Trimethoprim 200mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Trimethoprim

Available from:

Bristol Laboratories Ltd

ATC code:

J01EA01

INN (International Name):

Trimethoprim

Dosage:

200mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010800; GTIN: 5060013942334

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
TRIMETHOPRIM 100MG TABLETS
TRIMETHOPRIM 200MG TABLETS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it
again.
•
If you have any further questions, ask
your doctor or pharmacist.
•
This medicine has been prescribed for
you only. Do not pass it on to others. It
may harm them, even if their signs of
illness are the same as yours.
•
If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Trimethoprim Tablets are and
what they are used for
2.
What you need to know before you
take Trimethoprim Tablets
3.
How to take Trimethoprim Tablets
4.
Possible side effects
5.
How to store Trimethoprim Tablets
6.
Contents of the pack and other
information
1. WHAT TRIMETHOPRIM TABLETS ARE
AND WHAT THEY ARE USED FOR
Trimethoprim is a type of antibacterial
medicine which works by killing bacteria.
Trimethoprim tablets may be used:
•
to treat a wide range of infections
including
urinary
infections
and
respiratory tract infections.
•
for long-term prevention of recurrent
urinary tract infections.
2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE TRIMETHOPRIM TABLETS
DO NOT TAKE TRIMETHOPRIM TABLETS IF YOU
•
are
allergic
(hypersensitive)
t o
trimethoprim
or
any
of
the
other
ingredients of this medicine (listed in
section 6)
•
are PREGNANT
•
suffer from any BLOOD DISORDERS such as
anaemia.
•
suffer from severe LIVER problems
Trimethoprim should not be given to prema-
ture babies or infants under 4 months of age.
The tablet form is NOT recommended for use
in children under 6 years
- the oral liquid form should be used.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before
taking Trimethoprim tablets if you:
•
are pregnant
•
suffer from kidney problems/kidney
disease or are having dialysis treatment.
•
have a deficiency (are low) i

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Trimethoprim 200 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg of Trimethoprim
Excipient with known effect: Also contains Lactose monohydrate 22.50
mg
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablets
White to off-white circular, flat bevelled edged uncoated tablets with
breakline
dividing “TMP” and “200” on one side and plain on the other
side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment
of
susceptible
infections
caused
by
trimethoprim-sensitive
organisms including urinary and respiratory tract infections
Long-term prophylaxis of recurrent urinary tract infections.
Consideration should be given to official guidance regarding the
appropriate
use of antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY:
_Acute infections: _
Treatment should continue for a period of between 3days (eg,
uncomplicated
bacterial cystitis in women) to 2weeks depending on the nature and
severity of
the infection. The first dos may be doubled.
_ _
_Adults: _200 mg twice daily
_ _
PAEDIATRIC POPULATION:
_Children over 12 years: _Same as adult dose_ _
_Children 6 years to 12 years: _100 mg twice daily
Children under 6 years: This dosage form is not suitable for use in
children younger
than 6 years.
_Elderly_: Dosage is dependent on renal function, see special dosage
schedule.
_Dosage advised schedule where there is reduced kidney function: _
eGFR (ml/min)
Dosage advised
Over 30
Normal
15 - 30
Normal for three days then half
dose
Under 15
Half the normal dose
Monitoring of renal function and serum electrolytes should be
considered
particularly with longer term use, in patients with impaired renal
function.
Trimethoprim should only be initiated and used in dialysis patients
under close
supervision from specialists in both infectious disease and renal
medicine.
Trimethoprim is removed by dialysis.
Monitoring trimethoprim plasma concentration may be considered with
long
t