Trimethoprim 200mg tablets

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Trimethoprim

Dostupné z:

Kent Pharma (UK) Ltd

ATC kód:

J01EA01

INN (Medzinárodný Name):

Trimethoprim

Dávkovanie:

200mg

Forma lieku:

Oral tablet

Spôsob podávania:

Oral

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 05010800; GTIN: 5015201008200 5015201008804

Príbalový leták

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 kidney or 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 (a

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Trimogal
®
200mg Tablets
Trimethoprim 200mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains trimethoprim 200mg.
Excipients with known effect
Lactose
Sodium
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
White, round, biconvex, tablets with an approximate diameter of 9.0
mm,
embossed with 'T & 3' separated by a score line on one side and plain
on other
side.
The score line is not intended for breaking the tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of urinary tract infections 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 cystisis 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.
Monitori