Trimethoprim 200mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Trimethoprim

Available from:

Sandoz 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

Patient Information leaflet

PATIENT INFORMATION LEAFLET
TRIMETHOPRIM 200MG TABLETS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
x
Keep this leaflet. You may need to read it again.
x
If you have any further questions, ask your doctor
or pharmacist.
x
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.
x
If you get any side effects, talk to your doctor or
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet, See section 4.
IN THIS LEAFLET:
1. What Trimethoprim is and what it is used for
2. What you need to know before you take
Trimethoprim
3. How to take Trimethoprim
4. Possible side effects
5. How to store Trimethoprim
6. Contents of the pack and other information
1. WHAT TRIMETHOPRIM IS AND WHAT IT IS USED
FOR
Trimethoprim is an antibacterial medicine used to
treat a wide range of infections including urinary and
respiratory tract infections. It is also used for long
term prevention of recurrent urinary tract infections.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
TRIMETHOPRIM
DO NOT TAKE TRIMETHOPRIM IF YOU:
x
are sensitive (allergic) to trimethoprim or any of
the other ingredients of the tablet (see section 6)
x
have severe liver disease
x
are pregnant
x
have any blood disorder
Trimethoprim should not be given to premature
infants or during the first few weeks of life.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking these
tablets if you:
x
have kidney disease or are having dialysis
treatment
x
have a deficiency of folic acid (may cause
anaemia)
OTHER MEDICINES AND TRIMETHOPRIM
Tell your doctor or pharmacist if you are taking, have
recently taken any other medicines, including
medicines obtained without a prescription.
In particular, tell your doctor if you are taking:
x
cytotoxic drugs (tumour suppressing)
x
pyrimethamine (malaria prevention)
x
phenytoin (anticonvulsant-to treat epilepsy)
x
ciclosporin (preven

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 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 and for
long-term
prophylaxis of recurrent urinary tract infections.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ACUTE INFECTIONS: _
Treatment should continue for a period of between 3 days (eg,
uncomplicated
bacterial cystitis in women) to 2 weeks depending on the nature and
severity
of the infection. The first dose 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
below.
_Advised dosage schedule where _
_there is reduced kidney function: _
eGFR (ml/min)
Dosage advised
Over 30
Normal
15 – 30
Normal for 3 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
term therapy but the value of this in individual cases should first be
discussed
with specialists in infections d