Trimethoprim 100mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Trimethoprim

Available from:

Actavis UK Ltd

ATC code:

J01EA01

INN (International Name):

Trimethoprim

Dosage:

100mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010800; GTIN: 5012617005427

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 to 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 infants
under 4 months of age.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before
taking Trimethoprim tablets if you:
•
have DEFICIENCY OF FOLIC ACID (may cause
anaemia).
•
have KIDNEY problems or are having dialysis
treatment
•
have ACUTE PORPHYRIA (symptoms include
severe abdominal pain, nausea, vomiting
and constipation)
•
are also taking repaglinide (medicine for
treating diabetes)

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Trimethoprim 100mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Trimethoprim 100mg.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet: white coloured flat bevelled edged tablets engraved with
‘MT100’.
Slight characteristic odour.
4. CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
•
Treatment of susceptible infections caused by trimethoprim sensitive
organisms
including urinary infections and respiratory tract infections.
•
Long-term prophylaxis of recurrent urinary tract infections.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_Acute infections: _
Treatment should continue for a period of between three days (e.g.
uncomplicated bacterial cystitis in women) and two weeks according to
the
nature and severity of infection. The first dose can be doubled.
•
Adults and children over 12 years: 200mg twice daily.
•
Children 6-12 years: 100mg twice daily.
•
Children under 6 years of age: Not recommended; a more suitable dosage
form should be used in this age group.
•
Elderly: Dosage is dependent upon kidney function; see special dosage
schedule
_Long-term treatment and prophylactic therapy: _
•
Adults and children over 12 years: 100mg at night.
•
Children 6-12 years: 50mg at night. Where a single daily dose is
required,
dosage at bedtime may maximise urinary concentrations. The approximate
dosage in children is 2mg trimethoprim per kg body weight per day.
•
Elderly: Dosage is dependent upon kidney function; see special dosage
schedule
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 in