethoprim unless the plasma concentration of trimethoprim is
monitored repeatedly during treatment.
Trimethoprim should not be given to patients with severe
haematological disorders or documented megaloblastic
anaemia due to folate deficiency.
TRIMETHOPRIM MYLAN – PRODUCT INFORMATION
2
4