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TRIMETHOPRIM TABLETS BP 200MG

Active substance(s): TRIMETHOPRIM / TRIMETHOPRIM

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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.

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.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Trimethoprim is an antibacterial agent active in-vitro against a wide range of
Gram-negative and Gram-positive organisms. It is administered orally for the
following purposes.
Urinary Tract:
In the treatment of acute and chronic urinary tract infections and for
prophylactic treatment of patients with a tendency to recurrent urinary
infections.
Respiratory Tract:
In the treatment of acute and chronic bronchitis, bronchopneumonia and lobar
pneumonia.

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 and children over 12 years: 200 mg twice daily.



Children 6 - 12 years: 100 mg twice daily.



Elderly: Dosage is dependent upon kidney function; see special dosage schedule.



Children under 6 years of age: Not recommended; a more suitable dosage form
should be used in this age group.
Long-term treatment and prophylactic therapy:



Adults and children over 12 years: 100 mg at night.



Children 6-12 years: 50mg at night.
Where a single daily dose is required, dosage at bedtime may maximise urinary
concentrations. The approximate dosage in children is 2mg trimethoprim per kg body
weight per day.



Elderly: Dosage is dependent upon kidney function; see special dosage schedule.

Advised dosage Schedule where there is reduced kidney function:
Creatinine Clearance
Over 0.45
0.25 - 0.45
Under 0.25

Plasma creatinine
(micromol/l)
Men <250
Women <175
Men 250-600
Women 175-400
Men >600
Women >400

Dosage advised
Normal
Normal for 3 days then half
dose
Half the normal dose

Trimethoprim is removed by dialysis. However, it should not be administered to dialysis
patients unless plasma concentrations can be estimated regularly.

Route of administration: For oral administration.

4.3

4.4

Contraindications
1.

Hypersensitivity to trimethoprim or to any of the excipients listed in section 6.1.

2.

Severe renal insufficiency where blood levels cannot be monitored regularly.

3.

Pregnant women.

4.

Premature infants and neonates during the first two months of life.

5.

Blood dyscrasias.

6.

Severe hepatic insufficiency.

Special warnings and precautions for use
Caution should be exercised in patients with impaired renal function (refer to
Section 4.2. Posology and Method of Administration). In patients with renal
impairment, care should be taken to avoid accumulation.
This product is classified as unsafe for use in porphyria.
Long term therapy requires regular haematological examination.
Special care should be taken in patients with a predisposition to folate
deficiency and in elderly patients and administration of folate supplement
should be considered.
Although an effect on folate metabolism is possible, interference with
haematopoiesis rarely occurs at the recommended dose. If any such change

is seen, folinic acid should reverse the effect. Elderly people may be more
susceptible and a lower dose may be advisable.
Concomitant use of spironolactone known to cause hyperkalaemia with trimethoprim
may result in severe hyperkalaemia.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase
deficiency or glucose-galactose malabsorption should not take this medicine.

4.5

Interaction with other medicinal products and other forms of interaction
Antimalarials: There is an increased risk of antifolate effect when taken with
pyrimethamine.
Antibacterials: Concomitant use of trimethoprim and dapsone
may increase plasma concentrations of both drugs.
Anticoagulants: Trimethoprim should be used with caution in patients
receiving warfarin and acenocoumarol as potentiation of the effects of
these agents may occur.
Antiepileptics: Plasma concentration and antifolate effect of phenytoin is
increased when taken concurrently.
Antivirals: Lamivudine plasma concentration may be increased if taken
concurrently.
Cardiac glycosides: Plasma concentration of digoxin may be increased when
taken concurrently with trimethoprim.
Bone marrow depressants: trimethoprim may increase the potential for bone
marrow aplasia. Cytotoxic agents such as azathioprine, mercaptopurine and
methotrexate increase the risk of haematologic toxicity when given with
trimethoprim.
Rifampicin may increase the elimination and shorten the elimination half-life
of trimethoprim.
Ciclosporin may increase the nephrotoxicity of trimethoprim.
In addition to other medicinal products known to cause hyperkalaemia concomitant
use of trimethoprim with spironolactone may result in clinically relevant
hyperkalaemia.

4.6

Fertility, pregnancy and lactation
Trimethoprim should not be given to pregnant women, premature infants or
infants during the first few weeks of life.
Although trimethoprim is excreted in the breast milk, it is not necessarily
contraindicated for short-term therapy during lactation.

