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TIEMPE TABLETS 200MG

Active substance(s): TRIMETHOPRIM

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
TIEMPE/Trimethoprim 200mg.

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Trimethoprim BP 200 mg.

3

PHARMACEUTICAL FORM
Tablets.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Treatment of susceptible infections caused by Trimethoprim sensitive
organisms, including most Gram-positive and Gram-negative aerobic
organisms, including Haemophilus influenzae, Streptococcus pneumoniae,
Klebsiella pneumoniae, Staphylococcus aureus, E. Coli, Enterobacter, Proteus
and Streptococcus faecalis.
Exceptions include anaerobic bacteria. Mycobacterium tuberculosis, Neisseria
gonorrhoea, Pseudomonas auruginosa and Treponema pallidum.
Prophylaxis of recurrent urinary tract infections.

4.2

Posology and method of administration
Adults: Treatment of urinary tract infections and all other susceptible
infections: 200 mg twice daily.
Long term prophylaxis of recurrent urinary tract infections: 100 mg at night
before bedtime.

Children: 4 months to 12 years of age.
Treatment of urinary tract infections and all other susceptible infections:
6mg/kg bodyweight daily, subdivided into 2 equal doses.
Long term prophylaxis of recurrent urinary tract infections: 2.5mg/kg
bodyweight daily given as a single dose before bedtime.
Elderly: Treat as adults.
Route of Administration: Oral.

4.3

Contraindications
Severe hepatic insufficiency. Severe renal insufficiency. Megaloblastic
anaemia and other blood dyscrasias. Trimethoprim should not be administered
to premature infants or children under 4 months of age. Pregnancy Trimethoprim should not be administered to pregnant women.

4.4

Special warnings and precautions for use
Patients with marked impairment of renal function; care should be taken to
avoid accumulation and resulting adverse hepatological effects.
Regular haematological tests should be undertaken in patients receiving long-term
treatment and those pre-disposed to folate deficiency. Particular care should be
exercised in the haematological monitoring of children on long-term therapy.

4.5

Interaction with other medicinal products and other forms of interaction
No known interactions.

4.6

Pregnancy and lactation
The usual caution in prescribing any drug for women of child-bearing age
should be exercised with Trimethoprim. Trimethoprim is not contra-indicated
for short-term use in lactating mothers, although the drug is excreted in breast
milk.

4.7

Effects on ability to drive and use machines
Does not affect.

4.8

Undesirable effects
Nausea, vomiting, gastro-intestinal disturbance, headache, skin rashes and
pruritus. All these are rare.
Cases of Megaloblastic anaemia during prolonged therapy with Trimethoprim
in doses higher then those recommended rarely occur but are reversible with
discontinuation of therapy and administration of folinic acid.

4.9

Overdose
Treat symptomatically, gastric lavage and forced diuresis can be used.
Depression of haematopoiesis by Trimethoprim can be counteracted by
intramuscular injections of calcium folinate.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Trimethoprim has potent anti-microbial activity through its selective inhibition
of bacterial dihydrofolate reductase. It is effective against most gram-positive
and gram-negative aerobic organisms.

5.2

Pharmacokinetic properties
Absorption is by the oral route. Peak plasma levels are reached in about one
hour but significant plasma levels are obtained within half-an-hour.
Excretion is mainly in the urine in the form of unchanged drug. Trimethoprim
may cause an apparent rise in serum creatinine levels due to competition in the
tubular secretory mechanisms.

5.3

Preclinical safety data

Not applicable.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Lactose
Povidone
Crospovidone
Sodium starch glycollate
Magnesium stearate
Industrial methylated spirit
Purified water

6.2

Incompatibilities
There are no major incompatibilities.

6.3

Shelf life
36 months all pack sizes.

6.4

Special precautions for storage
Store in a dry place below 25°C.
Keep container well closed.

6.5

Nature and contents of container
Polypropylene or high density polystyrene with polythene closures and
polyurethane wads or polythene inserts.
Pack sizes: 50, 100, 500, 1000, 5000
250 micron PVC glass-clear/bluish rigid PVC (Pharmaceutical grade).
20 micron hard-tempered aluminium foil coated on the dull side with

6-7 gsm heat seal lacquer and printed on the bright side.
Pack sizes: 28

6.6

Special precautions for disposal
No special instructions

7

MARKETING AUTHORISATION HOLDER
Chelonia Healthcare Limited
11 Boumpoulinas Street,
3rd floor, 1060 Nicosia
Cyprus

8

MARKETING AUTHORISATION NUMBER(S)
PL 33414/0118

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION

10

DATE OF REVISION OF THE TEXT

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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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