Trimethoprim 200mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Trimethoprim

Available from:

Crescent Pharma Ltd

ATC code:

J01EA01

INN (International Name):

Trimethoprim

Dosage:

200mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010800; GTIN: 5017123322242

Patient Information leaflet

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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Trimethoprim Tablets BP 100 mg
Trimethoprim Tablets BP 200 mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Trimethoprim Tablets BP 100 mg
Each tablet contains 100 mg of trimethoprim BP.
Excipient with known effect.
Trimethoprim Tablets BP 100 mg contains 50mg of lactose.
Trimethoprim Tablets BP 200 mg
Each tablet contains 200 mg of trimethoprim BP.
Excipient with known effect.
Trimethoprim Tablets BP 200 mg contains 100mg of lactose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Trimethoprim Tablets BP 100 mg
Tablet.
White, round, flat bevelled edged tablets, engraved on one side with
the
company logo and with a breakline and A307 on the other side.
The score line is only to facilitate breaking for ease of swallowing
and not to
divide into equal doses.
Trimethoprim Tablets BP 200 mg
Tablet.
White, round, flat bevelled edged tablets, engraved on one side with
the
company logo and with a breakline and A322 on the other side.
The score line is only to facilitate breaking for ease of swallowing
and not to
divide into equal doses.
4.1
THERAPEUTIC INDICATIONS
Treatment of susceptible infections caused by trimethoprim-sensitive
organisms including urinary infections and respiratory tract
infections.
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: 200mg twice daily
Paediatric population:
Children over 12 years: Same as adult dose
Children 6 - 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.
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