FUROSEMIDE TABLETS 500MG

Active substance: FUROSEMIDE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Furosemide Tablets 500mg

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Furosemide 500mg BP

3.

PHARMACEUTICAL FORM
Tablet

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Furosemide is a potent diuretic with rapid action.
Furosemide tablets 500mg are indicated for the management of oliguria due to
acute or chronical renal insufficiency.

4.2

Posology and method of administration
For oral administration only.
Adults:
In patients with chronic renal sufficiency, an initial daily dose of 250mg (½
tablet) is employed. If a satisfactory diuresis is not produced then the dose
may be increased in steps of 250mg at four to six hourly intervals up to a
maximum daily dose of 1500mg in 24 hours. In exceptional cases up to
2000mg in 24 hours may be given.
Elderly:

The usual adult dose, but caution is advised as Furosemide is excreted more
slowly in the elderly. Dosage should be titrated until the required response is
achieved.
Children:
Furosemide tablets 500mg are unlikely to be suitable for use in children.

4.3.

Contraindications
Furosemide is contraindicated in the presence of anuria, electrolyte deficiency,
precoma associated with hepatic cirrhosis, digitalis intoxication, porphyria and
hypersensitivity to Furosemide or sulphonamides.

4.4.

Special warnings and precautions for use
Where indicated, steps should be taken to correct hypotension or
hypovolaemia before commencing therapy.
Regular monitoring of fluid and electrolyte balance is recommended.
Pre-existing metabolic alkalosis (e.g. in decompensated cirrhosis of the liver)
may be aggravated by Furosemide treatment.
Use with caution in patients with impaired hepatic or renal function, diabetes
mellitus or adrenal disease.
Use with care in elderly patients or those with prostatic hypertrophy or
impairment of micturition.
Latent diabetes may become manifest or the insulin requirements of diabetic
patients may increase.
Use with caution in patients with a history of gout.
Discontinue Furosemide if bone marrow suppression occurs.

4.5.

Interaction with other medicinal products and other forms of interaction
Furosemide may enhance the toxicity of cardiac glycosides by electrolyte
disturbance particularly potassium and magnesium.
The action of antihypertensive agents such as methyldopa may be enhanced by
Furosemide. Hypotension may occur if ace inhibitors are added to Furosemide

therapy. The dose of Furosemide should be reduced or the drug stopped before
initiating the ace inhibitor.
The nephrotoxic effect of cephaloridine and the aminoglycoside antibiotics
may be increased by Furosemide.
The action of diuretics such as Furosemide may be antagonised by certain
non-steroidal anti-inflammatory agents.
The renal clearance of lithium is decreased by Furosemide, resulting in
increased and possibly toxic serum levels. Concomitant administration should
be avoided unless plasma levels can be monitored.
Concurrent administration of glucocorticoids may cause sodium retention and
exacerbate potassium loss.
In cases of abuse of laxatives, the risk of an increased potassium loss should
be bourne in mind.
Furosemide decreases the effects of some drugs (e.g. antidiabetics and pressor
amines) and may potentiate the effects of others (e.g. salicylates, theophylline,
and curare type muscle relaxants).
Resultant hypokalaemia may potentiate the cardiac toxicity of certain drugs
such as antihistamines and antiarrhythmics. It may also antagonise the action
of antiarrhythmics such as lignocaine, mexiletine and tocainide.

4.6

Pregnancy and lactation
The safety of high dosage Furosemide in pregnancy has not been established
and Furosemide tablets 500mg should be used with caution, weighing
potential benefit to the patient against possible hazard to the foetus.
As it may inhibit lactation and passes into breast milk, Furosemide should be
used with caution in nursing mothers.

4.7.

Effects on ability to drive and use machines
Reduced mental alertness and rarely dizziness and blurred vision have been
reported. Patients so affected should not drive or operate machines.

4.8.

Undesirable effects

Fluid and electrolyte imbalance is the most common side effect. Uncommonly,
nausea, diarrhoea, blurred vision, dizziness, headache may occur. Pancreatitis,
photosensitivity, vasculitis and interstitial nephritis have occurred very rarely.
The incidence of allergic reactions such as skin rashes is very low, but when
these occur treatment should be withdrawn. A transient rise in creatinine may
occur as may hypotension and liver dysfunction. Muscle spasm and
paraesthesia have also been reported. Hyperuricaemia may be induced and
precipitate gout in some patients.
Temporary increase in plasma cholesterol and triglyceride concentrations may
occur. Latent diabetes may become manifest and the insulin requirements of
diabetic patients may increase. Bone marrow depression is a rare complication
and treatment should be withdrawn. The haemopoeitic status should therefore
be regularly monitored. Calcium depletion may occur and nephrocalcinosis
has been reported in premature infants. Tinnitus and deafness have occurred,
usually with large parenteral doses and rapid administration and in renal
impairment.

4.9.

Overdose
Treatment of overdose should be directed to correcting dehydration and
electrolyte depletion resulting from excessive diuresis. Gastric lavage may be
useful if ingestion is recent.

5.

PHARMACOLOGICAL PROPERTIES

5.1.

Pharmacodynamic properties
Fursomide is a potent diuretic with rapid action. Its primary site of action is in
the ascending loop of henle where it inhibits electrolyte re-absorption, thus
enhancing the excretion of water and sodium, potassium and chloride ions.

5.2.

Pharmacokinetic properties
Fursomide is rapidly absorbed from the gastrointestinal tract. Bioavailability
has been reported to be about 60-70%. It has a biphasic half-life in plasma
with terminal elimination phase up to about two hours but this is prolonged in
neonates, and in patients with hepatic and renal insufficiency. About 99% is
bound to plasma proteins. It is excreted mainly in the urine, largely
unchanged. Fursomide crosses the placental barrier and is excreted in milk.
The clearance of Fursomide is not increased by haemodialysis.

5.3.

Preclinical safety data
There is no preclinical safety data of relevance to the prescriber which are
additional to those already included in other section of the SPC.

6.

PHARMACEUTICAL PARTICULARS

6.1.

List of excipients
The tablet contains Microcrystalline Cellulose BP, Lactose BP, Polysorbate 80
BP, Maize Starch for Granulation BP, Magnesium Stearate BP, Talc BP,
Sodium Starch Glycollate BP, Maize Starch for Paste BP and Quinoline
Yellow.

6.2.

Incompatibilities
None known

6.3.

Shelf life
36 months

6.4.

Special precautions for storage
Protect from light. Store in a cool dry place.

6.5.

Nature and contents of container
Polyethylene pots with white polyethylene caps and polyethylene ullage filler
in pack sizes of 100, 250, 500 and 1000,

6.6.

Instructions for use/handling
No special requirements.

7

MARKETING AUTHORISATION HOLDER
Generics [UK] Ltd
t/a Mylan
Station Close
Potters Bar
Herts
EN6 1TL

8

MARKETING AUTHORISATION NUMBER(S)
PL 04569/0115

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION

07/02/2005

10.

DATE OF (PARTIAL) REVISION OF THE TEXT
June 2004

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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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