Trimethoprim 200mg tablets

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Trimethoprim

Dostopno od:

DE Pharmaceuticals

Koda artikla:

J01EA01

INN (mednarodno ime):

Trimethoprim

Odmerek:

200mg

Farmacevtska oblika:

Oral tablet

Pot uporabe:

Oral

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 05010800

Navodilo za uporabo

Package leaflet: Information for the patient
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, pharmacist or
nurse.
• 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, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. See section 4.
P0908T
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 belongs to a group of medicines known as anti-bacterials
which are effective against a wide range of 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 to any of the other
ingredients of this medicine (listed in section 6)
• you have severe liver problems
• you have a blood disorders such as anaemia
• you are pregnant or think you may be pregnant.
This medicine should not be given to premature babies or babies under
4 months old.
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 BEFORE TAKING TRIMETHOPRIM TABLETS IF:
• you are pregnant or think you may be pregnant
• you have porphyria (a disorder that causes skin sensitivity to
light, pain att

Lastnosti izdelka

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