SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT

Furosemide Tablets 500 mg

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains Furosemide 500 mg BP

3 PHARMACEUTICAL FORM

Tablet

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Furosemide is a potent diuretic with rapid action.

Furosemide tablets 500 mg are indicated for the management of oliguria due to acute or chronical renal insufficiency.

4.2    Posology and method of administration

Posology

Adults

In patients with chronic renal sufficiency, an initial daily dose of 250 mg ('A tablet) is employed. If a satisfactory diuresis is not produced then the dose may be increased in steps of 250 mg at four to six hourly intervals up to a maximum daily dose of 1500 mg in 24 hours. In exceptional cases up to 2000 mg 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.

Paediatric population

Furosemide tablets 500 mg are unlikely to be suitable for use in children.

Method of administration

For oral administration only.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or sulphonamides.

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

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.

Symptomatic hypotension leading to dizziness, fainting or loss of consciousness can occur in patients treated with furosemide, particularly in the elderly, patients on other medications which can cause hypotension and patients with other medical conditions that are risks for hypotension.

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 cefaloridine and the aminoglycoside antibiotics may be increased by Furosemide.

The action of diuretics such as Furosemide may be antagonised by certain nonsteroidal 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 borne 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 lidocaine, mexiletine and tocainide.

4.6    Fertility, pregnancy and lactation

Pregnancy

The safety of high dosage Furosemide in pregnancy has not been established and Furosemide tablets 500 mg should be used with caution, weighing potential benefit to the patient against possible hazard to the foetus.

Breast-feeding

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 interstital nephritis have occurred very rarely.

Nervous system disorders:

Not known: dizziness, fainting and loss of consciousness (caused by symptomatic hypotension)

Ear and labyrinth disorders:

Uncommon: deafness (sometimes irreversible)

Skin and subcutaneous tissue disorders:

Not known: acute generalised exanthematous pustulosis (AGEP)

The incidence of allergic reactions such as skin rashes is very low, but when these occur treatment should be withdrawn. A transient rise in creatine 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.

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

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

Furosemide 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

Furosemide 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. Furosemide crosses the placental barrier and is excreted in milk. The clearance of Furosemide 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.

6.1 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    Special precautions for disposal and other handling

No special requirements.

7    MARKETING AUTHORISATION HOLDER

Generics [UK] Ltd,

Station Close,

Potters Bar,

Herts,

EN6 1TL

8    MARKETING AUTHORISATION NUMBER(S)

PL 04569/0115

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date Granted: 13/02/86 Last Renewal: 14/04/99

10 DATE OF REVISION OF THE TEXT

07/01/2016