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SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Furoseimide Tablets BP 20mg.

2    QUALITATIVE AND QUANTITATIVE    COMPOSITION

Each tablet contains furosemide BP 20mg.

3    PHARMACEUTICAL FORM

Uncoated tablet.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Furosemide Tablets BP 20mg are recommended for use in all indications when a prompt and effective diuresis is required. They are indicated for the maintenance therapy of mild oedema of any origin.

4.2    Posology and method of administration

Adults:

Initially 40mg in the morning; maintenance 20mg daily or 40mg on alternate days, increasing in resistant oedema to 80mg daily.

Elderly:

Furosemide is generally eliminated more slowly in the elderly. The dosage should be titrated until the required response is achieved.

Children:

1mg to 3mg/kg daily up to maximum total dose of 40mg/day.

Method of administration: Oral.

4.3    Contraindications

•    Hypersensitivity to furosemide, any of its excipients, sulphonamides, sulphonamide derivatives/amiloride

•    Anuria and impaired renal function (creatinine clearance below 30mL/min per 1.73 m2 body surface area) and renal failure resulting from poisoning by nephrotoxic and/or hepatotoxic agents

•    Electrolyte disturbances (severe hyponatraemia: severe hypokalaemia, hypovolaemia), dehydration and/or hypotension (see section 4.4)

•    Concomitant potassium supplements or potassium sparing diuretics (see section 4.5)

•    Pre-coma/coma associated with hepatic cirrhosis or encephalopathy

•    Addison's disease

•    Digitalis intoxication (see also section 4.5)

•    Breast-feeding women (see section 4.6)

4.4    Special Warnings and Precautions for Use

Hypotension and/or hypovolaemia (see also section 4.3)

These and any acid-base disturbances should be corrected before furosemide is started.

Dose titration/adjustment (see section 4.2)

•    Patients with hypoproteinaemia (such as that associated with the nephrotic syndrome) require careful dose titration (reduced furosemide effect: increased risk of ototoxicity)

•    In moderate liver congestion dosage adjustment may be needed.

Caution required:

Caution needed in the following circumstances

•    impaired hepatic function (see sections 4.2 & 4.3 and below - monitoring required)

•    impaired renal function and hepato-renal syndrome (see section 4.3 and below -monitoring required)

•    diabetes mellitus (latent diabetes may become overt: insulin requirements in established diabetes may increase)

•    elderly patients

•    difficulty with micturition/potential obstruction in the urinary tract including prostatic hypertrophy (increased risk of acute retention).

•    gout (increased risk of hyperuricaemia)

•    patients at risk of pronounced falls in blood pressure.

Clinical monitoring requirements (see also section 4.8):

Regular monitoring for

•    blood dyscrasias. If these occur, stop furosemide immediately

•    liver damage

•    idiosyncratic reactions.

In premature infants there is a risk of development of nephrocalcinosis/nephrolithiasis. Renal function must be monitored and renal ultrasonography performed.

Laboratory monitoring requirements:

•    frequent BUN (blood urea nitrogen test) in first few months of treatment, periodically thereafter

•    serum electrolytes with replacement as appropriate.

Other alterations in lab values

•    Serum creatinine and urea levels tend to rise during treatment

•    Serum cholesterol and triglycerides may rise but usually return to normal within 6 months of starting furosemide

•    Furosemide should be discontinued before a glucose tolerance test.

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 medicaments and other forms of interaction

Antihypertensives - enhanced hypotensive effect possible with all types. Concurrent use with ACE inhibitors can result in marked falls in blood pressure. Furosemide should be stopped or the dose reduced before starting an ACE-inhibitor. There is a risk of a first-dose effect with post-synaptic alphablockers eg prazosin. Furosemide may interact with ACE inhibitors causing impaired renal function.

Antipsychotics - furosemide-induced hypokalaemia increases the risk of cardiac toxicity. Avoid concurrent use with pimozide. Increased risk of ventricular arrhythmias with amisulpride or sertindole. Enhanced hypotensive effect with phenothiazines.

Anti-arrhythmics (including amiodarone, disopyramide, flecanaide and sotalol) - risk of cardiac toxicity (because of furosemide-induced hypokalaemia). The effects of lidocaine, tocainide or mexiletine may be antagonised by furosemide.

Drugs associated with QTprolongation - cardiac toxicity may be increased by furosemide-induced hypokalaemia and/or hypomagnesaemia.

Cardiac glycosides - hypokalaemia and electrolyte disturbances (including magnesium) increases the risk of cardiac toxicity.