4.7

Effects on ability to drive and use machines

None reported.
4.8

Undesirable effects
The most frequent adverse effects at usual doses are pruritus and skin rash (in about 3
to 7% of patients) and mild, gastro-intestinal adverse effects including nausea,
vomiting and glossitis. These effects are generally mild and quickly reversible on
withdrawal of the drug.
Blood and lymphatic system disorders
Leucopenia, megaloblastic anaemia, thrombocytopenia, agranulocytosis,
hyperkalaemia (particularly in the elderly and in HIV patients),
methaemoglobinaemia. Trimethoprim therapy may affect haematopoiesis.
Prolonged administration may depress haematopoiesis due to an effect on folic
acid metabolism. This effect may be reversed by the administration of
calcium folinate.
Patients on long-term treatment and their carers should be taught to
recognise the following symptoms which may be indicative of a blood
disorder:
Fever, sore throat, rash, mouth ulcers, purpura or unexpected bruising or
bleeding.
Medical attention should be sought in the event of such symptoms.
Nervous system disorders
Aseptic meningitis.
Gastrointestinal disorders
Nausea, vomiting, glossitis, gastrointestinal disturbances, sore mouth.
Hepatobiliary disorders
Disturbances in liver enzyme values, cholestatic jaundice.
Skin and subcutaneous tissue disorders
Skin rash, exfoliative dermatitis, pruritus and urticaria . More severe skin
sensitivity or allergic reactions such as photosensitivity, angioedema,
erythema multiforme, Stevens Johnson syndrome and toxic epidermal
necrolysis have been reported rarely.
Frequency unknown: Pemphigoid
Musculoskeletal and connective tissue disorders
Myalgia.
Renal and urinary disorders
Raised serum creatinine and blood urea nitrogen levels. It is not known however,
whether this represents inhibition of creatinine tubular secretion or genuine renal
dysfunction.
General disorders and administration site conditions
Anaphylaxis, drug fever, headache.
Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after authorisation of the medicinal product is
important. It allows continued monitoring of the benefit/risk balance of the medicinal
product. Healthcare professionals are asked to report any suspected adverse reactions
via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

4.9

Overdose
Symptomatic treatment, gastric lavage and forced alkaline diuresis may be used.
Depression of haematopoiesis by trimethoprim may be countered with intramuscular
calcium folinate. Symptoms of overdosage are vomiting and diarrhoea.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Pharmacotherapeutic group: Systemic antibacterial.
ATC Code: J01EA01

Mechanism of action: Trimethoprim is a dihydrofolate reductase inhibitor which
affects the nucleoprotein metabolism of micro-organisms by interference in the folicfolinic acid systems.
Trimethoprim is effective in vitro against a wide range of Gram-positive and aerobic
Gram-negative organisms, including enterobacteria Escherica coli, Proteus, Klebsiella
pneumoniae, Streptococcus pneumoniae, Streptococcus faecalis, Haemophilus
influenzae and Staphylococcus aureus.
It is not effective against Anaerobes, Pseudomonas aeruginosa, Treponema pallidum,
Mycobacteria, Nocardia species, Neisseria species and Brucella abortus.

5.2

Pharmacokinetic properties
Trimethoprim is rapidly and almost completely absorbed from the gastrointestinal
tract and peak concentrations in the circulation occur about 1-4 hours after an oral
dose. Peak plasma concentrations of about 1µg/ml have been reported after a single
dose of 100mg. Approximately 40-70% is bound to plasma proteins. The half life is
approximately 8-10 hours. About 40-60% of a dose is excreted unchanged in the
urine within 24 hours, together with metabolites; hence, patients with impairment of
renal function such as the elderly may require a reduction in dosage due to
accumulation. It appears in breast milk.

5.3

Preclinical safety data
Not applicable.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Lactose
Maize starch
Pregelatinised maize starch
Magnesium stearate
Sodium starch glycollate

6.2

Incompatibilities
None reported.

6.3

Shelf life
Trimethoprim Tablets 100 mg
Opaque plastic containers:
60 months, as packaged for sale
Blister packs:
36 months, as packaged for sale
Trimethoprim Tablets 200 mg
Opaque plastic containers:
36 months, as packaged for sale
Blister packs:
36 months, as packaged for sale

6.4

6.5

6.6

Special precautions for storage
Protect from heat, light and moisture.
Nature and contents of container
The product may be packed in the following containers:
a) Opaque plastic containers composed of polypropylene tubes and
polyethylene made tamper-evident closures in pack sizes of 9, 10, 14, 15,
20, 21, 28, 30, 50, 56, 84, 100, 250, 500 and 1000 tablets.
b) Opaque plastic containers composed of either high density polypropylene
or high density polyethylene with a tamper-evident or child-resistant
tamper-evident closure composed of high density polyethylene with a
packing inclusion of standard polyether foam or polyethylene or
polypropylene made filler in pack sizes of 9, 10, 14, 15, 20, 21, 28, 30, 50,
56, 84, 100, 250, 500 and 1000 tablets.
c) Blister packs of aluminium/opaque PVC in pack sizes of 9, 10, 14, 15, 20,
21, 28, 30, 56 and 84 tablets.
Not all pack sizes may be marketed.
Special precautions for disposal
No special instructions for use/handling.

7

MARKETING AUTHORISATION HOLDER
Crescent Pharma Limited
Units 3 & 4, Quidhampton Business Units
Polhampton Lane
Overton
Hants
RG25 3ED
United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)

PL 20416/0160
PL 20416/0161

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
23/04/2004

10

DATE OF REVISION OF THE TEXT
02/05/2017

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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