Trimethoprim 100mg tablets

País: Regne Unit

Idioma: anglès

Font: MHRA (Medicines & Healthcare Products Regulatory Agency)

ingredients actius:

Trimethoprim

Disponible des:

Teva UK Ltd

Codi ATC:

J01EA01

Designació comuna internacional (DCI):

Trimethoprim

Dosis:

100mg

formulario farmacéutico:

Oral tablet

Vía de administración:

Oral

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 05010800; GTIN: 5017007212041

Informació per a l'usuari

PHARMA CODE
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.
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 contain the active
substance trimethoprim. Trimethoprim belongs to
a group of medicines called antibacterials.
•
Trimethoprim is used for the prevention and
treatment of infections, particularly in the urinary
and respiratory tracts.
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 or breast-feeding
•
suffer from any blood disorders such as anaemia
•
suffer from severe liver problems
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. Alternative dosage forms
are available.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking
Trimethoprim Tablets if you:
•
have kidney problems/kidney disease or are
having dialysis treatment
•
have folate-deficiency anaemia (a decrease in red
blood cells due to a poor diet, which can cause
tiredness, headache, a sore mouth and tongue
and pale skin)
•
are at greater risk of hig

Fitxa tècnica

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Trimethoprim Tablets 100 mg.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100 mg of trimethoprim.
Excipients with known effect
Each tablet contains 67.5 mg lactose
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
White, normal biconvex tablets, engraved Berk 2H7 or 2H7 with a
breakline on reverse.
The breakline is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Trimethoprim is indicated for the treatment of susceptible infections
caused by trimethoprim -
sensitive organisms including urinary tract and respiratory tract
infections.
Trimethoprim is also indicated for the prevention of recurrent urinary
tract infections.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Acute infections: _
_ _
_Adults and children over 12 years of age: _200 mg twice daily_ _
_ _
_Children 6 years to 12 years: _100 mg twice daily
_ _
_Children under 6 years of age:_
This dosage form is not suitable for use in children younger
than
6 years, a more suitable dosage form (such as a suspension) should be
used in this age group.
_Elderly:_ Depending on kidney function, see special dosage schedule.
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 can be doubled.
_Long-term treatment and prophylactic therapy: _
_ _
_Adults and children over 12 years: _100 mg at night
_Children 6 years to 12 years of age:_ 50 mg at night. Where a single
dose is required,
dosage at bedtime may maximise urinary concentrations. The approximate
dosage in
children is 2mg trimethoprim per kg body weight per day.
This dosage form is not
suitable for use in children younger than
12 years, a more suitable dosage form (such as a
suspension) should be used in this age group.
_ _
_Elderly: _Depending on kidney function, see speci