Vasodilators - enhanced hypotensive effect with moxisylyte (thymoxamine) or hydralazine.

Renin inhibitors - aliskiren reduces plasma concentrations of furosemide.

Nitrates - enhanced hypotensive effect.

Lithium - Furosemide reduces lithium excretion with increased plasma lithium concentrations (risk of toxicity). Avoid concomitant administration unless plasma levels are monitored.

Chelating agents - sucralfate may decrease the gastro-intestinal absorption of furosemide - the 2 drugs should be taken at least 2 hours apart.

Lipid regulating drugs - Bile acid sequestrants (eg colestyramine: colestipol) -reduced absorption of furosemide - administer 2 to 3 hours apart.

NSAIDs - increased risk of nephrotoxicity (especially if there is hypovolaemia). Indometacin and ketorolac may antagonise the effects of furosemide. In patients with dehydration or hypovolaemia, NSAIDs may cause acute renal insufficiency.

Salicylates - effects may be potentiated by furosemide.

Antibiotics - increased risk of ototoxicity with aminoglycosides, polymixins or vancomycin. Increased risk of nephrotoxicity with aminoglycosides or cefaloridine. Furosemide can decrease vancomycin serum levels after cardiac surgery.

Antidepressants - enhanced hypotensive effect with MAOIs. Increased risk of postural hypotension with TCAs (tricyclic antidepressants). Possible increased risk of hypokalaemia with reboxetine.

Antidiabetics - hypoglycaemic effects antagonised by furosemide.

Insulin - requirements may be increased (see section 4.4).

Antiepileptics - increased risk of hyponatraemia with carbamazepine. Diuretic effect reduced by phenytoin.

Antihistamines - hypokalaemia with increased risk of cardiac toxicity.

Antifungals - increased risk of hypokalaemia with amphoterecin.

Anxiolytics and hypnotics - enhanced hypotensive effect. Chloral or triclorfos may displace thyroid hormone from binding site.

CNS stimulants (drugs used for ADHD) - hypokalaemia increases the risk of ventricular arrhythmias.

Corticosteroids - diuretic effect antagonised (sodium retention) and increased risk of hypokalaemia.

Cytotoxics - increased risk of nephrotoxicity and ototoxicity with platinum compounds.

Other diuretics - profound diuresis possible when furosemide given with metolazone. Increased risk of hypokalaemia with thiazides.

Dopaminergics - enhanced hypotensive effect with levodopa.

Immunomodulators - enhanced hypotensive effect with aldesleukin.

Muscle relaxants - enhanced hypotensive effect with baclofen or tizanidine (see also Anaesthetic agents below - curare).

Oestrogens and progestogens - diuretic effect antagonized.

Prostaglandins - enhanced hypotensive effect with alprostadil.

Sympathomimetics - increased risk of hypokalaemia with high doses of beta₂ sympathomimetics (such as bambuterol, femoterol, salbutamol, salmeterol and terbutaline).

Theophylline - enhanced hypotensive effect.

Probenecid - reduced renal clearance of furosemide and decreased diuretic effect.

Anaesthetic agents - general anaesthetic agents may enhance the hypotensive effects of furosemide. The effects of curare may be enhanced by furosemide.

Alcohol - enhanced hypotensive effect.

Laxative abuse - increases the risk of potassium loss.

Liquorice - excess intake may increase the risk of hypokalaemia.

4.6    Pregnancy and lactation

The teratogenic and embryotoxic potential of furosemide in humans is unknown. There is little evidence of safety of high-dose furosemide in human pregnancy, although the results of animal work, in general, show no hazardous effects.

The drug should not be used in pregnant women unless the benefits to the patient outweigh the possible risk to the foetus which includes persistence of patent ductus arteriosus (section 4.8).

Furosemide may inhibit lactation or may pass into the breast milk, it should therefore be used with caution in nursing mothers.

4.7    Effects on ability to drive and operate machinery

Reduced alertness may impair ability to drive or operate dangerous machinery.

4.8    Undesirable Effects

Very common (>1/10); common (>1/100 to <1/10); uncommon (>1/1,000 to <1/100); rare (>1/10,000 to <1/1,000); very rare (<1/10,000); Frequency not known (cannot be estimated from the available data).

