Trimethoprim 100mg tablets

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Trimethoprim

Disponibil de la:

Kent Pharma (UK) Ltd

Codul ATC:

J01EA01

INN (nume internaţional):

Trimethoprim

Dozare:

100mg

Forma farmaceutică:

Oral tablet

Calea de administrare:

Oral

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: 05010800; GTIN: 5015201008194

Prospect

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TRIMETHOPRIM 100MG AND 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. THIS INCLUDES
ANY 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 WHAT TRIMETHOPRIM TABLETS ARE AND WHAT THEY ARE USED FOR
Trimethoprim Tablets belong to a group of medicines known as
antibacterials. They are used to kill a wide range of bacteria that
cause
infections in your body, primarily urinary and respiratory tract
infections.
This medicine can also be used for prevention of recurrent urinary
tract
infections.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRIMETHOPRIM TABLETS
DO NOT TAKE TRIMETHOPRIM TABLETS IF YOU: • are allergic (hypersensitive) to trimethoprim or to any of the
other
ingredients (see section 6, Contents of the pack and other
information) • are pregnant • suffer from severe liver problems • suffer from any blood disorders such as anaemia
Trimethoprim should not be administered to premature 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) in fol

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Trimogal
®
100mg Tablets
Trimethoprim 100mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains trimethoprim 100mg.
Excipients with known effect
Lactose
Sodium
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
White, round, flat faced bevelled edge tablet with an approximate
diameter of
7.5mm, embossed with 'T2' on one side and plain on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of acute urinary tract injections and long term prophylaxis
of
recurrent urinary tract infections.
Respiratory tract infections, in particular acute and chronic
bronchopneumonia
and pneumonia caused by organisms sensitive to trimethoprim.
Trimogal
is
particularly
useful
for
patients
known
to
be
sensitive
to
sulphonamides.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Acute infections:
Treatment should continue for a period of between 3 days (e.g.
uncomplicated
bacterial cystitis in women) to 2 weeks depending on the nature and
severity
of the infection. The first dose may be doubled.
Adults: 200mg twice daily.
Paediatric population:
Children over 12 years: Same as adult dose.
Children 6 – 12 years: 100mg 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