Blood and lymphatic system disorders:	Uncommon:	aplastic anaemia
	Rare:	bone marrow depression (necessitates withdrawal of treatment), eosinophilia, leucopenia.
	Very rare:	haemolytic anaemia, agranulocytosis, thrombocytopenia, vasculitis.
Metabolism and nutritional disorders:	Very common:	dehydration, hyponatraemia, hypochloremic metabolic alkalosis, hypocalcaemia, hypomagnesemia (incidences of the last three are reduced by triamterene), nephrocalcinosis in infants
	Common:	Hypovolaemia, hypochloraemia
	Uncommon:	impaired glucose tolerance (by hypokalaemia) hyperuricaemia, gout, reduction of serum HDL-cholesterol, elevation of serum LDL-cholesterol, elevation of serum triglycerides, hyperglycaemia
	Very rare:	tetany
	Frequency	aggravated pre-existing metabolic

	not known:	alkalosis (in decompensated cirrhosis of the liver), fluid and electrolyte disturbances, hyperglycaemia.
Psychiatric disorder:	Rare:	psychiatric disorder NOC
Nervous system disorders:	Rare:	paraesthesia, confusion, headache, dizziness.
Eye disorders:	Uncommon:	visual disturbance, blurred vision, yellow vision.
Ear and labyrinth disorders:	Rare:	tinnitus and reversible or irreversible loss of hearing (although usually transitory, particularly in patients with renal failure, hypoproteinaemia (e.g. in nephritic syndrome)
Cardiac disorders:	Uncommon:	orthostatic intolerance, cardiac arrhythmias, increased risk or persistence of patent ductus arteriosus in premature infants.
Vascular disorders:	Very common:	decreased blood pressure, (which, if pronounced may cause signs and symptoms such as impairment of concentration and reactions, lightheadedness, sensations of pressure in the head, headache, dizziness, drowsiness, weakness, disorders of vision, dry mouth, orthostatic intolerance).
	Uncommon:	hypotension, hypovolaemia
	Rare:	vasculitis, thrombosis, shock
Gastrointestinal disorders:	Uncommon:	dry mouth, thirst, nausea, bowel motility disturbances, vomiting, diarrhoea, constipation
	Rare:	acute pancreatitis (in long-term diuretic treatment, including furosemide).
Hepatobiliary disorders:	Rare:	pure intrahepatic cholestasis (jaundice), hepatic function abnormal.
Skin and subcutaneous tissue disorders:	Rare:	rash, pruritus, photosensitivity, toxic epidermal necrolysis.
	Frequency not known:	urticaria, erythema multiforme, purpura, exfoliative dermatitis, itching,

		allergic reactions, such as skin rashes, various forms of dermatitis including urticaria, bullous lesions,. When these occur treatment should be withdrawn.
Musculoskeletal and connective tissue disorders:	Uncommon:	muscle cramps, muscle weakness.
Renal and urinary disorders:	Uncommon:	reduced diuresis, urinary incontinence, urinary obstruction (in patients with hyperplasia of the prostate, bladder inability to empty, urethral stricture unspecified).
	Rare:	nephrocalcinosis (in pre-term infants treated with Furosemide), interstitial nephritis, acute renal failure.
Congenital, familial and genetic disorders:	Rare:	patent ductus arteriosus
General disorders and administration site conditions:	Uncommon:	Fatigue
	Rare:	malaise, fever, severe anaphylactoid or anaphylactic reactions (e.g. with shock).
	Frequency not known:	hypovolaemia
Investigations:	Common:	creatinine increased, blood urea increased
	Rare:	Transaminases increased, blood

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

Symptoms include dehydration, electrolyte depletion and hypotension due to excessive diuresis. In cirrhotic patients, overdosage may precipitate hepatic coma. Treatment should be aimed at fluid replacement and correction of the electrolyte imbalance. The drug should be discontinued and electrolyte and

water replacement instituted immediately; adjustment should be on the basis of careful monitoring.

Deleted: I)

5.1 Pharmacodynamic properties

ATC code: CO3C A01

The evidence from many experimental studies suggests that furosemide acts along the entire nephron with the exception of the distal exchange site. The main effect is on the ascending limb of the loop of Henley with a complex effect on renal circulation.

Blood-flow is diverted from the juxta-medullary region to the outer cortex.

The principle renal action of furosemide is to inhibit active chloride transport in the thick ascending limb. Re-absorption of sodium chloride from the nephron is reduced and a hypotonic or isotonic urine produced.

It has been established that prostaglandin (PG) biosynthesis and the renin-angiotensin system are affected by furosemide administration and that furosemide alters the renal permeability of the glomerulus to serum proteins.

5.3 Preclinical safety data

Not applicable.

5.3 Preclinical safety data

Not required.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Lactose

Starch

Magnesium stearate Povidine

Sodium starch glycollate

6.2 Incompatibilities

Not reported

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

28/08/2012

10 DATE OF REVISION OF THE TEXT

16/04/2014